Arizona Administrative Code

Question 1

The Board shall hold not less than _______________ meetings per fiscal year to conduct general business and interview permit and license applicants.

Answer 1

4

Question 2

A special meeting of the Board may be held at any time subject to the call of the:

Answer 2

President or a majority of the Board
members and in compliance with the notification requirements

Question 3

Define

AHCCCS

Answer 3

Arizona Health Care Cost Containment
System

Question 4

Define

Approved course in pharmacy law

Answer 4

a continuing education activity that addresses practice issues related to state or federal pharmacy statutes, rules, or regulations

Question 5

Define

Automated dispensing system

Answer 5

a mechanical system in a long-term care facility that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information

Question 6

Define

Automated storage and distribution system

Answer 6

a mechanical system that performs operations or activities other
than counting, compounding, or administration, relative to the
storage, packaging, or distributing of drugs or devices and that
collects, controls, and maintains all transaction information

Question 7

Define

Contact hour

Answer 7

means 50 minutes of participation in a continuing education activity sponsored by an Approved Provider

Question 8

Define

“Continuing education unit” or “CEU”

Answer 8

means 10 contact hours of participation in a continuing education activity sponsored by an Approved Provider.

Question 9

Define

Continuous quality assurance program or “CQA program”

Answer 9

means a planned process designed by a pharmacy permittee to
identify, evaluate, and prevent medication errors.

Question 10

Define

Current good compounding practices

Answer 10

means the minimum standards for methods used in, and facilities or controls used for, compounding a drug to ensure that the drug has the identity and strength and meets the quality and purity characteristics it is represented to possess

Question 11

Define

Current good manufacturing practice

Answer 11

means the minimum standard for methods used in, and facilities or controls used for manufacturing, processing, packing, or holding a drug to ensure that the drug meets the requirements of the federal act as to safety, and has the identity and strength and meets the quality and purity characteristics it is represented to possess.

Question 12

Define

DEA

Answer 12

“Drug enforcement administration” means the drug enforcement administration of the United States department of justice or its successor agency.

Question 13

Define

Delinquent license

Answer 13

means a pharmacist, intern, or pharmacy technician license the Board suspends for failure to renew or pay all required fees on or before the date the renewal is due.

Question 14

Define

Dispensing pharmacist

Answer 14

means a pharmacist who, in the process of dispensing a prescription medication after the complete preparation of the prescription medication and before delivery of the prescription medication to a patient or patient’s agent, verifies, checks, and initials the prescription medication label

Question 15

Define

Drug sample

Answer 15

a unit of a prescription drug that a manufacturer provides free of charge to promote the sale of the drug

Question 16

Define

“Durable medical equipment” or “DME”

Answer 16

Durable medical equipment” or “DME” means technologically sophisticated medical equipment that may be used by a
patient or consumer in a home or residence. DME may be prescription-only devices as defined in A.R.S. § 32-1901. DME
includes:
Air-fluidized beds,
Apnea monitors,
Blood glucose monitors and diabetic testing strips,
Continuous Positive Airway Pressure (CPAP) machines,
Electronic and computerized wheelchairs and seating
systems,
Feeding pumps,
Home phototherapy devices,
Hospital beds,
Infusion pumps,
Medical oxygen and oxygen delivery systems excluding
compressed medical gases,
Nebulizers,
Respiratory disease management devices

Question 17

Define

“Immediate notice”

Answer 17

means a required notice sent by mail, fax,
or electronic mail to the Board Office within 24 hours

Question 18

Define

Long-term care consultant pharmacist

Answer 18

means a pharmacist providing consulting services to a long-term care facility

Question 19

Define

Long-term care facility” or “LTCF”

Answer 19

means a nursing care
institution

Question 20

Define

Low-income subsidy

Answer 20

Medicare-provided assistance
that may partially or fully cover the costs of drugs and is based
on the income of an individual and, if applicable, the
individual’s spouse.

Question 21

Define

Materials approval unit

Answer 21

means any organizational element
having the authority and responsibility to approve or reject
components, in-process materials, packaging components, and
final products.

Question 22

Define

Mediated instruction

Answer 22

means information transmitted via
intermediate mechanisms such as audio or video tape or
telephone transmission

Question 23

Define

Medical practitioner-patient relationship

Answer 23

“Medical practitioner-patient relationship” means that before
prescribing, dispensing, or administering a prescription-only
drug, prescription-only device, or controlled substance to a
person, a medical practitioner shall first conduct a physical examination of that person or have previously conducted a physical examination.
.
This subdivision does not apply to:
-A medical practitioner who provides temporary patient
supervision on behalf of the patient’s regular treating
medical practitioner;
-Emergency medical situations
- Prescriptions written to prepare a patient for a medical
examination; or Prescriptions written, prescription-only drugs,
prescription-only devices, or controlled substances issued
for use by a county or tribal public health department for
immunization programs, emergency treatment, in
response to an infectious disease investigation, public
health emergency, infectious disease outbreak or act of
bioterrorism. For purposes of this subsection,
“bioterrorism”

Question 24

Define

Medicare

Answer 24

a federal health insurance program
established under Title XVIII of the Social Security Act.

Question 25

Define

Other designated personnel

Answer 25

means a non-pharmacist
individual who is permitted in the pharmacy area, for a limited
time, under the direct supervision of a pharmacist, to perform
non-pharmacy related duties, such as trash removal, floor
maintenance, and telephone or computer repair.

Question 26

Define

Prepackaged drug

Answer 26

means a drug that is packaged in a
frequently prescribed quantity, labeled in compliance with
A.R.S. §§ 32-1967 and 32-1968, stored, and subsequently
dispensed by a pharmacist or intern under the supervision of a
pharmacist, who verifies at the time of dispensing that the drug
container is properly labeled

Question 27

Define

Red C stamp

Answer 27

means a device used with red ink to imprint an
invoice with a red letter C at least one inch high, to make an
invoice of a Schedule III through IV controlled substance

Question 28

Define

Remote drug storage area

Answer 28

means an area that is outside the
premises of the pharmacy, used for the storage of drugs,
locked to deny access by unauthorized persons, and secured
against the use of force

Question 29

Define

Shared order filling

Answer 29

“Shared order filling” means the following:
Preparing, packaging, compounding, or labeling an order,
or any combination of these functions, that are performed
by:
A person with a current Arizona Board license, located at
an Arizona pharmacy, on behalf of and at the request of
another resident or nonresident pharmacy; or
A person, located at a nonresident pharmacy, on behalf of
and at the request of an Arizona pharmacy; and
Returning the filled order to the requesting pharmacy for
delivery to the patient or patient’s care-giver or, at the
request of this pharmacy, directly delivering the filled
order to the patient

Question 30

Define

“Shared order processing”

Answer 30

Interpreting the order, performing order entry verification, drug utilization review, drug compatibility and drug
allergy review, final order verification, and when necessary, therapeutic intervention, or any combination of
these order processing functions, that are performed by:

A pharmacist or intern, under pharmacist
supervision, with a current Arizona Board license,
located at an Arizona pharmacy, on behalf of and at
the request of another resident or nonresident
pharmacy
or
A pharmacist or intern, under pharmacist
supervision, located at a nonresident pharmacy, on
behalf of and at the request of an Arizona pharmacy;
and
After order processing is completed, returning the
processed order to the requesting pharmacy for order
filling and delivery to the patient or patient’s caregiver or, at the request of this pharmacy, returning
the processed order to another pharmacy for order
filling and delivery to the patient or patient’s caregiver.

Question 31

Define

Support personnel

Answer 31

means an individual, working under the
supervision of a pharmacist, trained to perform clerical duties
associated with the practice of pharmacy, including cashiering,
bookkeeping, pricing, stocking, delivering, answering nonprofessional telephone inquiries, and documenting third-party reimbursement. Support personnel shall not perform the tasks of a pharmacist, intern, pharmacy technician, or pharmacy
technician trainee

Question 32

Define

Temporary pharmacy facility

Answer 32

means a facility established as
a result of a declared state of emergency to temporarily
provide pharmacy services within or adjacent to declared
disaster areas.

Question 33

Define

Tourist

Answer 33

means an individual who is living in Arizona but
maintains a place of habitation outside of Arizona and lives
outside of Arizona for more than six months during a calendar
year.

Question 34

Define

Transfill

Answer 34

means a manufacturing process by which one or
more compressed medical gases are transferred from a bulk
container to a properly labeled container for subsequent
distribution or supply.

Question 36

Define

Wholesale distribution

Answer 36

means distribution of a drug to a person other than a consumer or patient, but does not include:
Selling, purchasing, or trading a drug or offering to sell,
purchase, or trade a drug for emergency medical reasons.
For purposes of this Section, “emergency medical
reasons” includes transferring a prescription drug by a
community or hospital pharmacy to another community
or hospital pharmacy to alleviate a temporary shortage;
Selling, purchasing, or trading a drug, offering to sell,
purchase, or trade a drug, or dispensing a drug as
specified in a prescription;
Distributing a drug sample by a manufacturers’ or
distributors’ representative; or
Selling, purchasing, or trading blood or blood
components intended for transfusion.

Question 37

Define

Wholesale distributor

Answer 37

means any person engaged in
wholesale distribution of drugs, including: manufacturers;
repackers; own-label distributors; private-label distributors;
jobbers; brokers; warehouses, including manufacturers’ and
distributors’ warehouses, chain drug warehouses, and
wholesale drug warehouses; independent wholesale drug
traders; and retail pharmacies that conduct wholesale
distributions in the amount of at least 5% of gross sales

Question 38

What are the requirements for obtaining or reinstating a pharmacist license in Arizona, and how must a pharmacy verify a pharmacist’s licensure? General

Answer 38

ARTICLE 2. PHARMACIST LICENSURE

R4-23-201. General

A. License Requirement: To practice as a pharmacist in Arizona, a valid pharmacist license from the Board is required.

B. Licensure Methods:
1. Examination using a Board-approved method.
2. Reciprocity as per A.R.S. § 32-1922(B).

C. Reinstatement:
1. If a pharmacist with an expired Arizona license (lapsed over five years) is practicing in another jurisdiction, they must pass the MPJE or another Board-approved exam and pay all fees and penalties to reinstate their license.
2. If a pharmacist’s Arizona license lapsed over five years ago and they haven’t practiced in the last 12 months, they must meet the above requirements and also appear before the Board to prove their fitness for licensure.

D. License Verification: A pharmacy permittee or pharmacist-in-charge must verify that a pharmacist is currently licensed by the Board before allowing them to practice.

Question 39

ARTICLE 2. PHARMACIST LICENSURE: Licensure by Examination- Application

Answer 39

Application Process for Licensure by Examination

1. Application Requirements:
   
   • Submit a completed application form provided by the Board.
   • Include the specified documents and application fee.
2. Application Receipt:
   
   • The Board office records the application receipt date when the form is date-stamped.
3. Examination Registration:
   
   • Register for the NAPLEX and jurisprudence exams through NABP. NABP will issue an authorization to test once eligibility is confirmed.
4. Application Validity:
   
   • Applications are invalid 12 months after receipt. To continue, submit a new application if the original is invalid.

Question 40

What are the time frames for the administrative completeness and substantive reviews of a licensure application by examination, and what happens if an applicant fails to submit required information on time?

Answer 40

Time Frames for Licensure by Examination

1. Administrative Completeness Review:
   
   • The Board will complete this review within 60 days of receiving the application.
   • If the application is complete, the Board will issue a notice of administrative completeness.
   • If incomplete, the Board will notify the applicant of missing information. The 60-day review period is suspended until the missing information is provided.
   • If no notice is received, the application is deemed complete after 60 days.
2. Submitting Missing Information:
   
   • Applicants must submit missing information within 90 business days of receiving the notice of incompleteness.
   • If additional time is needed, a 30-day extension request must be postmarked or delivered within 90 business days.
3. Application Closure:
   
   • If an applicant does not submit a complete application within the allowed time, the file will be closed. The applicant must reapply if they wish to continue.
4. Substantive Review:
   
   • The Board will complete this review within 120 days of finishing the administrative completeness review.
   • Applications are invalid 12 months after receipt.
   • If deficiencies are found, the Board will request additional documentation. The 120-day review period is suspended until all documentation is received.
   • The review period can be extended by up to 45 days if agreed upon in writing.
5. Overall Time Frames:
   
   • Administrative Completeness Review: 60 days
   • Substantive Review: 120 days
   • Total Overall Time Frame: 180 days

Question 41

. Time frames for licensure by examination.

Overall Time Frames:
- Administrative Completeness Review:
- Substantive Review:
- Total Overall Time Frame:

Answer 41

a. Administrative completeness review time frame: 60
days.
b. Substantive review time frame: 120 days.
c. Overall time frame: 180 days.

Question 42

What are the requirements for renewing a pharmacist license, and what are the consequences if the renewal fee is not paid by the deadline?

Answer 42

License Renewal

1. Renewal Process:
   
   • Pharmacists must submit a completed renewal application form provided by the Board, along with the biennial renewal fee.
2. Late Payment:
   
   • If the renewal fee is not paid by November 1 of the renewal year, the license is suspended, and the pharmacist cannot practice. To reinstate the license, the licensee must pay a reinstatement penalty.
3. Renewal Certificate:
   
   • The renewal certificate must be maintained at the practice site for Board inspection or public review.

Question 43

Q: What is the general continuing education requirement for license renewal?

Answer 43

A: In accordance with A.R.S. § 32-1925(F), a license will not be renewed unless the licensee has completed 30 contact hours (3.0 CEUs) of continuing education from an Approved Provider in the two years preceding the renewal application.

Question 45

Special continuing education requirement. The Board
shall not renew a license unless:

Answer 45

a. Immunizations and Emergency Medications: At least 2 contact hours related to administering immunizations, vaccines, and emergency medications for licensees certified to administer them.

b. Controlled Substances: At least 3 contact hours of opioid-related, substance use disorder-related, or addiction-related continuing education for licensees authorized to dispense controlled substances.

c. Hormonal Contraceptives: At least 3 contact hours related to self-administered hormonal contraceptives for licensees who dispense them under a standing prescription order.

Question 46

Acceptance of continuing education units CEUs. The Board shall:

Answer 46

A: The guidelines are:

1. Approved Providers: CEUs must be from continuing education activities sponsored only by an Approved Provider.
2. Accrual Period: CEUs must be accrued during the two-year period immediately before licensure renewal.
3. No Carryover: CEUs from one biennial renewal period cannot be carried forward to the next period.
4. Presentation CEUs: Pharmacists who lead, instruct, or lecture at a continuing education activity sponsored by an Approved Provider can receive CEUs for their presentation, following the same attendance procedures as other participants.
5. Normal Teaching Duties: CEUs will not be accepted for normal teaching duties performed by pharmacists whose primary role is the education of health professionals.

Question 47

Continuing education records and reporting CEUs. A pharmacist shall:

Answer 47

A: The requirements are:

1. Record Maintenance:
   
   • Maintain records verifying continuing education activities participated in during the past five years.
   • Records should include a statement of credit or certificate from an Approved Provider issued at the end of each continuing education activity.
2. Renewal Attestation:
   
   • At the time of licensure renewal, attest to the number of CEUs completed during the renewal period on the biennial renewal form.
3. Proof Submission:
   
   • Submit proof of continuing education participation to the Board office within 20 days if requested.

Question 48

Intern Licensure: The prerequisite for licensure as an intern is one of the following

Answer 48

1. Current enrollment, in good standing, in an approved college or school of pharmacy;
2. Graduation from a college or school of pharmacy along
   with:
   a. Proof the applicant is certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC),
   if applicable; or
   b. Application for licensure as a pharmacist by examination or reciprocity; or
3. By order of the Board if the Board determines the applicant needs intern training.

Question 50

What should an intern licensee do if they stop attending pharmacy school classes without graduating?

Answer 50

The intern licensee must immediately stop practicing as an intern and surrender the intern license to the Board or its designee within 30 days of the last attended class, unless they petition the Board as specified in R4-23-401 and receive approval to continue working as an intern. If a student re-enters a pharmacy program and wishes to continue internship training, they must reapply for intern licensure.

Question 51

Q: What are the requirements for experiential training for interns?

Answer 51

1. Supervised Training: The preceptor must ensure that the intern’s training includes activities and services defined as the “practice of pharmacy” under A.R.S. § 32-1901.
2. Out-of-State Training: The Board may credit experiential training received outside the state if it meets or exceeds the minimum requirements of Arizona. To receive credit, the applicant must provide a certified copy of training records from:
   • The Board of Pharmacy or intern licensing agency of the jurisdiction where the training occurred, or
   • If no intern licensing agency exists, from the director of the experiential training program at the applicant’s approved pharmacy school.

Question 52

Q: What are the procedures for issuing and managing intern licenses?

Answer 52

1. Ineligibility: If an applicant is found ineligible for intern licensure, the Board office will issue a written notice of denial.
2. Eligibility: If an applicant is eligible, the Board office will issue a certificate of licensure and a wall license. The intern may start practicing once assigned a license number and granted “open” status on the Board’s license verification site, even if the certificate has not yet been received.
3. Pending Status: An applicant with a “pending” status on the Board’s license verification site must wait to practice as an intern until the Board office issues the certificate of licensure.
4. Certificate Maintenance: The licensee must keep the certificate of licensure at the practice site for inspection by the Board or its designee and for public review.

Question 53

Q: What are the renewal procedures for an intern license?/ when to renew?

Answer 53

1. Renewal Within Six Years: An intern whose license expires before completing required education or training but within six years of the initial license issuance can renew their license for a period equal to the remaining time up to six years from the original issue date. They must pay a prorated renewal fee based on the initial license fee.
2. Relicensure After Six Years: If an intern does not graduate within six years, they are ineligible for renewal unless they obtain Board approval as per A.R.S. § 32-1923(E) and R4-23-401. With Board approval, they must pay a prorated renewal fee for the approved licensure period before the license expires.
3. Suspension for Non-Payment: If an intern with Board-approved relicensure does not pay the renewal fee before the license expires, the license is suspended. The intern cannot practice until they pay a penalty to reinstate the license, as outlined in A.R.S. § 32-1925 and R4-23-205.

Question 54

What are the notification requirements for an intern regarding training and address changes?

Answer 54

1. Training Notification: An intern must notify the Board within 10 days of starting, terminating, or changing their training site if employed outside the experiential training program of an approved pharmacy college or school.
2. Address Change: An intern must notify the Board within 10 days of any change in their employment or mailing address.

Question 55

To receive credit for intern training hours, an intern shall train
in a site that:

Answer 55

1. Holds a valid Arizona pharmacy permit; or
2. Is an alternative training site. For purposes of this Section, the term alternative training site is a non-pharmacy
   training site established and monitored by an approved
   college or school of pharmacy or other non-pharmacy site
   where pharmacy-related activities are performed and
   where an intern gains experience as specified in R4-23-
   301(D).

Question 56

Intern preceptor. To be an intern preceptor, a pharmacist shall:

Answer 56

1. Hold a current unrestricted pharmacist license;
2. Have at least one year of experience as an actively practicing pharmacist; and
3. If found guilty of violating any federal or state law relating to the practice of pharmacy, drug or device distribution, or recordkeeping or unprofessional conduct, enter
   into an agreement satisfactory to the Board that places
   restrictions on the pharmacist’s license.

Question 57

Q: What are the responsibilities of a preceptor in supervising an intern?

Answer 57

A preceptor is responsible for the actions of an intern during the training period. They must provide opportunities for skill development and offer timely, realistic feedback on the intern’s progress.

Question 58

Q: What is the process and timeline for the Board office to complete an administrative completeness review of a request?

Answer 58

A: The Board office has 15 days from the date of receipt of a written request to complete the administrative completeness review and open a request file. If no deficiencies are found, the Board office will issue a written notice of administrative completeness to the applicant. If the request is incomplete, the Board office will provide a written notice detailing the missing information. The 15-day review period is suspended from the date the notice of incompleteness is served until the applicant provides the missing information. If the Board office does not issue a notice of administrative completeness within the 15-day period, the request is deemed complete 15 days after receipt by the Board office.

Question 59

Q: What should an applicant do if their request is incomplete and they cannot submit all missing information within 30 days of receiving a notice of incompleteness?

Answer 59

A: An applicant must submit all missing information within 30 days of receiving the notice of incompleteness. If the applicant cannot meet this deadline, they can request an extension by sending a written request to the Board office, post-marked or delivered within 30 days of the notice. This written request must explain why the applicant cannot meet the 30-day deadline. The Board office will review the extension request and grant it if they determine that more time will help the applicant provide the missing information. The extension can be for no more than 30 days. The Board office will notify the applicant in writing of their decision. If additional time is needed, the applicant must submit another written request for further extension.

Question 60

Q: What is the process and timeline for the Board to complete a substantive review of a request after the administrative completeness review is finished?

Answer 60

A: From the date the administrative completeness review is finished, the Board has up to 120 days to complete the substantive review of the request. During this period, the Board will either approve or deny the request or, if deficiencies are found, request additional documentation from the applicant. If the Board approves or denies the request, the Board office will issue a written notice of approval or denial. If deficiencies are identified, the Board office will send a written request to the applicant for additional documentation. The 120-day review period is suspended from the date the request for additional documentation is issued until the next Board meeting after all required documentation is received. The applicant must submit additional documentation as per the specified requirements. Additionally, if both the applicant and the Board office agree in writing, the 120-day review period may be extended once by up to 30 days.

Question 61

Q: What are the established time-frames for Board approvals and special requests under A.R.S. § 41-1072 et seq.?

Answer 61

A: The time-frames established by the Board are as follows:
1. Administrative Completeness Review Time-frame: 15 days.
2. Substantive Review Time-frame: 120 days.
3. Overall Time-frame: 135 days.

Question 62

Part 1

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 62

1. Receive, reduce to written form, and manually initial oral
   prescription orders;
2. Obtain and record the name of the individual who communicates an oral prescription order;
3. Obtain, or assume responsibility to obtain, from the
   patient, patient’s agent, or medical practitioner and
   record, or assume responsibility to record, in the patient’s
   profile, the following information:
   a. Name, address, telephone number, date of birth (or
   age), and gender;
   b. Individual history including known diseases and
   medical conditions, known drug allergies or drug
   reactions, and if available a comprehensive list of
   medications currently taken and medical devices
   currently used;

Question 63

Part 2

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 63

4. Record, or assume responsibility to record, in the
   patient’s profile, a pharmacist’s, graduate intern’s, or
   pharmacy intern’s comments relevant to the patient’s
   drug therapy, including other information specific to the
   patient or drug;
5. Verify the legality and pharmaceutical feasibility of dispensing a drug based upon:
   a. The patient’s allergies,
   b. Incompatibilities with medications the patient currently takes,
   c. The patient’s use of unusual quantities of dangerous
   drugs or narcotics,
   d. A medical practitioner’s signature, and
   e. The frequency of refills;
6. Verify that a dosage is within proper limits

Question 64

Part 3

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 64

7. Interpret the prescription order, which includes exercising
   professional judgment in determining whether to dispense a particular prescription;
8. Compound, mix, combine, or otherwise prepare and
   package the prescription medication needed to dispense
   individual prescription orders;
9. Prepackage or supervise the prepackaging of drugs by a
   pharmacy technician or pharmacy technician trainee
   under R4-23-1104. For drugs prepackaged by a pharmacy
   technician or pharmacy technician trainee, a pharmacist
   shall:
   a. Verify the drug to be prepackaged;
   b. Verify that the label meets the official compendium’s standards;
   c. Check the completed prepackaging procedure and
   product; and
   d. Manually initial the completed label; or
   e. For automated packaging systems, manually initial
   the completed label or a written log or initial a computer-stored log

Question 65

Part 4

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 65

10. Check prescription order data entry to ensure:
- a. The data is for the correct patient (name, address, telephone number, gender, date of birth or age).
- b. The data is for the correct drug (name, strength, dosage form).
- c. Prescriber’s directions are accurate (dose, dosage form, route, frequency, quantity).
- d. The medical practitioner’s details are correct (name, address, telephone number).

11. Except as in 12, make a final accuracy check of the prescription label, ensuring:
- Medication accuracy.
- Correct patient’s name.
- Consistency with the prescription order.
- Drug utilization review.
- Initial the finished label by handwriting or another approved method.

12. If using technology-assisted verification, make a final accuracy check of the label for patient’s name, consistency with the prescription order, and drug utilization review. Product verification is not required if technology-assisted verification is used.

Question 66

Part 5

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 66

13. Record, or assume responsibility to record, a prescription
    serial number and date dispensed on the original prescription order;
14. Obtain, or assume responsibility to obtain, permission to
    refill a prescription order and record, or assume responsibility to record on the original prescription order:
    a. Date dispensed,
    b. Quantity dispensed, and
    c. Name of medical practitioner or medical practitioner’s agent who communicates permission to
    refill the prescription order;
15. Reduce to written or printed form, or assume responsibility to reduce to written or printed form, a new prescription order received by:
    a. Fax,
    b. E-mail, or
    c. Other means of communication;

Question 67

Part 6

A pharmacist or a graduate intern or pharmacy intern under the
supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication
from a prescription order:

Answer 67

16. Verify, or assume responsibility to verify, that a completed prescription medication is sold only to the correct
    patient, patient’s care-giver, or authorized agent;
17. Record on the original prescription order the name or initials of the pharmacist, graduate intern, or pharmacy
    intern who originally dispenses the prescription order;
    and
18. Record on the original prescription order the name or initials of the pharmacist, graduate intern, or pharmacy
    intern who dispenses each refill

Question 68

Only a pharmacist, graduate intern, or pharmacy intern shall
provide oral consultation about a prescription medication to a
patient or patient’s care-giver in an outpatient setting, including a patient discharged from a hospital. The oral consultation
is required whenever the following occurs:

Answer 68

A: Oral consultation by a pharmacist, graduate intern, or pharmacy intern is required when:

1. The medication has not been previously dispensed to the patient in the same strength, dosage form, or directions.
2. The pharmacist deems it necessary through professional judgment.
3. The patient or their caregiver requests it.

Question 69

Oral consultation shall include

Answer 69

1. Reviewing the name and strength of a prescription medication or name of a prescription-only device and the
   labeled indication of use for the prescription medication
   or prescription-only device;
2. Reviewing the prescription’s directions for use;
3. Reviewing the route of administration; and
4. Providing oral information regarding special instructions
   and written information regarding side effects, procedure
   for missed doses, or storage requirements

Question 70

When, in the professional judgment of the pharmacist or graduate intern or pharmacy intern under the supervision of a pharmacist, or when circumstance precludes it, oral consultation may be omitted if the pharmacist, graduate intern, or pharmacy intern:

Answer 70

1. Personally provides written information to the patient or
   patient’s care-giver that summarizes the information that
   would normally be orally communicated;
2. Documents, or assumes responsibility to document, both
   the circumstance and reason for not providing oral consultation by a method approved by the Board or its designee; and
3. Offers the patient or patient’s care-giver the opportunity
   to communicate with a pharmacist, graduate intern, or
   pharmacy intern at a later time and provides a method for the patient or patient’s care-giver to contact a pharmacist,
   graduate intern, or pharmacy intern at the pharmacy.

Question 71

The pharmacist or graduate intern or pharmacy intern under
the supervision of a pharmacist, through the exercise of professional judgment, may provide oral consultation that
includes:

Answer 71

1. Common severe adverse effects, interactions, or therapeutic contraindications, and the action required if they
   occur;
2. Techniques of self-monitoring drug therapy;
3. The duration of the drug therapy; and
4. Prescription refill information.

Question 72

Oral consultation documentation. When oral consultation is
required as specified in subsection (B), a pharmacist, graduate
intern, or pharmacy intern shall:

Answer 72

Q: What documentation is required related to oral consultation?

A: Documentation is required to:

1. Record that oral consultation was provided.
2. Document if oral consultation was not provided due to patient refusal or if someone other than the patient or caregiver picked up the prescription.
3. Note the circumstances and reasons for omitting oral consultation if decided under subsection (D).
4. Include the name, initials, or ID of the pharmacist, graduate intern, or pharmacy intern involved.

Question 73

When a prescription is delivered to the patient or patient’s
care-giver outside the immediate area of a pharmacy and a
pharmacist is not present, the prescription shall be accompanied by written or printed patient medication information that, in addition to the requirements in subsection (C), includes:

Answer 73

1. Approved use for the prescription medication;
2. Possible adverse reactions;
3. Drug-drug, food-drug, or disease-drug interactions;
4. Missed dose information; and
5. Telephone number of the dispensing pharmacy or another
   method approved by the Board or its designee that allows
   a patient or patient’s care-giver to consult with a pharmacist

Question 74

Q: Is a prescription medication or prescription-only device exempt from certain requirements when delivered to a patient at a location with a licensed health care professional responsible for its administration?

Answer 74

A: Yes, a prescription medication or prescription-only device delivered to a patient at a location where a licensed health care professional is responsible for administering it is exempt from the requirements of subsection (C).

Question 76

Q: What are the prohibitions related to rebates and payments for pharmacists and pharmacy permittees?

Answer 76

1. General Prohibition: Pharmacists and pharmacy permittees must not offer, deliver, receive, or accept any unearned rebate, refund, commission, preference, patronage dividend, discount, or other unearned consideration (money or otherwise) as compensation or inducement to refer a patient, client, or customer, except for a rebate or premium paid directly and completely to the patient.
2. Payments to Medical Practitioners: Payment in money or other consideration for a prescription order prescribed by a medical practitioner is prohibited.
3. Payments to Health Care Institutions: Payment to long-term care, assisted living facilities, or other health care institutions in money, discount, rental, or other consideration above the prevailing rate is prohibited for:
   • Prescription medication or devices dispensed or sold for patients or residents.
   • Drug selection, drug utilization review services, drug therapy management services, or other pharmacy consultation services provided for patients or residents.

Question 77

Prescription order-blank advertising prohibited. A pharmacist
or pharmacy permittee shall not:

Answer 77

1. Directly or indirectly furnish to a medical practitioner a
   prescription order-blank that refers to a specific pharmacist or pharmacy in any manner; or
2. Actively or passively participate in any arrangement or
   agreement where a prescription order-blank is prepared,
   written, or issued in a manner that refers to a specific
   pharmacist or pharmacy

Question 78

Fraudulent claim for a fee. A pharmacist or pharmacy permittee:

Answer 78

1. Shall not claim a fee for a service that is not performed or
   earned;
2. May divide a prescription order into two or more portions
   of prescription medication at the request of a patient, or
   for some other ethical reason, and charge a dispensing fee
   for the additional service; and
3. Shall not divide a prescription order merely to obtain an
   additional fee.

Question 79

Prohibiting a prescription-only drug or device from being dispensed over the counter. A pharmacist shall ensure that:

Answer 79

1. A prescription-only drug or device is dispensed only after
   receipt of a valid prescription order from a licensed medical practitioner;
2. The dispensed prescription-only drug or device is properly prepared, packaged, and labeled

Question 80

What are the rules for dispensing drugs based on internet-based prescriptions?What are the rules for dispensing drugs based on internet-based prescriptions?

Answer 80

1. Internet-Based Prescriptions: A pharmacist must not dispense a drug if they know, or reasonably should know, that the prescription was issued based on an internet-based questionnaire or consultation without a medical practitioner-patient relationship.
2. Unethical Conduct: Dispensing a prescription-only drug, prescription-only device, or controlled substance in violation of this rule is considered unethical conduct under A.R.S. § 32-1901.01.

Question 81

Prescription orders. A pharmacist shall ensure that:
1. A prescription order the pharmacist uses to dispense a
drug or device includes the following information:

Answer 81

a. Date of issuance;
b. Name and address of the patient for whom or the
owner of the animal for which the drug or device is
dispensed;
c. Drug name, strength, and dosage form or device
name;
d. Name of the manufacturer or distributor of the drug
or device if the prescription order is written generically or a substitution is made;
e. Prescribing medical practitioner’s directions for use;
f. Date of dispensing;
g. Quantity prescribed and if different, quantity dispensed;
h. For a prescription order for a controlled substance,
the medical practitioner’s address and DEA number;
i. For a written prescription order, the medical practitioner’s signature;
j. For an electronically transmitted prescription order,
the medical practitioner’s digital or electronic signature;
k. For an oral prescription order, the medical practitioner’s name and telephone number; and
l. Name or initials of the dispensing pharmacist;

Question 82

Q: How long must a pharmacist or pharmacy permittee keep a prescription order record?

Answer 82

A: A pharmacist or pharmacy permittee must keep a prescription order record for seven years from the date the drug or device is dispensed.

Question 83

Q: What are the labeling and packaging requirements for schedule II controlled substances that are opioids?

Answer 83

A: Schedule II controlled substances that are opioids must be placed in a container with a red cap and a warning label stating “CAUTION: OPIOID, Risk of Overdose and Addiction” or similar language indicating the risk of overdose and addiction. However, the Executive Director, under delegation from the Board, may waive the red-cap requirement if it is not feasible due to the specific dosage form or packaging type.

Question 84

Prescription refills. A pharmacist shall ensure that the following information is recorded on the back of a prescription order
when it is refilled:

Answer 84

1. Date refilled,
2. Quantity dispensed,
3. Name or approved abbreviation of the manufacturer or
   distributor if the prescription order is written generically
   or a substitution is made, and
4. The name or initials of the dispensing pharmacist.

Question 85

Prescription order adaptation. Except for a prescription order
for a controlled substance, a pharmacist, using professional
judgment, may make the following adaptations to a prescription order if the pharmacist documents the adaptation in the
patient’s record:

Answer 85

1. Change the prescribed quantity if the prescribed quantity
   is not a package size commercially available from the
   manufacturer;
2. Change the prescribed dosage form or directions for use
   if the change achieves the intent of the prescribing medical practitioner;
3. Complete missing information on the prescription order if
   there is sufficient evidence to support the change; and
4. Extend the quantity of a maintenance drug for the limited
   quantity necessary to achieve medication refill synchronization for the patient.

Question 86

Q: Can a pharmacist provide a copy of a prescription order to a patient or their authorized representative, and what are the conditions?

Answer 86

Yes, a pharmacist may provide a copy of a prescription order to the patient or their authorized representative, provided the copy is clearly marked “COPY FOR REFERENCE PURPOSES ONLY” or a similar statement. However, this copy is not a valid prescription order, and the pharmacist must not dispense a drug or device based on the information on the copy.

Question 87

Transfer of prescription order information. For a transfer of
prescription order information to be valid, a pharmacy permittee or pharmacist-in-charge shall ensure that:

Answer 87

1. Both the original and the transferred prescription order
   are maintained for seven years after the last dispensing
   date;
2. The original prescription order information for a Schedule III, IV, or V controlled substance is transferred only as
   specified in 21 CFR 1306.25
3. The original prescription order information for a noncontrolled substance drug is transferred without limitation only up to the number of originally authorized refills;
4. For a transfer within Arizona:
   a. The transfer of original prescription order information for a non-controlled substance drug meets the
   following conditions…in next slide :)

Question 88

For a transfer within Arizona:
a. The transfer of original prescription order information for a non-controlled substance drug meets the
following conditions:

Answer 88

Question 89

The transfer of original prescription order information for a Schedule III, IV, or V controlled substance
meets the following conditions

Answer 89

i. The transfer of information is communicated directly between two licensed pharmacists or interns electronically or verbally;
ii. The following information is recorded by the transferring pharmacist or intern:
(1) The word “void” is written on the face of the invalidated original prescription order unless it is an electronic or oral transfer and the transferred prescription order information is invalidated in the transferring pharmacy’s computer system;
and
(2) The name, address, and DEA number of the pharmacy to which the prescription is transferred, the name of the receiving pharmacist, the date of transfer, and the name of the transferring pharmacist is written on the back of the prescription order or entered into the transferring
pharmacy’s computer system; and
iii. The following information is recorded by the
receiving pharmacist on the transferred prescription order:
(1) The word “transfer;”
(2) Date of issuance of original prescription order;
(3) Original number of refills authorized on the original prescription order;
(4) Date of original dispensing;
(5) Number of valid refills remaining and the date of the last refill;
(6) Name, address, DEA number, and original prescription number of the pharmacy from which the prescription is transferred;
(7) Name of the transferring pharmacist; and
(8) Name of the receiving pharmacist

Question 90

Q: What are the conditions for the electronic transfer of original prescription order information?

Answer 90

A: The electronic transfer of original prescription order information must meet the following conditions:

1. Same Company: The transfer is between pharmacies owned by the same company using a common or shared database.
2. Non-Controlled Substances: For non-controlled substances, the transfer can be performed by a pharmacist, intern, pharmacy technician trainee, or pharmacy technician under the supervision of a pharmacist.
3. Controlled Substances: For controlled substances, the transfer must be performed between two licensed pharmacists.
4. The electronic transfer of original prescription order
   information for a non-controlled substance drug
   meets the following conditions: …in next slide!

Question 91

The electronic transfer of original prescription order
information for a non-controlled substance drug
meets the following conditions:

Answer 91

i. The transferring pharmacy’s computer system:
(1) Invalidates the transferred original prescription order information;
(2) Records the identification code, number, or address of the pharmacy to which the prescription order information is
transferred;
(3) Records the name or identification code of the receiving pharmacist, intern, pharmacy technician trainee, or pharmacy
technician; and
(4) Records the date of transfer; and
.
ii. The receiving pharmacy’s computer system;
(1) Records that a prescription transfer occurred;
(2) Records the date of issuance of the original prescription order;
(3) Records the original number of refills authorized on the original prescription order;
(4) Records the date of original dispensing;
(5) Records the number of valid refills remaining and the date of the last refill;
(6) Records the identification code, number, or address and original prescription number of the pharmacy from which the
prescription is transferred;
(7) Records the name or identification code of the receiving pharmacist or intern, pharmacy technician trainee, or pharmacy
technician; and
(8) Records the date of transfer;

Question 92

The electronic transfer of original prescription order
information for a controlled substance meets the following conditions:

Answer 92

The transferring pharmacy’s computer system:
(1) Invalidates the transferred original prescription order information;
(2) Records the identification code, number, or address, and DEA number of the pharmacy to which the prescription order
information is transferred;
(3) Records the name or identification code of the receiving pharmacist;
(4) Records the date of transfer; and
(5) Records the name or identification code of the transferring pharmacist

Question 94

Q: What are the conditions for transmitting a prescription order by fax from a medical practitioner to a pharmacy?

Answer 94

A: The faxing of a prescription order is allowed under these conditions:

1. Destination: The prescription is faxed only to the pharmacy of the patient’s choice.
2. Content Requirements:
   
   • It must include all required information as per A.R.S. §§ 32-1968 and 36-2525.
   • It should only be faxed from the medical practitioner’s practice location, except for cases where a nurse at a hospital, long-term care facility, or inpatient hospice sends it for a patient at the facility.
3. Additional Information Required:
   
   • The date the prescription is faxed.
   • The fax number of the prescribing medical practitioner or facility, and the facility’s telephone number.
   • The name of the person transmitting the fax if not the medical practitioner.

Question 95

Q: What are the requirements for the electronic transmission of a prescription order from a medical practitioner to a pharmacy?

Answer 95

1. General Transmission: A medical practitioner or their agent may transmit a prescription order electronically, directly or through an intermediary (e.g., E-prescribing network), unless prohibited by law.
2. Controlled Substances: For Schedule II, III, IV, or V controlled substances, both the medical practitioner and pharmacy must ensure compliance with federal security requirements.
3. Privacy Compliance: All electronic transmissions must comply with state and federal laws related to the privacy of protected health information.
4. Additional Information Required:
   
   • The date of transmission.
   • The name of the medical practitioner’s authorized agent if they transmit the prescription order.
5. Pharmacy Responsibilities: The pharmacy must maintain the electronic prescription order as specified by A.R.S. § 32-1964 or R4-23-408(H)(2).
6. Pharmacy Choice: The electronic prescription order must be transmitted only to the pharmacy of the patient’s choice.

Question 96

Exceptions under A.R.S. § 36-2525 regarding electronic prescribing requirements:

Answer 96

1. Medical Practitioner Exceptions: A medical practitioner authorized to prescribe controlled substances may use a written prescription order instead of an electronic one in the following cases:
- Out-of-State: The prescription is written in this state but intended to be filled outside the state.
- Compounding: The medication requires compounding two or more ingredients.
- Not in Database: The medication is not in the E-prescribing database.
- In Custody: The individual is detained by or in custody of an Arizona or federal law enforcement agency.

2. Pharmacist Exceptions: A pharmacist may dispense a controlled substance from a written prescription if:
- Out-of-State Practitioner: The prescription is from a medical practitioner not licensed in this state.
- Compounding: The medication requires compounding two or more ingredients.
- Not in Database: The medication is not in the E-prescribing database.
- In Custody: The individual is detained by or in custody of an Arizona or federal law enforcement agency.

Question 97

Dispensing an Opioid Antagonist

Community member

Answer 97

“Community member” means any person in position to assist an individual at risk of experiencing an opioidrelated overdose. This includes emergency first responders, peace officers or other law enforcement personnel, fire department personnel, school district employees, and personnel of a facility or center that provides services to individuals at risk of experiencing an opioid-related overdose

Question 98

Dispensing an Opioid Antagonist

Opioid antagonist

Answer 98

“Opioid antagonist” means any drug approved by the
U.S. Food and Drug Administration that binds to opioid
receptors, effectively blocking or inhibiting the receptor
and preventing the body from responding to the opioid.
Naloxone hydrochloride is an opioid antagonist.

Question 99

Dispensing an Opioid Antagonist

Opioid-related overdose

Answer 99

means an acute condition
caused by excessive opioids. An opioid-related overdose
can be identified by a triad of symptoms: decreased level
of consciousness, pinpoint pupils, and respiratory depression. Other symptoms may include seizures, muscle spasms, and coma or death. An opioid-related overdose requires medical assistance

Question 100

When dispensing an opioid antagonist under A.R.S. § 32-
1979, a pharmacist or pharmacy intern shall provide the following education to the individual to whom the opioid antagonist is dispensed

Answer 100

1. How to prevent an opioid-related overdose;
2. How to recognize an opioid-related overdose;
3. How to administer an opioid antagonist safely to an individual experiencing an opioid-related overdose;
4. Precautions regarding: a. Potential side effects, and b. Possible adverse events associated with administration of the opioid antagonist; and
5. Importance of seeking emergency medical assistance for
   the individual experiencing an opioid-related overdose
   before or after administering the opioid antagonist.

Question 101

Before dispensing an opioid antagonist under A.R.S. § 32-
1979(A), a licensed pharmacist shall complete an opioid prevention and treatment training program that includes the following information:

Answer 101

1. How to recognize the symptoms of an opioid-related
   overdose,
2. How to respond to a suspected opioid-related overdose,
3. How to administer all preparations of an opioid antagonist, and
4. The information needed by an individual to whom an opioid antagonist is dispensed.

Question 102

A pharmacist who has completed an opioid prevention and
treatment training program may . . .

Answer 102

1. May administer an opioid antagonist to an individual the
   pharmacist believes is experiencing an opioid-related overdose, and
2. Is exempt from civil liability under the terms of A.R.S. §
   36-2267(B)

Question 103

Dispensing a Self-administered Hormonal Contraceptive

Standard procedures. The first time a pharmacist dispenses a
self-administered hormonal contraceptive under a standing
prescription order, as authorized under A.R.S. § 32-1979.01, to
a patient, the pharmacist shall:

Answer 103

1. Determine the patient is at least 18 years old;
2. Obtain from the patient a completed self-screening risk
   assessment based on nationally recognized guidelines;
3. Provide the patient with written information prepared by
   the manufacturer of the hormonal contraceptive; and
4. Provide the following information orally to the patient:
   a. How hormonal contraception works;
   b. When and how to take the self-administered hormonal contraceptive;
   c. Risks associated with taking a self-administered hormonal contraceptive; and
   d. When to seek medical assistance while taking a selfadministered hormonal contraceptive.

Question 104

Q: What is required of a pharmacist who dispenses a self-administered hormonal contraceptive under a standing prescription order?

Answer 104

A: The pharmacist must have the patient complete a self-screening risk assessment based on nationally recognized guidelines annually.

Question 105

Q: What documentation must a pharmacist maintain when dispensing a self-administered hormonal contraceptive under a standing prescription order?

Answer 105

A: The pharmacist must maintain evidence of the patient’s age at the time of initial dispensing and the completed nationally recognized self-screening risk assessment for at least seven years. This information must be readily retrievable and available to the Board upon request.

Question 107

Q: What continuing education requirement must a pharmacist fulfill during each biennial renewal period if they dispense self-administered hormonal contraceptives under a standing prescription order?

Answer 107

A: The pharmacist must complete three contact hours of continuing education during each biennial renewal period.

Question 108

Q: What are the requirements for a pharmacy permittee or pharmacist-in-charge regarding computer system policies and procedures?

Answer 108

1. Develop and Implement Policies: The pharmacy permittee or pharmacist-in-charge must:
   
   • Create and follow policies for output documentation, system interruptions, backup procedures, audit procedures, and data entry validation.
2. Biennial Review: Review and, if necessary, revise these policies every two years.
3. Document Review: Document the biennial review.
4. Written Manual: Assemble the policies into a written manual or another Board-approved method.
5. Accessibility: Ensure the manual is available within the pharmacy for reference by staff and inspection by the Board or its designee.

Question 109

Q: What are the requirements for a pharmacy permittee or pharmacist-in-charge regarding computer system data storage and retrieval?

Answer 109

1. Sight-Readable Information: The computer system must be capable of producing sight-readable information on all original and refill prescription orders and patient profiles.
2. Online Retrieval of Prescription Information: The system must provide online retrieval (via CRT display or hard-copy printout) of original prescription order information as required by A.R.S. § 32-1968(C), R4-23-402(A), and R4-23-407(A).
3. Online Retrieval of Patient Profiles: The system must provide online retrieval (via CRT display or hard-copy printout) of patient profile information as required by R4-23-402(A).
4. Documentation of Dispensing Pharmacist: The system must provide documentation identifying the pharmacist responsible for dispensing each original or refill prescription order. If the system in use before the effective date of this section cannot provide this documentation, manual documentation identifying the dispensing pharmacist is acceptable.
5. Printout of Prescription Order Information: The system must produce a printout of all prescription order information, including a single-drug usage report containing:
   
   • The name of the prescribing medical practitioner.
   • The name and address of the patient.
   • The quantity dispensed on each original or refill prescription order.
   • The date of dispensing for each original or refill prescription order.
   • The name or identification code of the dispensing pharmacist.
   • The serial number of each prescription order.
6. Printout of Requested Information: The system must provide a printout of requested prescription order information to an individual pharmacy within 72 hours of the request if the information is maintained in a centralized computer record system.

Question 110

A pharmacy permittee or pharmacist-in-charge of a pharmacy
that uses a pharmacy computer system:

Answer 110

1. Notification: The pharmacy must notify the D.E.A. and the Board in writing that original and refill prescription order information and patient profiles are stored in the pharmacy computer system.
2. Compliance: The pharmacy must comply with the requirements of this section if the computer system’s refill records are used as an alternative to the manual refill records required in R4-23-407(B).
3. Exemption: The pharmacy is exempt from the manual refill recordkeeping requirements of R4-23-407(B) if the computer system complies with the requirements of this section.
4. Accuracy Documentation: The pharmacy must ensure that documentation of the accuracy of original and refill prescription order information entered into the computer system is provided by each pharmacist and kept on file for seven years from the date of the last refill. Documentation options include:
   • Hard-Copy Printout:
     
     • States that original and refill data for prescriptions dispensed by each pharmacist is reviewed for accuracy.
     • Includes the printed name of each dispensing pharmacist.
     • Signed and initialed by each dispensing pharmacist.
   • Log Book or Separate File:
     
     • States that original and refill data for prescriptions dispensed by each pharmacist is reviewed for accuracy.
     • Includes the printed name of each dispensing pharmacist.
     • Signed and initialed by each dispensing pharmacist.

Question 111

Q: What actions must a pharmacy permittee or pharmacist-in-charge take if the pharmacy computer system does not comply with the requirements of subsections (A), (B), and (F)?

Answer 111

1. Compliance Deadline: The pharmacy permittee or pharmacist-in-charge must bring the computer system into compliance within three months of receiving a notice of noncompliance or violation letter.
2. Manual Recordkeeping: If the computer system remains noncompliant with subsections (A), (B), or (F) after the three-month period, the pharmacy permittee or pharmacist-in-charge must immediately revert to the manual recordkeeping requirements of R4-23-402 and R4-23-407.

Question 112

Security. To maintain the confidentiality of patient records, a
pharmacy permittee or pharmacist-in-charge shall ensure:

Answer 112

1. The computer system has security and systems safeguards designed to prevent and detect unauthorized
   access, modification, or manipulation of prescription
   order information and patient profiles; and
2. After a prescription order is dispensed, any alteration of
   prescription order information is documented, including
   the identification of the pharmacist responsible for the
   alteration

Question 113

Q: What are the requirements for using an electronic imaging recordkeeping system for prescription records instead of filing original hard-copy prescriptions?

Answer 113

1. System Capabilities: The electronic imaging recordkeeping system must:
   
   • Capture, store, and reproduce the exact image of a prescription order, including the reverse side if necessary.
   • Ensure that any notes of clarification or alterations are directly associated with the electronic image of the prescription order.
2. Retention Period: The system must retain the prescription order image and any associated notes for at least seven years from the date the prescription was last dispensed.
3. Policies and Procedures: Develop, implement, review, and revise policies and procedures for the electronic imaging system as described in subsection (A).
4. Controlled Substances: The prescription cannot be for a controlled substance.

Question 114

A pharmacy permittee or pharmacist-in-charge shall make all
prescription records available within ________ after a Board
request.

Answer 114

72 hours

Question 115

R4-23-409. Returning Drugs and Devices

Q: Under what conditions can a pharmacist or pharmacy permittee accept a returned drug or device for resale or reuse?

Answer 115

1. Drugs:
   
   • General Rule:
     
     • The drug must be in its original, unopened container.
     • The drug or its container must not show signs of contamination or deterioration.
   • Exceptions:
     
     • Hospital Inpatients: Drugs dispensed to hospital inpatients are exempt.
     • Long-Term Care Facility Residents: Drugs dispensed to residents of a long-term care facility where a licensed healthcare professional administers the drug, provided:
       
       • The drug has been stored in compliance with official compendium requirements.
       • The drug is not visibly contaminated or deteriorated.
2. Devices:
   
   • The device must:
     
     • Be inspected and free of defects.
     • Be rendered incapable of transferring disease.
     • Not be claimed as new or unused if resold or reused.

Question 116

R4-23-410. Current Good Compounding Practices

Q: What are the requirements for compounding pharmaceutical products in a pharmacy?

Answer 116

1. Substance Quality and Source:
   
   • Quality Standards:
     
     • Substances must meet official compendium requirements.
     • Must be of high quality (e.g., Chemically Pure (CP), Analytical Reagent (AR), ACS certified, or Food Chemical Codex (FCC) grade).
     • Alternatively, substances must come from a source deemed acceptable and reliable by the pharmacist.
2. Compounding in Anticipation:
   
   • Before compounding a pharmaceutical product in large quantities, the pharmacist must have a history of compounding valid prescriptions for that product.
3. Distribution of Compounded Products:
   
   • General Rule: Compounded products cannot be provided to other pharmacies, medical practitioners, or persons for dispensing or distribution.
   • Exception: Products may be provided to a medical practitioner for patient administration if:
     
     • Each container includes a written list and a label with:
       
       • Pharmacy’s name, address, and phone number.
       • Product name and required information.
       • Lot or control number.
       • Beyond-use date (based on the pharmacist’s judgment, up to the maximum recommended in the compendium).
       • “Not For Dispensing” and “For Office or Hospital Administration Only” statements.
4. Advertising Compounding Services:
   
   • Pharmacies and pharmacists are allowed to advertise or promote their prescription compounding services.

Question 117

R4-23-410. Current Good Compounding Practices

A pharmacy permittee shall ensure compliance with the organization, training, and personnel issues in this subsection.
1. Before dispensing a compounded pharmaceutical product, a pharmacist:

Answer 117

a. Inspects and approves or rejects, or assumes responsibility for inspecting and approving or rejecting,
components, pharmaceutical product containers and
closures, in-process materials, and labeling;
b. Prepares or assumes responsibility for preparing all
compounding records;
c. Reviews all compounding records to ensure that no
errors occur in the compounding process;
d. Ensures the proper use, cleanliness, and maintenance of all compounding equipment; and
e. Documents by hand-written initials or signature in
the compounding record the completion of the
requirements of subsections

Question 118

You GOT this! :)

Question 119

Q: What are the responsibilities of a pharmacist engaged in compounding?

Answer 119

a. Compliance:
- Adheres to current good compounding practices and applicable state pharmacy laws.

b. Proficiency:
- Maintains compounding skills through ongoing awareness, training, and continuing education.

c. Personnel Requirements:
- Ensures that compounding personnel wear:
- Clean Clothing: Appropriate for the work performed.
- Protective Apparel: Such as coats, aprons, gowns, gloves, or masks to protect against chemical exposure and prevent contamination of pharmaceutical products.

Question 120

A pharmacy permittee shall ensure the security, safety, and
quality of a compounded pharmaceutical product by conforming with the following standards:

Answer 120

1. Implement procedures to exclude from direct contact
   with components, pharmaceutical product containers and
   closures, in-process materials, labeling, and pharmaceutical products, any person with an apparent illness or open
   lesion that may adversely affect the safety or quality of a
   compounded pharmaceutical product, until the illness or
   lesion, as determined by competent medical personnel,
   does not jeopardize the safety or quality of a compounded
   pharmaceutical product; and
2. Require all personnel to inform a pharmacist of any
   health condition that may adversely affect a compounded
   pharmaceutical product.

Question 121

Q: What are the requirements for equipment and utensils used in pharmaceutical product compounding to ensure safety and quality?

Answer 121

1. Design and Location:
   
   • Equipment and utensils must be appropriately designed, adequately sized, and suitably located for proper operation, cleaning, and maintenance.
2. Material:
   
   • They should be made of materials that are non-reactive, non-additive, and non-absorptive when exposed to components, in-process materials, or pharmaceutical products.
3. Cleaning:
   
   • Equipment and utensils must be cleaned and protected from contamination before use.
4. Inspection:
   
   • They should be inspected and determined suitable for use before starting compounding operations.
5. Routine Checks:
   
   • Equipment and utensils must be routinely inspected, calibrated, or checked to ensure proper performance.

Question 122

Q: What procedures must a pharmacy permittee ensure to prevent cross-contamination in compounding?

Answer 122

1. Procedures for Cross-Contamination Prevention:
   
   • The pharmacist-in-charge must establish, implement, and comply with procedures to prevent cross-contamination, especially when compounding products requiring special precautions (e.g., penicillin).
2. Options for Preventing Cross-Contamination:
   
   • Dedication of Equipment: Use dedicated equipment solely for certain pharmaceutical products.
   • Meticulous Cleaning: Thoroughly clean equipment that has been contaminated before using it for compounding other products.

Question 123

A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with control procedures for components and pharmaceutical product containers and closures, either written or electronically stored
with printable documentation, that conform with the standards
in this subsection

Answer 123

1. Components and pharmaceutical product containers and
   closures are:
   a. Stored off the floor,
   b. Handled and stored to prevent contamination, and
   c. Rotated so the oldest approved stock is used first.
2. Container closure systems comply with official compendium standards.
3. Pharmaceutical product containers and closures are clean
   and made of material that is not reactive, additive, or
   absorptive.

Question 124

Q: What must a pharmacy permittee ensure regarding compounding controls and procedures?

Answer 124

1. Compounding Procedures Availability:
   
   • Procedures must be available in written or electronic form with printable documentation.
2. Content of Procedures:
   
   • Description of Each Pharmaceutical Product:
     
     • Components: Manufacturer, lot number, expiration date, amounts, order of addition, and compounding process.
     • Equipment and utensils used.
     • Container and closure system appropriate for the product’s sterility and stability.
   • Testing and Validation:
     
     • Monitor and Validate:
       
       • Dosage form weight variation.
       • Adequacy of mixing for uniformity and homogeneity.
       • Clarity, completeness, and pH of solutions (if applicable).

Question 125

Components for pharmaceutical product compounding
are accurately weighed, measured, or subdivided. To
ensure that each weight, measure, or subdivision is correct as stated in the compounding procedures, a pharmacist:

Answer 125

a. Checks and rechecks, or assumes responsibility for
checking and re-checking, the operations at each
stage of the compounding process; and
b. Documents by hand-written initials or signature the
completion and accuracy of the compounding process.

Question 126

When a component is removed from its original container
and transferred to another container, the new container
label contains, in full text or an abbreviated code system,
the following:

Answer 126

a. The component name,
b. The manufacturer’s or supplier’s name,
c. The lot or control number,
d. The weight or measure,
e. The beyond-use-date
f. The transfer date

Question 127

Q: What additional labeling requirements must be included for a compounded pharmaceutical product beyond A.R.S. § 32-1968(D)?

Answer 127

1. Identification:
   
   • A statement, symbol, designation, or abbreviation indicating that the pharmaceutical product is compounded.
2. Beyond-Use-Date:
   
   • A clearly specified beyond-use-date as outlined in the relevant subsection.

Question 128

A pharmacy permittee shall ensure that the pharmacist-incharge stores any quantity of compounded pharmaceutical
product produced in excess of the quantity dispensed in accordance with subsection (B):

Answer 128

1. In an appropriate container with a label that contains:
   a. A complete list of components or the pharmaceutical
   product’s name;
   b. The preparation date;
   c. The assigned lot or control number; and
   d. A beyond-use-date
2. Under conditions, dictated by the pharmaceutical product’s composition and stability characteristics, that ensure
   its strength, quality, and purity.

Question 129

A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with recordkeeping procedures that comply with this subsection:

Answer 129

1. Pharmaceutical product compounding procedures and
   other records required by this Section are maintained by
   the pharmacy for not less than seven years, and
2. Pharmaceutical product compounding procedures and
   other records required by this Section are readily available for inspection by the Board or its designee.

Question 130

R4-23-411. Pharmacist or Intern-administered Immunizations

Q: Under what conditions can a pharmacist or intern administer immunizations, vaccines, and emergency medications to eligible adult and minor patients?

Answer 130

1. Eligibility:
   
   • Eligible Adult Patient: 13 years of age or older.
   • Eligible Minor Patient: At least 3 years of age but less than 13 years old.
2. For Eligible Adult Patients:
   
   • The immunization or vaccine must be:
     
     • Recommended for adults by the U.S. Centers for Disease Control and Prevention (CDC).
     • Recommended by the CDC’s Health Information for International Travel.
   • The immunization or vaccine must not be on the Arizona Department of Health Services
3. For Eligible Minor Patients:
   
   • Immunizations or vaccines can be administered for:
     
     • Influenza or a booster dose
     • Other immunizations or vaccines only in response to a public health emergency declared by the Governor
4. Administration Without Prescription:
   
   • Immunizations, vaccines, and emergency medications can be administered without a prescription under these conditions.

Question 131

R4-23-411. Pharmacist or Intern-administered Immunizations

A pharmacist or intern who is authorized to administer immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient shall:

Answer 131

1. Not delegate the authority to any other pharmacist, intern,
   or employee not specifically authorized by rule; and
2. Maintain their current certificate for inspection by the
   Board or its designee or review by the public.

Question 132

Q: What are the qualifications required for a pharmacist or intern to administer immunizations, vaccines, and emergency medications to eligible patients?

Answer 132

1. Current License:
   
   • The pharmacist or intern must have a current license to practice pharmacy in this state.
2. Training Program:
   
   • The pharmacist or intern must successfully complete a training program specified in subsection (E).
3. Certification:
   
   • The pharmacist or intern must have a current certificate in basic cardiopulmonary resuscitation (CPR).

Note: Authorization to administer these medications is granted by the Board upon receipt of a completed application form.

Question 133

Q: What are the training program requirements for pharmacists or interns to administer immunizations, vaccines, and emergency medications?

Answer 133

A: The training program must include the following courses of study:

1. Basic Immunology:
   
   • Understanding the human immune response.
2. Vaccine Information:
   
   • Mechanics of immunity, adverse effects, dosage, and administration schedule of available vaccines.
3. Emergency Response:
   
   • Handling emergency situations resulting from the administration of immunizations, vaccines, or medications, including administering emergency medications to counteract adverse effects.
4. Intramuscular Injections:
   
   • Techniques for administering intramuscular injections.
5. Other Administration Methods:
   
   • Various methods of immunization administration.
6. Recordkeeping and Reporting:
   
   • Requirements for proper documentation and reporting as specified in subsection (F).

Question 134

A pharmacist or intern authorized under this Section to
administer immunizations, vaccines, and emergency
medications to an eligible patient shall provide to the
pharmacy the following information and documentation
regarding each immunization, vaccine, or emergency
medication administered:

Answer 134

a. The name, address, and date of birth of the patient;
b. The date of administration and site of injection;
c. The name, dose, manufacturer’s lot number, and expiration date of the vaccine, immunization, or emergency medication;
d. The name and address of the patient’s identified primary-care provider or physician;
e. The name of the pharmacist or intern administering the immunization, vaccine, or emergency medication;
f. A record of the pharmacist’s or intern’s consultation
with the patient determining that the patient is an eligible patient
g. Consultation or other professional information provided to the patient by the pharmacist or intern;
h. The name and date of the immunization or vaccine
information sheet provided to the patient; and
i. For an immunization or vaccine given to an eligible
minor patient, a consent form signed by the minor’s
parent or guardian

Question 135

Q: What are the requirements for reporting and maintaining records after administering immunizations, vaccines, or emergency medications?

Answer 135

1. Report to Primary-Care Provider:
   
   • The pharmacist or intern must provide a written or electronic report to the patient’s primary-care provider or physician, including the documentation
   • The pharmacy must document the time and date the report is sent.
   • This record must be available for inspection by the Board or its designee within 72 hours of request.
2. Record Maintenance:
   
   • The pharmacy’s pharmacist-in-charge or permittee must maintain the records for a minimum of seven years from the administration date.

Question 136

Q: What are the guidelines for emergency refill prescription dispensing during a state of emergency?

Answer 136

1. Initial Emergency Refill:
   
   • When Applicable: During a state of emergency declared affecting prescription refills.
   • Conditions:
     
     1. The medication is essential for life maintenance or continuation of therapy, as determined by the pharmacist.
     2. The pharmacist must make a good faith effort to reduce the information to a written prescription marked “emergency prescription” and file and maintain it as required by law.
   • Quantity: Up to a 30-day supply.
2. Subsequent Emergency Refill:
   
   • When Applicable: If the state of emergency continues for at least 21 days after the initial emergency refill.
   • Conditions: The pharmacist must comply with the requirement to reduce the information to a written prescription marked “emergency prescription” and file and maintain it as required by law.
   • Quantity: One additional emergency refill of up to a 30-day supply.
3. End of Authority:
   
   • The pharmacist’s authority to dispense emergency prescriptions ends when the declared state of emergency is terminated.

Question 137

Q: What are the conditions for temporary recognition of nonresident licensure during a state of emergency?

Answer 137

1. For Nonresident Pharmacists:
   
   • Eligibility: A pharmacist not licensed in this state but licensed in another state may dispense medications in affected areas if:
     
     1. Proof of current licensure in another state is provided.
     2. The pharmacist is engaged in a relief effort during the state of emergency.
   • Scope: Applies only to the counties, cities, or towns affected by the state of emergency.
2. For Nonresident Pharmacy Technicians or Interns:
   
   • Eligibility: A pharmacy technician or intern not licensed in this state but licensed or registered in another state may assist in dispensing medications if:
     
     1. Proof of current licensure or registration in another state is provided.
     2. The pharmacy technician or intern is engaged in a relief effort during the state of emergency.
   • Supervision Requirement: Must be under the direct supervision of a pharmacist.

End of Recognition: The temporary recognition of nonresident licensure or registration ends with the termination of the declared state of emergency.

Question 138

Q: What is the Board’s approach to handling impaired licensees? and what are the different participants classification

Answer 138

1. Program Operation:
   
   • The Board may contract with qualified organizations to manage a treatment and rehabilitation program for licensees impaired by alcohol or drug abuse, as per A.R.S. § 32-1932.01.
2. Participant Classification:
   
   • Confidential Participants:
     
     • Self-referred.
     • Remain unidentified to the Board.
     • Must comply with their program contract.
   • Known Participants:
     
     • Ordered by the Board to complete a minimum tenure in the program.
     • May have their license reinstated after completing the minimum tenure if the Board decides to terminate the order.

Question 139

The program contract with a qualified organization shall
include as a minimum the following:

Answer 139

1. Duties and responsibilities of each party.
2. Duration, not to exceed two years, of contract and terms of compensation.
3. Quarterly reports from the program administrator to the
   Board indicating:
   a. Identity of participants;
   i. By name, if a known participant; or
   ii. By case number, if a confidential participant;
   b. Status of each participant, including;
   i. Clinical findings;
   ii. Diagnosis and treatment recommendations;
   iii. Program activities; and
   iv. General recovery and rehabilitation program information.
4. The program administrator shall report immediately to
   the Board the name of any impaired licensee who poses a danger to self or others.
5. The program administrator shall report to the Board, as
   soon as possible, the name of any impaired licensee:
   a. Who refuses to submit to treatment,
   b. Whose impairment is not substantially alleviated
   through treatment, or
   c. Who violates the terms of their contract.
6. The program administrator shall periodically provide
   informational programs to the profession, including
   approved continuing education programs on the topic of
   drug and chemical impairment, treatment, and rehabilitation.

Question 140

Q: Under what circumstances can the Board publish the names of participants, and what are the requirements for providing treatment records?

Answer 140

1. Publication of Names:
   
   • The Board may publish the names of participants under current Board orders as authorized by A.R.S. § 32-1903(F).
2. Treatment Records:
   
   • Request for Records: The Board or its executive director may request treatment records for any participant. The program administrator must provide these records within 10 working days of receiving a written request.
   • Authorization: Participants must authorize the release of their records from drug and alcohol treatment facilities or private practitioners to the program administrator or the Board upon request.
3. Informal Meetings:
   
   • On recommendation by the program administrator or a Board member, and with mutual consent, the program administrator, Board member, Board staff, and program participant may meet informally to discuss program compliance.

Question 141

Controlled Substances Prescription Monitoring

Q: Who is required to have a current Controlled Substances Prescription Monitoring Program (CSPMP) registration?

Answer 141

• A medical practitioner licensed under A.R.S. Title 32, Chapters 7, 11, 13, 14, 15, 16, 17, 21, 25, or 29, and who has a current DEA registration under the Federal Controlled Substances Act, must have a current CSPMP registration issued by the Board, as per A.R.S. § 36-2606.

Question 142

CSPMP

1. An applicant for CSPMP registration shall:

Answer 142

a. Submit a completed application for CSPMP registration electronically or manually on a form furnished
by the Board, and
b. Submit with the application form the documents
specified in the application form.
2. The Board office shall deem an application form received
on the date the Board office electronically or manually
date-stamps the form.

Question 143

Q: What is the process for CSPMP registration and renewal?

Answer 143

1. Registration Process:
   
   • Within seven business days of receiving a completed application, the Board office will determine if the application is complete.
   • If complete, the Board will issue a registration number and provide a registration certificate by mail or electronically.
   • If incomplete, the Board will issue a notice of incompleteness, and the applicant must address the issues
2. Registration Renewal:
   
   • The Board will automatically suspend the registration of any registrant who fails to renew by May 1 of the renewal year
   • The suspension will be vacated upon submission of a renewal application.
   • Registrants with suspended CSPMP database access credentials are prohibited from accessing the database.

Question 144

Q: What are the procedures for obtaining CSPMP database access for medical practitioners and pharmacists?

Answer 144

1. Medical Practitioners (Licensed in Arizona):
   
   • Request access from the CSPMP Director by completing an electronic access user registration form.
   • The CSPMP Director or designee will issue access credentials if the medical practitioner complies with registration requirements.
2. Pharmacists (Licensed in Arizona):
   
   • Request access from the CSPMP Director by completing an electronic access user registration form.
   • The CSPMP Director or designee will issue access credentials if the pharmacist has an active pharmacist license.
3. Medical Practitioners or Pharmacists (Not Licensed in Arizona):
   
   • Complete an electronic access user registration form.
   • Print and notarize the access user registration form.
   • Mail the notarized form along with a current nonresident state license and driver’s license.
   • The CSPMP Director or designee will issue access credentials if the nonresident license shows an active license in another state.

Question 145

A. Each dispenser shall submit to the Board or its designee by electronic means information regarding each prescription dispensed for a controlled substance listed in Schedules II, III, and IV of A.R.S. Title 36, Chapter 27, the Arizona Uniform Controlled Substances Act. The information reported shall conform to the August 31, 2005 Version 003, Release 000 ASAP Rules-based Standard Implementation Guide for Prescription Monitoring Programs published by the American Society for Automation in Pharmacy as specified in A.R.S. § 36-2608(B). The information submitted for each prescription shall include:

Answer 145

1. The name, address, telephone number, prescription number, and DEA registration number of the dispenser;
2. The name, address, gender, date of birth, and telephone number of the person or, if for an animal, the owner of the animal for whom the prescription is written;
3. The name, address, telephone number, and DEA registration number of the prescribing medical practitioner;
4. The quantity and National Drug Code (NDC) number of the Schedule II, III, or IV controlled substance dispensed;
5. The date the prescription was dispensed;
6. The number of refills, if any, authorized by the medical practitioner;
7. The date the prescription was issued;
8. The method of payment identified as cash or third party; and
9. Whether the prescription is new or a refill.

Question 146

Q: What privacy and security standards must a dispenser’s electronic data transfer equipment meet?

Answer 146

A: A dispenser’s electronic data transfer equipment, including hardware, software, and internet connections, must meet the privacy and security standards of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, as amended, and A.R.S. § 12-2292. Additionally, it must adhere to common internet industry standards for privacy and security.

Question 147

Q: What data protection requirements must be met for each electronic transmission of prescription data?

Answer 147

Data Encryption: Data must be encrypted with at least 128-bit encryption during transmission and while at rest.

Transmission Methods: Data must be transmitted via secure methods such as secure e-mail, telephone modem, diskette, CD-ROM, tape, secure File Transfer Protocol (FTP), Virtual Private Network (VPN), or other Board-approved media.

Question 148

R4-23-503. Access to CSPMP Data

Q: What is the procedure if the Board or its designee suspects unprofessional or illegal conduct based on prescription information?

Answer 148

If the Board or its designee has reason to believe an act of
unprofessional or illegal conduct has occurred, the Board or its
designee shall notify the appropriate professional licensing
board or law enforcement or criminal justice agency and provide the prescription information required for an investigation.

Question 149

R4-23-503. Access to CSPMP Data

The Board or its designee is authorized to release data collected by the program to the following:

Answer 149

1. A person who is authorized to prescribe or dispense a
   controlled substance to assist that person to provide medical or pharmaceutical care to a patient or to evaluate a
   patient;
2. An individual who requests the individual’s own controlled substance prescription information
3. A professional licensing board established under A.R.S.
   Title 32, Chapter 7, 11, 13, 14, 15, 16, 17, 18, 21, 25, or
4. Except as required under subsection (B), the Board or
   its designee shall provide this information only if the
   requesting board states in writing that the information is
   necessary for an open investigation or complaint;
5. A local, state, or federal law enforcement or criminal justice agency. Except as required under subsection (B), the
   Board or its designee shall provide this information only
   if the requesting agency states in writing that the information is necessary for an open investigation or complaint;
6. The Arizona Health Care Cost Containment System
   Administration regarding individuals who are receiving
   services . Except as required under subsection (B), the Board or its designee shall provide this information only if the Administration states in writing that the information is necessary for an open investigation or complaint;
7. A person serving a lawful order of a court of competent
   jurisdiction;
8. A person who is authorized to prescribe or dispense a
   controlled substance and who performs an evaluation on
   an individual; and
9. The Board staff for purposes of administration and
   enforcement of A.R.S. Title 36, Chapter 28 and this Article.

Question 150

Q: What is the purpose of the Task Force appointed by the Board under R4-23-504?

Answer 150

A: The Task Force is appointed to assist the Board in administering the computerized central database tracking system as specified in A.R.S. § 36-2603.

Question 151

Q: How often does the Task Force meet, and for what purpose?

Answer 151

A: The Task Force meets at least once each year and at the call of the chairperson to establish procedures and conditions related to the release of prescription information as specified in A.R.S. § 36-2604 and R4-23-503.

Question 152

Q: What are the responsibilities of the Task Force?

Answer 152

A: The Task Force is responsible for:
Determining the information to be screened.
Setting the frequency and thresholds for screening.
Defining the parameters for using the information to notify medical practitioners, patients, and pharmacies for education and patient management.

Question 153

ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
R4-23-601. General Provisions-
.
A. Permit required to sell a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical. A person shall have a current Board permit to:

Answer 153

1. Sell a narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor
   chemical, or regulated chemical in Arizona; or
2. Sell a narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor
   chemical, or regulated chemical from outside Arizona
   and ship the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical into Arizona

Question 154

How does the Board interact with the Task Force’s established procedures and conditions?

Answer 154

A: The Board reviews and approves the procedures and conditions established by the Task Force as needed, but at least once every calendar year

Question 155

ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
R4-23-601. General Provisions-
.
Q: What are the details regarding the permit fee?

Answer 155

A: Permits are issued biennially, with expiration dates alternating between odd and even years based on the assigned permit number. The fee for the permit is specified in R4-23-205 and is non-refundable unless the Board fails to comply with the permit time frames established in R4-23-602.

Question 156

Q: What records are required for the receipt and disposal of controlled substances and other drugs?

Answer 156

• A:
  
  1. Manufacturing, Repackaging, or Relabeling Records:
     
     • Every person involved in manufacturing, repackaging, or relabeling controlled substances, prescription-only drugs, nonprescription drugs, precursor chemicals, or regulated chemicals must prepare and retain records for a minimum of three years. These records must include the date of manufacturing, repackaging, or relabeling.
       ​
  2. Receipt, Sale, Delivery, or Disposal Records:
     
     • Every person involved in receiving, selling, delivering, or disposing of these substances must record and retain the following information for no fewer than three years:
       
       • The name, strength, dosage form, and quantity of the substance.
       • The name, address, and license or permit number of the person from whom the substance was received.
       • The name, address, and license or permit number of the person to whom the substance was sold, delivered, or disposed.
       • The date of receipt, sale, delivery, or disposal.
         ​
  3. Availability for Inspection:
     
     • The records must be available for inspection by the Board or its compliance officer during regular business hours.
       ​
  4. Centralized Recordkeeping System:
     
     • If records are stored in a centralized system and not immediately available for inspection, the permittee, manager, or pharmacist-in-charge must provide the records within four working days of a request from the Board or its compliance officer.

Question 157

ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
.
R4-23-602. Permit Application Process and Time frames
C. Time frames for permits.
.

Q: How long does the Board office have to complete an administrative completeness review of an application?

Answer 157

• A:
  
  1. Review Time Frame:
     
     • The Board office must complete the administrative completeness review within 60 days from the date the application form is received.
  2. Notice of Administrative Completeness:
     
     • If no deficiencies are found, the Board office will issue a written notice of administrative completeness to the applicant.
  3. Incomplete Application:
     
     • If the application form is incomplete, the Board office will send a written notice detailing the missing information. The 60-day review time frame is suspended from the date the notice is served until the applicant submits all the missing information.
  4. Deemed Complete:
     
     • If the Board office does not provide a written notice of administrative completeness, the application form is considered complete 60 days after receipt by the Board office.

Question 158

ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS
.
R4-23-602. Permit Application Process and Time frames
C. Time frames for permits.

Q: What should an applicant do if their application form is incomplete?

Answer 158

A:
1. Submission Deadline:
- The applicant must submit all missing information to the Board office within 90 days of receiving the notice of incompleteness.

2. Extension Request:
   
   • If the applicant cannot meet the 90-day deadline, they may request an extension by sending a written request to the Board office. This request must be postmarked or delivered no later than 90 days from the notice of incompleteness.
3. Extension Request Details:
   
   • The written request must explain why the applicant is unable to meet the 90-day deadline.
4. Review and Granting of Extension:
   
   • The Board office will review the extension request and may grant it if they determine that an extension will help the applicant gather and submit the missing information. The extension can be for no more than 30 days.
5. Notification:
   
   • The Board office will notify the applicant in writing whether the extension request is granted or denied.

Question 159

Q: What is the process for issuing a permit and how long does the review take?

Answer 159

A:
For nonprescription drug, compressed medical gas distributor, and durable medical equipment and compressed medical gas supplier permit applicants, the Board office will issue a permit on the day it determines that an administratively complete application is received.
For other permits, the Board office must complete a substantive review within 120 days from finishing the administrative completeness review. If deficiencies are found, the review time is suspended until all required additional documentation is received. The 120-day review period may be extended once for up to 45 days if both parties agree in writing.

Question 160

Q: What are the time frames for permit processing according to the Board?

Answer 160

A:
- Administrative Completeness Review:
- Time Frame: 60 days

• Substantive Review:
  
  • Nonprescription drug permit, compressed medical gas distributor permit, and durable medical equipment and compressed medical gas supplier permit: None
  • All other permits: 120 days
• Overall Time Frame:
  
  • Nonprescription drug permit, compressed medical gas distributor permit, and durable medical equipment and compressed medical gas supplier permit: 60 days
  • All other permits: 180 days

Question 161

Q: What are the requirements and time frames for renewing a permit?

Answer 161

• A:
  
  1. Submission of Renewal Application:
     
     • Requirement: Submit a completed renewal application electronically or manually on a form provided by the Board.
     • Fee: Pay the biennial renewal fee
  2. Late Payment and Suspension:
     
     • Deadline: If the biennial renewal fee is not paid by November 1 of the renewal year, the permit is suspended.
     • Penalty: The permittee must pay a penalty to lift suspension

Question 162

R4-23-603. Resident-Nonprescription Drugs, Retail

A. Permit. A person, including the following, shall not sell or distribute a nonprescription drug without a current Board-issued permit:

Answer 162

1. A grocer;
2. Other non-pharmacy retail outlet; or
3. Mobile or non-fixed location retailer, such as a swapmeet vendor

Question 163

R4-23-603. Resident-Nonprescription Drugs, Retail

Application. To obtain a permit to sell a nonprescription drug,
a person shall submit:

Answer 163

1. A completed application form and fee; and
2. Documentation of compliance with local zoning laws, if
   required by the Board.

Question 164

R4-23-603. Resident-Nonprescription Drugs, Retail

Drug sales. A nonprescription drug permittee:

Answer 164

1. Shall sell a drug only in the original container packaged
   and labeled by the manufacturer; and
2. Shall not package, repackage, label, or relabel any drug.

Question 165

R4-23-603. Resident-Nonprescription Drugs, Retail

Q: What are the quality control requirements for a nonprescription drug permittee?

Answer 165

• A:
  
  1. Drug Stock Management:
     
     • a. Ensure all drugs stocked, sold, or offered for sale are:
       
       • i. Kept clean.
       • ii. Protected from contamination, excessive heat, cold, sunlight, and other factors that may cause deterioration.
       • iii. In compliance with federal law.
       • iv. Received from a supplier with a current Board-issued permit
  2. Expiration and Quarantine Program:
     
     • a. Develop and implement a program to:
       
       • i. Regularly review expiration-dated drugs.
       • ii. Move any drug that has exceeded its expiration date, is deteriorated or damaged, or does not comply with federal law to a quarantine area to ensure it is not sold or distributed.
       • iii. Destroy or return any quarantined drug to its source of supply.

Question 166

R4-23-603. Resident-Nonprescription Drugs, Retail

Notification. A nonprescription drug permittee shall submit
using the permittee’s online profile or provide written notice
by mail, fax, or e-mail to the Board office within __________ of
changes involving the telephone or fax number, e-mail or
mailing address, or business name.

Answer 166

10 days

Question 167

R4-23-603. Resident-Nonprescription Drugs, Retail

Relocation. No less than ____ before an existing nonprescription drug permittee relocates, the permittee shall submit a completed application for relocation electronically or manually on a form furnished by the Board, and the documentation required

Answer 167

30 days

Question 168

Q: What are the requirements for operating a nonprescription drug vending machine outlet?

Answer 168

1. Permit Requirement:
   
   • Each vending machine needs a Board-issued nonprescription drug permit.
2. Identification Seal:
   
   • Each machine must display a Board-furnished seal with the permit number, serial number, owner’s name, and contact number.
3. Location and Conditions:
   
   • Machines must be in a weather-tight structure, protected from sunlight, and maintained between 59°F and 86°F.
4. Packaging and Labeling:
   
   • Drugs must be in their original, FDA-approved packaging.
5. Inspection:
   
   • Machines are subject to inspection:
     
     • The owner must provide access within 24 hours if requested.
     • Alternatively, Board compliance staff may access independently.
6. Relocation/Retirement:
   
   • Notify the Board in writing before relocating or retiring a machine, including permit number, serial number, action planned, and disposition of drug contents.
7. Prohibitions:
   
   • Selling precursor or regulated chemicals in vending machines is prohibited.
   • Expired drugs must not be sold or distributed.

Question 169

Before issuing a drug manufacturer permit, the Board shall

Answer 169

1. Receive and approve a completed permit application;
2. Interview the applicant and manager, if different from the
   applicant, at a Board meeting; and
3. Receive a satisfactory compliance inspection report on
   the facility from a Board compliance officer

Question 170

Notification. A resident drug manufacturer permittee shall
notify the Board of changes involving the drug list, address,
telephone number, business name, or manager, including manager’s telephone number. The resident drug manufacturer permittee shall submit using the permittee’s online profile or a written notice by mail, fax, or e-mail to the Board office within
_____ of the change.

Answer 170

24 hours

Question 171

A drug manufacturer permittee shall manufacture and
distribute a drug only:

Answer 171

a. To a pharmacy, drug manufacturer, or full-service or
nonprescription drug wholesaler currently permitted
by the Board;
b. To a medical practitioner currently licensed as a
medical practitioner as defined in A.R.S. § 32-1901;
or
c. To a properly permitted, registered, licensed, or certified person or firm of another jurisdiction

Question 172

Q: What must a drug manufacturer permittee do before manufacturing and distributing a new drug not listed on their permit application?

Answer 172

A:
- Submit a Written Request: Send a written request to amend the permit application to the Board office.
- Include Documentation: Provide documentation of FDA approval for the new drug.

• Board Approval Time Frame: The Board or its designee will approve the amendment request within 30 days of receiving it.

Question 173

Records. A drug manufacturer permittee shall:

Answer 173

1. Establish and implement written procedures for maintaining records pertaining to production, process control,
   labeling, packaging, quality control, distribution, complaints, and any information required by federal or state law;
2. Retain the records for at least two years after distribution of a drug or one year after the expiration date of a drug, whichever is longer; and
3. Make the records available within 48 hours for review by
   a Board compliance officer or other authorized officer of
   the law

Question 174

Manufacturing radiopharmaceuticals. Before manufacturing a
radiopharmaceutical, a drug manufacturer permittee shall:

Answer 174

1. Comply with the regulatory requirements of the Arizona
   Radiation Regulatory Agency, the U.S. Nuclear Regulatory Commission, the FDA, and this Section; and
2. Hold a current Arizona Radiation Regulatory Agency
   Radioactive Materials License. If a drug manufacturer
   permittee who manufactures radiopharmaceuticals fails
   to maintain a current Arizona Radiation Regulatory
   Agency Radioactive Materials License, the permittee’s
   drug manufacturer permit shall be immediately suspended pending a hearing by the Board.

Question 175

Q: What is required to obtain a permit to operate a full-service or nonprescription drug wholesale firm in Arizona?

Answer 175

A:
1. Submit an Application:
- Complete the application form provided by the Board.
- Pay the fee specified in R4-23-205.

2. Before Issuance of the Permit:
   
   • Application Approval: The Board must receive and approve the completed application.
   • Interview: The applicant and the designated representative (if different from the applicant) must be interviewed at a Board meeting.
   • Inspection Report: Obtain a satisfactory compliance inspection report from a Board compliance officer.
   • Fingerprint Clearance: For a full-service drug wholesale permit, a fingerprint clearance must be issued to a qualified designated representative. If the clearance is denied, the applicant must appoint another representative and submit the necessary documentation, fingerprints, and fee.

Question 176

What are the notification requirements for a resident full-service or nonprescription drug wholesale permittee?

Answer 176

A:

1. Notify the Board of Changes:
   
   • Inform the Board of changes involving:
     
     • Type of drugs sold or distributed
     • Address
     • Telephone number
     • Business name
     • Manager or designated representative (including their telephone number)
   • Submit the notification via the permittee’s online profile or by written notice (mail, fax, or email) within 10 days of the change.
2. Change of Designated Representative:
   
   • For changes to the designated representative:
     
     • Submit the required documentation
     • Provide fingerprints
     • Pay the specified fee, as detailed in the permit application.

Question 177

Q: What are the record-keeping requirements for a full-service drug wholesale permittee?

Answer 177

1. Record Maintenance:
   
   • Full Accountability: Maintain records ensuring full accountability of:
     
     • Narcotics and other controlled substances
     • Prescription-only drugs and devices
     • Nonprescription drugs
     • Precursor chemicals
     • Regulated chemicals
   • Records must include:
     
     • Dates of receipt and sales
     • Names, addresses, and DEA registration numbers (if applicable) of suppliers or sources
     • Names, addresses, and DEA registration numbers (if applicable) of customers
2. Record Filing and Accessibility:
   
   • Filing: Keep records in a readily retrievable manner for at least three years.
   • Availability: Make records available for inspection by a Board compliance officer or authorized law enforcement during regular business hours. If records are stored centrally and not electronically retrievable, they must be made available within two business days.
3. Additional Compliance:
   
   • Track and Trace Documents: Follow the retention requirements for track and trace documents under the Drug Supply Chain and Security Act for prescription-only drugs leaving the normal distribution channel.

Question 178

What are the record-keeping requirements for a nonprescription drug wholesale permittee?

Answer 178

A:

1. Record Maintenance:
   
   • Full Accountability: Maintain records to ensure accountability of:
     
     • Nonprescription drugs
     • Precursor chemicals
     • Regulated chemicals
   • Records must include:
     
     • Dates of receipt and sales
     • Names, addresses, and DEA registration numbers (if applicable) of suppliers or sources
     • Names, addresses, and DEA registration numbers (if applicable) of customers
2. Record Filing and Accessibility:
   
   • Filing: Keep records in a readily retrievable manner for at least three years.
   • Availability: Make records available for inspection by a Board compliance officer or authorized law enforcement during regular business hours. If records are stored centrally and not electronically retrievable, they must be made available within two business days.

Question 179

What are the drug sales requirements for a full-service drug wholesale permittee?

Answer 179

A:

1. Packaging and Distribution:
   
   • Original Containers: Must sell, distribute, give away, or dispose of narcotics, controlled substances, prescription-only drugs, nonprescription drugs, precursor chemicals, or regulated chemicals only in the original container packaged and labeled by the manufacturer or repackager.
   • No Repackaging: Cannot package, repackage, label, or relabel any of these substances.
2. Sales Restrictions:
   
   • Controlled Substances & Prescription Drugs: Can only sell, distribute, give away, or dispose of to:
     
     • Pharmacies
     • Drug manufacturers
     • Full-service drug wholesalers
     • Licensed medical practitioners under A.R.S. Title 32
   • Nonprescription Drugs, Precursors, & Regulated Chemicals: Can only sell, distribute, give away, or dispose of to:
     
     • Pharmacies
     • Drug manufacturers
     • Full-service or nonprescription drug wholesalers
     • Nonprescription drug retailers
     • Licensed medical practitioners under A.R.S. Title 32
3. Documentation:
   
   • Track and Trace Documents: Provide documents required under the Drug Supply Chain and Security Act upon request. These should be available immediately or within two business days.
   • Permit/License Records: Maintain a copy of the current permit or license for each entity buying, receiving, or disposing of drugs. Provide these records upon request, immediately if available, or within two business days.

Question 180

What are the drug sales requirements for a nonprescription drug wholesale permittee?

Answer 180

1. Packaging and Distribution:
   
   • Original Containers: Must sell, distribute, give away, or dispose of nonprescription drugs, precursor chemicals, or regulated chemicals only in the original container packaged and labeled by the manufacturer or repackager.
   • No Repackaging: Cannot package, repackage, label, or relabel these substances.
2. Sales Restrictions:
   
   • Authorized Recipients: Can only sell or distribute to:
     
     • Pharmacies
     • Drug manufacturers
     • Full-service or nonprescription drug wholesalers
     • Nonprescription drug retailers
     • Medical practitioners licensed under A.R.S. Title 32
3. Documentation:
   
   • Permit/License Records: Must maintain a record of the current permit or license for each person buying, receiving, or disposing of these substances. Provide these records upon request, immediately if available, or within two business days.
4. Returns:
   
   • Source of Supply: Allows for the return of any drug or chemical to the original source of supply.

Question 181

Q: What are the requirements for out-of-state drug sales for a full-service drug wholesale permittee?

Answer 181

A:

1. Packaging and Distribution:
   
   • Original Containers: Must sell, distribute, give away, or dispose of drugs and chemicals only in the original container packaged and labeled by the manufacturer or repackager.
   • No Repackaging: Cannot package, repackage, label, or relabel these substances.
2. Authorized Recipients:
   
   • Proper Permits: Can only sell, distribute, give away, or dispose of drugs and chemicals to individuals or entities that are properly permitted, registered, licensed, or certified in another jurisdiction.
3. Documentation:
   
   • Track and Trace: Must provide track and trace documents as required under the Drug Supply Chain and Security Act upon request, immediately if available, or within two business days.
   • Permit/License Records: Must maintain and provide a copy of the current permit, registration, license, or certificate for each person that buys, receives, or disposes of these substances upon request, immediately if available, or within two business days.

Question 182

Q: What are the requirements for a nonprescription drug wholesale permittee?

Answer 182

A: A nonprescription drug wholesale permittee must:

1. Original Packaging: Sell, distribute, give away, or dispose of nonprescription drugs, precursor chemicals, or regulated chemicals only in the original container as packaged and labeled by the manufacturer or repackager.
2. No Repackaging: Not package, repackage, label, or relabel any nonprescription drug, precursor chemical, or regulated chemical.
3. Permitted Recipients Only: Sell or distribute these substances only to individuals or entities that are properly permitted, registered, licensed, or certified in another jurisdiction.
4. Record Maintenance: Keep a record of the current permit, registration, license, or certificate of each person who buys, receives, or disposes of these substances.
5. Record Provision: Provide these records upon request. They must be available immediately or within two business days if requested by a Board compliance officer or other authorized law officer (as defined in A.R.S. § 32-1901(5)).

Question 183

Q: What are the requirements for completing a cash-and-carry sale for a full-service drug wholesale permittee?

Answer 183

A: For a full-service drug wholesale permittee, the following steps must be completed for a cash-and-carry sale or distribution:

1 Verification of Order: Ensure the validity of the order.

2 Identity Verification: Confirm the identity of the pick-up person, ensuring they are the same individual who placed the order.

3 Prescription-Only Drugs: For prescription-only drugs, confirm that the sale or distribution meets the immediate needs of a specific patient as indicated in the order

Question 184

Q: What are the requirements for completing a cash-and-carry sale for a nonprescription drug wholesale permittee?

Answer 184

A: For a nonprescription drug wholesale permittee, the following steps must be completed for a cash-and-carry sale or distribution:

Verification of Order: Ensure the validity of the order.

Identity Verification: Confirm the identity of the pick-up person, ensuring they are the same individual who placed the order.

Question 185

Q: What are the criteria for returning or exchanging prescription-only drugs by a pharmacy or chain pharmacy warehouse?

Answer 185

A: For a full-service drug wholesale permittee, the following criteria must be met:

1. Drug Condition: The prescription-only drug must not be adulterated or counterfeited. However, if the drug is adulterated or counterfeited and is subject to an FDA or manufacturer recall, it may be returned for destruction or subsequent return to the manufacturer.
2. Quantity Limit: The quantity of the prescription-only drug being returned or exchanged must not exceed the quantity that was originally sold to the pharmacy or chain pharmacy warehouse by the permittee or a permittee under common ownership.
3. Documentation: The pharmacy or chain pharmacy warehouse must provide documentation that includes:
   • Drug Details: The name, strength, and manufacturer of the prescription-only drug being returned or exchanged.
   • Storage Compliance: A statement confirming that the prescription-only drug was maintained according to the storage conditions specified on the drug label or manufacturer’s package insert.

Question 186

Q: What are the requirements for handling returned, outdated, damaged, or otherwise problematic drugs for a full-service drug wholesale permittee?

Answer 186

A: The following criteria must be met:

1. General Criteria for Problematic Drugs:
   
   • Any narcotic, controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical that is outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, or contraband, or suspected of such, must be:
     
     • Quarantined and physically separated from other substances.
     • Destroyed or returned to the manufacturer or wholesale distributor as authorized by the Board and FDA.
2. Misbranded, Counterfeited, or Contraband Packaging:
   
   • For drugs with misbranded, counterfeited, or contraband immediate or sealed outer/secondary containers or product labeling:
     
     • Quarantine and separate from other substances.
     • Notify the Board, FDA, and the manufacturer or distributor within three business days of the determination.
     • Destroy or return the drugs as authorized by the Board and FDA.
3. Opened or Used Drugs:
   
   • Drugs that have been opened or used but are not adulterated, misbranded, counterfeited, or contraband must be:
     
     • Identified as opened or used.
     • Quarantined and separated.
     • Destroyed or returned to the manufacturer or distributor as authorized by the Board and FDA.
4. Doubt on Safety, Identity, Strength, Quality, or Purity:
   
   • If there are doubts about the safety, identity, strength, quality, or purity of the drugs due to the conditions of return:
     
     • Quarantine and separate from other substances.
     • Destroy or return the drugs unless testing proves they meet appropriate standards.
     • Consider storage, shipping conditions, and the condition of the drugs and their containers.
5. Retention of Evidence:
   
   • For identified problematic drugs (under subsections (I)(1)(a) or (b)), retain the drugs and any evidence of criminal activity and accompanying documentation until authorized disposition by the Board and FDA.

Question 187

Q: What are the criteria for handling the return of nonprescription drugs, precursor chemicals, or regulated chemicals by a nonprescription drug wholesale permittee?

Answer 187

A: The following criteria must be met:

1. General Handling:
   
   • Condition: Quarantine and separate nonprescription drugs, precursor chemicals, or regulated chemicals that are outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, or contraband, or suspected of such.
   • Disposition: Destroy or return these items to the manufacturer or wholesale distributor as authorized by the Board and FDA.
2. Misbranded, Counterfeited, or Contraband Packaging:
   
   • Condition: Quarantine and separate items with misbranded, counterfeited, or contraband immediate or sealed outer/secondary containers or product labeling.
   • Disposition: Destroy or return these items to the manufacturer or distributor.
   • Notification: Notify the Board, FDA, and manufacturer or distributor within three business days of determining misbranding, counterfeiting, or contraband.
3. Opened or Used Items:
   
   • Condition: Identify as opened or used, quarantine, and separate items that are not adulterated, misbranded, counterfeited, or contraband.
   • Disposition: Destroy or return these items to the manufacturer or distributor.
4. Doubt on Safety, Identity, Strength, Quality, or Purity:
   
   • Condition: Quarantine and separate items if the conditions of return cast doubt on their safety, identity, strength, quality, or purity.
   • Disposition: Destroy or return these items unless testing proves they meet appropriate standards.
   • Considerations: Evaluate storage, shipping conditions, and the condition of the items and their containers.
5. Retention of Evidence:
   
   • Condition: Retain and do not destroy any identified items and evidence of criminal activity, along with documentation, until authorized for disposition by the Board and FDA.

Question 188

Q: What are the facility requirements for a full-service or nonprescription drug wholesale permittee?

Answer 188

A: The following requirements must be met:

1. Facility Conditions:
   
   • Size and Construction: The facility must be adequately sized and constructed.
   • Lighting and Cleanliness: It must be well-lighted (inside and outside), clean, uncluttered, and sanitary.
   • Ventilation: Proper ventilation is required.
2. Warehouse Security:
   
   • Unauthorized Entry: The warehouse must be secure from unauthorized entry.
   • Security System: An operational security system designed to protect against theft must be in place.
3. Access Control in Full-Service Facilities:
   
   • Authorized Personnel: Only authorized personnel may enter areas where narcotics, controlled substances, prescription-only drugs, devices, nonprescription drugs, precursor chemicals, or regulated chemicals are kept.
4. Access Control in Nonprescription Drug Facilities:
   
   • Authorized Personnel: Only authorized personnel may enter areas where nonprescription drugs, precursor chemicals, or regulated chemicals are kept.
5. Storage of Thermolabile Substances in Full-Service Facilities:
   
   • Temperature Control: Thermolabile substances must be stored where the room temperature complies with storage conditions prescribed on the product label.
6. Storage of Thermolabile Substances in Nonprescription Drug Facilities:
   
   • Temperature Control: Thermolabile substances must be stored where the room temperature complies with storage conditions prescribed on the product label.
7. Facility Inspection:
   
   • Inspection Access: The facility must be available for inspection by a Board compliance officer or other authorized law officer during regular business hours.
8. Quarantine Area in Full-Service Facilities:
   
   • Quarantine Storage: A quarantine area must be provided for substances that are outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, contraband, suspected of being such, unfit for consumption, or in open containers.
9. Quarantine Area in Nonprescription Drug Facilities:
   
   • Quarantine Storage: A quarantine area must be provided for nonprescription drugs, precursor chemicals, or regulated chemicals that are outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, contraband, suspected of being such, unfit for consumption, or in open containers.

Question 189

Q: What are the quality control requirements for a full-service drug wholesale permittee?

Answer 189

A: The following quality control measures must be implemented:

1. Sales and Distribution:
   
   • Criteria Compliance: Ensure that any narcotic, controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical meeting the criteria in subsection (I)(1) is not sold, distributed, or delivered for human or animal consumption.
2. Manufacturing and Labeling:
   
   • Employee Activities: Ensure that no narcotic, controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is manufactured, packaged, repackaged, labeled, or relabeled by employees.
3. Storage and Protection:
   
   • Cleanliness: Ensure that all items are kept clean.
   • Contamination Prevention: Protect items from contamination and other environmental factors that could cause deterioration.
   • Compliance: Store items in compliance with applicable federal and state laws and official compendium storage requirements.
4. Temperature and Humidity Monitoring:
   
   • Recording Devices: Maintain manual or automatic temperature and humidity recording devices or logs to document conditions in storage areas.
5. Expiration and Quarantine Program:
   
   • Expiration Review: Regularly review expiration-dated items.
   • Quarantine and Disposal:
     
     • Quarantine: Move items with less than 120 days remaining on their expiration date, or that are deteriorated, damaged, or non-compliant with federal law, to a quarantine area and do not sell or distribute them.
     • Disposition: Ensure that quarantined items are either destroyed or returned to the manufacturer or wholesale distributor from which they were acquired.

Question 190

Q: What are the quality control requirements for a nonprescription drug wholesale permittee?

Answer 190

A: The following quality control measures must be implemented:

1. Sales and Distribution:
   
   • Criteria Compliance: Ensure that any nonprescription drug, precursor chemical, or regulated chemical meeting the criteria in subsection (I)(2) is not sold, distributed, or delivered for human or animal consumption.
2. Manufacturing and Labeling:
   
   • Employee Activities: Ensure that no nonprescription drug, precursor chemical, or regulated chemical is manufactured, packaged, repackaged, labeled, or relabeled by employees.
3. Storage and Protection:
   
   • Cleanliness: Ensure that all items are kept clean.
   • Contamination Prevention: Protect items from contamination and other environmental factors that could cause deterioration.
   • Compliance: Store items in compliance with applicable federal and state laws and official compendium storage requirements.
4. Temperature and Humidity Monitoring:
   
   • Recording Devices: Maintain manual or automatic temperature and humidity recording devices or logs to document conditions in storage areas.
5. Expiration and Quarantine Program:
   
   • Expiration Review: Regularly review expiration-dated items.
   • Quarantine and Disposal:
     
     • Quarantine: Move items with fewer than 120 days remaining on their expiration date, or that are deteriorated, damaged, or non-compliant with federal law, to a quarantine area and do not sell or distribute them.
     • Disposition: Ensure that quarantined items are either destroyed or returned to the manufacturer or wholesale distributor from which they were acquired.

Question 191

Q: What are the requirements for fingerprint clearance for a designated representative?

Answer 191

A: The following requirements apply:

1. Issuance of Fingerprint Clearance:
   
   • Criminal History Review: After receiving the state and federal criminal history record of a designated representative, the Board will compare it with the list of criminal offenses that preclude clearance.
   • Approval: If the criminal history record does not contain any of the offenses listed in subsection (L)(2), the Board will issue a fingerprint clearance.
2. Disqualifying Offenses:
   
   • Ineligible for Clearance: The Board will not issue a fingerprint clearance if the designated representative:
     
     • Is awaiting trial for or has been convicted of committing or attempting or conspiring to commit any of the following offenses:
       
       • Unlawfully administering intoxicating liquors, controlled substances, dangerous drugs, or prescription-only drugs.
       • Sale of peyote.
       • Possession, use, or sale of marijuana, dangerous drugs, prescription-only drugs, or controlled substances.
       • Manufacture or distribution of an imitation controlled substance.
       • Manufacture or distribution of an imitation prescription-only drug.
       • Possession or possession with intent to use an imitation controlled substance.
       • Possession or possession with intent to use an imitation prescription-only drug.
       • A felony involving sale, distribution, or transportation of, or conspiracy to sell, transport, or distribute marijuana, dangerous drugs, prescription-only drugs, or controlled substances.
3. Notification of Denial:
   
   • Denial of Clearance: If the Board cannot issue a fingerprint clearance due to disqualifying criminal history, it will notify the full-service drug wholesale applicant or permittee.
   • Contents of Notice: The notice will include the criminal history information on which the denial was based. This information is subject to dissemination restrictions

Question 192

Q: What are the requirements for obtaining and maintaining a pharmacy permit in Arizona?

Answer 192

A: The requirements are as follows:

1. Permit Requirement:
- Operation: A person must have a current Board-issued pharmacy permit to operate a pharmacy in Arizona.

2. Application for Permit:
- Submission: Submit a completed application form available from the Board, along with the specified fee
- Approval:
- The Board must receive and approve a completed permit application.
- The Board must receive a satisfactory compliance inspection report from a Board compliance officer.
- Interview: The Board may interview the applicant and the pharmacist-in-charge (if different from the applicant) at a Board meeting if additional information is needed.

3. Notification Requirements:
- Changes: Notify the Board office within 10 days of changes in:
- Type of pharmacy operated
- Telephone or fax number
- E-mail or mailing address
- Business name
- Staff pharmacist
- Pharmacist-in-Charge: Provide immediate notice of any change in the pharmacist-in-charge.

4. Nonprescription Drug Sales:
- Sales Outside Pharmacy Area: If nonprescription drugs are sold outside the pharmacy area when the pharmacy area is closed, the business must have a current, Board-issued nonprescription drug permit

5. Relocation or Remodel:
- Application: Submit a completed application for remodel or relocation electronically or manually at least 30 days before the change. No fee is required for these applications.
- Inspection: The new or remodeled facility must pass a final inspection by a Board compliance officer before starting operations.

Question 193

R4-23-607. Nonresident Permits
A. Permit. A person that is not a resident of Arizona shall not sell
or distribute any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical into Arizona without possessing both:

Answer 193

1. A current Board-issued nonresident pharmacy permit,
   nonresident manufacturer permit, nonresident full-service
   or nonprescription drug wholesale permit, or nonresident
   nonprescription drug permit; and
2. A current equivalent license or permit issued by the
   licensing authority in the jurisdiction where the person
   resides.

Question 194

Q: What are the notification requirements for nonresident permittees in Arizona when changes occur?

Answer 194

A: Notification requirements are as follows:

1. Nonresident Pharmacy:
   
   • Changes to Notify: Type of pharmacy operated, address, telephone number, business name, or pharmacist-in-charge.
   • Notification Method: Use online profile or written notice via mail, fax, or e-mail to the Board office within 10 days of the change.
2. Nonresident Manufacturer:
   
   • Changes to Notify: Listed drugs, address, telephone number, business name, or manager (including manager’s telephone number).
   • Notification Method: Use online profile or written notice via mail, fax, or e-mail to the Board office within 10 days of the change.
3. Nonresident Drug Wholesaler (Full-Service or Nonprescription):
   
   • Changes to Notify: Types of drugs sold or distributed, address, telephone number, business name, or manager/designated representative (including manager’s or designated representative’s telephone number).
   • Change of Designated Representative: Submit documentation, fingerprints, and fee as required in the application under subsection (B).
   • Notification Method: Use online profile or written notice via mail, fax, or e-mail to the Board office within 10 days of the change.
4. Nonresident Nonprescription Drug Retailer:
   
   • Changes to Notify: Permit category, address, telephone number, business name, or manager (including manager’s telephone number).
   • Notification Method: Use online profile or written notice via mail, fax, or e-mail to the Board office within 10 days of the change.

Question 195

Q: What are the drug sales regulations for nonresident pharmacies in Arizona?

Answer 195

A: Nonresident pharmacy permittees must adhere to the following regulations:

1. Controlled Substances and Prescription-Only Drugs:
   
   • Sales Restrictions:
     
     • Nonresident pharmacies cannot sell, distribute, give away, or dispose of narcotics, controlled substances, or prescription-only drugs to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, or full-service drug wholesaler currently permitted by the Board.
       2. A medical practitioner currently licensed
       3. An Arizona resident upon receipt of a valid prescription order for the resident.
2. Nonprescription Drugs, Precursors, and Regulated Chemicals:
   
   • Sales Restrictions:
     
     • Nonresident pharmacies cannot sell, distribute, give away, or dispose of nonprescription drugs, precursor chemicals, or regulated chemicals to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer currently permitted by the Board.
       2. A medical practitioner currently licensed
       3. An Arizona resident either upon receipt of a valid prescription order or in the original container packaged and labeled by the manufacturer.
3. Record Keeping:
   
   • Documentation: Nonresident pharmacies must maintain a copy of the current permit or license for each person in Arizona that buys, receives, or disposes of any narcotic or controlled substance, prescription-only drug, nonprescription drug, precursor chemical, or regulated chemical, except for drug sales resulting from a valid prescription order for an Arizona resident.
   • Provision of Records:
     
     • Permit and license records must be provided upon request if immediately available, or within no fewer than two business days from the request of a Board compliance officer or other authorized officer of the law.

Question 196

Q: What are the drug sales regulations for nonresident manufacturers in Arizona?
.
Nonresident manufacturer. A nonresident manufacturer permittee shall:

Answer 196

A: Nonresident manufacturer permittees must follow these regulations:

1. Controlled Substances and Prescription-Only Drugs:
   
   • Sales Restrictions:
     
     • Nonresident manufacturers cannot sell, distribute, give away, or dispose of narcotics, controlled substances, or prescription-only drugs to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, or full-service drug wholesaler currently permitted by the Board.
       2. A medical practitioner currently licensed
2. Nonprescription Drugs, Precursors, and Regulated Chemicals:
   
   • Sales Restrictions:
     
     • Nonresident manufacturers cannot sell, distribute, give away, or dispose of nonprescription drugs, precursor chemicals, or regulated chemicals to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer currently permitted by the Board.
       2. A medical practitioner currently licensed
3. Record Keeping:
   
   • Documentation:
     
     • Nonresident manufacturers must maintain a copy of the current permit or license for each person in Arizona that buys, receives, or disposes of any narcotic or controlled substance, prescription-only drug, nonprescription drug, precursor chemical, or regulated chemical.
   • Provision of Records:
     
     • Permit and license records must be provided upon request, if immediately available, or within no more than two business days from the date of the request by a Board compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901.

Question 197

Q: What are the drug sales regulations for nonresident full-service drug wholesalers in Arizona?

Answer 197

A: Nonresident full-service drug wholesalers must adhere to the following regulations:

1. Distribution Restrictions:
   
   • Original Packaging:
     
     • They cannot sell, distribute, give away, or dispose of any narcotic, controlled substance, prescription-only drug, device, nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona, except in the original container, as packaged and labeled by the manufacturer or repackager.
2. Packaging and Labeling:
   
   • Restrictions:
     
     • They are prohibited from packaging, repackaging, labeling, or relabeling any narcotic, controlled substance, prescription-only drug, device, nonprescription drug, precursor chemical, or regulated chemical for shipment or delivery to anyone in Arizona.
3. Track and Trace Documentation:
   
   • Provision:
     
     • They must provide track and trace documents required under the Drug Supply Chain and Security Act upon request. These documents should be provided if immediately available, or within no more than two business days from the date of the request by a Board compliance officer or other authorized officer of the law.
4. Sales Restrictions:
   
   • Controlled Substances and Prescription-Only Drugs:
     
     • They cannot sell, distribute, give away, or dispose of any narcotic, controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, or full-service drug wholesaler currently permitted by the Board.
       2. A medical practitioner currently licensed under A.R.S. Title 32.
   • Nonprescription Drugs, Precursors, and Regulated Chemicals:
     
     • They cannot sell, distribute, give away, or dispose of nonprescription drugs, precursor chemicals, or regulated chemicals to anyone in Arizona except:
       
       1. A pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer currently permitted by the Board.
       2. A medical practitioner currently licensed under A.R.S. Title 32.
5. Record Keeping:
   
   • Documentation:
     
     • They must maintain a copy of the current permit or license for each person in Arizona that buys, receives, or disposes of any narcotic, controlled substance, prescription-only drug, device, nonprescription drug, precursor chemical, or regulated chemical.
   • Provision of Records:
     
     • Permit and license records must be provided upon request, if immediately available, or within no more than two business days from the date of the request by a Board compliance officer or other authorized officer of the law.

Question 198

Q: What are the regulations for nonresident nonprescription drug wholesalers in Arizona?

Answer 198

A: Nonresident nonprescription drug wholesalers must adhere to the following regulations:

Distribution Restrictions:

Original Packaging:
They cannot sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except in the original container, as packaged and labeled by the manufacturer or repackager.
Packaging and Labeling:

Restrictions:
They are prohibited from packaging, repackaging, labeling, or relabeling any nonprescription drug, precursor chemical, or regulated chemical for shipment or delivery to anyone in Arizona.
Sales Restrictions:

Authorized Recipients:
They cannot sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except:
A pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer currently permitted by the Board.
A medical practitioner currently licensed under A.R.S. Title 32.
Record Keeping:

Documentation:

They must maintain a copy of the current permit or license for each person in Arizona that buys, receives, or disposes of any nonprescription drug, precursor chemical, or regulated chemical.
Provision of Records:

Permit and license records must be provided upon request, if immediately available, or within no more than two business days from the date of the request by a Board compliance officer or other authorized officer of the law.

Question 199

Q: What are the regulations for nonresident nonprescription drug retailers in Arizona?

Answer 199

A: Nonresident nonprescription drug retailers must adhere to the following regulations:

Distribution Restrictions:

Original Packaging:
They cannot sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except in the original container, as packaged and labeled by the manufacturer.
Packaging and Labeling:

Restrictions:
They are prohibited from packaging, repackaging, labeling, or relabeling any drug, precursor chemical, or regulated chemical for shipment or delivery to anyone in Arizona.
Condition of Drugs:

Compliance with Federal Law:
They cannot sell, distribute, give away, or dispose of any drug, precursor chemical, or regulated chemical to anyone in Arizona if it exceeds its expiration date, is contaminated or deteriorated from excessive heat, cold, sunlight, moisture, or other factors, or does not comply with federal law.

Question 200

Q: What laws must be followed when selling or distributing drugs into Arizona?

Answer 200

A: When selling or distributing any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical into Arizona, a nonresident pharmacy, nonresident manufacturer, nonresident full-service or nonprescription drug wholesaler, or nonprescription drug permittee must comply with:

1. Federal Law:
   
   • Adhere to all applicable federal regulations governing the sale and distribution of drugs and chemicals.
2. Resident State Drug Law:
   
   • Follow the drug laws and regulations of the state where the permittee resides.
3. Arizona Regulations:
   
   • Comply with the specific requirements set forth in Arizona’s regulations for nonresident permittees as detailed in the relevant sections.

Question 201

R4-23-608. Change of Personnel and Responsibility
A. A community, hospital, or limited-service pharmacy permittee
shall give the Board:

Answer 201

1. Notice by mail, facsimile, or electronic mail within ten
   days of employing or terminating a pharmacist; and
2. Immediate notice of designating or terminating a pharmacist-in-charge.

Question 202

B. Responsibility of ownership and management. The owner and management of a pharmacy shall:

Answer 202

1. Ensure that pharmacists, interns, and other pharmacy
   employees comply with state and federal laws and administrative rules; and
2. Not overrule a pharmacist in matters of pharmacy ethics
   and interpreting laws pertaining to the practice of pharmacy or the distribution of drugs and devices.

Question 204

Q: What is the minimum area required for a community pharmacy primarily devoted to stocking drugs and dispensing medications?

Answer 204

A: The minimum area of a community pharmacy dedicated to stocking drugs, compounding, and dispensing prescription medication must be at least 300 square feet. This area does not include office or support function areas.

Question 205

Q: How many pharmacy personnel can work simultaneously in the minimum 300 square feet area?

Answer 205

A: A maximum of three pharmacy personnel can work simultaneously in the minimum 300 square feet area.

Question 206

Q: What additional space is required for each additional pharmacy personnel beyond the initial three?

Answer 206

A: For each additional pharmacist, graduate intern, pharmacy intern, pharmacy technician, pharmacy technician trainee, or support personnel who may work simultaneously, an additional 60 square feet of floor area must be provided.

Question 207

Q: What are the requirements for the allotted square footage in terms of its utility for pharmacy practice?

Answer 207

A: The allotted square footage must be designed to support efficient pharmaceutical practice, allowing free movement and enabling visual surveillance of personnel by the pharmacist. Adequate shelving should also be included.

Question 208

Q: What is the minimum counter area required for a pharmacy counter that supports one pharmacy personnel after January 6, 2004?

Answer 208

A: The minimum counter area required is three square feet, with a depth of not less than 16 inches and a length of at least 24 inches.

Question 209

Q: How is the additional counter space determined for each additional pharmacy personnel?

Answer 209

A: For each additional pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee working simultaneously, an additional three square feet of counter area is required, with the same dimensions of 16 inches in depth and 24 inches in length.

Question 210

Q: How does the Board determine the total required compounding and dispensing counter area for a pharmacy?

Answer 210

A: The Board determines the total required counter area by multiplying the maximum number of personnel allowed in the pharmacy (as specified in the minimum area requirements) by three square feet per person.

Question 211

Q: Can a pharmacy operate with a total counter working area that is equal to the number of personnel times three square feet per person?

Answer 211

A: Yes, a pharmacy permittee or pharmacist-in-charge can operate with a total counter working area that is equal to the maximum number of pharmacists, graduate interns, pharmacy interns, pharmacy technicians, and pharmacy technician trainees working simultaneously, multiplied by three square feet per person.

Question 213

Q: What are the requirements for the working area at the compounding and dispensing counter in a pharmacy?

Answer 213

A: The aisle floor area used by pharmacists, interns, or technicians at the counter must extend the full length of the counter and be clear and continuous for at least 36 inches from any counter, fixture, or structure. This ensures adequate space for movement and access, facilitating efficient practice and preventing obstructions.

Question 214

Q: What is required for the patient counseling area in a pharmacy?

Answer 214

A: On or after April 1, 1995, a pharmacy permit applicant or remodel/relocation applicant must provide a separate and distinct patient counseling area that ensures patient privacy.

Question 215

Narcotic cabinet or safe. To prevent diversion, narcotics and
other controlled substances may be:

Answer 215

1. Kept in a separate locked cabinet or safe, or
2. Dispersed throughout the pharmacy’s prescription-only
   drug stock.

Question 217

Q: What are the building security standards for the community pharmacy area?

Answer 217

A: The pharmacy area must be enclosed by a permanent barrier or partition from floor or counter to structural ceiling or roof, with entry doors that can be securely locked. The barrier should be designed so that only a pharmacist can access areas where prescription-only drugs, narcotics, and other controlled substances are stored, compounded, and dispensed. The barrier can be made of materials other than solid, but any openings must be too small to allow removal of items. The material must be strong and thick enough to prevent easy removal, penetration, or bending. Plans and specifications for the barrier must be submitted to the Board for approval.

Question 218

Q: What are the requirements for drug storage and security in a pharmacy?

Answer 218

A:

1. Drug Storage Conditions:
   
   • Drugs and devices must be stored in a dry, well-lit, ventilated, clean, and orderly area.
   • The storage area must maintain temperatures that ensure the drugs’ integrity, as specified in the official compendium or by the manufacturer’s/distributor’s labeling.
2. Additional Storage Area for Restricted Drugs:
   
   • If additional storage space is needed for drugs restricted to sale by a pharmacist, it must be enclosed by a permanent barrier from floor or counter to structural ceiling or roof.
   • All doors and gates to this storage area must be locked.
   • Only a pharmacist with a key is permitted to enter this area, except in extreme emergencies.

Question 219

Q: How must the pharmacy working counter area be protected from unauthorized access while the pharmacy is open for business?

Answer 219

• The pharmacy working counter area must be protected from unauthorized access by a barrier that is at least 66 inches in height or another method approved by the Board or its designee.

Question 220

Q: What is the responsibility of the pharmacist-in-charge regarding Board directives?

Answer 220

A:
The pharmacist-in-charge is responsible for ensuring communication and compliance with Board directives to the management, other pharmacists, interns, and technicians of the pharmacy.

Question 221

Q: What are the responsibilities of the pharmacist-in-charge regarding pharmacy policies and procedures?

Answer 221

A:
The pharmacist-in-charge shall.
a. Ensure that all pharmacy policies and procedures required under 4 A.A.C. 23 are prepared, implemented, and complied with.
b. Review all pharmacy policies and procedures biennially and revise them if necessary.
c. Document the review of policies and procedures.
d. Ensure that all pharmacy policies and procedures required under 4 A.A.C. 23 are assembled into a written or electronic manual.
e. Make all pharmacy policies and procedures available in the pharmacy for employee reference and inspection by the Board or its staff.

Question 222

Q: Who is permitted in the pharmacy area of a community pharmacy, and under what conditions?

Answer 222

A: Personnel permitted in the pharmacy area of a community pharmacy include:
- Pharmacists
- Graduate interns
- Pharmacy interns
- Compliance officers
- Drug inspectors
- Peace officers acting in their official capacity
- Other persons authorized by law
- Pharmacy technicians
- Pharmacy technician trainees
- Support personnel
- Other designated personnel

Pharmacy interns, graduate interns, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel are allowed in the pharmacy area only when a pharmacist is on duty, except in an extreme emergency as defined in R4-23-110.

1. The pharmacist-in-charge must comply with the minimum area requirements specified in R4-23-609 for a community pharmacy and the compounding and dispensing counter area.
2. A pharmacist employed by the pharmacy is responsible for ensuring that the pharmacy is physically secure while on duty.

Question 223

Q: What are the security requirements for the pharmacy area and additional drug storage area in a community pharmacy when a pharmacist is not present?

Answer 223

A: In a community pharmacy, a pharmacist shall ensure that:
- The pharmacy area and any additional storage area for drugs restricted to access only by a pharmacist are locked when a pharmacist is not present.
- The only exception to this requirement is in an extreme emergency.

Question 224

Q: Who is permitted to unlock the pharmacy area or additional restricted drug storage area in a community pharmacy?

Answer 224

A: A pharmacist is the only person permitted by the Board to unlock the pharmacy area or any additional storage area for drugs restricted to access only by a pharmacist, except in an extreme emergency.

Question 225

Q: What is required for the handling of prescription-only drugs and controlled substances received outside the pharmacy area?

Answer 225

A: A pharmacy permittee or pharmacist-in-charge shall ensure that any prescription-only drugs and controlled substances received outside the pharmacy area are immediately transferred unopened to the pharmacy area. The pharmacist-in-charge must ensure that any shipments of prescription-only drugs and controlled substances are opened and marked by pharmacy personnel in the pharmacy area under the supervision of a pharmacist, graduate intern, or pharmacy intern.

Question 226

Q: Can a pharmacy permittee or pharmacist-in-charge use a small opening for prescriptions when the pharmacist is not present?

Answer 226

A: Yes, a pharmacy permittee or pharmacist-in-charge may provide a small opening or slot through which a written prescription order or a prescription medication container to be refilled may be left in the prescription area when the pharmacist is not present.

Question 227

A pharmacist shall ensure that prescription medication is not
left outside the prescription area or picked up by the patient
when the pharmacist is not present by either:

Answer 227

1. Delivering the prescription medication to the patient, or
2. Securing the prescription medication inside the locked
   pharmacy, except when using an automated storage and
   distribution system

Question 228

R4-23-611. Pharmacy Facilities
A. Facilities. A pharmacy permittee or pharmacist-in-charge shall
ensure that:

Answer 228

R4-23-611. Pharmacy Facilities

A. Facilities. A pharmacy permittee or pharmacist-in-charge shall ensure that:

1. Compliance with Laws: A pharmacy’s facilities are constructed according to state and local laws and ordinances.
2. Maintenance and Cleanliness:
   
   • a. Walls, ceilings, windows, floors, shelves, and equipment are clean and in good repair and order.
   • b. Counters, shelves, aisles, and open spaces are not cluttered.
3. Trash Management: Adequate trash receptacles are provided and emptied periodically during the day.
4. Toilet Facilities: For pharmacies issued or remodeled after February 1, 2014:
   
   • a. Access to toilet facilities is provided either within the pharmacy area or no further than 100 feet from the pharmacy area, or an alternative distance approved by the Board or its designee.
5. Sanitary Condition: The toilet facilities are maintained in a sanitary condition and in good repair.
6. Cleanliness of Personnel: All professional personnel and staff of the pharmacy keep themselves and their apparel clean while in the pharmacy area.
7. Animal Policy: No animals, except licensed assistance animals and guard animals, are allowed in the pharmacy.
8. Pest Control: The pharmacy facility is kept free of insects and rodents.
9. Handwashing Facilities: There is a sink with hot and cold running water, other than a sink in a toilet facility, within the pharmacy area for use in preparing drug products.

Question 229

B. Supply of drugs and chemicals. A pharmacy permittee or pharmacist-in-charge shall ensure that:

Answer 229

B. Supply of Drugs and Chemicals. A pharmacy permittee or pharmacist-in-charge shall ensure that:

1. Stock Maintenance:
   
   • a. The pharmacy maintains a stock of drugs and chemicals that is sufficient to meet the normal demands of the trading area or patient base served.
   • b. The stock meets all standards of strength and purity as established by the official compendiums.
2. Contamination Prevention: All stock, materials, drugs, and chemicals held for sale or supply to the consumer are free from contamination.
3. Policies and Procedures:
   
   • a. Policies and procedures are developed, implemented, and complied with to prevent the sale or use of a drug or chemical that:
     
     • i. Exceeds its expiration date.
     • ii. Is deteriorated or damaged due to age, heat, light, cold, moisture, crystallization, chemical reaction, rupture of coating, disintegration, solidification, separation, discoloration, change of odor, precipitation, or other changes as determined by examination.
     • iii. Is improperly labeled.
     • iv. Has a defective container.
     • v. Does not comply with federal law.
4. Availability and Compliance of Policies and Procedures:
   
   • a. The policies and procedures described in subsection (B)(3) are made available in the pharmacy for employee reference and inspection by the Board or its designee.
   • b. The policies and procedures provide:
     
     • i. Regular review of any expiration-dated drug or chemical.
     • ii. Removal to a quarantine area of any drug or chemical that exceeds its expiration date, is deteriorated or damaged, improperly labeled, has a defective container, or does not comply with federal law; such items must not be sold or distributed.
     • iii. Proper destruction or return of any quarantined drug or chemical to its source of supply.

Question 230

R4-23-612. Equipment
A pharmacy permittee or pharmacist-in-charge shall ensure that a pharmacy has the necessary equipment to allow a pharmacist to practice the profession of pharmacy, including the following:

Answer 230

R4-23-612. Equipment

A pharmacy permittee or pharmacist-in-charge shall ensure that a pharmacy has the necessary equipment to allow a pharmacist to practice the profession of pharmacy, including:

1. Refrigeration: Adequate refrigeration equipment dedicated to the storage of drugs and biologicals.
2. Controlled Substance Register: A C-V controlled substance register, if C-V controlled substances are sold without a medical practitioner’s order.
3. Graduates: Graduates in assorted sizes.
4. Mortar and Pestle: One mortar and pestle, unless the pharmacy permittee states in the application that compounding will not be performed in the pharmacy.
5. Spatulas: Spatulas of assorted sizes, including one nonmetallic.
6. Prescription Balance: One Class A prescription balance with weights or an electronic balance of equal or greater accuracy, unless the pharmacy permittee states in the application that compounding will not be performed in the pharmacy.
7. Ointment Tile: One ointment tile or equivalent, unless the pharmacy permittee states in the application that compounding will not be performed in the pharmacy.
8. Regulatory Information: A current hard copy or access to a current electronic copy of the Arizona Pharmacy Act and administrative rules, and the Arizona Controlled Substances Act.
9. Professional Reference Library: A professional reference library consisting of at least one current reference or text, in hard copy or electronic media, addressing:
   
   • a. Pharmacology or toxicology,
   • b. Therapeutics,
   • c. Drug compatibility, and
   • d. Drug product equivalency.
10. Labels: An assortment of labels, including prescription labels, transfer labels for controlled substances, and cautionary and warning labels.
11. Red C Stamp: A red C stamp as defined in R4-23-110, if C-III, C-IV, and C-V controlled substance invoices are not filed separately from other invoices.
12. Antidote and Drug Interaction Information: Current antidote and drug interaction information.
13. Poison Control: The regional poison control phone number prominently displayed in the pharmacy area.

Question 231

Q: What is the procedure for discontinuing the operation of a pharmacy according to R4-23-613?

Answer 231

A: To discontinue the operation of a pharmacy, the permittee or pharmacist-in-charge must follow these steps:

1. Written Notice:
   
   • When: At least 14 days before discontinuing operations.
   • Where: Provide written notice to both the Board and the Drug Enforcement Administration (D.E.A.).
   • Information to Include:
     
     • Pharmacy Information: Name, address, pharmacy permit number, and D.E.A. registration number of the pharmacy discontinuing business.
     • Recipient Information: Name, address, pharmacy permit number (if applicable), and D.E.A. registration number (if applicable) of the licensee, permittee, or registrant who will receive or take over any narcotic or controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical.
     • Record Storage: Name and address of the location where the pharmacy’s records of purchase and disbursement will be kept, and the responsible person. These records must be retained for at least three years from the date the pharmacy is discontinued.
     • Prescription Files and Patient Profiles: Name and address of the location where the pharmacy’s prescription files and patient profiles will be kept, and the responsible person. These records must be maintained for at least seven years from the date the last original or refill prescription was dispensed.
     • Discontinuation Date: The proposed date of discontinuing business operations.
       .
       B. The pharmacy permittee shall ensure that all pharmacy signs
       and symbols are removed from both the inside and outside of
       the premises.
       C. The pharmacy permittee or pharmacist-in-charge shall ensure
       that all state permits and certificates of registration are
       returned to the Board office and that D.E.A. registration certificates and unused D.E.A. Schedule II order forms are returned to the D.E.A. Regional Office in Phoenix

Question 232

Q: What responsibilities does the pharmacist-in-charge have when discontinuing the business of a pharmacy according to R4-23-613?

Answer 232

A: When a pharmacy is discontinuing business, the pharmacist-in-charge must ensure the following:

1. Access Control:
   
   • Only a pharmacist has access to the prescription-only drugs and controlled substances until they are transferred to the licensee, permittee, or registrant specified in the notice.
2. Removal of Drugs:
   
   • All narcotics, controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals must be removed from the premises on or before the date the pharmacy is discontinued.
3. Transfer of Controlled Substances:
   
   • Inventory: Take an inventory of all controlled substances being transferred, following the procedures outlined in R4-23-1003.
   • Documentation: Include a copy of this inventory with the controlled substances being transferred.
   • Record Keeping: Keep the original inventory with the discontinued pharmacy’s records of purchase and disbursement for a minimum of three years from the discontinuation date.
   • D.E.A. Form 222: Use a D.E.A. Form 222 to transfer any Schedule II controlled substances.
   • Destruction: Transfer controlled substances that need to be destroyed in the same manner as all other controlled substances.

Question 233

Q: What should be done with outdated or damaged controlled substances received from a discontinued pharmacy?

Answer 233

A: Upon receipt of outdated or damaged controlled substances from a discontinued pharmacy, the licensee, permittee, or registrant described in subsection (A)(2) must:

1. Contact a D.E.A. Registered Reverse Distributor:
   
   • Reach out to a D.E.A. registered reverse distributor to arrange for the proper destruction of the outdated or damaged controlled substances.
2. If Rejected by the Reverse Distributor:
   
   • If the reverse distributor will not accept certain controlled substances, contact the Board office.
   • Request an inspection from the Board for the purpose of drug destruction.

Question 234

Q: What is required for the retention and provision of records from a discontinued pharmacy?

Answer 234

A: During the three-year record retention period specified in subsection (A)(3):

• The person responsible for the records must:
  
  • Provide the Board with records of the discontinued pharmacy’s purchase and disbursement of narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals upon request.

Question 235

Q: What is required for the retention and provision of prescription files and patient profiles from a discontinued pharmacy?

Answer 235

A: During the seven-year record retention period specified in subsection (A)(4):

• The person responsible for the records must:
  
  • Provide the Board with records of the discontinued pharmacy’s prescription files and patient profiles upon request.

Question 236

A. Before using an automated storage and distribution system, a
pharmacy permittee or pharmacist-in-charge shall:

Answer 236

1. Ensure that the automated storage and distribution system and the policies and procedures comply with subsection
   (B); and
2. Notify the Board in writing of the intent to use an automated storage and distribution system, including the type or name of the system.

Question 237

B. A pharmacy permittee or pharmacist-in-charge shall establish
policies and procedures for appropriate performance and use
of the automated storage and distribution system that:

Answer 237

A: A pharmacy permittee or pharmacist-in-charge shall establish policies and procedures for the automated storage and distribution system that include:

1. Maintenance and Security:
   
   • Ensure the system is in good working order with appropriate recordkeeping and security safeguards.
2. Patient Access System:
   
   • Prescription Handling:
     
     • Only contain prescriptions that do not require oral consultation (as per R4-23-402(B)).
     • Be properly labeled and verified by a pharmacist before placement and release.
   • Patient Choice:
     
     • Allow patients to choose whether to use the system.
   • Location and Security:
     
     • Be located within the pharmacy or within 20 feet of the pharmacy if secured properly against unauthorized removal.
     • Provide a method to identify the patient and release only their prescriptions.
     • Be secure from unauthorized access and removal.
   • Pharmacist Consultation:
     
     • Provide a method for patients to request consultation with a pharmacist.
   • Oral Counseling Requirement:
     
     • Not dispense refilled prescriptions if oral counseling is required by a pharmacist (as per R4-23-402(B)).
3. Authorized Personnel Access System:
   
   • Security:
     
     • Ensure adequate security to prevent unauthorized access to drugs or devices.
   • Filling and Restocking:
     
     • Allow only Board licensees or other authorized licensed personnel to fill, stock, or restock the system.
4. Quality Assurance:
   
   • Implement an ongoing quality assurance program to monitor compliance with policies, procedures, and relevant laws.

Question 238

Q: What are the responsibilities of a pharmacy permittee or pharmacist-in-charge regarding the policies and procedures for an automated storage and distribution system?

Answer 238

A: The pharmacy permittee or pharmacist-in-charge shall:

Ensure Compliance:

Ensure that the policies and procedures required for the automated storage and distribution system are prepared, implemented, and complied with.
Review and Revise:

Review these policies and procedures biennially and revise them if necessary.
Document Review:

Document the review of the policies and procedures.
Manual Assembly:

Assemble the policies and procedures into a written or electronic manual.
Accessibility:

Make the manual available for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside the pharmacy where the automated system is used.

Question 239

Q: What actions can the Board take if there is non-compliance with the automated storage and distribution system requirements?

Answer 239

A: The Board may prohibit the pharmacy permittee or pharmacist-in-charge from using the automated storage and distribution system if the permittee or the pharmacy’s employees do not comply with the specified requirements.

Question 241

Q: What are the requirements for a mechanical storage and counting device used for drugs in solid, oral dosage form in a pharmacy?

Answer 241

A: The pharmacy permittee or pharmacist-in-charge shall ensure that the mechanical storage and counting device complies with the following:

Identification of Contents: The drug name and strength must be affixed to the front of each cell or cassette of the device.
.
Log Requirements:

Maintain a paper or electronic log for each cell or cassette, which includes:
Identification: Drug name and strength or the cell/cassette number.
Manufacturer Information: Drug’s manufacturer or National Drug Code (NDC) number.
Expiration Details: Expiration date and lot number from the manufacturer’s stock bottle. If multiple lot numbers are used, document each lot number and expiration date, with the earliest expiration date being used for the mixed lot.
Filling Date: The date the cell or cassette is filled.
Filler’s Identity: Documentation of the identity of the licensee who placed the drug into the cell or cassette.
Supervisor’s Identity: If the filler is not a pharmacist, document the identity of the pharmacist who supervised the non-pharmacist licensee.
.
Log Availability:
Ensure the paper or electronic log is available in the pharmacy for inspection by the Board or its designee for at least two years.

Question 242

Q: What are the regulations regarding the handling of drugs previously counted by a mechanical storage and counting device in a pharmacy?

Answer 242

A: The pharmacy permittee or pharmacist-in-charge shall ensure the following:

Return Restrictions:

Any drug that has been counted by a mechanical storage and counting device and has not left the pharmacy cannot be returned to the drug’s cell, cassette, or stock bottle unless the drug return method is approved by the Board or its designee as specified in subsection (G).
.
Alternative Counting Methods:

The restriction does not prevent the use of manual or mechanical counting devices to count and dispense a previously counted drug, provided that: The drug has not left the pharmacy.
The drug is dispensed before its beyond-use-date.

Question 243

A pharmacy permittee or pharmacist-in-charge shall ensure
the accuracy of any mechanical storage and counting device
for a drug in a solid, oral dosage form that is used by a pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist by documenting completion of the following:

Answer 243

1. Training in the maintenance, calibration, and use of the
   mechanical storage and counting device for each
   employee who uses the mechanical storage and counting
   device;
2. Maintenance and calibration of the mechanical storage
   and counting device as recommended by the device’s
   manufacturer; and
3. Routine quality assurance and accuracy validation testing
   for each mechanical storage and counting device.

Question 244

Q: What responsibilities does a pharmacy permittee or pharmacist-in-charge have regarding the policies and procedures for using a mechanical storage and counting device for drugs in solid, oral dosage form?

Answer 244

A: The pharmacy permittee or pharmacist-in-charge shall:

1. Prepare, Implement, and Comply:
   
   • Ensure that policies and procedures for the performance and use of the mechanical storage and counting device are prepared, implemented, and complied with.
2. Biennial Review and Revision:
   
   • Review the policies and procedures biennially and revise them if necessary.
3. Document the Review:
   
   • Document the review required under subsection (2).
4. Assemble Policies:
   
   • Assemble the policies and procedures into a written or electronic manual.
5. Make Policies Available:
   
   • Ensure that the policies and procedures are available within the pharmacy for employee reference and inspection by the Board or its staff.

Question 245

Q: What responsibilities does a pharmacy permittee or pharmacist-in-charge have regarding the policies and procedures for using a mechanical storage and counting device for drugs in solid, oral dosage form?

Answer 245

A: The pharmacy permittee or pharmacist-in-charge shall:

1. Prepare, Implement, and Comply:
   
   • Ensure that policies and procedures for the performance and use of the mechanical storage and counting device are prepared, implemented, and complied with.
2. Biennial Review and Revision:
   
   • Review the policies and procedures biennially and revise them if necessary.
3. Document the Review:
   
   • Document the review required under subsection (2).
4. Assemble Policies:
   
   • Assemble the policies and procedures into a written or electronic manual.
5. Make Policies Available:
   
   • Ensure that the policies and procedures are available within the pharmacy for employee reference and inspection by the Board or its staff.

Question 246

Q: What steps must a pharmacy permittee or pharmacist-in-charge follow to return a drug previously counted by a mechanical storage and counting device to the drug’s cell or cassette?

Answer 246

A: To return a drug previously counted by a mechanical storage and counting device that has not left the pharmacy to the drug’s cell or cassette, a pharmacy permittee or pharmacist-in-charge must:

Apply for Board Approval:

Apply for approval from the Board or its designee for the drug return method.
Develop a Drug Return Method:

Develop a drug return method that utilizes technology, such as bar coding, to prevent drug return errors.
Provide Documentation:

Provide documentation that depicts the drug return method.
Demonstrate the Method:

Demonstrate the drug return method to a Board Compliance Officer.
Receive Board Approval:

Receive approval from the Board or its designee for the drug return method.

Question 247

R4-23-616. Mechanical Counting Device for a Drug in Solid,
Oral Dosage Form
A. A pharmacy permittee or pharmacist-in-charge shall ensure
the accuracy of any mechanical counting device for a drug in a
solid, oral dosage form that is used by a pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist by documenting completion of the following:

Answer 247

1. Training in the maintenance, calibration, and use of the
   mechanical counting device for each employee who uses
   the mechanical counting device;
2. Maintenance and calibration of the mechanical counting
   device as recommended by the device’s manufacturer;
   and
3. Routine quality assurance and accuracy validation testing
   for each mechanical counting device

Question 248

R4-23-616. Mechanical Counting Device for a Drug in Solid,
Oral Dosage Form
.
C. A pharmacy permittee or pharmacist-in-charge shall:

Answer 248

1. Ensure that policies and procedures for the performance
   and use of a mechanical counting device for a drug in a
   solid, oral dosage form are prepared, implemented, and
   complied with;
2. Review biennially and, if necessary, revise the policies
   and procedures required under subsection (C)(1);
3. Document the review required under subsection (C)(2);
4. Assemble the policies and procedures as a written or electronic manual; and
5. Make the policies and procedures available within the
   pharmacy for employee reference and inspection by the
   Board or its staff.

Question 249

R4-23-617. Temporary Pharmacy Facilities or Mobile Pharmacies
A. Pharmacies located in declared disaster areas, nonresident
pharmacies, and pharmacies licensed or permitted in another
state but not licensed or permitted in this state, if necessary to
provide pharmacy services during a declared state of emergency, may arrange to temporarily locate to a temporary pharmacy facility or mobile pharmacy or relocate to a temporary pharmacy facility or mobile pharmacy if the pharmacist-incharge of the temporary pharmacy facility or mobile pharmacy ensures that:

Answer 249

1. The pharmacy is under the control and management of
   the pharmacist-in-charge or a supervising pharmacist designated by the pharmacist-in-charge;
2. The pharmacy is located within or adjacent to the
   declared disaster area;
3. The Board is notified of the pharmacy’s location;
4. The pharmacy is properly secured to prevent theft and
   diversion of drugs;
5. The pharmacy’s records are maintained in accordance
   with Arizona statutes and rules; and
6. The pharmacy stops providing pharmacy services when
   the declared state of emergency ends, unless it possesses
   a current resident pharmacy permit issued by the Board
   .
   Note: A mobile pharmacy, placed in operation during a declared state of emergency, shall not operate permanently.

Question 250

R4-23-620. Continuous Quality Assurance Program
A. Each pharmacy permittee shall implement or participate in a
continuous quality assurance (CQA) program. A pharmacy
permittee meets the requirements of this Section if it holds a
current general, special or rural general hospital license from
the Arizona Department of Health Services and is any of the
following:

Answer 250

1. Certified by the Centers for Medicare and Medicaid Services to participate in the Medicare or Medicaid programs;
2. Accredited by the Joint Commission on the Accreditation
   of Healthcare Organizations; or
3. Accredited by the American Osteopathic Association.

Question 251

R4-23-620. Continuous Quality Assurance Program
.
B. A pharmacy permittee or the pharmacist-in-charge shall ensure that:

Answer 251

1. The pharmacy develops, implements, and utilizes a CQ
   program consistent with the requirements of this Section
   and A.R.S. § 32-1973;
2. The medication error data generated by the CQA program
   is utilized and reviewed on a regular basis, as required by
   subsection (D); and
3. Training records, policies and procedures, and other program records or documents, other than medication error
   data, are maintained for a minimum of two years in the
   pharmacy or in a readily retrievable manner.
   .
   A pharmacy permittee or pharmacist-in-charge shall:
4. Ensure that policies and procedures for the operation and
   management of the pharmacy’s CQA program are prepared, implemented, and complied with;
5. Review biennially and, if necessary, revise the policies
   and procedures required under subsection (C)(1);
6. Document the review required under subsection (C)(2);
7. Assemble the policies and procedures as a written or electronic manual; and
8. Make the policies and procedures available within the
   pharmacy for employee reference and inspection by the
   Board or its staff.

Question 252

R4-23-620. Continuous Quality Assurance Program
.
The policies and procedures shall address a planned process
to:

Answer 252

1. Train all pharmacy personnel in relevant phases of the
   CQA program;
2. Identify and document medication errors;
3. Record, measure, and analyze data collected to:
   a. Assess the causes and any contributing factors relating to medication errors, and
   b. Improve the quality of patient care;
4. Utilize the findings from subsections (D)(2) and (3) to
   develop pharmacy systems and workflow processes
   designed to prevent or reduce medication errors; and
5. Communicate periodically, and at least annually, with
   pharmacy personnel to review CQA program findings
   and inform pharmacy personnel of any changes made to
   pharmacy policies, procedures, systems, or processes as a result of CQA program findings

Question 253

Q: What must a pharmacy have before participating in shared services?

Answer 253

Before participating in shared services, a pharmacy shall have
either a current resident or non-resident pharmacy permit
issued by the Board

Question 254

B. A pharmacy may provide or utilize shared services functions
only if the pharmacies involved:

Answer 254

1. Have the same owner, or
2. Have a written contract or agreement that outlines the services provided and the shared responsibilities of each
   party in complying with federal and state pharmacy statutes and rules, and
3. Share a common electronic file or technology that allows
   access to information necessary or required to perform
   shared services in conformance with the pharmacy act
   and the Board’s rules.

Question 255

R4-23-621. Shared Services
.
C. Notifications to patients.
1. Before using shared services provided by another pharmacy, a pharmacy permittee shall:

Answer 255

a. Notify patients that their orders may be processed or
filled by another pharmacy; and
b. Provide the name of that pharmacy or, if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies
may process or fill the order, notify the patient of
this fact. The notification may be provided through a
one-time written notice to the patient or through use
of a sign in the pharmacy.

Question 257

Q: What information must a filling pharmacy permittee ensure is included with a prescription delivered directly to the patient when utilizing shared services?

Answer 257

A: The filling pharmacy permittee must ensure the following is provided:
1. Contact Information:
- The local and, if applicable, the toll-free telephone number of the pharmacy utilizing shared services that has access to the patient’s records.

2. Patient Information Statement:
   
   • A statement that reads:
     
     • “Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the local and toll-free telephone numbers of the pharmacy utilizing shared services that has access to the patient’s records).”

Question 258

Q: What are the responsibilities of a pharmacy permittee engaged in shared services?

Answer 258

A: A pharmacy permittee engaged in shared services must:

1. Maintain Records:
   
   • Keep manual or electronic records identifying, for each order processed, the name, initials, or identification code of each individual involved in:
     
     • Order interpretation
     • Order entry verification
     • Drug utilization review
     • Drug compatibility and drug allergy review
     • Final order verification
     • Therapeutic intervention
     • Refill authorization
2. Filling and Dispensing Records:
   
   • Keep manual or electronic records identifying, for each order filled or dispensed, the name, initials, or identification code of each individual involved in:
     
     • Filling
     • Dispensing
     • Counseling
3. Report Disciplinary Actions:
   
   • Report to the Board as soon as practical any disciplinary actions taken by another state’s pharmacy regulatory agency involving shared services.
4. Track Orders:
   
   • Maintain a mechanism for tracking orders during each step of the processing and filling procedures.
5. Protect Patient Information:
   
   • Provide adequate security to protect the confidentiality and integrity of patient information.
6. Provide Access to Records:
   
   • Ensure that any required record or information is available for inspection by the Board or its designee within 72 hours of request.

Question 259

Each pharmacy permittee that provides or utilizes shared services shall develop, implement, review, revise, and comply
with joint policies and procedures for shared services in the
manner described in R4-23-610(A)(2). Each pharmacy permittee is required to maintain only those portions of the joint policies and procedures that relate to that pharmacy’s operations.
The policies and procedures shall:

Answer 259

1. Outline the responsibilities of each of the pharmacies;
2. Include a list of the name, address, telephone numbers,
   and all license and permit numbers of the pharmacies
   involved in shared services; and
3. Include policies and procedures for:
   a. Notifying patients that their orders may be processed
   or filled by another pharmacy and providing the name of that pharmacy;
   b. Protecting the confidentiality and integrity of patient
   information;
   c. Dispensing orders when the filled order is not
   received or the patient comes in before the order is
   received;
   d. Maintaining required manual or electronic records to
   identify the name, initials, or identification code and
   specific activity or activities of each pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee who performed any shared services;
   e. Complying with federal and state laws; and
   f. Operating a continuous quality improvement program for shared services, designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

Question 260

Q: Can an individual pharmacist or pharmacy staff access a pharmacy’s electronic database from outside the pharmacy?

Answer 260

A: Yes, an individual pharmacist licensed in Arizona, or an Arizona-licensed graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee working under the pharmacist’s supervision, can access the pharmacy’s electronic database from inside or outside the pharmacy to perform order processing functions permitted by the pharmacy act. However, this is allowed only if:

1. Controls are Established:
   
   • The pharmacy establishes controls to protect the confidentiality and integrity of patient information.
2. No Duplication or Removal:
   
   • None of the database is duplicated, downloaded, or removed from the pharmacy’s electronic database.

Question 261

Hospital Pharmacy Permit
A. The following rules are applicable to all hospitals

Question 262

. Each hospital pharmacy shall be directed by a pharmacist who
is licensed to engage in the practice of pharmacy in Arizona
and is referred to as the Director of Pharmacy. The Director of
Pharmacy shall be the pharmacist-in-charge, as defined in
A.R.S. § 32-1901 or shall appoint a pharmacist-in-charge. The
Director of Pharmacy and the pharmacist-in-charge, if a different individual, shall:

Answer 262

1. Be responsible for all the activities of the hospital pharmacy and for meeting the requirements of the Arizona
   Pharmacy Act and these rules;
2. Ensure that the policies and procedures required by these
   rules are prepared, implemented, and complied with;
3. Review biennially and, if necessary, revise the policies
   and procedures required under these rules;
4. Document the review required under subsection (A)(3);
5. Assemble the policies and procedures as a written manual
   or by another method approved by the Board or its designee; and
6. Make the policies and procedures available within the
   pharmacy for employee reference and inspection by the
   Board or its designee

Question 263

Q: What are the requirements for pharmacist coverage in hospitals?

Answer 263

A: The requirements for pharmacist coverage in hospitals are as follows:

1. Pharmacist Presence:
   
   • A pharmacist must be present in the hospital during the time the pharmacy is open for pharmacy services, except in extreme emergencies as defined in R4-23-110.
2. Minimum Hours of Operation:
   
   • Pharmacy services must be provided for a minimum of 40 hours per week. If a hospital needs to operate for fewer hours, it must request an exception in writing from the Board or its designee.
3. On-Call Requirement:
   
   • In hospitals where the pharmacy is not open 24 hours a day, a pharmacist must be “on-call” as defined in R4-23-651 when the pharmacy is closed.

Question 264

Hospital Pharmacy

Pharmacists. A pharmacist or a pharmacy intern or graduate
intern under the supervision of a pharmacist shall perform the
following professional practices:

Answer 264

A: A pharmacist in a hospital setting is responsible for the following tasks:

1. Medication Order Verification:
   
   • Verify a patient’s medication order before administration, except:
     
     • In an emergency medical situation; or
     • In a hospital where the pharmacy is open less than 24 hours a day, verify within four hours of the pharmacy opening.
2. Feasibility Verification:
   
   • Assess the medication order’s pharmaceutical and therapeutic feasibility based on:
     
     • The patient’s medical condition,
     • The patient’s allergies,
     • Pharmaceutical and therapeutic incompatibilities,
     • Recommended dosage limits.
3. Drug Preparation:
   
   • Measure, count, pour, or otherwise prepare and package a drug needed for dispensing. Pharmacy technicians or trainees may perform these tasks under the pharmacist’s supervision as per approved policies.
4. Drug Compounding:
   
   • Compound, admix, combine, or otherwise prepare and package a drug needed for dispensing. Pharmacy technicians may perform these tasks under the pharmacist’s supervision as per approved policies.
5. Verification of Drug Preparation:
   
   • Verify the accuracy, procedure, and safety of drugs prepared and packaged by pharmacy technicians or trainees according to approved policies.
6. Repackaging Supervision:
   
   • Supervise drug repackaging and check the completed repackaged product.
7. Training and Education:
   
   • Supervise training and education in aseptic techniques and drug incompatibilities for personnel involved in parenteral admixtures.
8. Consultation with Medical Practitioners:
   
   • Consult with medical practitioners regarding the patient’s drug therapy or medical condition.
9. Patient Consultation:
   
   • Provide consultation to patients, their agents, or when deemed necessary, regarding medication orders, patient profiles, or overall drug therapy.
10. Drug Therapy Monitoring:
    
    • Monitor a patient’s drug therapy for safety and effectiveness.
11. Drug Information Provision:
    
    • Provide drug information to patients and healthcare professionals.
12. Management of Personnel:
    
    • Manage pharmacy technicians, trainees, and other personnel to ensure accurate and safe performance of all activities.
13. Medication Order Accuracy:
    
    • Verify the accuracy of all aspects of the original and completed medication orders.
14. Quality Assurance:
    
    • Ensure compliance by pharmacy personnel with the hospital’s quality assurance program.

Question 265

Hopsital Pharamcy

Q: What are the requirements for a pharmacy technician training program in a hospital pharmacy?

Answer 265

A: The requirements for a pharmacy technician training program are as follows:

1. Director of Pharmacy or Pharmacist-in-Charge Responsibilities:
   
   • The Director of Pharmacy or pharmacist-in-charge must comply with the training program requirements outlined in R4-23-1105, tailored to the specific needs of the hospital pharmacy.
2. Pharmacy Technician or Trainee Responsibilities:
   
   • Tasks and Training:
     
     • Perform only those tasks for which they have demonstrated training and competency.
   • Restrictions:
     
     • Do not perform professional practices reserved for a pharmacist, graduate intern, or pharmacy intern, except as specified in subsections (E)(3) and (4).

Question 266

Q: What are the supervision requirements for a hospital pharmacy?

Answer 266

A: The supervision requirements for a hospital pharmacy are as follows:

1. Director of Pharmacy and Pharmacist-in-Charge:
   
   • The Director of Pharmacy and the pharmacist-in-charge (if they are different individuals) must supervise all activities and operations of the hospital pharmacy.
2. Pharmacist Supervision:
   
   • A pharmacist must oversee all functions and activities performed by pharmacy technicians, pharmacy technician trainees, and other hospital pharmacy personnel.
   • This supervision ensures that all functions and activities are carried out competently, safely, and without risk of harm to patients.

Question 267

Q: What are the requirements for a hospital pharmacy when a pharmacist is absent?

Answer 267

A: When a pharmacist is absent from the hospital, the following requirements must be met:

1. Access to Drugs:
   
   • Before the pharmacist’s absence, the Director of Pharmacy or pharmacist-in-charge must arrange for the medical staff and authorized personnel to have access to drugs in:
     
     • The remote drug storage area, or
     • The hospital pharmacy if a drug is not available in the remote storage area and is needed to treat a patient’s immediate needs.
   • A pharmacist must be on-call during the absence.
2. Telephone Access:
   
   • If the pharmacist is not on duty in the hospital pharmacy, the Director of Pharmacy or pharmacist-in-charge must ensure that medical staff and authorized personnel have telephone access to an on-call pharmacist.
3. Pharmacist Duty:
   
   • The hospital pharmacy permittee must ensure that the hospital pharmacy is not without a pharmacist on duty for more than 72 consecutive hours.

Question 268

Remote drug storage area. The Director of Pharmacy or pharmacist-in-charge shall, in consultation with the appropriate
committee of the hospital:

Answer 268

1. Develop and maintain an inventory listing of the drugs to
   be included in a remote drug storage area; and
2. Develop, implement, review, and revise in the same manner described in R4-23-653(A) and comply with policies
   and procedures that ensure proper storage, access, and
   accountability for drugs in a remote drug storage area.

Question 269

Q: What are the requirements for ensuring access to the hospital pharmacy during a pharmacist’s absence?

Answer 269

A: The Director of Pharmacy or pharmacist-in-charge must ensure that access to the hospital pharmacy during the pharmacist’s absence meets the following requirements:

1. Access Delegation:
   
   • Access is delegated to only one supervisory nurse per shift.
2. Communication:
   
   • The policy and the name of the supervisory nurse are communicated in writing to the medical staff of the hospital.
3. Training:
   
   • Access is only granted to a nurse who has received training from the Director of Pharmacy, pharmacist-in-charge, or the Director’s designee on proper access procedures, drug removal, and recordkeeping.
4. Emergency Access:
   
   • The supervisory nurse may delegate access to another nurse only in an emergency.

Question 270

Q: What steps must a nurse take when removing a drug from the hospital pharmacy during the pharmacist’s absence?

Answer 270

A: When a nurse removes a drug from the hospital pharmacy, they must:

Record Information:

Document the following on a form or by another method approved by the Board or its designee:
Patient’s name.
Drug name, strength, and dosage form.
Quantity of drug removed.
Date and time of removal.
Sign the Form:

Sign or initial the form recording the drug removal, provided there is a corresponding signature on file in the hospital pharmacy.
Attach Medication Order:

Attach the original or a direct copy of the medication order for the drug to the form recording the drug removal.
Place the Form:

Place the form recording the drug removal in a conspicuous location within the hospital pharmacy.

Question 271

Q: What must a pharmacist do upon returning from an absence?

Answer 271

A: Within four hours after returning, the pharmacist must verify all records of drug removal that occurred during their absence according to R4-23-653(E).

Question 272

Q: What is the minimum area requirement for a hospital pharmacy?

Answer 272

A:

• For any hospital pharmacy permit issued or hospital pharmacy remodeled after January 31, 2003, the minimum area primarily devoted to drug dispensing and preparation functions must be at least 500 square feet.
• This area requirement excludes bulk drug storage, satellite pharmacy, and office areas.
• The minimum area requirement may be varied upon approval by the Board for out-of-the-ordinary conditions or systems that require less space.

Question 273

Q: Under what circumstances may the Board require a hospital pharmacy permittee or applicant to provide more than the minimum area?

Answer 273

A:

1. Crowding Issues: If equipment, inventory, personnel, or other factors cause crowding to a degree that interferes with safe pharmacy practice.
2. Increased Use of Drugs: If there is an increased number of specific drugs prescribed per day, increased use of intravenous and irrigating solutions, or increased use of disposable and prepackaged products.
3. Special Requirements: If additional areas are needed to handle investigational drugs, emergency drug kits, chemotherapeutics, alcohol and other flammables, poisons, external preparations, radioisotopes, or to accommodate quality control procedures.
4. Additional Office Space: If there is a need for more space for increased personnel, a drug information library, a poison information library, research support, teaching and conferences, or a waiting area.

Question 274

Q: What are the requirements for the hospital pharmacy area and storage areas?

Answer 274

1. Hospital Pharmacy Area:
   
   • The hospital pharmacy area must be enclosed by a permanent barrier or partition extending from floor to ceiling.
   • Entry doors must be securely lockable.
   • Construction must comply with the specifications outlined in R4-23-609(F).
2. Hospital Pharmacy Storage Areas:
   
   • All undispensed or undistributed drugs must be stored in designated areas within the hospital pharmacy or other locked areas controlled by a pharmacist.
   • These areas must ensure proper:
     
     • Sanitation
     • Temperature control
     • Light control
     • Ventilation
     • Moisture control
     • Segregation
     • Security

Question 275

Q: What are the sanitation and equipment requirements for a hospital pharmacy?

Answer 275

A:

1. Professional Reference Library:
   
   • The hospital pharmacy must have a professional reference library consisting of hard-copy or electronic media that is appropriate for the scope of pharmacy services provided by the hospital.
2. Sink:
   
   • The pharmacy must have a sink (not in a toilet facility) with:
     
     • Hot and cold running water.
     • Located within the hospital pharmacy area for preparing drug products.
     • Maintained in a sanitary condition and in good repair.
3. Room Temperature:
   
   • The pharmacy must maintain a room temperature within a range compatible with the proper storage of drugs.
4. Refrigerator and Freezer:
   
   • The pharmacy must have:
     
     • A refrigerator and freezer.
     • Temperature must be maintained within ranges suitable for the proper storage of drugs requiring refrigeration or freezing.
5. Sterile Product Preparation Area:
   
   • The pharmacy must have a designated area for a laminar air flow hood and other supplies required for the preparation of sterile products, as specified in R4-23-670.

Question 276

Q: What are the personnel security standards for a hospital pharmacy?

Answer 276

A:

1. Pharmacy Access:
   
   • No one is allowed in the pharmacy unless a pharmacist is present, except as outlined in this section and R4-23-654.
   • If the only pharmacist on duty must leave for an emergency or patient care, non-pharmacist personnel may remain in the pharmacy to perform specific duties as described in R4-23-653.
   • All C-II controlled substances must be secured to prevent access by anyone other than a pharmacist, and the pharmacist must remain available in the hospital.
2. Security of Pharmacy Areas:
   
   • All areas of the hospital pharmacy must be locked using keys or programmable locks to prevent access by unauthorized personnel.
3. Identification Badges:
   
   • Pharmacists, pharmacy or graduate interns, pharmacy technicians, pharmacy technician trainees, and other personnel working in the pharmacy must wear identification badges that display their name and position while on duty.

Question 277

Q: What are the requirements for prescription blank security in a hospital pharmacy?

Answer 277

A:

• Policy Development and Implementation:
  
  • The Director of Pharmacy must develop, implement, review, and revise policies and procedures for the safe distribution and control of prescription blanks bearing the hospital’s identification5959

Question 278

R4-23-658. Drug Distribution and Control
.
Responsibility. The Director of Pharmacy is responsible for
the safe and efficient procurement, dispensing, distribution,
administration, and control of drugs, including the following:

Answer 278

1. In consultation with the appropriate department personnel
   and medical staff committee, develop a medication formulary for the hospital;
2. Proper handling, distribution, and recordkeeping of
   investigational drugs; and
3. Regular inspections of drug storage and preparation areas
   within the hospital.

Question 279

R4-23-658. Drug Distribution and Control
.
C. Physician orders. A Director of Pharmacy or pharmacist-incharge shall ensure that:

Answer 279

1. Drugs are dispensed from the hospital pharmacy only
   upon a written order, direct copy or facsimile of a written
   order, or verbal order of an authorized medical practitioner; and
2. A pharmacist reviews the original, direct or facsimile
   copy, or verbal order before an initial dose of medication
   is administered,

Question 280

D. Labeling. A Director of Pharmacy or pharmacist-in-charge
shall ensure that all drugs distributed or dispensed by a hospital pharmacy are packaged in appropriate containers and
labeled as follows:
1. For use inside the hospital.
a. Labels for all single unit packages contain at a minimum, the following information:

Answer 280

i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date; and
iii. Appropriate auxiliary labels

Question 281

D. Labeling. A Director of Pharmacy or pharmacist-in-charge
shall ensure that all drugs distributed or dispensed by a hospital pharmacy are packaged in appropriate containers and
labeled as follows:
1. For use inside the hospital.
b. Labels for repackaged preparations contain at a minimum the following information:

Answer 281

b. Labels for repackaged preparations contain at a minimum the following information:
i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date;
iii. Appropriate auxiliary labels; and
iv. Mechanism to identify pharmacist accountable
for repackaging

Question 282

D. Labeling. A Director of Pharmacy or pharmacist-in-charge
shall ensure that all drugs distributed or dispensed by a hospital pharmacy are packaged in appropriate containers and
labeled as follows:
1. For use inside the hospital.
c. Labels for all intravenous admixture preparations
contain at a minimum the following information:

Answer 282

c. Labels for all intravenous admixture preparations
contain at a minimum the following information:
i. Patient’s name and location;
ii. Name and quantity of the basic parenteral solution;
iii. Name and amount of drug added;
iv. Date of preparation;
v. Beyond-use-date and time;
vi. Guidelines for administration;
vii. Appropriate auxiliary label or precautionary
statement; and
viii. Initials of pharmacist responsible for admixture
preparation

Question 284

Q: What are the requirements for dispensing drugs from the emergency services department of a hospital when the pharmacy is unable to provide this service?

Answer 284

• Policies and Procedures:
  
  • Develop, implement, review, and revise written policies and procedures for dispensing drugs for outpatient use from the emergency services department, in accordance with R4-23-653(A).
• Dispensing Requirements:
  
  1. Patient Admission: Drugs are dispensed only to patients admitted to the emergency services department.
  2. Authorized Personnel: Drugs are dispensed only by an authorized medical practitioner, not a designee or agent.
  3. Drug Selection: The drugs available for dispensing should meet the immediate needs of patients treated in the hospital.
  4. Quantity: Drugs are dispensed in quantities sufficient only until outpatient pharmacy services are available.
  5. Prepackaging: Drugs are prepackaged by a pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under a pharmacist’s supervision. Containers must be suitably labeled with the drug name, strength, dosage form, quantity, manufacturer, lot number, beyond-use date, and any necessary auxiliary labels.
  6. Labeling: Upon dispensing, the authorized medical practitioner must complete the label on the prescription container as per R4-23-658(D) requirements.
  7. Documentation: Maintain a dispensing log, hardcopy prescription, or electronic record, approved by the Board or its designee, including:
     
     • Patient name and address
     • Drug name, strength, dosage form, quantity
     • Directions for use
     • Medical practitioner’s signature or identification code
     • DEA registration number, if applicable

Question 285

Q: What are the requirements and procedures for a hospital to allow self-administration of medications by a patient?

Answer 285

A: A hospital must have policies and procedures for self-administration developed, implemented, reviewed, and revised by the Director of Pharmacy or pharmacist-in-charge, in consultation with appropriate department personnel and the medical staff committee. The policies must comply with R4-23-653(A). Self-administration of medications is allowed only if:
1. It is specifically ordered by a medical practitioner.
2. The patient is educated and trained in the proper manner of self-administration.

Question 286

When policy allows the administration of a patientowned drug, the drug is not administered to the patient
unless:

Answer 286

a. A pharmacist or medical practitioner identifies the
drug, and
b. A medical practitioner writes a medication order
specifying administration of the identified patientowned drug

Question 287

2. If a patient-owned drug will not be used during the
   patient’s hospitalization, the hospital pharmacy’s personnel shall:

Answer 287

a. Package, seal, and give the drug to the patient’s
agent for removal from the hospital; or
b. Package, seal, and store the drug for return to the
patient at the time of discharge from the hospital.

Question 288

Q: What is the responsibility of the Director of Pharmacy or pharmacist-in-charge regarding drug samples in a hospital?

Answer 288

A: The Director of Pharmacy or pharmacist-in-charge is responsible for the receipt, storage, distribution, and accountability of drug samples within the hospital. This includes developing, implementing, reviewing, and revising policies and procedures for drug samples, in compliance with R4-23-653(A).

Question 289

Q: What information concerning an investigational drug must be available to hospital personnel?

Answer 289

A: The following information must be available:

Composition
Pharmacology
Adverse reactions
Administration guidelines
All other available information concerning the drug

Question 290

Q: What are the requirements for the handling of investigational drugs in a hospital?

Answer 290

An investigational drug is:
a. Properly stored in, labeled, and dispensed from the
pharmacy, and
b. Not dispensed before the drug is approved by the
appropriate medical staff committee of the hospital.

Question 291

Q: What are the requirements for the sterile pharmaceutical product compounding area in a pharmacy?

Answer 291

A: The sterile pharmaceutical product compounding area must:

• Be at least 100 square feet of contiguous floor area, unless the pharmacy was issued a permit or remodeled before November 1, 2006, in which case it can be 60 square feet until ownership changes or remodeling occurs.
• Be dedicated to the preparation and compounding of sterile pharmaceutical products.
• Be isolated from other pharmacy functions.
• Restrict entry or access.
• Be free from unnecessary disturbances in air flow.
• Have non-porous and cleanable floor, wall, and ceiling materials.
• Meet the minimum air cleanliness standards of an ISO Class 7 environment, unless all compounding occurs within an ISO Class 5 environment isolator.

Question 292

Q: What exceptions are there to the ISO Class 7 environment requirement for sterile pharmaceutical product compounding?

Answer 292

A: An ISO Class 7 environment is not required if all sterile pharmaceutical product compounding occurs within an ISO Class 5 environment isolator, such as a glove box, pharmaceutical isolator, barrier isolator, pharmacy isolator, or hospital pharmacy isolator.

Question 293

Q: What equipment must a pharmacy have before compounding a sterile pharmaceutical product?

Answer 293

A: In addition to the equipment requirements in R4-23-611 and R4-23-612 or R4-23-656, a pharmacy must ensure that a pharmacist who compounds sterile pharmaceutical products has:

• Environmental control devices capable of maintaining an “ISO Class 5 environment” (e.g., laminar airflow hoods, HEPA filtered zonal airflow devices, glove boxes, pharmaceutical isolators, barrier isolators, pharmacy isolators, hospital pharmacy isolators, biological safety cabinets).
• Disposal containers for needles, syringes, and other materials used in compounding sterile products, with separate containers for cytotoxic, chemotherapeutic, and infectious waste if applicable.
• Freezer storage units with thermostatic control and thermometer, if applicable.

Question 295

Q: What additional equipment and resources are required for compounding sterile pharmaceutical products?

Answer 295

A: Additional requirements include:

• Packaging or delivery containers capable of maintaining official compendial drug storage conditions.
• Infusion devices and accessories, if applicable.
• A current reference pertinent to the preparation of sterile pharmaceutical products, in addition to the reference library requirements of R4-23-612

Question 296

Before compounding a sterile pharmaceutical product, the
pharmacy permittee, limited-service pharmacy permittee, or
pharmacist-in-charge shall:

Answer 296

1. Prepare, implement, and comply with policies and procedures for compounding and dispensing sterile pharmaceutical products,
2. Review biennially and if necessary revise the policies and
   procedures required under subsection (C)(1),
3. Document the review required under subsection (C)(2),
4. Assemble the policies and procedures as a written manual
   or by another method approved by the Board or its designee, and
5. Make the policies and procedures available in the pharmacy for employ

Question 297

R4-23-670. Sterile Pharmaceutical Products.
.
The assembled policies and procedures shall include, where
applicable, the following subjects:

Answer 297

1. Supervisory controls and verification procedures to
   ensure the quality and safety of sterile pharmaceutical
   products;
2. Clinical services and drug monitoring procedures for:
   a. Patient drug utilization reviews;
   b. Inventory audits;
   c. Patient outcome monitoring;
   d. Drug information; and
   e. Education of pharmacy and other health professionals;
3. Controlled substances;
4. Supervisory controls and verification procedures for:
   a. Cytotoxics handling, storage, and disposal;
   b. Disposal of unused supplies and pharmaceutical
   products; and
   c. Handling and disposal of infectious wastes;
5. Pharmaceutical product administration, including guidelines for the first dosing of a pharmaceutical product;
6. Drug and component procurement;
7. Pharmaceutical product compounding, dispensing, and
   storage;
8. Duties and qualifications of professional and support
   staff;
9. Equipment maintenance;
10. Infusion devices and pharmaceutical product delivery
    systems;
11. Investigational drugs and their protocols;
12. Patient profiles;
13. Patient education and safety;
14. Quality management procedures for:
    a. Adverse drug reactions;
    b. Drug recalls
    c. Expired pharmaceutical products;
    d. Beyond-use-dating for both standard-risk and substantial-risk sterile pharmaceutical products consistent with the requirements of R4-23-410(B)(3)(d);
    e. Temperature and other environmental controls;
    f. Documented process and product validation testing;
    and
    g. Semi-annual certification of the laminar air flow
    hood or other ISO class 5 environment, other equipment, and the ISO class 7 environment, including
    documentation of routine cleaning and maintenance
    for each laminar air flow hood or other ISO class 5
    environment, other equipment, and the ISO class 7
    environment; and
15. Sterile pharmaceutical product delivery requirements for:
    a. Shipment to the patient;
    b. Security; and
    c. Maintaining official compendial storage conditions.

Question 298

. Standard-risk sterile pharmaceutical product compounding.
Before compounding a standard-risk sterile pharmaceutical
product, a pharmacy permittee or pharmacist-in-charge shall
ensure compliance with the following minimum standards:

Answer 298

1. Compounding occurs only in an ISO class 5 environment
   within an ISO class 7 environment, and the ISO class 7
   environment may have a specified prep area inside the
   environment;
2. Compounding sterile pharmaceutical products from sterile commercial drugs or sterile pharmaceutical otic or
   ophthalmic products from non-sterile ingredients occurs
   using procedures that involve only a few closed-system,
   basic, simple aseptic transfers and manipulations;
3. Each person who compounds wears adequate personnel
   protective clothing for sterile preparation that includes
   gown, gloves, head cover, and booties. Each person who
   compounds is not required to wear personnel protective
   clothing when all sterile pharmaceutical compounding
   occurs within an ISO class 5 environment isolator, and
   the ISO Class 5 environment isolator is not inside an ISO
   Class 7 environment; and
4. Each person who compounds completes an annual mediafill test to validate proper aseptic technique.

Question 299

Substantial-risk sterile pharmaceutical product compounding.
Before compounding a substantial-risk sterile pharmaceutical
product, a pharmacy permittee or pharmacist-in-charge shall
ensure compliance with the following minimum standards:

Answer 299

1. Compounding parenteral or injectable sterile pharmaceutical products from non-sterile ingredients occurs only in
   an ISO class 5 environment within an ISO class 7 environment and the ISO class 7 environment shall not have a
   prep area inside the environment;
2. Each person who compounds wears adequate personnel
   protective clothing for sterile preparation that includes
   gown, gloves, head cover, and booties. Each person who
   compounds is not required to wear personnel protective
   clothing when all sterile pharmaceutical compounding
   occurs within an ISO class 5 environment isolator, and
   the ISO Class 5 environment isolator is not inside an ISO
   Class 7 environment; and
3. Each person who compounds completes a semi-annual
   media-fill test that simulates the most challenging or
   stressful conditions for compounding using dry non-sterile media to validate proper aseptic technique.

Question 300

R4-23-671. General Requirements for Limited-service Pharmacy

The limited-service pharmacy permittee shall secure the limited-service pharmacy by conforming with the following standards:

Answer 300

1. Permit no one to be in the limited-service pharmacy
   unless the pharmacist-in-charge or a pharmacist authorized by the pharmacist-in-charge is present;
2. Require the pharmacist-in-charge to designate in writing,
   by name, title, and specific area, those persons who will
   have access to particular areas of the limited-service
   pharmacy;
3. Implement procedures to guard against theft or diversion
   of drugs, including controlled substances; and
4. Require all persons working in the limited-service pharmacy to wear badges, with their names and titles, while
   on duty.

Question 301

R4-23-671. General Requirements for Limited-service Pharmacy

Q: How can a limited-service pharmacy permittee obtain permission to deviate from the minimum area requirements set forth in R4-23-609, R4-23-673, or R4-23-682?

Answer 301

A: To obtain permission for deviation, a limited-service pharmacy permittee must:
1. Submit a written request to the Board.
2. Include documentation showing that the deviation will facilitate experimentation or technological advances in pharmacy practice as defined in A.R.S. § 32-1901.
3. If the Board determines that the deviation will enhance the practice of pharmacy and benefit the public, the Board will grant the requested deviation.

Question 302

Before dispensing from a limited-service pharmacy, the limited-service pharmacy permittee or pharmacist-in-charge shall:

Answer 302

1. Prepare, implement, and comply with written policies and
   procedures for pharmacy operations and drug dispensing
   and distribution,
2. Review biennially and if necessary revise the policies and
   procedures required under subsection (E)(1),
3. Document the review required under subsection (E)(2),
4. Assemble the policies and procedures as a written manual
   or by another method approved by the Board or its designee, and
5. Make the policies and procedures available in the pharmacy for employee reference and inspection by the Board
   or its designee.

Question 303

Who is authorized to be in a limited-service correctional pharmacy?

Answer 303

The pharmacist-in-charge of a limited-service correctional
pharmacy shall authorize only pharmacists, interns, pharmacy
technicians, pharmacy technician trainees, compliance officers, drug inspectors, peace officers, and correctional officers
acting in their official capacities, other persons authorized by
law, support personnel, and other designated personnel to be in
the limited-service correctional pharmacy

Question 304

Q: What must the pharmacist-in-charge arrange when no pharmacist will be on duty in a correctional facility?

Answer 304

A: The pharmacist-in-charge must arrange, before the pharmacist is off duty, for:
1. Medical staff and other authorized personnel to have access to drugs in remote drug storage areas.
2. If a drug is not available in a remote drug storage area but is required to treat the immediate needs of a patient, access to the drug in the limited-service correctional pharmacy.

Question 305

1. The pharmacist-in-charge shall, in consultation with the
   appropriate committee of the correctional facility,
   develop and implement procedures to ensure that remote drug storage areas:

Answer 305

a. Contain only properly labeled drugs that might reasonably be needed and can be administered safely during the pharmacist’s absence,
b. Contain drugs packaged only in amounts sufficient
for immediate therapeutic requirements,
c. Are accessible only with a physician’s written order,
d. Provide a written record of each drug withdrawn,
e. Are inventoried at least once each week, and
f. Are audited for compliance with the requirements of
this rule at least once each month

Question 306

The pharmacist-in-charge shall, in consultation with the
appropriate committee of the correctional facility,
develop and implement procedures to ensure that access
to the limited-service correctional pharmacy when no
pharmacist is on duty conforms to the following requirements:

Answer 306

a. Is delegated to only one nurse, who is in a supervisory position;
b. Is communicated in writing to medical staff of the
correctional facility;
c. Is delegated only to a nurse who has received training from the pharmacist-in-charge in proper methods of access, removal of drugs, and recordkeeping procedures; and
d. Is delegated by the supervisory nurse to another
nurse only in an emergency.

Question 307

When a nurse to whom authority to access the limitedservice correctional pharmacy is delegated removes a
drug from the limited-service correctional pharmacy, the
nurse shall:
a. Record the following information on a form:

Answer 307

i. Patient’s name,
ii. Name of the drug and its strength and dosage
form,
iii. Dose prescribed,
iv. Amount of drug removed, and
v. Date and time of removal

Question 308

When a nurse to whom authority to access the limitedservice correctional pharmacy is delegated removes a
drug from the limited-service correctional pharmacy, the
nurse shall: . . .in addition to recording info on the form…

Answer 308

b. Sign the form recording the drug removal
c. Attach the original or a direct copy of a physician’s
written order for the drug to the form recording the
drug removal; and
d. Place the form recording the drug removal conspicuously in the limited-service correctional pharmacy
.
.
.
4. Within four hours after a pharmacist in the limited-service correctional pharmacy returns to duty following an
absence in which the limited-service correctional pharmacy was accessed by a nurse to whom authority had
been delegated, the pharmacist shall verify all records of
drug removal according

Question 309

Q: What must the pharmacist-in-charge arrange when no pharmacist will be on duty in a correctional facility?

Answer 309

A: The pharmacist-in-charge must arrange, before the pharmacist is off duty, for:

Medical staff and other authorized personnel to have telephone access to a pharmacist.

Question 310

The limited-service pharmacy permittee shall ensure that the
limited-service correctional pharmacy is not without a pharmacist on duty for more than ___________ consecutive hours.

Answer 310

96

Question 311

Q: How must a limited-service correctional pharmacy be secured when no pharmacist is on duty?

Answer 311

A: The limited-service pharmacy permittee must:
1. Permit no one to be in the limited-service correctional pharmacy unless a pharmacist is on duty, except:
- As provided in subsection (C)(3) when a pharmacist is not on duty.
- A pharmacy technician or pharmacy technician trainee may remain to perform duties when a pharmacist is temporarily absent from the pharmacy, provided:
- All controlled substances are secured to prohibit access by anyone other than a pharmacist.
- Activities performed by the pharmacy technician or pharmacy technician trainee are verified by the pharmacist immediately upon return.
- Any drug prepared by a pharmacy technician or pharmacy technician trainee is verified by the pharmacist immediately upon return.
- Any drug not verified by a pharmacist for accuracy is not dispensed, supplied, or distributed while the pharmacist is temporarily absent.

Question 312

Q: What security measures must be provided for a limited-service correctional pharmacy?

Answer 312

The limited-service pharmacy permittee must provide keyed or programmable locks to all areas of the limited-service correctional pharmacy.

Question 313

The pharmacist-in-charge of a limited-service correctional
pharmacy shall ensure that the written policies and procedures
for pharmacy operations and drug distribution within the correctional facility include the following:

Answer 313

1. Physicians’ orders, prescription orders, or both;
2. Authorized abbreviations;
3. Formulary system;
4. Clinical services and drug utilization management including:
   a. Participation in drug selection,
   b. Drug utilization reviews,
   c. Inventory audits,
   d. Patient outcome monitoring
   e. Committee participation,
   f. Drug information, and
   g. Education of pharmacy and other health professionals;
5. Duties and qualifications of professional and support
   staff;
6. Products of abuse and contraband medications;
7. Controlled substances;
8. Drug administration;
9. Drug product procurement;
10. Drug compounding, dispensing, and storage;
11. Stop orders;
12. Pass or discharge medications;
13. Investigational drugs and their protocols;
14. Patient profiles;
15. Quality management procedures for:
    a. Adverse drug reactions;
    b. Drug recalls;
    c. Expired and beyond-use-date drugs;
    d. Medication or dispensing errors;
    e. Drug storage; and
    f. Education of professional staff, support staff, and
    patients;
16. Recordkeeping;
17. Sanitation;
18. Security;
19. Access to remote drug storage areas by non-pharmacists;
    and
20. Access to limited-service correctional pharmacy by nonpharmacists.

Question 314

Q: What are the design and construction requirements for a limited-service mail-order pharmacy, specifically for dispensing and non-dispensing areas?

Answer 314

A: The limited-service pharmacy permittee must ensure:
1. There is a dispensing area devoted to stocking, compounding, and dispensing prescription medications, which is physically separate from a non-dispensing area for non-dispensing pharmacy services.
2. The dispensing area must be:
- At least 300 square feet if three or fewer persons work simultaneously.
- 300 square feet plus 60 square feet for each additional person if more than three persons work simultaneously.
3. The dispensing area must allow efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist.
4. The non-dispensing area must be:
- At least 30 square feet for each person working simultaneously.
- Allow free movement of personnel and visual surveillance by the pharmacist.

Question 315

Q: What are the design and construction requirements for a limited-service mail-order pharmacy with a contiguous area?

Answer 315

A: The limited-service pharmacy permittee must ensure:
1. There is a contiguous area where both dispensing and non-dispensing pharmacy services are provided.
2. The contiguous area must be:
- At least 300 square feet if three or fewer persons work simultaneously.
- 300 square feet plus 60 square feet for each additional person if more than three persons work simultaneously.
3. The contiguous area must allow efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist.

Question 316

Who is authorized to be in a limited-service mail-order pharmacy (or basically anything that’s limited services - except nuclear!)?

Answer 316

A: The pharmacist-in-charge shall authorize only:

Pharmacists
Interns
Pharmacy technicians
Pharmacy technician trainees
Compliance officers
Drug inspectors
Peace officers acting in their official capacities
Support personnel
Other persons authorized by law
Other designated personnel

Question 317

Q: What must the pharmacist-in-charge ensure regarding prescription medication when no pharmacist is present?

Answer 317

A: The pharmacist-in-charge must ensure that prescription medication is either:

Delivered to the patient, or
Locked in the dispensing area when a pharmacist is not present in the pharmacy.

Question 318

What are the communication requirements for a limited-service mail-order pharmacy?

Answer 318

A: The limited-service pharmacy permittee must:

• Provide toll-free telephone service during regular hours of operation, at least five days a week and a minimum of 40 hours per week, to facilitate communication between patients and a pharmacist who has access to patient records.
• Disclose this toll-free number on a label affixed to each container of drugs dispensed from the limited-service mail-order pharmacy.

Question 319

The pharmacist-in-charge of a limited-service mail-order pharmacy shall ensure that the written policies and procedures for pharmacy operations and drug distribution include the following:

Answer 319

1. Prescription orders;
2. Clinical services and drug utilization management for:
   a. Drug utilization reviews,
   b. Inventory audits,
   c. Patient outcome monitoring,
   d. Drug information, and
   e. Education of pharmacy and other health professionals;
3. Duties and qualifications of professional and support
   staff;
4. Controlled substances;
5. Drug product procurement;
6. Drug compounding, dispensing, and storage;
7. Patient profiles;
8. Quality management procedures for:
   a. Adverse drug reactions,
   b. Drug recalls,
   c. Expired and beyond-use-date drugs,
   d. Medication or dispensing errors, and
   e. Education of professional and support staff;
9. Recordkeeping;
10. Sanitation;
11. Security;
12. Drug delivery requirements for:
    a. Transportation,
    b. Security
    c. Temperature and other environmental controls,
    d. Emergency provisions, and
13. Patient education.

Question 320

R4-23-674. Limited-service Long-term Care Pharmacy

Q: What must the pharmacist-in-charge ensure regarding prescription medication when no pharmacist is present in a limited-service long-term care pharmacy?

Answer 320

A: The pharmacist-in-charge must ensure that prescription medication is either:

Delivered to the patient’s long-term care facility, or
Locked in the dispensing area of the pharmacy when a pharmacist is not present.

Question 321

R4-23-674. Limited-service Long-term Care Pharmacy

Q: What can the long-term care consultant pharmacist and pharmacist-in-charge develop for the long-term care facility?

Answer 321

A: In consultation with the long-term care facility’s medical director and director of nursing, they may develop a medication formulary if necessary. This formulary ensures:

Safe and efficient procurement
Dispensing
Distribution
Administration
Control of drugs in the long-term care facility

Question 322

R4-23-674. Limited-service Long-term Care Pharmacy

The limited-service long-term care pharmacy permittee or
pharmacist-in-charge shall ensure that the written policies and
procedures required in R4-23-671(E) include the following:

Answer 322

1. Clinical services and drug utilization management for:
   a. Drug utilization reviews,
   b. Inventory audits,
   c. Patient outcome monitoring,
   d. Drug information, and
   e. Education of pharmacy and other health professionals;
2. Controlled substances;
3. Drug compounding, dispensing, and storage;
4. Drug delivery requirements for:
   a. Transportation,
   b. Security,
   c. Temperature and other environmental controls, and
   d. Emergency provisions;
5. Drug product procurement;
6. Duties and qualifications of professional and support
   staff;
7. Emergency drug supply unit procedures
8. 8. Formulary, including development, review, modification,
      use, and documentation, if applicable;
9. Patient profiles;
10. Patient education;
11. Prescription orders, including:
    a. Approved abbreviations,
    b. Stop-order procedures, and
    c. Leave-of-absence and discharge prescription order
    procedures;
12. Quality management procedures for:
    a. Adverse drug reactions,
    b. Drug recalls,
    c. Expired and beyond-use-date drugs,
    d. Medication or dispensing errors, and
    e. Education of professional and support staff;
13. Recordkeeping;
14. Sanitation; and
15. Security.

Question 323

Q: What are the telephone service requirements for a limited-service sterile pharmaceutical products pharmacy?

Answer 323

A: The limited-service pharmacy permittee must:

• Provide toll-free telephone service during regular hours of operation, but not less than a minimum of 40 hours per week.
• Facilitate communication between patients and a pharmacist who has access to patient records.
• Disclose the toll-free number on a label affixed to each container dispensed from the pharmacy.

Question 324

Q: What policies and procedures must be developed, implemented, reviewed, and revised for a limited-service sterile pharmaceutical products pharmacy?

Answer 324

A: The limited-service pharmacy permittee or pharmacist-in-charge must ensure compliance with policies and procedures for:

Pharmaceutical product compounding
Dispensing
Distribution

Question 325

Q: What non-dispensing roles may a pharmacist perform in a limited-service sterile pharmaceutical products pharmacy?

Answer 325

A: Non-dispensing roles may include:

• Chart reviews
• Audits
• Drug therapy monitoring
• Committee participation
• Drug information
• In-service training of pharmacy and other health professionals

Question 326

Q: What are the requirements and processes for obtaining and maintaining a third-party logistics provider permit?

Answer 326

A: To provide logistics services, a person must:
1. Obtain a third-party logistics provider permit from the Board for each facility (R4-23-676(A)).
2. Submit a completed application using a form from the Board’s website and pay the specified fee (R4-23-676(C)).
3. Comply with R4-23-601(F) for any change of ownership.
4. Renew the permit as specified under R4-23-602(D).
5. The Board will process initial or renewal applications within the time frames specified in R4-23-602(C) (R4-23-676(F)).

Question 327

Q: What are the requirements for obtaining and operating an automated prescription-dispensing kiosk permit?

Answer 327

A:
1. Only a person with a Board-issued pharmacy permit under A.R.S. § 32-1929 can apply for an automated prescription-dispensing kiosk permit under A.R.S. § 32-1930.
2. A separate permit is required for each automated prescription-dispensing kiosk.
3. To obtain the permit, submit a completed application using a form from the Board’s website and pay the fee specified in R4-23-205.
4. Designate a pharmacist in charge for the automated prescription-dispensing kiosk.
5. The kiosk must not be placed in a gas station or convenience store.

Question 328

Q: What policies and procedures must be established for an automated prescription-dispensing kiosk?

Answer 328

A: The pharmacy permittee must establish policies and procedures addressing:
1. Transaction Records: Maintain a record of each transaction attached to the permit number of the kiosk.
2. Access Control: Control access to the kiosk.
3. Operation: Guidelines for operating the kiosk.
4. Training: Train personnel who use the kiosk.
5. Patient Services: Maintain patient services when the kiosk is not operating or drugs/devices are unavailable.
6. Security: Secure the kiosk against unauthorized removal and access to drugs/devices.
7. Pharmacy Services: Ensure patients receive necessary pharmacy services, including consultation with a pharmacist.
8. Information Integrity: Maintain the integrity of system information and patient confidentiality.
9. Stocking: Procedures for stocking and restocking the kiosk.
10. Compliance: Ensure compliance with packaging and labeling requirements.
11. Handling Waste: Procedures for removing drugs/devices without dispensing and handling wasted or discarded items.

Question 329

Q: How should the policies and procedures for an automated prescription-dispensing kiosk be maintained?

Answer 329

A: The pharmacy permittee must:
1. Review and Revision: Review policies and procedures biennially and make necessary revisions.
2. Documentation: Document the biennial review.
3. Manual: Assemble policies and procedures into a written or electronic manual.
4. Accessibility: Make the manual available within the pharmacy for reference by personnel and inspection by the Board.

Question 330

R4-23-681. General Requirements for Limited-service Nuclear Pharmacy
.
A. To be an authorized nuclear pharmacist, a pharmacist shall:

Answer 330

1. Hold a current pharmacist license issued by the Board;
2. Be certified as a nuclear pharmacist by:
   a. The Board of Pharmaceutical Specialties, or
   b. A similar group recognized by the Arizona State
   Board of Pharmacy; or
3. Satisfy each of the following requirements:
   a. Meet minimal standards of training for status as an
   authorized user of radioactive material, as specified
   by the Arizona Radiation Regulatory Agency and
   the United States Nuclear Regulatory Commission;
   b. Submit certification of completion of a Boardapproved nuclear pharmacy training program or
   other training program recognized by the Arizona
   Radiation Regulatory Agency, with 200 hours of
   didactic training in the following areas:
   i. Radiation physics and instrumentation,
   ii. Radiation protection,
   iii. Mathematics pertaining to the use and measurement of radioactivity,
   iv. Radiation biology, and
   v. Radiopharmaceutical chemistry;
   c. Submit evidence of a minimum of 500 hours of clinical/practical nuclear pharmacy training under the
   supervision of an authorized nuclear pharmacist in
   the following areas:
   i. Procuring radioactive materials;
   ii. Compounding radiopharmaceuticals;
   iii. Performing routine quality control procedures;
   iv. Dispensing radiopharmaceuticals;
   v. Distributing radiopharmaceuticals;
   vi. Implementing basic radiation protection procedures; and
   vii. Consulting and educating the nuclear medicine
   community, patients, pharmacists, other health
   professionals, and the general public; and
   d. Submit written certification, signed by a preceptor
   who is an authorized nuclear pharmacist, that the
   above training was satisfactorily completed

Question 331

Q: What are the regulations for handling and dispensing radiopharmaceuticals?

Answer 331

A:
1. Possession and Disposal:
- Radiopharmaceuticals can only be sold, bartered, disposed of, or possessed under the conditions specified in A.R.S. § 32-1929.

2. Manufacture and Dispensing:
   
   • Only pharmacists or pharmacy interns under direct supervision of a pharmacist may manufacture, compound, sell, or dispense radiopharmaceuticals, in accordance with A.R.S. § 32-1961 and relevant rules.
   • Exceptions (if licensed by the Arizona Radiation Regulatory Agency):
     
     • Medical practitioners administering radiopharmaceuticals to patients (A.R.S. § 32-1921(A)).
     • Hospital nuclear medicine departments.
     • Medical practitioners’ offices.
3. Board Cooperation:
   
   • The Board shall work with the Arizona Radiation Regulatory Agency and other state and federal agencies to enforce radiopharmaceutical regulations, which may involve information exchange, joint inspections, and other collaborative activities.

Question 332

Q: What additional compliance requirements must a limited-service nuclear pharmacy permittee follow?

Answer 332

A: In addition to adhering to all applicable federal and state drug laws and rules, whether radioactive or not, a limited-service nuclear pharmacy permittee must also comply with:

Arizona Radiation Regulatory Agency (ARRA) Laws and Rules
U.S. Nuclear Regulatory Commission (NRC) Laws and Rules
Emergency and Safety Provisions as specified by both ARRA and NRC.

Question 333

Q: What are the requirements for operating a limited-service nuclear pharmacy?

Answer 333

A:
1. Permit Requirements:
- Obtain a permit in compliance with A.R.S. §§ 32-1929, 32-1930, and 32-1931, and R4-23-606.

2. Permit Issuance:
   
   • Must employ an authorized nuclear pharmacist.
   • Must hold a current Arizona Radiation Regulatory Agency Radioactive Materials License.
   • If the Radioactive Materials License lapses, the permit will be suspended pending revocation by the Board.
   • Copies of ARRA inspection reports must be available for Board inspection.
3. Pharmacist-in-Charge Responsibilities:
   
   • Designate an authorized nuclear pharmacist as the pharmacist-in-charge.
   • Responsibilities include:
     
     • Overseeing pharmacy operations related to the practice of pharmacy and drug distribution.
     • Communicating Board directives to all pharmacy personnel.
     • Ensuring compliance with federal and state pharmacy laws and rules.
4. Supervision and Presence:
   
   • The authorized nuclear pharmacist must directly supervise all personnel involved in radiopharmaceutical preparation and distribution.
   • Must be present whenever the pharmacy is open for business.

Question 334

A limited-service nuclear pharmacy shall contain separate areas for:

Answer 334

a. Preparing and dispensing radiopharmaceuticals,
b. Receiving and shipping radiopharmaceuticals,
c. Storing radiopharmaceuticals, and
d. Decaying radioactive waste.

Question 335

Q: What are the requirements for pharmacy area space and access designation?

Answer 335

1. Area Requirements:
   
   • The Board may mandate more than the minimum area requirements if:
     
     • Equipment, inventory, personnel, or other factors create crowding.
     • Such crowding interferes with safe pharmacy practice.
2. Access Designation:
   
   • The pharmacist-in-charge must:
     
     • Designate in writing the individuals who may access specific pharmacy areas.
     • Include the title and specific area for each designated person.

Question 336

E. A limited-service nuclear pharmacy permittee shall maintain
records of acquisition, inventory, and disposition of radiopharmaceuticals, other radioactive substances, and other drugs in accordance with federal and state statutes and rules.
1. A prescription order, in addition to the requirements in
A.R.S. § 32-1968(C) and R4-23-407(A), shall contain:

Answer 336

in addition to these other general requirements: R4-23-407. Prescription Requirements
A. Prescription orders. A pharmacist shall ensure that:
1. A prescription order the pharmacist uses to dispense a
drug or device includes the following information:
a. Date of issuance;
b. Name and address of the patient for whom or the
owner of the animal for which the drug or device is
dispensed;
c. Drug name, strength, and dosage form or device
name;
d. Name of the manufacturer or distributor of the drug
or device if the prescription order is written generically or a substitution is made;
e. Prescribing medical practitioner’s directions for use;
f. Date of dispensing;
g. Quantity prescribed and if different, quantity dispensed;
h. For a prescription order for a controlled substance,
the medical practitioner’s address and DEA number;
i. For a written prescription order, the medical practitioner’s signature;
j. For an electronically transmitted prescription order,
the medical practitioner’s digital or electronic signature;
k. For an oral prescription order, the medical practitioner’s name and telephone number; and
l. Name or initials of the dispensing pharmacist;
.
.
.
Radioactive rx should also include: a. The date and time of calibration of the radiopharmaceutical,
b. The name of the procedure for which the radiopharmaceutical is prescribed, and
c. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product.

Question 337

2. The lead container used to store and transport a radiopharmaceutical shall have a label that, in addition to the
   requirements in A.R.S. § 32-1968(D), includes:

Answer 337

a. The date and time of calibration of the radiopharmaceutical,
b. The name of the radiopharmaceutical,
c. The molybdenum 99 content to USP limits,
d. The name of the procedure for which the radiopharmaceutical is prescribed,
e. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product,
f. The words “Caution: Radioactive Material,” and
g. The standard radiation symbol.

Question 338

3. The radiopharmaceutical container shall have a label that includes:

Answer 338

a. The date and time of calibration of the radiopharmaceutical;
b. The name of the patient, recorded before dispensing,
if the radiopharmaceutical is therapeutic or for a
blood product;
c. The words “Physician’s Use Only” instead of the
name of the patient if the radiopharmaceutical is
nontherapeutic or for a nonblood product;
d. The name of the radiopharmaceutical;
e. The dose of radiopharmaceutical;
f. The serial number;
g. The words “Caution: Radioactive Material”; and
h. The standard radiation symbol.

Question 339

The following minimum requirements are in addition to the
requirements of the Arizona Radiation Regulatory Agency, the
applicable U.S. Nuclear Regulatory Commission regulations,
and the applicable regulations of the federal Food and Drug
Administration. A limited-service nuclear pharmacy permittee
shall provide:
1. In addition to the minimum pharmacy area requirements

Answer 339

a. An area for the storing, compounding, and dispensing of radiopharmaceuticals completely separate from pharmacy areas for nonradioactive drugs;
b. A minimum of 80 sq. ft. for a hot lab and storage
area; and
c. A minimum of 300 sq. ft. of compounding and dispensing area;

Question 340

The following minimum requirements are in addition to the
requirements of the Arizona Radiation Regulatory Agency, the
applicable U.S. Nuclear Regulatory Commission regulations,
and the applicable regulations of the federal Food and Drug
Administration. A limited-service nuclear pharmacy permittee
shall provide:
2. The following equipment:

Answer 340

a. Fume hood, approved by the Arizona Radiation
Regulatory Agency;
b. Laminar flow hood;
c. Dose calibrator;
d. Refrigerator;
e. Prescription balance, Class A, and weights or an
electronic balance of equal or greater accuracy;
f. Well scintillation counter;
g. Incubator oven;
h. Microscope;
i. An assortment of labels, including prescription
labels and cautionary and warning labels;
j. Glassware necessary for compounding and dispensing radiopharmaceuticals as required by the Arizona
Radiation Regulatory Agency;
k. Other equipment necessary for radiopharmaceutical
quality control for products compounded or dispensed as required by the Arizona Radiation Regulatory Agency;
l. Current antidote and drug interaction information;
and
m. Regional poison control phone number prominently
displayed in the pharmacy area

Question 341

Even more requirement:
Q: What are the additional minimum requirements for a limited-service nuclear pharmacy?

Answer 341

A:

1. Compliance:
   
   • Must adhere to the Arizona Radiation Regulatory Agency regulations.
   • Must follow U.S. Nuclear Regulatory Commission regulations.
   • Must comply with federal Food and Drug Administration regulations.
2. Supplies:
   
   • Provide supplies necessary for compounding and dispensing radiopharmaceuticals as required by the Arizona Radiation Regulatory Agency.
3. Professional Reference Library:
   
   • Maintain at least one current reference or text in each of the following areas:
     
     • Therapeutics
     • Nuclear pharmacy practice
     • Imaging
4. Current Editions and Supplements:
   
   • Have up-to-date copies of:
     
     • A.R.S. §§ 30-651 through 30-696 (Arizona Radiation Regulatory Agency)
     • Rules of the Arizona Radiation Regulatory Agency
     • FDA regulations on radioactive drugs
     • Arizona Pharmacy Act and rules
     • Arizona Uniform Controlled Substances Act
     • Radiological Health Handbook

Question 342

Q: What written policies and procedures must a limited-service nuclear pharmacy include?

Answer 342

A:

1. Prescription Orders
2. Clinical Services and Drug Utilization Management:
   
   • Drug utilization reviews
   • Inventory audits
   • Patient outcome monitoring
   • Drug information
   • Education of pharmacy and health professionals
3. Duties and Qualifications:
   
   • Professional and support staff
4. Radioactive Material Handling, Storage, and Disposal
5. Drug Product Procurement
6. Drug Compounding, Dispensing, and Storage
7. Investigational Drugs and Their Protocols
8. Patient Profiles
9. Quality Management Procedures:
   
   • Adverse drug reaction reports
   • Drug recall
   • Expired and beyond-use-date drugs
   • Medication or dispensing errors
   • Radiopharmaceutical quality assurance
   • Radiological health and safety
   • Drug storage and disposition
   • Education of professional staff, support staff, and patients
10. Recordkeeping
11. Sanitation
12. Security
13. Drug Delivery Requirements:
    - Transportation
    - Security
    - Radiological health and safety procedures
    - Temperature and environmental controls
    - Emergency provisions
14. Patient Education

Question 343

Q: What are the requirements for operating as a Compressed Medical Gas (CMG) Distributor in Arizona?

Answer 343

A:

1. Permit Requirement:
   
   • A person must have a current Board-issued resident or nonresident compressed medical gas distributor permit to:
     
     • Manufacture
     • Process
     • Transfill
     • Package
     • Label compressed medical gases in Arizona
     • Manufacture, process, transfill, package, or label compressed medical gases outside Arizona and ship them into Arizona
2. FDA Registration:
   
   • Before operating as a compressed medical gas distributor, a person must:
     
     • Register with the FDA as a medical gas manufacturer
     • Comply with the drug listing requirements of the federal act

Question 344

Q: What are the requirements for notification, change of ownership, and relocation for a Compressed Medical Gas (CMG) Distributor permit?

Answer 344

A:

1. Notification:
   
   • Submit changes to telephone/fax number, e-mail/mailing address, or business name within 10 days.
   • Use the permittee’s online profile or provide written notice via mail, fax, or e-mail.
2. Change of Ownership:
   
   • Comply with R4-23-601(F) regarding the change of ownership process.
3. Relocation:
   
   • Resident CMG Distributor:
     
     • Submit a completed relocation application form to the Board electronically or manually at least 30 days before relocation.
     • No fee is required for the relocation application.
   • Nonresident CMG Distributor:
     
     • Provide written notice to the Board office at least 10 days before relocating via mail, fax, or e-mail.

Question 345

Q: What are the additional requirements for a Compressed Medical Gas (CMG) Distributor permit regarding sales, facility conditions, and good manufacturing practices?

Answer 345

A:

1. Authorized Sales:
   
   • A CMG distributor may only sell or distribute compressed medical gases to:
     
     • Durable medical equipment and compressed medical gas suppliers.
     • Entities that are registered, licensed, or permitted to use, administer, or distribute compressed medical gases.
2. Facility Requirements:
   
   • The facility must be:
     
     • Clean
     • Uncluttered
     • Sanitary
     • Temperature controlled
     • Secure from unauthorized access
3. Current Good Manufacturing Practice (CGMP):
   
   • Must comply with the federal Good Manufacturing Practice requirements under 21 CFR Parts 210 and 211.

Question 346

Q: What are the record-keeping requirements for a Compressed Medical Gas (CMG) Distributor permit?

Answer 346

A:

1. Establishing Procedures:
   
   • Implement written procedures for maintaining records related to:
     
     • Production
     • Transfilling
     • Process control
     • Labeling
     • Packaging
     • Quality control
     • Distribution
     • Returns
     • Recalls
     • Training of personnel
     • Complaints
     • Compliance with federal or state law
2. Record Retention:
   
   • Retain records for at least:
     
     • Three years, or
     • One year after the expiration date of the compressed medical gas, whichever is longer.
3. Record Availability:
   
   • Make records available for inspection by the Board or its compliance officer.
   • If records are centralized and not electronically retrievable, provide them within four working days of a request.

Question 347

Q: What are the inspection and permit renewal requirements for a Compressed Medical Gas (CMG) Distributor permit?

Answer 347

A:

1. Inspection:
   
   • Resident CMG Distributor:
     
     • Make the facility available for inspection by the Board or its compliance officers as per A.R.S. § 32-1904.
   • Nonresident CMG Distributor:
     
     • Provide a copy of the most recent inspection report from the permittee’s resident licensing authority, FDA, or a third-party auditor approved by the resident authority or the Board, within 10 days of a request.
     • The Board may also inspect or hire a third-party auditor to inspect as per A.R.S. § 32-1904.
2. Permit Renewal:
   
   • Comply with the renewal requirements specified in R4-23-602(D).
3. Emergency Use:
   
   • The section does not prohibit the emergency administration of oxygen by licensed healthcare personnel, emergency medical technicians, first responders, firefighters, law enforcement officers, and other trained emergency personnel.

Question 348

Q: What are the requirements and responsibilities of a long-term care consultant pharmacist?

Answer 348

A:

1. Licensing:
   
   • Possess a valid Arizona pharmacist license issued by the Board.
2. Pharmaceutical Patient Care:
   
   • Ensure the provision of pharmaceutical patient care services as defined in R4-23-110.
3. Drug and Device Management:
   
   • Review the distribution and storage of drugs and devices.
   • Assist the facility in establishing policies and procedures for the distribution and storage of drugs and devices.
4. Resident Evaluation Programs:
   
   • Provide programs for monitoring therapeutic responses and utilization of drugs and devices.
   • Use current guidelines established by the Centers for Medicare and Medicaid Services, as required in 42 CFR 483.60 (revised October 1, 2010).
5. Education Services:
   
   • Serve as a resource for pharmacy-related education services within the facility.
6. Quality Management:
   
   • Participate in the quality management of resident care in the facility.
7. Communication:
   
   • Communicate with the provider pharmacy to address areas of mutual concern and resolution.

Question 349

Q: What responsibilities and requirements must a long-term care consultant pharmacist adhere to?

Answer 349

A:

1. Emergency Drug Arrangements:
   
   • Ensure arrangements are made for emergency drugs when the provider pharmacy is closed, in cooperation with the pharmacist-in-charge and facility staff.
   • Emergency drugs must be available through an emergency drug supply unit at the facility.
2. Labeling and Packaging Compliance:
   
   • Ensure that the labeling and packaging of prescription-only and non-prescription drugs comply with state and federal laws.
3. Controlled Substance Management:
   
   • Ensure controlled substances are stored in a separately locked and permanently affixed compartment, unless using a single-unit package medication distribution system.
   • Maintain accurate records of controlled substance administration or disposition.
4. Records and Reports:
   
   • Ensure availability of records and reports for evaluating drug use, including:
     
     • Provider pharmacy patient profiles and facility medication administration records.
     • Reports of suspected adverse drug reactions.
     • Inspection reports of drug storage areas.
     • Accountability reports detailing:
       
       • Date and time of administration.
       • Name of the person who administered the drug.
       • Documentation of wasted or partial doses.
       • Exception reports for refused doses.
       • Drug destruction forms.
5. Drug Irregularities and Errors:
   
   • Identify and report drug irregularities and dispensing errors to the prescriber, director of nursing, and provider pharmacy.
6. Disposal of Drugs:
   
   • Ensure discontinued or outdated drugs, including controlled substances, are destroyed or disposed of timely, following federal, state, and local requirements.
   • Ensure drug containers with illegible or missing labels are identified and replaced or relabeled by the dispensing pharmacy.

Question 350

Q: What are the responsibilities of a provider pharmacy at a long-term care facility?

Answer 350

A:

1. Prescription Medication Provision:
   
   • Provide prescription medication only with a valid prescription order for an individual long-term care facility resident.
   • Ensure the medication is properly labeled for that resident.
   • Nonprescription drugs can be supplied in an unopened container or through an emergency drug supply unit as per R4-23-701.02.
2. Prescription Medication Label Requirements:
   
   • Labels must comply with A.R.S. §§ 32-1968 and 36-2525.
   • Include:
     
     • Drug name, strength, dosage form, and quantity.
     • Beyond-use-date.
3. Relabeling and Alteration:
   
   • Only a pharmacist employed by the dispensing pharmacy may relabel or alter a prescription medication label if it is illegible or missing.
4. Drug Recall Policies:
   
   • Develop and implement policies and procedures for drug recalls to protect resident health and safety.
   • Procedures must include:
     
     • Immediate discontinuation of any recalled drug at the patient level.
     • Notification to the prescriber and the facility’s director of nursing.
5. Repackaging Restrictions:
   
   • Do not repackage drugs previously dispensed to a resident by another pharmacy or drugs previously dispensed by the provider pharmacy.

Question 351

Q: What are the requirements for emergency drug supplies in long-term care facilities?

Answer 351

A:

1. Emergency Drug Supply Unit:
   
   • Ensure an emergency drug supply unit is available within the long-term care facility.
2. Ownership:
   
   • Drugs in the emergency drug supply unit remain the property of the provider pharmacy.
3. Controlled Substances:
   
   • Controlled substances in the emergency drug supply unit must be included in all required inventories as specified in A.R.S. § 36-2523(B) and R4-23-1003(A).

Question 352

Q: What are the criteria for an emergency drug supply unit in a long-term care facility?

Answer 352

A:

1. Drug Necessity:
   
   • Drugs must meet the immediate and emergency therapeutic needs of residents, as determined by the provider pharmacy’s pharmacist-in-charge in consultation with the facility’s medical director and nursing director.
2. Purpose:
   
   • The unit is not meant to replace the provider pharmacy’s responsibility for routine drug provision but to ensure availability for immediate and emergency needs.
3. Packaging and Labeling:
   
   • Drugs must be in a manufacturer’s unit-of-use package or prepackaged and labeled with:
     
     • Drug name
     • Strength
     • Dosage form
     • Manufacturer
     • Lot number
     • Expiration date
     • Provider pharmacy’s name, address, telephone number, and pharmacist’s initials

Question 353

Q: What are the requirements for storing and labeling an emergency drug supply unit in a long-term care facility?

Answer 353

A:

1. Storage:
   
   • Temperature Control: The unit must be stored in a temperature-controlled area.
   • Access Control: It must be kept in a location that prevents unauthorized access.
2. Exterior Labeling:
   
   • Emergency Use Only: The unit must have a label indicating that the contents are for emergency use only.
   • Contents List: A complete list of the contents by drug name, strength, dosage form, quantity, and the provider pharmacy’s name, address, and telephone number must be displayed.
   • Earliest Expiration Date: The label must indicate the date of the earliest drug expiration.
   • Inspection Information: The label must include the date of the last inspection and the name of the responsible pharmacist.
3. Security:
   
   • The unit must be secured with a tamper-evident seal or locked in a manner that reveals if it has been opened or tampered with.

Question 354

Q: What are the responsibilities of a limited-service pharmacy permittee or pharmacist-in-charge regarding an emergency drug supply unit in a long-term care facility?

Answer 354

A:

1. Policies and Procedures:
   
   • Preparation and Compliance: Prepare, implement, review, and revise written policies and procedures for the storage and use of the emergency drug supply unit, in accordance with R4-23-671(E).
   • Accessibility: Ensure policies are available in both the provider pharmacy and the long-term care facility for employee reference and Board inspection.
2. Required Policies:
   
   • Drug Removal Procedures:
     
     • Obtain a valid prescription order for each drug removed.
     • Notify the provider pharmacy when a drug is removed.
   • Outdated Drug Replacement: Include procedures for replacing outdated drugs.
   • Security and Inspection: Establish procedures for security and regular inspections.
3. Restocking and Exchange:
   
   • Frequency: Exchange or restock the emergency drug supply unit weekly, or as needed, to maintain an adequate supply.
   • Staffing: Restocking must be done by an Arizona licensed pharmacist, or an intern, graduate intern, technician, or technician trainee under the direct supervision of a pharmacist.
4. Education:
   
   • Training: Educate both pharmacy and long-term care facility personnel on the storage and use of the emergency drug supply unit.

Question 355

Q: What are the requirements for using an automated emergency drug supply unit in a long-term care facility?

Answer 355

A:

1. Notification:
   
   • Inform the Board: The pharmacy permittee or pharmacist-in-charge must notify the Board in writing of the intent to use an automated emergency drug supply unit, including the name and type of unit.
2. Electronic Notification:
   
   • Access Alerts: The provider pharmacy must be notified electronically when the automated emergency drug supply unit is accessed.
3. Record Keeping:
   
   • Access Records: All events involving access to the unit must be recorded electronically and maintained for at least two years.
4. Reporting:
   
   • Transaction Reports: The provider pharmacy must be able to produce a report of all transactions and a single drug usage report on inspection by the Board.
5. Policies and Procedures:
   
   • System Malfunction: Develop procedures for accessing the unit during system malfunctions or downtime.
   • User Access: Establish procedures for authorizing and modifying user access.
   • Quality Assurance: Implement an ongoing quality assurance program including:
     
     • Training for all authorized users.
     • Maintenance and calibration as recommended by the manufacturer.
6. Documentation:
   
   • Maintenance Records: Maintain documentation of maintenance and calibration for inspection by the Board for at least two years.

Question 356

The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that every emergency drug prescription order is evaluated according to the requirements of R4-3-402(A) by a pharmacist within _________ hours of the first dose of drug administered by long-term care facility personnel under the emergency drug prescription order.

Answer 356

72 hours

Question 357

Q: What are the requirements for using an automated dispensing system in long-term care facilities?

Answer 357

A:

1. Notification:
   
   • Written Intent: Notify the Board or its staff in writing about the intent to use an automated dispensing system, including its name and type.
2. Controlled Substances Registration:
   
   • Separate Registration: Obtain a separate controlled substances registration for each long-term care facility where the system containing controlled substances will be located.
   • Documentation: Maintain copies of these registrations at the provider pharmacy for Board inspection.

Question 358

Q: What are the requirements for drugs and policies related to automated dispensing systems in long-term care facilities?

Answer 358

A:

1. Drug Ownership and Inventory:
   
   • Ownership: Drugs in the automated dispensing system remain the property of the provider pharmacy.
   • Controlled Substances: Include controlled substances in all required inventories under A.R.S. § 36-2523(B) and R4-23-1003(A).
   • Schedule II Drugs: Schedule II drugs must not be stocked in the automated dispensing system.
   • Emergency Drug Supply: Ensure a separate emergency drug supply unit is available per R4-23-701.02.
2. Policies and Procedures:
   
   • Preparation and Implementation: Prepare, implement, and comply with policies and procedures for using the automated dispensing system.
   • Biennial Review: Review and revise policies and procedures biennially, if needed.
   • Documentation: Document the review of policies and procedures.
   • Manual: Assemble policies and procedures in a written or electronic manual.
   • Availability: Make policies and procedures available for reference and Board inspection both within the pharmacy and at any external location where the system is used.

Question 359

Q: What are the written policies and procedures required for drug removal from an automated dispensing system?

Answer 359

A:
1. Drug Removal Procedures:
- Prescription Order: A drug must be provided by a valid prescription order for an individual long-term care facility resident.
- Pharmacist Review:
- The pharmacist must review and verify the resident’s prescription order as required by R4-23-402(A).
- The pharmacist must electronically authorize access for that drug for the specific resident.
- Labeling: Each drug packet must be labeled with a resident-specific label, including the resident’s room number or facility identification number, complying with R4-23-701.01(2).

Question 360

Q: What security procedures are required for an automated dispensing system?

Answer 360

A:
1. Security Procedures:
- User Access:
- The pharmacy permittee or pharmacist-in-charge is responsible for authorizing user access, including adding, removing, and modifying users.
- Authorized users must be Board licensees or authorized licensed personnel of the long-term care facility.
- System Security: The automated dispensing system must be secured at the long-term care facility by electronic or mechanical means, or a combination thereof, to prevent unauthorized access.

Question 361

Q: How should drugs be stocked in an automated dispensing system?

Answer 361

A:
1. Drug Stocking Procedures:
- Non-Removable Containers:
- Stocked by an Arizona licensed pharmacist employed by the provider pharmacy, or by an Arizona licensed intern, graduate intern, technician, or technician trainee under the direct onsite supervision of an Arizona licensed pharmacist.
- Use bar code or other technologies to ensure the correct drug is placed in the correct canister or container.
- Removable Containers:
- Prepackaged at the provider pharmacy.
- A pharmacist must verify the container has been properly filled and labeled, and it must be secured with a tamper-evident seal.
- Containers must be transported in a secure, tamper-evident shipping container.
- The system must use microchip, bar-coding, or other technologies to ensure containers are accurately loaded.

Question 362

Q: What recordkeeping and report procedures must be followed for automated dispensing systems?

Answer 362

A:
1. Recordkeeping and Reporting:
- Event Recording:
- All access events must be recorded electronically and maintained for not less than two years.
- Reporting Capabilities:
- The provider pharmacy must be able to produce a report of all transactions, including:
- A single drug usage report as required by R4-23-408(B)(5).
- An authorized user history including date, time of access, and type of transaction.
- Monitoring Procedures:
- Safeguard storage, packaging, and distribution by monitoring:
- Current inventory
- Expiration dates
- Controlled substance dispensing
- Re-dispense requests
- Wastage

Question 363

Q: What are the requirements for maintaining an electronic log for each container fill in a provider pharmacy?

Answer 363

A:
1. Electronic Log Contents:
- Container Identification:
- Identify the container by drug name, strength, and container number.
- Drug Information:
- Include the drug’s manufacturer or National Drug Code (NDC) number.
- Expiration and Lot Information:
- Document the expiration date and lot number from the manufacturer’s stock bottle used to fill the container. If multiple lot numbers are used, each must be documented.
- Filling Date:
- Record the date the container is filled.
- Identity of Licensee:
- Document the identity of the licensee who placed the drug into the container.
- Supervision Documentation:
- If the container was filled by a non-pharmacist licensee, document the identity of the pharmacist who supervised the non-pharmacist licensee.

2. Record Retention:
   
   • Maintain the electronic log for inspection by the Board or its staff for not less than two years.

Question 364

Q: What are the requirements for an ongoing quality assurance program for automated dispensing systems in a provider pharmacy?

Answer 364

A:
1. Quality Assurance Program Components:
- Training:
- Provide training in the use of the automated dispensing system for all authorized users.
- Maintenance and Calibration:
- Ensure maintenance and calibration of the automated dispensing system as recommended by the device manufacturer.
- Accuracy Validation:
- Conduct routine accuracy validation testing no less than every three months.
- Downtime and Malfunction Procedures:
- Implement procedures to address downtime and malfunctions to ensure timely medication provision to long-term care facility residents.

Question 365

Q: What are the requirements for a pharmacy permittee providing pharmacy services to patients in a hospice inpatient facility?

Answer 365

A:
1. Prescription Medication Provision:
- Provide prescription medications only with a valid prescription order for each individual hospice inpatient facility patient.
- Ensure proper labeling of the medication for the patient.
- Non-prescription drugs can be supplied in their manufacturer’s unopened container.

2. Prescription Medication Label Requirements:
   
   • Comply with A.R.S. §§ 32-1968 and 36-2525.
   • Label must include:
     
     • Drug name
     • Strength
     • Dosage form
     • Quantity
     • Beyond-use date
3. Labeling and Relabeling:
   
   • If the label on a drug container becomes damaged or soiled, a pharmacist must relabel the drug container.
   • Only pharmacists are permitted to label or alter drug container labels.

Question 366

Q: What are the requirements for dispensing, selling, or delivering drugs to residents of assisted living facilities?

Answer 366

A:

1. Verification of Facility License:
   
   • Before dispensing, selling, or delivering any prescription or nonprescription drug, the pharmacy permittee must verify that the assisted living facility has a current and active license issued by the Arizona Department of Health Services.
2. Controlled Substances:
   
   • Prescription Order: A controlled substance prescription drug may only be dispensed, sold, or delivered to a resident if a valid prescription order from the resident’s medical practitioner is received.
   • Labeling: The controlled substance prescription drug must be labeled in accordance with A.R.S. §§ 32-1963.01, 32-1968, and 36-2525, and must include the beyond-use date on the label.

Question 367

Q: What are the requirements for dispensing, selling, or delivering Schedule III, IV, or V controlled substances to assisted living facility residents?

Answer 367

A:

1. Prescription Order Sources:
   
   • Written or Oral Prescription Order: A pharmacy permittee may dispense, sell, or deliver a Schedule III, IV, or V controlled substance if they receive a written or oral prescription order from:
     
     • a. The resident’s medical practitioner.
     • b. An individual licensed by the Arizona Board of Nursing, acting within the scope of their license.
     • c. The manager or a caregiver of the assisted living facility, if:
       
       • The resident’s medical practitioner has a written agreement with the assisted living facility designating the representative as an agent of the medical practitioner.
       • A licensed medical practitioner provides the prescription order.

Question 368

Q: What are the requirements for dispensing, selling, or delivering non-controlled substances to assisted living facility residents?

Answer 368

1. Prescription Order Sources:
   
   • Written or Oral Prescription Order: A pharmacy permittee may dispense, sell, or deliver a non-controlled substance prescription or non-prescription drug if they receive a written or oral prescription order from:
     
     • a. The resident’s medical practitioner.
     • b. An individual licensed by the Arizona Board of Nursing, acting within the scope of their license.
     • c. An assisted living facility manager or caregiver, if acting under the authority of a licensed medical practitioner.
2. Order Requirements:
   
   • a. The order must include the name and title of the individual transmitting the prescription.

Question 369

Q: What are the requirements and restrictions for managing drug containers and pharmacy services in assisted living facilities?

Answer 369

1. Relabeling Damaged Containers:
   
   • If the label on a drug container becomes damaged or soiled, only a pharmacist employed by the pharmacy permittee that dispensed the drug may relabel the container. This must be done through the exercise of professional judgment.
2. Assistance with Policies and Procedures:
   
   • Pharmacists may assist assisted living facility personnel in developing written policies and procedures for:
     
     • Procuring
     • Administering
     • Storing
     • Controlling
     • Keeping records of drugs
     • Disposing of drugs
   • Pharmacists can also provide information on the safe and effective supervision of drug self-administration.
3. Prohibited Equipment:
   
   • Emergency drug supply units and automated dispensing systems are not permitted in assisted living facilities.
4. Repackaging Restrictions:
   
   • A pharmacist shall not repackage a drug that was previously dispensed to an assisted living facility resident.

Question 370

If the pharmacist-in-charge of a pharmacy is replaced by
another pharmacist-in-charge, the new pharmacist-incharge shall complete an inventory of all controlled substances in the pharmacy within 10 days of assuming the
responsibility. This inventory and any other required controlled substance inventory shall:

Answer 370

a. Include an exact count of all Schedule II controlled
substances;
b. Include an exact count of all Schedule III through
Schedule V controlled substances or an estimated
count if the stock container contains fewer than 1001
units;
c. Indicate the date the inventory is taken and whether
the inventory is taken before opening of business or
after close of business for the pharmacy;
d. Be signed by:
i. The pharmacist-in-charge; or
ii. For other required inventories, the pharmacist
who does the inventory;
e. Be kept separately from all other records; and
f. Be available in the pharmacy for inspection by the
Board or its designee for not less than three years.

Question 371

Q: What are the requirements for reporting the loss of a controlled substance?

Answer 371

Reporting Timeline:
- Within 10 days: The loss must be reported within 10 days of its discovery.

Form and Documentation:
- DEA Form 106: The loss must be reported using DEA Form 106.
- Copy Retention: A copy of DEA Form 106 must be kept on file by the pharmacy permittee.

Responsible Parties:
- Pharmacist-in-Charge: The loss must be reported by the pharmacist-in-charge of the pharmacy or a manufacturer.
- Full-Service Wholesaler: The loss must also be reported by the permittee or designated representative of a full-service wholesaler.

Notification Recipients:
- Federal DEA: Report to the Drug Enforcement Administration (DEA).
- Department of Public Safety (DPS): Notify the Narcotic Division of DPS.
- Board of Pharmacy: Inform the Board of Pharmacy.

Additional Information:
- Police Investigation: DEA Form 106 must state whether the police investigated the loss.

Question 372

Every person receiving, selling, delivering, or disposing
of any controlled substance shall record and retain for not
less than three years the following information:

Answer 372

a. The name, strength, dosage form, and quantity of
each controlled substance received, sold, delivered,
or disposed;
b. The name, address, and DEA registration number of
the person from whom each controlled substance is
received;
c. The name, address, and DEA registration number of
the person to whom each controlled substance is
sold or delivered or who disposes of each controlled
substance; and
d. The date of each transaction.

Question 373

A full-service drug wholesale permittee or the designated
representative shall complete an inventory of all controlled substances in the manner prescribed in subsection
(A)(1). The permittee or designated representative shall
conduct this inventory:

Answer 373

a. On May 1 of each year or as directed by the Board;
and
b. If there is a change of ownership, or discontinuance
of business, or within 10 days of a change of a designated representative

Question 374

6. A drug manufacturer permittee or the pharmacist-incharge shall complete an inventory of all controlled substances in the manner prescribed in subsection (A)(1).
   The permittee or pharmacist-in-charge shall conduct this
   inventory:

Answer 374

a. On May 1 of each year or as directed by the Board;
and
b. If there is a change of ownership, or discontinuance
of business, or within 10 days of a change of a pharmacist-in-charge.

Question 375

License required. A person shall not work as a pharmacy technician or pharmacy technician trainee in Arizona, unless the
person possesses a pharmacy technician or pharmacy technician trainee license issued by the Board.
B. Eligibility.
1. To be eligible for licensure as a pharmacy technician
trainee, a person shall:

Answer 375

a. Be of good moral character,
b. Be at least 18 years of age, and
c. Have a high school diploma or the equivalent of a
high school diploma

Question 376

To be eligible for licensure as a pharmacy technician, a person shall:

Answer 376

a. Meet the requirements of subsection (B)(1) - the previous ones for the trainees,
b. Complete a pharmacy technician training program
that meets the standards
c. Pass the Pharmacy Technician Certification Board
(PTCB) examination or another Board-approved
pharmacy technician examination.

Question 377

A pharmacy technician delinquent license. Before an Arizona
pharmacy technician license will be reinstated, a pharmacy
technician whose Arizona pharmacy technician license is
delinquent for five or more consecutive years shall furnish to
the Board satisfactory proof of fitness to be licensed as a pharmacy technician and pay all past due biennial renewal fees and penalty fees. Satisfactory proof includes:
.
1. For a person with a delinquent license who is practicing
as a pharmacy technician out-of-state with a pharmacy
technician license issued by another jurisdiction:

Answer 377

a. Proof of current, unrestricted pharmacy technician
licensure in another jurisdiction; and
b. Proof of employment as a pharmacy technician
during the last 12 months

Question 378

A pharmacy technician delinquent license. Before an Arizona
pharmacy technician license will be reinstated, a pharmacy
technician whose Arizona pharmacy technician license is
delinquent for five or more consecutive years shall furnish to
the Board satisfactory proof of fitness to be licensed as a pharmacy technician and pay all past due biennial renewal fees and penalty fees. Satisfactory proof includes:
.
2. For a person with a delinquent license who did not practice as a pharmacy technician within the last 12 months:

Answer 378

a. Take and pass a Board-approved pharmacy technician examination, and
b. Complete 20 contact hours or two CEUs of continuing education activity sponsored by an approved
provider, including at least two contact hours or 0.2
CEUs of continuing education activity in pharmacy
law.

Question 379

Q: What are the requirements for obtaining licensure as a pharmacy technician in Arizona?

Answer 379

A:

1. Eligibility:
   
   • Training Program: Complete a pharmacy technician training program that meets the standards prescribed in R4-23-1105(B)(2).
   • Certification Exam: Pass the Pharmacy Technician Certification Board (PTCB) examination or another Board-approved pharmacy technician examination.
   • Alternative Requirements: Meet the requirements specified in R4-23-1105(D)(1) or (2).
2. Application Process:
   
   • Submit Application:
     
     • Complete and submit the application electronically or manually on a form provided by the Board.
   • Required Documents:
     
     • Include documents specified in the application form.
     • Pay the initial licensure fee
     • Pay the wall license fee

Question 380

Q: What is the process for issuing and maintaining pharmacy technician licensure in Arizona?

Answer 380

1. Ineligibility:
   
   • If an applicant is found ineligible for licensure, the Board office will issue a written notice of denial.
2. Eligibility:
   
   • If eligible, the Board office will issue a certificate of licensure and a wall license.
   • An applicant with a license number and “open” status on the Board’s license verification site may begin practice before receiving the physical certificate of licensure.
3. Pending Status:
   
   • An applicant with a “pending” status on the Board’s license verification site must wait until the Board office issues the certificate of licensure before practicing.
4. Maintenance:
   
   • The licensee must keep the certificate of licensure at their practice site for inspection by the Board or its designee and for public review.

Question 381

Q: What are the requirements and procedures for renewing a pharmacy technician license in Arizona?

Answer 381

A:

1. Renewal Application:
   
   • Submit a completed renewal application electronically or manually using the form provided by the Board.
   • Include the biennial renewal fee specified in R4-23-205.
2. Suspension and Penalties:
   
   • If the biennial renewal fee is not paid by November 1 of the renewal year, the license is suspended.
   • The licensee must pay a penalty as outlined in A.R.S. § 32-1925 and R4-23-205 to lift the suspension.
3. Maintenance:
   
   • Keep the renewal certificate of licensure at the practice site for inspection by the Board or its designee and for public review.

Question 382

Q: What are the requirements and procedures for obtaining and maintaining a pharmacy technician trainee license in Arizona?

Answer 382

A:

1. Eligibility:
   
   • Must provide proof of eligibility under R4-23-1101(B)(1).
2. Application:
   
   • Submit:
     
     • Completed application electronically or manually on the form provided by the Board.
     • Documents specified in the application form.
     • Licensure fee and wall license fee as specified in R4-23-205.
   • Receipt: The Board office will date-stamp the application form upon receipt.
3. Licensure:
   
   • Denial: If ineligible, a written notice of denial will be issued.
   • Certificate Issuance:
     
     • If eligible, a certificate of licensure and a wall license will be issued.
     • Applicants with an “open” status on the Board’s verification site may begin practice as a trainee before receiving the certificate.
     • Those with a “pending” status must wait for the certificate before practicing.
   • Maintenance: Keep the certificate of licensure at the practice site for inspection.
4. Validity:
   
   • The license is valid for 36 months from issuance.
   • Must complete the prescribed training program and pass a Board-approved pharmacy technician exam before expiration:
     
     • Approved Exams:
       
       • Pharmacy Technician Certification Board (PTCB) Exam
       • Exam for the Certification of Pharmacy Technicians (ExCPT)
   • If not completed by expiration, the licensee is not eligible for further licensure and must cease practicing.

Question 383

Pharm tech vs pharm tech trainee roles/ duties

Answer 383

note: Prohibited activities. A pharmacy technician or pharmacy
technician trainee shall not perform a professional practice
reserved for a pharmacist or intern…unless allow by rules
.
A pharmacy technician or pharmacy technician trainee shall
wear a badge indicating name and title while on duty.

Question 384

A. By complying with this Section, the permittee of a retail, institutional, or limited-service pharmacy may implement a technology-assisted verification of product program that allows a pharmacy technician licensed under R4-23-1102 and qualified
under subsection (D) to perform final product verification.
B. Written program description required. Before implementing a
technology-assisted verification of product program the permittee of a retail, institutional, or limited-service pharmacy
shall prepare a written program description that includes the
following:

Answer 384

1. Responsibility of both the pharmacist in charge and permittee to ensure compliance with this Section;
2. Responsibility of the permittee to design, implement, and
   monitor a process that ensures the accuracy and safety of
   the product dispensed;
3. Duties of a verification technician;
4. The training necessary to qualify and remain qualified as
   a verification technician;
5. The monitoring and evaluation procedures to be used to
   ensure competency of the verification technician; and
6. Prohibition of a verification technician performing a final
   accuracy check of a completed prescription label.

Question 385

Q: What are the requirements for implementing a technology-assisted verification of product program in a retail, institutional, or limited-service pharmacy?

Answer 385

A:
1. Posting: The written program description must be posted in the pharmacy area.
2. Distribution: Provide a copy of the written program description to both the pharmacist in charge and the verification technician.
3. Signature and Personnel File: Obtain the signatures of the pharmacist in charge and the verification technician on a copy of the written program description, and place the signed copy in their personnel files.
4. Scanning Technology: Ensure that the scanning technology used in the program captures both product and patient information.
5. Updating: Update the written program description as needed.

Question 386

. Verification technician training: The permittee of a retail, institutional, or limited-service pharmacy implementing a technology-assisted verification of product program shall ensure a pharmacy technician does not perform the duties of a verification technician unless the pharmacy technician has the following qualifications:

Answer 386

1. Is licensed
2. Has at least 1,000 hours of pharmacy technician work
   experience in the same kind of pharmacy practice site in
   which the technology-assisted verification of product will
   be performed;
3. Completes a training program that includes at least the
   following:
   a. Role of a verification technician in the dispensing
   process,
   b. Legal requirements of a verification technician
   c. How to use the technology-assisted verification system,
   d. Primary causes of medication errors, and
   e. Identifying and resolving dispensing errors; and
4. Completes at least four hours of the continuing education on patient safety

Question 387

The permittee of a retail, institutional, or limited-service pharmacy implementing a technology-assisted verification of product program shall ensure a verification technician verifies only the following:

Answer 387

1. A product with scanning technology that identifies product, or
2. A robotically prepared unit-dose product.

Question 388

The permittee of a retail, institutional, or limited-service pharmacy implementing a technology-assisted verification of product program shall ensure a verification technician does not
verify the following:

Answer 388

1. A product that involves a combination of drugs resulting
   from compounding or mixing two or more ingredients or
   products,
2. A product that involves or results from an alteration of a
   drug, or
3. A DEA schedule II controlled substance

Question 389

The permittee of a retail, institutional, or limited-service pharmacy implementing a technology-assisted verification of product program shall perform an unannounced evaluation of the competency of a verification technician at least ___
and take steps to remediate any deficiencies identified including removing verification duties from the technician.

Answer 389

twice a year

Question 390

The permittee of a retail, institutional, or limited-service pharmacy implementing a technology-assisted verification of product program shall maintain the following records:

Answer 390

1. Date the pharmacy technician was designated as a verification technician,
2. Date the pharmacy technician completed the training
   required under subsection (D)(3),
3. Dates and results of the evaluations conducted under subsection (H), and
4. Date and reason for any disciplinary action against the
   verification technician arising from performing the duties
   of a verification technician

Question 391

Q: What are the identification and qualifications required for a verification technician in a technology-assisted verification of product program?

Answer 391

A:
1. Identification:
- A verification technician must wear identification that includes the title “Verification Technician” while on duty.

2. Definition:
   
   • A verification technician is an individual who:
     
     1. Is qualified under subsection (D).
     2. Uses a combination of scanning technology and visual confirmation to verify that a product prepared for dispensing matches the prescription and label.
     3. Performs verification of work done by other pharmacy technicians before a pharmacist or pharmacy intern (under a pharmacist’s supervision) conducts the final accuracy check.

Question 392

Q: What are the requirements for a pharmacy technician trainee training program according to R4-23-1105?

Answer 392

1. Program Development and Compliance:
   
   • A pharmacy permittee or pharmacist-in-charge must develop, implement, review, and revise the pharmacy technician trainee training program according to the needs of the individual pharmacy, following the procedures
2. Training Guidelines:
   
   • The training program must include:
     
     • Specific Tasks: Define the specific tasks a pharmacy technician trainee is expected to perform.
     • Competency Assessment: Specify how and when the pharmacist-in-charge will assess the pharmacy technician trainee’s competency.
     • Policies and Procedures: Address the policies and procedures as specified in R4-23-1104(G) and the permissible activities as specified in R4-23-1104(A).
3. Documentation:
   
   • A pharmacist-in-charge must:
     
     • Document the date when a pharmacy technician trainee successfully completes the training program.
     • Maintain this documentation for inspection by the Board or its designee.

Question 393

Q: What are the requirements for a pharmacy technician drug compounding training program according to R4-23-1105?

Answer 393

1. Program Development and Compliance:
   
   • A pharmacy permittee or pharmacist-in-charge must:
     
     • Develop, implement, review, and revise the pharmacy technician drug compounding training program based on the individual pharmacy’s needs
2. Training Guidelines:
   
   • The training program must include:
     
     • Specific Tasks: Define the specific tasks a pharmacy technician is expected to perform.
     • Competency Assessment: Specify how and when the pharmacist-in-charge will assess the pharmacy technician’s competency.
     • Procedures and Tasks: Address the following procedures and tasks:
       
       • Area Preparation: Prepare the compounding area.
       • Component Preparation: Prepare the components used in compounding.
       • Aseptic Technique and Product Preparation: Apply aseptic techniques and prepare the product.
       • Packaging and Labeling: Package and label the compounded product.
       • Area Cleanup: Clean up the compounding area.
3. Documentation:
   
   • A pharmacist-in-charge must:
     
     • Document the date when a pharmacy technician successfully completes the drug compounding training program.
     • Maintain this documentation for inspection by the Board or its designee.

Question 394

Q: What are the requirements for alternative pharmacy technician training for obtaining a pharmacy technician license?

Answer 394

1. Eligibility:
   
   • An individual who has passed a Board-approved pharmacy technician examination but has not followed the standard path (i.e., obtaining a pharmacy technician trainee license and completing a pharmacy technician-trainee training program) may still obtain a pharmacy technician license.
2. Requirements:
   
   • Employment in Pharmacy: The individual must be employed in a pharmacy.
   • On-the-Job Training Program: The individual must complete an on-the-job training program as part of the employment orientation, which includes:
     
     • Reading and Discussing Board Rules: Reviewing and discussing the Board rules concerning pharmacy technicians and pharmacy technician trainees with the pharmacist-in-charge.
     • Job Descriptions: Reviewing the pharmacy technician and pharmacy technician trainee job descriptions.
     • Policies and Procedures Manual: Reading and discussing the pharmacy’s policies and procedures manual.

Question 395

Q: What documentation must be provided if a pharmacy technician leaves a training program before successful completion?

Answer 395

A:

• Written Documentation: The pharmacist-in-charge must provide the pharmacy technician with written documentation that includes:
  
  • Hours of Training Completed: The total number of training hours the pharmacy technician has completed.
  • Tasks for Which Competence Was Demonstrated: A list of the specific tasks for which the pharmacy technician has demonstrated competence.

This ensures that the pharmacy technician has a record of their completed training and demonstrated competencies, which may be useful for future employment or training opportunities.

Question 396

Q: What are the continuing education requirements for pharmacy technicians?

Answer 396

A:

General Requirements:
- Contact Hours/CEUs: A pharmacy technician must complete:
- 20 Contact Hours or 2 CEUs of continuing education activity.
- The education must be sponsored by an Approved Provider
- Exemption: Pharmacy technicians are exempt from this requirement between the time of initial licensure and their first renewal.

Special Continuing Education Requirement:
- Vaccine Administration: To administer vaccines (as per R4-23-1104(B)(5)):
- The pharmacy technician must complete at least 2 Contact Hours of continuing education.
- The education must be approved by the Accreditation Council for Pharmacy Education and related to vaccine administration.

Question 397

Q: What are the rules for continuing education units (CEUs) for pharmacy technicians?

Answer 397

A:

Valid CEUs:
1. Provider Requirement: CEUs must be sponsored by an Approved Provider.
2. Accrual Period: CEUs must be accrued during the two-year period immediately before licensure renewal.
3. Carry Forward: CEUs cannot be carried forward to the succeeding biennial renewal period.
4. CEUs for Presenters: Pharmacy technicians who lead, instruct, or lecture at a continuing education activity sponsored by an Approved Provider may receive CEUs for their presentation, following the same attendance procedures as other attendees.
5. Exclusions: Normal teaching duties within a learning institution, where the primary responsibility is the education of health professionals, do not qualify for CEUs.

Question 398

Q: What are the requirements for maintaining and reporting continuing education units (CEUs) for pharmacy technicians?

Answer 398

A:

1. Maintaining CE Records:
- Verify Participation: Records must verify participation in continuing education activities during the preceding five years.
- Proof of Completion: Include a statement of credit or a certificate issued by an Approved Provider at the conclusion of each activity.

2. Reporting at Renewal:
- Attestation: At the time of licensure renewal, the pharmacy technician must attest to the number of CEUs participated in during the renewal period on the biennial renewal form.

3. Submission Upon Request:
- Proof Submission: When requested by the Board office, the pharmacy technician must submit proof of continuing education participation within 20 days of the request.

Question 399

Q: What are the guidelines for charging fees related to donated medicine?

Answer 399

1. Fees Charged to Eligible Patients:
- Reasonable Cost: The fee must not exceed the reasonable cost of receiving, handling, and dispensing the donated medicine.
- Consistency with Program Purpose: The fee must align with the purpose of the donated medicine program, including adjustments for the quantity and retail cost of the medicine dispensed.

2. Fees Charged to Donors or Authorized Recipients:
- Usual and Customary Expenses: An authorized recipient may charge a fee for usual and customary expenses incurred in receiving and handling donated medicine.