PharmLaw Set #3 (AZ)

Question 1

36-2525. Prescription orders; labels; packaging; definition

What are the conditions for dispensing Schedule II controlled substances?

Answer 1

Except in emergency situations or specific conditions outlined in subsections E, F, and G, or when dispensed directly by a medical practitioner to an ultimate user, a Schedule II controlled substance cannot be dispensed without:
- A written prescription order in ink, indelible pencil, or typewritten and manually signed by the medical practitioner
- An electronic prescription order as prescribed by federal law or regulation
- Beginning January 1, 2020, a Schedule II controlled substance that is an opioid can only be dispensed with an electronic prescription order as prescribed by federal law or regulation.
- A prescription order for a Schedule II controlled substance cannot be dispensed more than 90 days after the date on which the prescription order was issued.

Question 2

32-1961.01. Remote dispensing site pharmacies

Q: What are the requirements for a remote dispensing site pharmacy?

Answer 2

A:
1. The remote dispensing site pharmacy must either be jointly owned by a supervising pharmacy in the state or operate under a contract with a pharmacy that is licensed and located in the state.
2. It must be supervised by a pharmacist who is licensed and located in the state and designated as the pharmacist responsible for the oversight of the remote dispensing site pharmacy.
3. The facility must display a sign visible to the public indicating that it is a remote dispensing site pharmacy, is under continuous video surveillance, and that the video is recorded and retained.
4. The remote dispensing site pharmacy must use a common electronic recordkeeping system with the supervising pharmacy or allow the supervising pharmacy to access all of its dispensing system records.

Question 3

32-1961.01. Remote dispensing site pharmacies

Q: What are the supervision limits for a pharmacist at a remote dispensing site pharmacy?

Answer 3

A:
1. A pharmacist may supervise one remote dispensing site pharmacy if they are also supervising and dispensing at a licensed pharmacy.
2. A pharmacist may supervise up to two remote dispensing site pharmacies if they are not simultaneously supervising and dispensing at another licensed pharmacy.
3. A pharmacist may supervise additional remote dispensing site pharmacies with board approval.

Question 4

32-1961.01. Remote dispensing site pharmacies

Q: What are the requirements for a remote dispensing site pharmacy?

Answer 4

A:
1. The remote dispensing site pharmacy must either be jointly owned by a supervising pharmacy in the state or operate under a contract with a pharmacy that is licensed and located in the state.
2. It must be supervised by a pharmacist who is licensed and located in the state and designated as the pharmacist responsible for the oversight of the remote dispensing site pharmacy.
3. The facility must display a sign visible to the public indicating that it is a remote dispensing site pharmacy, is under continuous video surveillance, and that the video is recorded and retained.
4. The remote dispensing site pharmacy must use a common electronic recordkeeping system with the supervising pharmacy or allow the supervising pharmacy to access all of its dispensing system records.

Question 5

32-1961.01. Remote dispensing site pharmacies

Q: What must be included in the policy and procedures manual of a remote dispensing site pharmacy?

Answer 5

A: The policy and procedures manual of a remote dispensing site pharmacy must include the following information:

1. Compliance with Laws:
   
   • A description of how the remote dispensing site pharmacy will comply with federal and state laws, rules, and regulations.
2. Supervision and Counseling Procedures:
   
   • The procedure for supervising the remote dispensing site pharmacy and counseling the patient or patient’s caregiver using audio and visual technology that complies with the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
3. Monthly Inspections:
   
   • The elements of a monthly inspection of the remote dispensing site pharmacy by the pharmacist responsible for its oversight. This includes requirements for documentation and retention of the results of each inspection.
4. Controlled Substances Inventory Reconciliation:
   
   • The procedure for reconciling on a monthly basis the perpetual inventory of controlled substances to the on-hand count of controlled substances at the remote dispensing site pharmacy.
5. Patient Access Improvement:
   
   • A description of how the remote dispensing site pharmacy will improve patient access to a pharmacist and pharmacy services.

Question 6

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
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Q: What is the purpose of licensure as a pharmacy intern or graduate intern and how can an applicant request a waiver of intern licensure requirements?

Answer 6

A:
- Purpose of Licensure: Licensure as a pharmacy intern or graduate intern is for the purpose of complementing the individual’s academic or experiential education in preparation for licensure as a pharmacist.
- Requesting a Waiver: An applicant may request a waiver of intern licensure requirements by:
1. Submitting a written request as specified in R4-23-401.
2. Appearing in person at a Board meeting.

Question 7

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
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Q: What are the prerequisites for licensure as a pharmacy intern?

Answer 7

A:
1. Current Enrollment: Enrollment in good standing at a Board-approved college or school of pharmacy.
2. Graduation from a Non-Approved School: Graduation from a college or school of pharmacy that is not approved by the Board.
3. Certification: Proof of certification by the Foreign Pharmacy Graduate Examination Committee (FPGEC).
4. Board Order: As determined by the Board if the Board requires the applicant to complete intern training.

Question 8

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What should a pharmacy intern licensee do if they stop attending pharmacy school before graduation?

Answer 8

A:
1. Immediate Action: The licensee must immediately stop practicing as a pharmacy intern.
2. License Surrender: The pharmacy intern license must be surrendered to the Board or its designee within 30 days of the last attended class.
3. Petition for Continuation: The licensee may petition the Board as specified in R4-23-401 and seek approval to continue working as a pharmacy intern.
4. Reapplication: If the student re-enters the pharmacy program and wishes to continue internship training, they must reapply for pharmacy intern licensure.

Question 9

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What are the prerequisites for licensure as a graduate intern?

Answer 9

Q: What are the prerequisites for licensure as a graduate intern?

A:
1. Graduation: The applicant must have graduated from a Board-approved college or school of pharmacy.
2. Application for Pharmacist Licensure: The applicant must apply for licensure as a pharmacist by examination or reciprocity.
3. Board Order: If determined by the Board, the applicant may need intern training as specified by the Board.

Question 10

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: How can an intern receive credit for experiential training received outside the state?

Answer 10

A:
An intern may receive credit for experiential training from outside the state if the Board determines that the training meets or exceeds the minimum requirements for intern training in this state. To obtain credit, the applicant must provide a certified copy of the intern training records from:
1. Board of Pharmacy or Licensing Agency: The Board of Pharmacy or intern licensing agency of the jurisdiction where the training was received.
2. College or School of Pharmacy: If there is no intern licensing agency, then from the director of the experiential training program at the applicant’s Board-approved college or school of pharmacy.

Question 11

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What is required before a pharmacy or graduate intern can practice at a pharmacy?

Answer 11

A:
A pharmacy permittee or pharmacist-in-charge must verify that the person is currently licensed by the Board as a pharmacy or graduate intern before permitting them to practice as an intern at the pharmacy.

Question 12

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What is required for an applicant seeking licensure as a pharmacy intern or graduate intern?

Answer 12

A:
1. The applicant must:
a. Submit a completed application either electronically or manually using a form provided by the Board.
b. Include with the application form:
i. The documents specified in the application form.
ii. The initial licensure fee as specified in R4-23-205.
iii. The wall license fee as specified in R4-23-205.

2. The application is considered received by the Board on the date it is electronically or manually date-stamped by the Board office.

Question 13

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What are the licensure procedures for a pharmacy intern or graduate intern?

Answer 13

A:
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 found eligible, the Board office will:
   
   • Issue a certificate of licensure and a wall license.
   • Allow the applicant to begin practicing as a pharmacy intern or graduate intern once assigned a license number and granted “open” status on the Board’s license verification site, even if the physical certificate has not yet been received.
3. Pending Status: An applicant with a “pending” status on the Board’s license verification site may not practice 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 14

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What are the requirements and procedures for renewing a pharmacy intern license?

Answer 14

A:
1. Renewal Before Six Years:
- A pharmacy intern whose license expires before completing the education or training required for pharmacist licensure, but within six years from the initial issuance, may renew the intern license.
- The renewal period is equal to the difference between the expiration date of the initial license and six years from the issue date of the initial license.
- The renewal requires payment of a prorated fee based on the initial license fee as specified in R4-23-205.

2. Renewal After Six Years:
   
   • If the intern does not graduate from a Board-approved college or school of pharmacy within six years from the initial license issuance, they are not eligible for relicensure as an intern unless they obtain Board approval.
   • To remain in good standing, an intern who receives Board approval for relicensure must pay a prorated renewal fee for the approved number of licensure months before the license expiration date.
3. Failure to Pay Renewal Fee:
   
   • If an intern who receives Board approval for relicensure does not pay the renewal fee before the license expiration date, the license is suspended.
   • The intern must pay a penalty as provided in A.R.S. § 32-1925 and R4-23-205 to lift the suspension and resume practice.

Question 15

ARTICLE 3. INTERN TRAINING AND PHARMACY INTERN PRECEPTORS R4-23-301. Intern Licensure
.
Q: What are the notification requirements for a pharmacy intern or graduate intern regarding their training?

Answer 15

A:
1. Pharmacy Intern Employment Notification:
- A pharmacy intern employed outside the experiential training program of a Board-approved college or school of pharmacy, or a graduate intern, must notify the Board within 10 days of:
- Starting new training.
- Terminating training.
- Changing training site.

2. Intern Training Report:
   
   • The director of a Board-approved college or school of pharmacy’s experiential training program must provide the Board with an intern training report as specified in R4-23-304(B)(3).

Question 16

R4-23-404. Unethical Practices

Q: What are the prohibitions regarding rebates and compensation for pharmacists and pharmacy permittees?

Answer 16

A:
1. General Prohibition:
- A pharmacist or pharmacy permittee must not offer, deliver, receive, or accept any unearned rebate, refund, commission, preference, patronage dividend, discount, or other unearned consideration (whether money or otherwise) as compensation or inducement to refer a patient, client, or customer to any person.
- The only exception is a rebate or premium paid completely and directly to a patient.

2. Specific Prohibitions:
   
   • Payment to Medical Practitioners: A pharmacist or pharmacy permittee cannot make payments to a medical practitioner in money or other consideration for a prescription order prescribed by that medical practitioner.
   • Payments to Health Care Institutions: A pharmacist or pharmacy permittee cannot make payments to a long-term care or assisted living facility or other health care institution in money, discount, rental, or other consideration that exceeds the prevailing rate for:
     
     • Prescription medication or devices dispensed or sold for a patient or resident of the facility or institution.
     • Drug selection, drug utilization review services, drug therapy management services, or other pharmacy consultation services provided for a patient or resident of the facility or institution.

Question 17

R4-23-407. Prescription Requirements

A. Prescription orders. a pharmacist shall ensure that:

Answer 17

A:
1. Record Keeping:
- A pharmacist must ensure that a prescription order is kept as a record of the dispensing of a drug or device for seven years from the date the drug or device is dispensed.

2. Packaging Compliance:
   
   • The dispensing of a drug or device must comply with the packaging requirements of the official compendium and state and federal law.
3. Special Requirements for Schedule II Controlled Substances (Opioids):
   
   • If the drug dispensed is a Schedule II controlled substance that is an opioid, it must be placed in a container with a red cap and a warning label stating “CAUTION: OPIOID, Risk of Overdose and Addiction” or other similar clear language indicating the possibility of overdose and addiction.
   • 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 18

You are a staff pharmacist at a community pharmacy in Mesa, AZ, and you receive an electronic prescription for a patient for testosterone. The prescription is issued for #90 capsules, inject 1 mL intramuscularly every 14 days, 5 refills. You realize the prescriber probably meant to prescribe a vial of testosterone liquid because there are no testosterone capsules available on the market, and therefore there is a mistake in the quantity. As a pharmacist, you

Choose ALL answers that apply.

A
May change the quantity since capsules are not available, to achieve the intent of the prescriber

B
May change the dosage form to the vial size available, to achieve the intent of the prescriber

C
Need a new prescription, issued with the correct quantity

Answer 18

C! Testosterone is a controlled substance, so no changes can be made to the prescription

Question 19

R4-23-407. Prescription Requirements

Q: What are the requirements for transferring prescription order information?

Answer 19

A:
1. Record Keeping:
- Both the original and the transferred prescription order must be maintained for seven years after the last dispensing date.

2. Controlled Substances (Schedules III, IV, or V):
   
   • The transfer of the original prescription order information for a Schedule III, IV, or V controlled substance must be done as specified in 21 CFR 1306.25.
3. Noncontrolled Substances:
   
   • The original prescription order information for a noncontrolled substance drug can be transferred without limitation, but only up to the number of originally authorized refills.

Question 20

R4-23-407. Prescription Requirements

Q: What are the rules for transferring prescription information for controlled substances in Schedules III, IV, and V?

Answer 20

One-Time Transfer: Transfer of original prescription information for refill purposes is allowed only once between pharmacies.
.
Electronic Transfers: Pharmacies with real-time, online databases can transfer up to the maximum authorized refills as permitted by law and the prescriber’s authorization.
.
NOTE: Schedule II controlled substance: Federal and state regulations prohibit the transfer of prescriptions for Schedule II substances, whether for initial dispensing or refills. Therefore, you cannot transfer this prescription to another pharmacy, regardless of the circumstances!!

Question 21

You are a staff pharmacist at an independent pharmacy in Mesa, AZ, and you receive a call from a chain pharmacy nearby asking for a transfer of lisdexamfetamine for a mutual patient. This prescription was issued for lisdexamfetamine 30mg, #30, take 1 capsule PO daily. You may

Choose ALL answers that apply.

A
Not transfer this prescription to the pharmacy

B
Transfer this prescription to the pharmacy on a one-time basis only and it may not be transferred again

C
Transfer this prescription to the pharmacy up to the maximum allowable refills permitted by the prescriber

D
Transfer this prescription to the pharmacy only if the two pharmacies share an electronic real-time online database

Answer 21

A! The correct answer is A: Not transfer this prescription to the pharmacy because:

Lisdexamfetamine is classified as a Schedule II controlled substance. Federal and state regulations prohibit the transfer of prescriptions for Schedule II substances, whether for initial dispensing or refills. Therefore, you cannot transfer this prescription to another pharmacy, regardless of the circumstances.
Options B, C, and D are incorrect because:

B is incorrect as Schedule II prescriptions cannot be transferred at all, even on a one-time basis.
C is incorrect because Schedule II prescriptions cannot be transferred, so refills are not applicable.
D is incorrect because the ability to transfer Schedule II prescriptions is not influenced by whether the pharmacies share an electronic real-time online database.

Question 22

R4-23-407. Prescription Requirements
F. Transmission of a prescription order from a medical practitioner to a pharmacy by fax.
.
Q: What are the requirements for transmitting prescription orders by fax to a pharmacy?

Answer 22

1. Faxing Schedule III, IV, or V Controlled Substances, Prescription-Only Drugs, or Nonprescription Drugs:
   
   • a. The prescription order must be faxed only to the pharmacy of the patient’s choice.
   • b. The faxed prescription order must:
     
     • i. Contain all required information as specified in A.R.S. §§ 32-1968 and 36-2525.
     • ii. Be faxed from the medical practitioner’s practice location, except that a nurse in a hospital, long-term care facility, or inpatient hospice may fax a prescription for a patient of the facility.
   • c. The faxed prescription order must include:
     
     • i. The date the prescription order is faxed.
     • ii. The fax number of the prescribing medical practitioner or the facility and the telephone number of the facility.
     • iii. The name of the person who transmits the fax, if different from the medical practitioner.
2. Faxing Schedule II Controlled Substances:
   
   • A Schedule II controlled substance prescription may be faxed for information purposes only unless it meets the requirements of A.R.S. § 36-2525(F) and (G), in which case it may serve as the original written prescription.
3. Receiving Faxed Prescriptions for Schedule II Controlled Substances:
   
   • A pharmacy may receive a faxed prescription for a Schedule II controlled substance for information purposes only. A faxed prescription for a Schedule II controlled substance that meets the requirements of A.R.S. § 36-2525(F) and (G) may serve as the original written prescription.
4. Record Retention:
   
   • To meet the seven-year record retention requirement of A.R.S. § 32-1964, a pharmacy must receive a faxed prescription order on plain paper or make a photocopy of the faxed prescription order.
5. Faxing Refill Authorizations:
   
   • A medical practitioner or their agent may fax refill authorizations to a pharmacy, provided the fax includes the medical practitioner’s telephone and fax numbers, the signature of the medical practitioner or the name of the medical practitioner’s agent, and the date of authorization.

Question 23

R4-23-407. Prescription Requirements

Q: What are the exceptions to electronic prescribing requirements under A.R.S. § 36-2525?
.
Medical Practitioner Exceptions:

Answer 23

1. Medical Practitioner Exceptions:
   
   • A medical practitioner authorized to prescribe a controlled substance may furnish a written prescription order instead of an electronic prescription order if:
     
     • a. The prescription is written in this state but to be filled in a jurisdiction outside this state.
     • b. The medication requires compounding two or more ingredients.
     • c. The medication is not in the E-prescribing database.
     • d. The prescription is for an individual detained by or in custody of an Arizona or federal law enforcement agency.
     • e. The prescription is issued under A.R.S. § 36-2525(N) or (O).

Question 24

R4-23-407. Prescription Requirements

Q: What are the exceptions to electronic prescribing requirements under A.R.S. § 36-2525?
.
Pharmacist Exceptions:

Answer 24

2. Pharmacist Exceptions:
   
   • A pharmacist may dispense a controlled substance from a written rather than an electronically transmitted prescription order if:
     
     • a. The prescription is written by a medical practitioner who is licensed in a jurisdiction outside this state. The pharmacist is not required to verify the practitioner’s licensure.
     • b. The prescription is for a medication that requires compounding two or more ingredients.
     • c. The prescription is for a medication that is not in the E-prescribing database.
     • d. The prescription is for an individual detained by or in custody of an Arizona or federal law enforcement agency.
     • e. The prescription is received under A.R.S. § 36-2525(D).

Question 25

Q: What are the exceptions to the requirement for electronic prescription orders for Schedule II controlled substances that are opioids, effective January 1, 2020?

Answer 25

1. System Unavailability: A medical practitioner is not in violation of the electronic prescribing requirement if:
   
   • The electronic prescribing system or pharmacy management system is not operational or available in a timely manner. In this case, the medical practitioner may write a prescription order, noting on the written prescription that the system was not operational. The practitioner must maintain a record of the system’s unavailability for a period prescribed by the board.
2. Specific Facilities: The requirement does not apply if:
   
   • The prescription is for a Schedule II controlled substance that is an opioid and is to be dispensed from:
     
     • A veterans administration facility,
     • A health facility on a military base,
     • An Indian health services hospital or other Indian health service facility, or
     • A tribal-owned clinic.

Question 26

R4-23-408. Computer Records

Q: Under what conditions can a pharmacy permittee or pharmacist-in-charge use an electronic imaging recordkeeping system instead of filing original hard-copy prescription orders?

Answer 26

A pharmacy permittee or pharmacist-in-charge may use an electronic imaging recordkeeping system if:

1. System Capabilities: The system can capture, store, and reproduce an exact image of the prescription order, including the reverse side if necessary.
2. Notes and Clarifications: Any notes of clarification or alterations to the prescription are directly associated with the electronic image of the prescription order.
3. Retention: The prescription order image and associated notes are retained for no fewer than seven years from the date the prescription was last dispensed.
4. Policies and Procedures: Policies and procedures for using the electronic imaging system are developed, implemented, reviewed, and revised as required.
5. Controlled Substances Exclusion: The prescription is not for a controlled substance.

Question 27

R4-23-408. Computer Records
Q: Under what conditions can an automated record from a pharmacy’s computer system be considered the original prescription order instead of requiring a hard copy or electronic image?

Answer 27

An automated record from a pharmacy’s computer system can be considered the original prescription order if:

1. Automatic Population: The computer system’s fields are automatically populated by an electronically transmitted prescription order.
2. System Capabilities: The system can maintain, print, and provide all prescription order information required by A.R.S. §§ 32-1968 and 36-2525 and R4-23-407(A).
3. Availability: The information can be provided within 72 hours of a request by the Board, its compliance officers, other authorized regulatory board agents, or authorized officers of the law.

Question 28

R4-23-410. Current Good Compounding Practices

Q: What procedures must a pharmacy permittee ensure regarding cross-contamination and control of components and pharmaceutical product containers and closures?

Answer 28

1. Procedures to Prevent Cross-Contamination:
- Cross-Contamination Control: The pharmacist-in-charge must establish, implement, and comply with procedures to prevent cross-contamination, particularly when using substances that require special precautions, such as penicillin. This includes:
- Dedication of Equipment: Dedicate specific equipment to handle such substances.
- Meticulous Cleaning: Thoroughly clean contaminated equipment before using it for other pharmaceutical products.

2. Control Procedures for Components and Containers:
- Storage and Handling: Components and pharmaceutical product containers and closures must:
- Be Stored Off the Floor: Ensure they are not in direct contact with the floor.
- Prevent Contamination: Be handled and stored in a manner that prevents contamination.
- Rotate Stock: Use the oldest approved stock first.
- Compliance: Container closure systems must meet official compendium standards.
- Cleanliness and Material: Containers and closures should be clean and made of materials that are not reactive, additive, or absorptive.

Question 29

R4-23-410. Current Good Compounding Practices

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

Answer 29

A:
To ensure pharmaceutical product safety and quality, a pharmacy permittee must ensure that equipment and utensils used in compounding are:

1. Design and Location: Appropriately designed, adequately sized, and suitably located for proper operation, cleaning, and maintenance.
2. Material: Made of materials that are not reactive, additive, or absorptive when exposed to components, in-process materials, or pharmaceutical products.
3. Cleaning: Cleaned and protected from contamination before use.
4. Inspection: Inspected and determined suitable for use before compounding operations begin.
5. Routine Checks: Routinely inspected, calibrated, or checked to ensure proper performance.

Question 30

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition
.
Q: What are the requirements for a pharmacist administering an immunization, vaccine, or emergency medication?

Answer 30

A:
1. Notification: The pharmacist must notify the person’s identified primary care provider or physician within forty-eight (48) hours after administering the immunization, vaccine, or emergency medication, following Board-prescribed rules.
2. Efforts to Identify Provider: The pharmacist must make reasonable efforts to identify the primary care provider or physician using:
- Arizona State Immunization Information System: Checking the state system established by the Department of Health Services.
- Pharmacy Records: Reviewing pharmacy records.
- Requesting Information: Asking the person or, for minors, the person’s parent or guardian for the information.

Question 31

R4-23-411. Pharmacist-administered or Intern-administered Immunizations
.
Q: What are the recordkeeping and reporting requirements for pharmacists or interns administering immunizations, vaccines, or emergency medications?

Answer 31

A:

1. Documentation Required: The pharmacist or intern must provide the pharmacy with the following details for each administered immunization, vaccine, or emergency medication:
   
   • Patient Information: Name, address, and date of birth.
   • Administration Details: Date and site of injection.
   • Product Information: Name, dose, manufacturer’s lot number, and expiration date.
   • Primary-Care Provider: Name and address of the patient’s primary-care provider or physician.
   • Administering Pharmacist/Intern: Name of the pharmacist or intern.
   • Eligibility Record: Record of consultation confirming the patient is eligible as per R4-23-110.
   • Consultation Information: Details of any professional information provided to the patient.
   • Information Sheet: Name and date of the immunization or vaccine information sheet given to the patient.
   • Minor Consent Form: For minors, a consent form signed by the parent or guardian.
2. Reporting to Primary-Care Provider: A written or electronic report containing documentation (subsection F(1)(a) through (d) above) must be sent to the patient’s primary-care provider or physician. The pharmacy must document the time and date of the report and make this record available for Board inspection within 72 hours.
3. Record Retention: The records must be maintained in the pharmacy or database for at least seven years from the administration date.

Question 32

R4-23-412. Emergency Refill Prescription Dispensing

Q: What are the conditions under which a pharmacist may dispense a one-time emergency refill during a state of emergency?

Answer 32

A:

When a state of emergency is declared under A.R.S. § 32-1910(A) or (B), resulting in individuals being unable to refill existing prescriptions, a pharmacist may dispense a one-time emergency refill of up to a 30-day supply if:

1. Medication Necessity: The pharmacist believes the medication is essential to maintaining life or continuing therapy.
2. Documentation: The pharmacist makes a good faith effort to obtain a written prescription marked “emergency prescription” and files and maintains it as required by law.

Question 33

R4-23-412. Emergency Refill Prescription Dispensing

Q: What additional action can a pharmacist take if a state of emergency continues for at least 21 days after dispensing an initial emergency prescription?

Answer 33

If the state of emergency declared under A.R.S. § 32-1910(A) or (B) persists for at least 21 days after dispensing the initial emergency prescription, the pharmacist may dispense one additional emergency refill of up to a 30-day supply. This is contingent upon the pharmacist complying with the documentation requirements stated in subsection (A)(2).

Question 34

R4-23-503. Access to Controlled Substances Prescription Monitoring Progr

Q: What are the confidentiality and disclosure requirements for prescription information submitted to the Board?

Answer 34

1. Confidentiality: Prescription information submitted to the Board or its designee is confidential and not subject to public inspection, except as provided in A.R.S. § 36-2604(B) and (C) and other relevant sections.
2. Disclosure for Investigation: The Board or its designee will review the prescription information. If they suspect unprofessional or illegal conduct, they will notify the appropriate professional licensing board or law enforcement agency and provide the necessary prescription information for investigation.

Question 35

R4-23-503. Access to Controlled Substances Prescription Monitoring Progr

Q: Under what conditions can the Board or its designee release data collected by the prescription program?

Answer 35

A: The Board or its designee can release data under the following conditions:

1. To Authorized Prescribers or Dispensers: To assist in providing medical or pharmaceutical care to a patient or evaluating a patient.
2. To Individuals: To individuals requesting their own controlled substance prescription information under A.R.S. § 12-2293.
3. To Professional Licensing Boards: To boards established under A.R.S. Title 32, Chapters 7, 11, 13, 14, 15, 16, 17, 18, 21, 25, or 29, but only if the board provides a written statement that the information is necessary for an open investigation or complaint.
4. To Law Enforcement or Criminal Justice Agencies: To local, state, or federal agencies if they provide a written statement that the information is necessary for an open investigation or complaint.
5. To the Arizona Health Care Cost Containment System Administration: For individuals receiving services under A.R.S. Title 36, Chapter 29, provided a written statement is given that the information is necessary for an open investigation or complaint.
6. To Court Orders: To comply with a lawful order from a court of competent jurisdiction.
7. To Evaluators: To those authorized to prescribe or dispense a controlled substance who are performing an evaluation under A.R.S. § 23-1026.
8. To Board Staff: For the administration and enforcement of A.R.S. Title 36, Chapter 28 and related regulations.

Question 36

R4-23-505. Reports

Q: What must a person authorized to access CSPMP data submit in their request?

Answer 36

A: The request must include:

1. Specific Information: The information requested for the report.
2. For Medical Practitioners: A statement that the report’s purpose is to provide medical or pharmaceutical care to a patient or to evaluate a patient.
3. For Individuals: A form of non-expired government-issued photo identification.
4. For Professional Licensing Boards: A statement that the information is necessary for an open investigation or complaint.
5. For Law Enforcement or Criminal Justice Agencies: A statement that the information is necessary for an open investigation or complaint.
6. For AHCCCS Administration: A statement that the information is necessary for an open investigation or complaint.
7. For Court Orders: A copy of the court order.

Question 37

Prescriptions for an opioid which is a Schedule II Controlled Substances may be issued

I. Electronically
II. In writing
III. By fax only for certain patients in specific situations

Answer 37

I and III only!

Question 38

36-2525. Prescription orders; labels; packaging; definition

Q: Under what conditions can a prescription order for a Schedule II controlled substance, including opioids, be transmitted by fax according to A.R.S. § 36-2525(F)?

Answer 38

A: A prescription order for a Schedule II controlled substance can be transmitted by fax if:

1. Compounded for Direct Administration: It is to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.
2. Long-Term Care Facility Resident: It is for a resident of a long-term care facility.
3. Hospice Care Patient: It is for a patient enrolled in a hospice care program that is certified or paid for by Medicare or licensed by the state. The prescription must indicate that the patient is a hospice patient.

Question 39

R4-23-670. Sterile Pharmaceutical Products

Q: What are the requirements for a sterile pharmaceutical product compounding area according to R4-23-609(A) and R4-23-655(B)?

Answer 39

A: The sterile pharmaceutical product compounding area must:

1. Minimum Size: Provide at least 100 square feet of contiguous floor area. Pharmacies issued or remodeled before November 1, 2006, may use a minimum of 60 square feet until a new permit is issued or a remodel occurs.
2. Dedicated Purpose: Be dedicated solely to preparing and compounding sterile pharmaceutical products.
3. Isolation: Be isolated from other pharmacy functions.
4. Restricted Access: Restrict entry or access to the area.
5. Controlled Air Flow: Be free from unnecessary disturbances in air flow.
6. Non-Porous Materials: Have non-porous and cleanable floor, wall, and ceiling materials.
7. Air Cleanliness: Meet ISO Class 7 air cleanliness standards, unless all compounding is performed within an ISO Class 5 environment isolator.

Question 40

R4-23-670. Sterile Pharmaceutical Products

Q: What are the minimum standards for standard-risk sterile pharmaceutical product compounding?

Answer 40

A: For standard-risk sterile pharmaceutical product compounding, the following standards must be met:

1. Environment: Compounding must occur only in an ISO Class 5 environment, which is located within an ISO Class 7 environment. The ISO Class 7 environment may include a designated prep area.

Question 41

R4-23-608. Change of Personnel and Responsibility

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

Answer 41

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.
   C. The Board may suspend or revoke a pharmacy permit if the owner or management of a pharmacy violates subsection (B).

Question 42

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

Answer 42

Facilities Standards for Pharmacies

1. Facilities must be constructed per state and local laws and ordinances.
2. Pharmacy facilities’:
   a. Walls, ceilings, windows, floors, shelves, and equipment must be clean and in good repair.
   b. Counters, shelves, aisles, and open spaces must be uncluttered.
3. Adequate trash receptacles must be provided and emptied periodically.
4. Facilities must have access to toilet facilities:
   a. Within the pharmacy area or
   b. No more than 100 feet away, or an alternative distance approved by the Board.
5. Toilet facilities must be maintained in sanitary condition and good repair.
6. All pharmacy personnel must keep themselves and their apparel clean.
7. No animals are allowed in the pharmacy, except licensed assistant or guard animals.
8. The facility must be free of insects and rodents.
9. There must be a sink with hot and cold running water for preparing drug products, other than a sink in a toilet facility.

Question 43

R4-23-613. Procedure for Discontinuing a Pharmacy

What are the responsibilities of the pharmacist-in-charge when a pharmacy is discontinuing business?

Answer 43

Pharmacy Discontinuation Procedures

1. Only a pharmacist should have access to prescription-only drugs and controlled substances until they are transferred as specified.
2. Remove all narcotics, controlled substances, prescription-only drugs, nonprescription drugs, precursor chemicals, and regulated chemicals from the premises before discontinuation.
3. For transferring controlled substances:
   a. Take an inventory using procedures from R4-23-1003.
   b. Include a copy of the inventory with the transferred substances.
   c. Keep the original inventory with the pharmacy’s records for at least three years.
   d. Use DEA Form 222 for transferring Schedule II controlled substances.
   e. Handle controlled substances requiring destruction according to the same procedures as other controlled substances.

Question 44

R4-23-615. Mechanical Storage and Counting Device for a Drug
in Solid, Oral Dosage Form
.
Q: What must a pharmacy permittee or pharmacist-in-charge ensure regarding drugs previously counted by a mechanical storage and counting device?

Answer 44

A: The pharmacist-in-charge must ensure:

1. Any drug previously counted by a mechanical device for a solid, oral dosage form, which has not left the pharmacy, is not returned to its original cell, cassette, or stock bottle unless the return method is approved by the Board or its designee.
2. The drug can be counted and dispensed manually or using a mechanical device, provided it is done before the drug’s beyond-use-date.

Question 45

R4-23-615. Mechanical Storage and Counting Device for a Drug in Solid, Oral Dosage Form
.
Q: What are the requirements for returning a drug previously counted by a mechanical storage and counting device to its cell or cassette?

Answer 45

A: Before returning the drug, the pharmacy permittee or pharmacist-in-charge must:

1. Apply for Approval:
   
   • Submit an application to the Board or its designee for the drug return method.
2. Develop and Document a Drug Return Method:
   
   • Create a method using technology (e.g., bar coding) to prevent errors.
   • Provide documentation of this method.
3. Demonstrate the Method:
   
   • Show the drug return method to a Board Compliance Officer.
4. Receive Approval:
   
   • Obtain approval from the Board or its designee for the drug return method.

Additional Requirements for Waiver Approval:

1. Request Submission:
   
   • Submit a written request to the Board or its designee.
2. Documentation Review:
   
   • Provide documentation of the drug return method.
3. Inspection Report:
   
   • Obtain a satisfactory inspection report from a Board Compliance Officer confirming the method uses technology to prevent errors.

Question 46

R4-23-621. Shared Services

Q: What are the requirements for a pharmacy to participate in shared services?

Answer 46

A: To participate in shared services, a pharmacy must:

1. Have a Current Permit:
   
   • Possess either a current resident or non-resident pharmacy permit issued by the Board.
2. Meet Shared Services Conditions:
   
   • Ownership: Either have the same owner or
   • Written Agreement: Have a written contract or agreement detailing services provided and shared responsibilities in compliance with federal and state pharmacy statutes and rules.
   • Shared Technology: Share a common electronic file or technology for accessing necessary information.
3. Patient Notifications:
   
   • Before Shared Services:
     
     • Notify patients that their orders may be processed or filled by another pharmacy.
     • Provide the name of that pharmacy or inform the patient that the order may be filled by any pharmacy in a network under common ownership. Notification can be given via a one-time written notice or a sign in the pharmacy.
   • For Direct Delivery Orders:
     
     • Ensure the prescription container or a separate sheet includes:
       
       • The local and toll-free telephone numbers of the pharmacy utilizing shared services with access to the patient’s records.
       • A statement: “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).”
   • Exemption:
     
     • The notification provisions do not apply to orders delivered to patients in facilities where a licensed health care professional administers the medication.

Question 47

R4-23-658. Drug Distribution and Control
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:

Answer 47

1. For use inside the hospital.
   a. Labels for all single unit packages contain at a minimum, the following information:
   i. Drug name, strength, and dosage form;
   ii. Lot number and beyond-use-date; and
   iii. Appropriate auxiliary labels;
   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;
   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; and
2. For use outside the hospital. Any drug dispensed to a patient by a hospital pharmacy that is intended for self-administration outside of the hospital is labeled as specified in A.R.S. §§ 32-1963.01(C) and 32-1968(D) and A.A.C. R4-23-402.

Question 48

R4-23-653. Personnel: Professional or Technician
E. Pharmacists. A pharmacist or a pharmacy intern or graduate intern under the supervision of a pharmacist shall perform the following professional practices:

Answer 48

1. Verify a patient’s medication order before administration of a drug to the patient, except:
   a. In an emergency medical situation; or
   b. In a hospital where the pharmacy is open less than 24 hours a day for pharmacy services, a pharmacist shall verify a patient’s medication order within four hours of the time the pharmacy opens for pharmacy services;

Question 49

Hospital pharmacies must

I. Have a professional reference library
II. Maintain room temperature conditions
III. Have a laminar air flow hood only if the hospital contains greater than 150 patient beds

Answer 49

I and II

Question 50

R4-23-656. Sanitation and Equipment
A hospital pharmacy permittee or Director of Pharmacy shall ensure that a hospital pharmacy:

Answer 50

Hospital Pharmacy Requirements:

1. Professional Reference Library:
   
   • Maintain a library with hardcopy or electronic media suitable for the scope of services.
2. Sink:
   
   • Features: Hot and cold running water.
   • Location: Within the pharmacy area, not in a toilet facility.
   • Condition: Must be sanitary and in good repair.
3. Room Temperature:
   
   • Maintain a temperature compatible with proper drug storage.
4. Refrigeration:
   
   • Provide a refrigerator and freezer with temperatures suitable for drugs requiring refrigeration or freezing.
5. Sterile Product Preparation:
   
   • Designate an area for a laminar air flow hood and related supplies for sterile product preparation.

Question 51

R4-23-670. Sterile Pharmaceutical Products

E. 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 51

Standard-Risk Sterile Pharmaceutical Product Compounding:

1. Compounding Environment:
   
   • Must occur in an ISO Class 5 environment inside an ISO Class 7 environment, which may include a dedicated prep area.
2. Procedures:
   
   • Use simple, closed-system aseptic techniques for compounding from sterile commercial drugs or for creating sterile products from non-sterile ingredients.
3. Protective Clothing:
   
   • Wear gown, gloves, head cover, and booties. If using an ISO Class 5 isolator outside an ISO Class 7 environment, protective clothing is not required.
4. Aseptic Technique:
   
   • Complete an annual media-fill test to ensure proper aseptic technique.

Question 52

R4-23-670. Sterile Pharmaceutical Products

F. 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 52

High-Risk Sterile Pharmaceutical Product Compounding:

1. Compounding Environment:
   
   • Must occur in an ISO Class 5 environment within an ISO Class 7 environment. The ISO Class 7 environment cannot have a prep area inside it.
2. Protective Clothing:
   
   • Wear gown, gloves, head cover, and booties. Protective clothing is not required if compounding occurs in an ISO Class 5 isolator that is not inside an ISO Class 7 environment.
3. Aseptic Technique:
   
   • Complete a semi-annual media-fill test using dry non-sterile media to simulate challenging conditions and validate aseptic technique.

Question 53

Main Differences Between High-Risk and Standard-Risk Sterile Pharmaceutical Product Compounding:

Answer 53

Main Differences Between High-Risk and Standard-Risk Sterile Pharmaceutical Product Compounding:

1. Compounding Environment:
   
   • High-Risk: Must occur in an ISO Class 5 environment within an ISO Class 7 environment. The ISO Class 7 environment cannot have a prep area inside it.
   • Standard-Risk: Occurs in an ISO Class 5 environment within an ISO Class 7 environment. The ISO Class 7 environment may have a specified prep area inside it.
2. Compounding Procedures:
   
   • High-Risk: Involves compounding parenteral or injectable products from non-sterile ingredients, which generally requires more stringent controls.
   • Standard-Risk: Involves procedures with a few closed-system, basic, simple aseptic transfers and manipulations, often using sterile commercial drugs or sterile pharmaceutical products.
3. Protective Clothing:
   
   • High-Risk: Requires wearing gown, gloves, head cover, and booties. Protective clothing is not required if using an ISO Class 5 isolator not inside an ISO Class 7 environment.
   • Standard-Risk: Requires wearing gown, gloves, head cover, and booties. Protective clothing is required even if using an ISO Class 5 isolator inside an ISO Class 7 environment.
4. Testing for Aseptic Technique:
   
   • High-Risk: Requires a semi-annual media-fill test using dry non-sterile media to simulate challenging conditions.
   • Standard-Risk: Requires an annual media-fill test to validate proper aseptic technique.

Question 54

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
What should a pharmacist do if a medical practitioner prescribes a brand name drug but does not indicate an intent to prevent substitution?

Answer 54

If a medical practitioner prescribes a brand name drug and does not indicate an intent to prevent substitution as prescribed in subsection E of this section, a pharmacist may fill the prescription with a generic equivalent drug.

Question 55

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
Q: Under what conditions may a pharmacist substitute a biological product for a prescribed biological product?

Answer 55

A: A pharmacist may substitute a biological product for a prescribed biological product if:

1. The FDA has determined the substituted product to be an interchangeable biological product.
2. The prescribing physician has not prohibited substitution in writing or electronically.
3. The patient or person presenting the prescription is informed of the substitution.
4. Within five business days of dispensing, the pharmacist or designee makes an entry of the specific product provided, including the name and manufacturer, into an electronic medical records system or communicates it to the prescriber by fax, phone, or electronic means, unless:
   
   • No interchangeable biological product is approved by the FDA for the prescribed product.
   • A refill prescription is unchanged from the previous fill.
5. The pharmacy retains a record of the dispensed biological product as required by law.

Question 56

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
When must pharmacy personnel notify the person presenting the prescription of the price difference between a brand name drug or biological product and a generic or interchangeable product?

Answer 56

A: Pharmacy personnel must notify the person presenting the prescription of the price difference if:

• The medical practitioner has not indicated an intent to prevent substitution with a generic or interchangeable product.
• The transaction is not subject to third-party reimbursement.

Question 57

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
Q: What must a pharmacist include on the container when dispensing a generic or interchangeable biological product?

Answer 57

A: The pharmacist must place the following on the container:

• The name of the drug or biological product dispensed.
• The words “generic equivalent for” or “interchangeable biological product for.”
• The brand or trade name of the product being replaced by the generic or interchangeable product.

Additionally, the brand or trade name must be included on the container or label of any contact lenses dispensed.

Question 58

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
Q: Under what conditions must a prescription be dispensed as written?

Answer 58

A: A prescription must be dispensed as written if:

1. In-State Prescriptions: The prescriber writes or clearly displays any of the following on the prescription form:
   
   • “DAW”
   • “dispense as written”
   • “do not substitute”
   • “medically necessary”
   • Any statement that clearly indicates an intent to prevent substitution.
2. Out-of-State or U.S. Government Prescriptions: The prescriber writes or clearly displays any of the following on the prescription form:
   
   • “do not substitute”
   • “dispense as written”
   • “medically necessary”
   • Any statement that clearly indicates an intent to prevent substitution.

Question 59

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
Q: Can an employer or agent require a pharmacist to dispense or substitute a specific drug against their professional judgment?

Answer 59

A: No, an employer or agent of an employer cannot require a pharmacist to:
1. Dispense a specific generic equivalent drug or interchangeable biological product.
2. Substitute a specific generic equivalent drug or interchangeable biological product for a brand name drug or biological product.

This prohibition applies if such actions go against the professional judgment of the pharmacist or the order of the prescriber.

Question 60

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
Q: What is the liability of a pharmacist when substituting drugs according to this section?

Answer 60

A: The liability of a pharmacist in substituting drugs as specified in this section is no greater than that incurred in filling a generically written prescription. This does not limit or diminish the pharmacist’s responsibility for the strength, purity, or quality of drugs, as outlined in section 32-1963. Additionally, a prescriber’s failure to specify “no substitution” does not constitute evidence of negligence.

Question 61

32-1963.01. Substitution for prescription drugs or biological products; requirements; label; definitions
.
I. A pharmacist may not make a substitution pursuant to this section unless the manufacturer or distributor of the generic equivalent drug or interchangeable biological product has shown that:

Answer 61

1. All products dispensed have an expiration date on the original package.
2. The manufacturer or distributor maintains recall and return capabilities for unsafe or defective drugs or biological products.

Question 62

§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
.
Q: What are the conditions under which an individual practitioner can issue multiple prescriptions for a Schedule II controlled substance?

Answer 62

A: An individual practitioner may issue multiple prescriptions for a Schedule II controlled substance, authorizing a total of up to a 90-day supply, if the following conditions are met:

1. Legitimate Medical Purpose: Each prescription is issued for a legitimate medical purpose and in the usual course of professional practice.
2. Written Instructions: Each prescription (except the first one if intended to be filled immediately) includes written instructions specifying the earliest date on which the pharmacy may fill each prescription.
3. Risk Assessment: The practitioner determines that issuing multiple prescriptions does not pose an undue risk of diversion or abuse.
4. Compliance with State Laws: The practice complies with applicable state laws.
5. Adherence to Regulations: The practitioner adheres to all applicable requirements under the Act, regulations, and additional state laws.

Note: This provision does not require or encourage practitioners to issue multiple prescriptions or to see patients only every 90 days. Practitioners should use their medical judgment and established standards to decide the appropriateness of issuing multiple prescriptions and patient visit frequency.

Question 63

R4-23-701.02. Long-term Care Facilities Pharmacy Services: Emergency Drugs
A. The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall
ensure that:

Answer 63

1. An emergency drug supply unit is available within the long-term care facility,
2. Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy, and
3. Controlled substance drugs contained in an emergency drug supply unit are included in all inventories required under A.R.S. § 36-2523(B) and R4-23-1003(A).

Question 64

R4-23-701.03. Long-term Care Facilities Pharmacy Services: Emergency Drug Prescription Order
.
Q: What is required of a limited-service pharmacy permittee or pharmacist-in-charge regarding emergency drug prescription orders in a provider pharmacy?

Answer 64

A: The limited-service pharmacy permittee or pharmacist-in-charge must ensure that every emergency drug prescription order is evaluated by a pharmacist according to the requirements of R4-23-402(A) within 72 hours of the first dose of the drug being administered by long-term care facility personnel under the emergency drug prescription order.

Question 65

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

Answer 65

A: A pharmacy permittee must ensure the following:

1. Prescription Medication:
   
   • Provided only by a valid prescription order for an individual hospice inpatient facility patient.
   • Properly labeled for the patient.
   • Non-prescription drugs can be supplied in unopened manufacturer’s containers.
2. Prescription Medication Labeling:
   
   • Must comply with A.R.S. §§ 32-1968 and 36-2525.
   • Include drug name, strength, dosage form, quantity, and beyond-use date.
3. Relabeling:
   
   • If the label becomes damaged or soiled, a pharmacist may relabel the drug container. Only a pharmacist can label or alter drug container labels.
4. Policies and Procedures:
   
   • Pharmacists may assist in developing policies and procedures for drug management in the facility.
5. Pharmacist Services:
   
   • The pharmacy may provide services such as medication therapy evaluation, identification of adverse drug reactions, and recommendations for corrective action.
6. Emergency Drug Supply Unit:
   
   • Must comply with the requirements of R4-23-701.02.
7. Automated Dispensing Systems:
   
   • Not allowed in hospice inpatient facilities.
8. Repackaging:
   
   • Drugs previously dispensed to a patient by another pharmacy or by the provider pharmacy shall not be repackaged.

Question 66

Q: What are the record-keeping requirements for controlled substances according to R4-23-1003?

Answer 66

A: The following records must be maintained for at least three years:

1. Manufacturing, Repackaging, or Relabeling:
   
   • Record and retain the date of manufacturing, repackaging, or relabeling for each controlled substance.
2. Receiving, Selling, Delivering, or Disposing:
   
   • Record and retain:
     
     • The name, strength, dosage form, and quantity of each controlled substance.
     • The name, address, and DEA registration number of the person from whom the controlled substance was received.
     • The name, address, and DEA registration number of the person to whom the controlled substance was sold, delivered, or who disposed of it.
     • The date of each transaction.
3. Inventory for Full-Service Drug Wholesale Permittee:
   
   • Conduct an inventory:
     
     • On May 1 of each year or as directed by the Board.
     • If there is a change of ownership, discontinuance of business, or within 10 days of a change in designated representative.
4. Inventory for Drug Manufacturer Permittee or Pharmacist-in-Charge:
   
   • Conduct an inventory:
     
     • On May 1 of each year or as directed by the Board.
     • If there is a change of ownership, discontinuance of business, or within 10 days of a change in pharmacist-in-charge.
5. Order Form:
   
   • For A.R.S. § 36-2524, “Order Form” means DEA Form 222c.

Question 67

Q: What are the requirements for implementing a technology-assisted verification of product program in a pharmacy according to R4-23-1104.01?

Answer 67

A: To implement a technology-assisted verification program, a pharmacy must adhere to the following:

1. Written Program Description:
   
   • Content: Include responsibilities of the pharmacist-in-charge and permittee, duties of the verification technician, necessary training, and monitoring procedures.
   • Posting & Distribution: Post the description in the pharmacy, provide copies to the pharmacist-in-charge and verification technician, and keep signed copies in personnel files.
   • Updates: Update the program description as needed and repeat posting and distribution.
2. Training and Qualifications for Verification Technicians:
   
   • Licensing & Experience: The technician must be licensed and have at least 1,000 hours of relevant work experience.
   • Training Program: Must cover the technician’s role, legal requirements, system usage, medication error causes, and error resolution.
   • Continuing Education: Complete at least four hours of patient safety continuing education.
3. Technology & Equipment:
   
   • Data Storage: The pharmacy must have a compliant computer data storage and retrieval system.
   • Verification Limits: Technicians can verify products with scanning technology or robotically prepared unit doses but cannot verify compounded products, altered drugs, or DEA schedule II controlled substances.
4. Evaluation & Records:
   
   • Competency Evaluation: Perform unannounced evaluations of verification technicians at least twice a year and address deficiencies.
   • Record Keeping: Maintain records of technician designation, training completion, evaluation results, and any disciplinary actions.
5. Identification & Role:
   
   • Identification: Verification technicians must wear identification with their title.
   • Definition: A verification technician uses scanning technology and visual confirmation to verify products and performs initial verification before a final accuracy check by a pharmacist or intern.

Question 68

A registered nurse practitioner (RNP) can issue outpatient prescriptions for (Select all that apply)

Choose ALL answers that apply.

A
Schedule II controlled substances

B
Schedule III controlled substances, but no refills are allowed

C
Schedule III controlled substances, with refills

D
Schedule IV controlled substances, but no refills are allowed

E
Schedule IV controlled substances, with refills

F
Schedule V controlled substances, but no refills are allowed

G
Schedule V controlled substances, with refills

Answer 68

The correct answer is ‘A’ ‘C’ ‘E’ ‘G’

Question 69

If authorized verbally by the prescriber, the pharmacist may make changes to a written or electronic schedule II controlled substance prescription order, except for any of the following:

Answer 69

1. The patient’s name.
2. The prescriber’s name.
3. The drug name.

Question 70

You are a pharmacist at a community pharmacy, and you’ve received an electronic prescription for Morphine for a patient. If you speak with the prescriber verbally to clarify, you may (Select all that apply)

Choose ALL answers that apply.

A
Not make any changes to this prescription because it is a Schedule II Controlled Substance

B
Change the patient’s name

C
Change the prescribed drug

D
Change the prescribed quantity

E
Change the prescribed dosage form

F
Change the directions (sig)

Answer 70

The correct answer is ‘D’ ‘E’ ‘F’

Question 71

Q: What are the dispensing requirements for controlled substances in Schedule III or IV?

Answer 71

A: The requirements for dispensing Schedule III or IV controlled substances are:

1. Prescription Requirement:
   
   • Must be dispensed only with a written, oral, or electronic prescription order from a medical practitioner, except when dispensed directly by the medical practitioner to the ultimate user.
2. Prescription Validity:
   
   • The prescription order cannot be filled or refilled more than six months after the date it was issued.
3. Refill Limits:
   
   • A prescription order can be refilled up to a maximum of five times.
4. Additional Quantities:
   
   • Any additional quantities beyond the initial prescription must be authorized by the prescribing practitioner through a new prescription order, which is considered a new and separate prescription.

Question 72

Q: What are the dispensing requirements for Schedule V controlled substances?

Answer 72

A: The requirements for dispensing Schedule V controlled substances are:

1. Prescription Requirement:
   
   • Must be dispensed with a written or oral prescription order from a medical practitioner, except when dispensed directly by the medical practitioner to the ultimate user.
2. Refill Limits:
   
   • The prescription order may be refilled as authorized by the prescribing medical practitioner.
3. Prescription Validity:
   
   • The prescription order cannot be filled or refilled more than one year after the date it was issued.

Question 73

Schedule?

Ketamine

Answer 73

III

Question 74

Schedule?

Carisoprodol

Answer 74

IV

Question 75

Schedule?

Pregabalin

Answer 75

V

Question 76

Schedule?

Hydrocodone + Acetaminophen ( Vicodin®, Lorcet®, and Lortab®)

Answer 76

II

Question 77

Schedule?

Zolpidem

Answer 77

IV

Question 78

Schedule?

Morphine

Answer 78

II

Question 79

Q: What are the criteria for compounding each drug preparation according to USP Chapter 795?

Answer 79

A: The criteria for compounding each drug preparation are:

1. Single Preparation:
   
   • Only one preparation is compounded at a time in a specific workspace.
2. Compounding Facilities:
   
   • Facilities must have adequate space specifically designated for compounding prescriptions.
   • Areas used for sterile preparations must be separate and distinct from nonsterile compounding areas.

Question 80

60. Is an entity required to have two sets of equipment, one set for compounding HDs and a second set for compounding non-HDs?

Answer 80

A: Equipment used in compounding hazardous drugs must follow these guidelines:

1. Dedicated Equipment:
   
   • Disposable or clean equipment (e.g., mortars, pestles, spatulas) must be dedicated solely for HD use.
   • Equipment or parts that come in direct contact with HDs must be dedicated for HD use.
2. Shared Equipment:
   
   • Equipment that does not contact HDs can be shared with non-HD areas if it is deactivated, decontaminated, and cleaned before removal from the HD area.
3. Operation:
   
   • Equipment used in HD compounding must be operated within the Containment Secondary Engineering Control (C-SEC) unless it is a closed system (e.g., certain mixers, autoclaves, convection ovens).

Question 81

Q: What are the requirements for compounding hazardous drugs according to USP Chapter 797?

Answer 81

A: The requirements for compounding hazardous drugs are:

1. Training:
   
   • All personnel who compound hazardous drugs must be fully trained in their storage, handling, and disposal.
   • Training must occur before preparing or handling hazardous drugs and must be verified through specific testing of preparation techniques.
   • Verification of training must be documented annually for each person.
   • Training includes:
     
     • Overview of hazardous drugs, including their mutagenic, teratogenic, and carcinogenic properties.
     • Ongoing training for new hazardous drugs.
     • Safe aseptic manipulation practices.
     • Negative pressure techniques when using a Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI).
     • Correct use of Closed System Drug Transfer (CSTD) devices.
     • Containment, cleanup, and disposal procedures for breakages and spills.
     • Treatment procedures for personnel contact and inhalation exposure.
   • Personnel of reproductive capability must confirm in writing their understanding of the risks.
2. Environmental Sampling:
   
   • To ensure containment, especially when preparing large volumes, routine environmental sampling should be performed (initially as a benchmark and at least every 6 months or more frequently if needed).
   • Sampling includes:
     
     • Surface wipe sampling of BSCs and CACIs.
     • Countertops where finished preparations are placed.
     • Areas adjacent to BSCs and CACIs, including the floor directly under the working area.
     • Patient administration areas.
   • Common marker hazardous drugs for assay include cyclophosphamide, ifosfamide, methotrexate, and fluorouracil.
3. Disposal:
   
   • Disposal of hazardous drug wastes must comply with all applicable federal and state regulations.
   • Personnel performing custodial waste removal and cleaning in hazardous drug areas must be trained in appropriate procedures to protect themselves and prevent contamination.

Question 82

What are the requirements for a valid prescription for a controlled substance?

Answer 82

A: To be valid, a prescription for a controlled substance must meet the following criteria:

1. Authorized Practitioner:
   
   • It must be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is authorized to prescribe controlled substances by the jurisdiction in which they are licensed.
2. Legitimate Medical Purpose:
   
   • The prescription must be issued for a legitimate medical purpose.
3. Professional Practice:
   
   • It must be issued by a practitioner acting in the usual course of professional practice.
4. Prohibition:
   
   • Prescriptions cannot be issued for the purpose of the individual practitioner obtaining controlled substances for their own general dispensing to patients.

Question 83

Q: What are the responsibilities of central fill pharmacies regarding prescription filling?

Answer 83

A: Central fill pharmacies can prepare both initial and refill prescriptions, provided they adhere to all relevant state and federal regulations. Key responsibilities include:

1. Licensed Pharmacist:
   
   • Only a licensed pharmacist may fill the prescription.
2. Corresponding Responsibility:
   
   • Both retail and central fill pharmacists must ensure the prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
3. Compliance:
   
   • Both must comply with DEA regulations and other applicable requirements.

Question 84

Section 208.1(c) authorizes FDA to require a Medication Guide if FDA determines one or more of the following circumstances exist:

Answer 84

1.(1) The drug product is one for which patient labeling could help prevent serious adverse effects.
2.(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product.
3.(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

Question 85

The HIPAA Privacy Rule states that an individual has a right to adequate notice of how a covered entity may use and disclose protected health information about the individual, as well as his or her rights and the covered entity’s obligations with respect to that information. Select all that apply

I. A “Notice of Privacy Practices” must be given to each patient for whom services are in the pharmacy
II. The patient is required to sign the acknowledgement of receipt of the notice, or else services are not to be provided
III. A pharmacy chain needs only one acknowledgement per patient which will suffice for all of its stores

Answer 85

I and III

Question 86

What are the federal requirements for reporting the theft or significant loss of controlled substances?

Answer 86

Notification: Registrants must notify the Field Division Office of the DEA in their area, in writing, within one business day of discovering the theft or significant loss of any controlled substance, disposal receptacles, or listed chemicals.

Form Submission: The registrant must also complete and submit DEA Form 106 to the Field Division Office regarding the loss or theft.

Online Reporting: DEA Form 106 can be completed via Theft/Loss Reporting Online (TLR).

Question 87

An over-the-counter drug must be labeled with all of the following except:

Choose ALL answers that apply.

A
Directions for use

B
The lot number

C
Pregnancy or breast-feeding warnings

D
“Questions?” followed by a phone number to answer questions

E
The phone number to a national poison control center

Answer 87

E

Question 88

Q: What are the key requirements for drug labeling under CFR Title 21, Chapter 1, Subchapter C?

Answer 88

• Directions for Use (§ 201.5): Must be clear for laypersons to use safely and correctly. Inadequacies may include omissions or incorrect specifications.
• Control Numbers (§ 201.18): Lot numbers should provide complete manufacturing history. Incorrect numbers may cause misbranding.
• Pregnancy/Breastfeeding Warning (§ 201.63): OTC drugs for systemic use must have a warning: “If pregnant or breast-feeding, ask a health professional before use,” in bold. A symbol may also be used.
• OTC Labeling Content (§ 201.66): Labels must include required headings and may include a “Questions?” section with a phone number, days, and times of availability in at least 6-point bold type. A telephone graphic can be used.