PharmLaw Set #1 (AZ)

Question 1

32-1901.01. Definition of unethical and unprofessional conduct; permittees; licensees.
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A. In this chapter, unless the context otherwise requires, for the purposes of disciplining a permittee, “unethical conduct” means the following, whether occurring in this state or elsewhere:

Answer 1

13. Knowingly filing with the board any application, renewal or other document that contains false or misleading information.
14. Failing to notify the board of a change of ownership, management or pharmacist in charge.
15. Distributing premiums or rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient.
16. Failing to maintain effective controls against the diversion of controlled substances or precursor chemicals to unauthorized persons or entities.
17. Fraudulently claiming to have performed a service.
18. Advertising drugs or devices, or services pertaining to drugs or devices, in a manner that is untrue or misleading in any particular, and that is known, or that by the exercise of reasonable care should be known, to be untrue or misleading.

Question 2

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Substitution for Prescription Drugs: What can a pharmacist do if a medical practitioner prescribes a brand name drug and does not prevent substitution?

Answer 2

A pharmacist may fill the prescription with a generic equivalent drug.

Question 3

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Conditions for Substituting Biological Products: Under what conditions can a pharmacist substitute a biological product?

Answer 3

• The FDA has determined the substituted product to be an interchangeable biological product.
• The prescribing physician does not designate in writing or electronically that substitution is prohibited.
• The pharmacy informs the patient or person presenting the prescription of the substitution.
• Within five business days after dispensing a biological product, the pharmacist or the pharmacist’s designee records the specific product provided, including the name and manufacturer, in an electronically accessible system or communicates it to the prescriber.
• The pharmacy retains a record of the biological product dispensed.

Question 4

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Within five business days after dispensing a biological product, the dispensing pharmacist or the pharmacist’s designee makes an entry of the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by:

Answer 4

making an entry that is electronically accessible to the prescriber through an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record. Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using fax, telephone, electronic transmission or other prevailing means, except that communication is not required if one of the following applies:
(a) There is no interchangeable biological product approved by the United States food and drug administration for the product prescribed.
(b) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

Question 5

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Any pharmacy personnel shall notify the person presenting the prescription of the amount of the price difference between the brand name drug or biological product prescribed and the generic equivalent drug or interchangeable biological product, if both of the following apply:

Answer 5

1. The medical practitioner does not indicate an intent to prevent substitution with a generic equivalent drug or interchangeable biological product.
2. The transaction is not subject to third-party reimbursement.

Question 6

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Q: What labeling requirements must a pharmacist follow when dispensing a drug or biological product?

Answer 6

The pharmacist must place on the container the name of the drug or biological product dispensed followed by “generic equivalent for” or “interchangeable biological product for” and the brand or trade name of the product being replaced. For contact lenses, the brand or trade name must also be included on the label.

Question 7

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

A prescription generated in this state must be dispensed as written only if the prescriber writes or clearly displays:

Answer 7

“DAW”, “dispense as written”, “do not substitute” or “medically necessary” or any statement by the prescriber that clearly indicates an intent to prevent substitution on the face of the prescription form

Question 8

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

A prescription from out of state or from agencies of the United States government must be dispensed as written only if the prescriber writes or clearly displays

Answer 8

“do not substitute”, “dispense as written” or “medically necessary” or any statement by the prescriber that clearly indicates an intent to prevent substitution on the face of the prescription form.

Question 9

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Scope of application: To which prescriptions does this section apply?

Answer 9

A: This section applies to all prescriptions, including those presented by or on behalf of persons receiving state or federal assistance payments.

Question 10

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Q: Can an employer require a pharmacist to dispense a specific generic equivalent drug or interchangeable biological product against the professional judgment of the pharmacist or the order of the prescriber?

Answer 10

A: No, an employer or agent of an employer of a pharmacist shall not require this.

Question 11

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Liability of Pharmacists
Q: What is the liability of a pharmacist in substituting according to this section?

Answer 11

A: The liability is no greater than that incurred in filling a generically written prescription. This subsection does not limit or diminish the responsibility for the strength, purity, or quality of drugs provided. The failure of a prescriber to specify that no substitution is authorized does not constitute evidence of negligence.

Question 12

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

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 12

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 13

32-1963.01. Sub. for rx drugs or biological products; req; label; defs

Public Information
Q: What must the board maintain on its public website?

Answer 13

A: The board must maintain a link to the current list of each biological product determined by the FDA to be an interchangeable biological product.

Question 14

32-1934. Remote hospital-site pharmacy permittee; requirements

A remote hospital-site pharmacy permittee shall ensure that:

Answer 14

1. The remote hospital-site pharmacy is supervised by a pharmacist who is located in this state and who is employed by the hospital.
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2. The remote hospital-site pharmacy displays a sign visible to the public identifying the pharmacy as a remote hospital-site pharmacy and warning that the remote hospital-site pharmacy is under continuous video surveillance that is recorded and retained.
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3. The remote hospital-site pharmacy uses an electronic recordkeeping system that is shared with and accessible by the pharmacy located in the hospital.
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4. All drugs and devices furnished from the remote hospital-site pharmacy to patients of the satellite facility are verified by a pharmacist who is licensed in this state and who is employed by the hospital. If the satellite facility is an emergency department of the hospital, in the pharmacist’s absence a registered nurse practitioner or professional nurse who is licensed pursuant to chapter 15 of this title, a physician who is licensed pursuant to chapter 13 or 17 of this title or a physician assistant who is licensed pursuant to chapter 25 of this title may obtain from the remote hospital-site pharmacy necessary drugs and devices that are ordered by a medical practitioner and that are needed by a patient in an emergency, according to policies approved by the hospital.
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5. The pharmacist in charge develops and implements procedures regarding obtaining, storing and dispensing drugs for inpatient administration and devices and recordkeeping requirements.
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6. If a noncontrolled substance single-patient use multidose medication was dispensed to a patient in a container for inpatient administration, the remote hospital-site pharmacy dispenses that medication for the patient on discharge, if needed.

Question 15

32-1934. Remote hospital-site pharmacy permittee; requirements

A remote hospital-site pharmacy permittee shall:

Answer 15

• Develop and maintain a policy and procedures manual, available to the board upon request.
• Maintain a perpetual inventory of controlled substances.
• Ensure continuous video surveillance, keeping recorded videos for at least sixty days.
• Have the hospital pharmacy’s pharmacist in charge reconcile the inventory of controlled substances monthly.

Question 16

32-1934. Remote hospital-site pharmacy permittee; requirements

Q: Can a pharmacist work at multiple remote hospital-site pharmacies simultaneously?

Answer 16

A: Yes, at a reasonable number as determined and approved by the hospital.

Question 17

32-1934. Remote hospital-site pharmacy permittee; requirements

Q: Who can adopt additional rules necessary to implement this section?

Answer 17

A: The board

Question 18

R4-23-410. Current Good Compounding Practices

Can a pharmacy permittee or pharmacist provide a compounded pharmaceutical product to a pharmacy, medical practitioner, or other person for dispensing or distributing?

Answer 18

A: No, except a compounded pharmaceutical product may be provided to a medical practitioner to administer to a patient if each container is accompanied by a written list and has a specific label.

Question 19

R4-23-410. Current Good Compounding Practices

Q: What must the label on a compounded pharmaceutical product include?

Answer 19

The label must include:
a. The pharmacy’s name, address, and telephone number.
b. The pharmaceutical product’s name and the required information.
c. A lot or control number.
d. A beyond-use-date based on the pharmacist’s judgment, not exceeding maximum guidelines unless stability test data supports a longer period.
e. The statement “Not For Dispensing.”
f. The statement “For Office or Hospital Administration Only.”

Question 20

R4-23-410. Current Good Compounding Practices

Can a pharmacy or pharmacist advertise their prescription compounding services?

Answer 20

A: Yes, a pharmacy or pharmacist may advertise or otherwise promote that they provide prescription compounding services.

Question 21

R4-23-410. Current Good Compounding Practices

What must the pharmacist-in-charge establish and comply with regarding compounding controls?

Answer 21

A: The pharmacist-in-charge must establish, implement, and comply with pharmaceutical product compounding controls that conform with specific standards, including labeling requirements.

Question 22

R4-23-410. Current Good Compounding Practices

In addition to the labeling requirements of A.R.S. § 32-1968(D), the label contains:

Answer 22

a. A statement, symbol, designation, or abbreviation that the pharmaceutical product is a compounded pharmaceutical product, and
b. A beyond-use-date as specified in subsection (B)(3)(d).

Question 23

R4-23-410. Current Good Compounding Practices

What must be provided to the patient at the time of dispensing a compounded pharmaceutical product?

Answer 23

A: A written list of the compounded pharmaceutical product’s active ingredients must be given to the patient.

Question 24

R4-23-407.1. Dispensing an Opioid Antagonist

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 24

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 25

# R4-23-407.1. Dispensing an Opioid Antagonist A pharmacist who has completed an opioid prevention and treatment training program:

Answer 25

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 26

# R4-23-407.1. Dispensing an Opioid Antagonist How is dispensing an opioid antagonist under A.R.S. § 32-1979 to a community member classified?

Answer 26

A: It is not considered wholesale distribution as defined at A.R.S. § 32-1981.

Question 27

# R4-23-407.1. Dispensing an Opioid Antagonist What must a pharmacist or pharmacy intern comply with when dispensing an opioid antagonist on a standing order according to A.R.S. § 32-1968?

Answer 27

They must comply with R4-23-407 (except subsection (A)(1)(b)), R4-23-408, and R4-23-409.

Question 28

# 32-1979. Pharmacists; dispensing opioid antag; board protocols; immunity Under what conditions can a pharmacist dispense naloxone hydrochloride or other opioid antagonists according to A.R.S. § 32-1979?

Answer 28

A pharmacist may dispense these medications pursuant to a standing order issued under section 36-2266 and according to board-adopted protocols to a person at risk of an opioid-related overdose or to someone in a position to assist that person.

Question 29

# 32-1979. Pharmacists; dispensing opioid antag; board protocols; immunity What must a pharmacist do when dispensing an opioid antagonist under A.R.S. § 32-1979?

Answer 29

1. Document the dispensing consistent with board rules. 2. Instruct the individual to whom the opioid antagonist is dispensed to summon emergency services as soon as practicable after administering the opioid antagonist.

Question 30

# 32-1979. Pharmacists; dispensing opioid antag; board protocols; immunity Does A.R.S. § 32-1979 affect a pharmacist’s authority to fill or refill prescriptions for opioid antagonists?

Answer 30

This section does not affect the authority of a pharmacist to fill or refill a prescription for naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration.

Question 31

# 32-1979. Pharmacists; dispensing opioid antag; board protocols; immunity What legal protection does a pharmacist have when dispensing an opioid antagonist under A.R.S. § 32-1979?

Answer 31

A pharmacist is immune from professional liability and criminal prosecution for decisions made, acts, or omissions resulting from dispensing an opioid antagonist, as long as they act with reasonable care and in good faith, except in cases of wanton or willful neglect.

Question 32

# R4-23-407. Prescription Requirements Can a pharmacy receive a faxed prescription order for a Schedule II controlled substance?

Answer 32

Yes, but it is for information purposes only unless the faxed prescription order meets the requirements of A.R.S. § 36-2525(F) and (G), in which case it can serve as the original written prescription order.

Question 33

# R4-23-407. Prescription Requirements How should a pharmacy retain a faxed prescription order to meet the seven-year record retention requirement?

Answer 33

The pharmacy should receive the faxed prescription order on plain paper or make a photocopy of the faxed prescription order.

Question 34

# R4-23-407. Prescription Requirements What information must be included in faxed refill authorizations from a medical practitioner or their agent?

Answer 34

The faxed authorization must include the medical practitioner’s telephone and fax numbers, the medical practitioner’s signature or the medical practitioner’s agent’s name, and the date of authorization.

Question 35

# 36-2525. Prescription orders; labels; packaging; definition Notwithstanding subsections D and N of this section, a patient's medical practitioner or the medical practitioner's agent may transmit to a pharmacy by fax a prescription order written for a schedule II controlled substance, including opioids, if the prescription order is any of the following:

Answer 35

1. To be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion. 2. For a resident of a long-term care facility. 3. For a patient who is enrolled in a hospice care program that is certified or paid for by medicare under title XVIII or a hospice program that is licensed by this state. The medical practitioner or the medical practitioner's agent must note on the prescription that the patient is a hospice patient.

Question 36

# R4-23-407. Prescription Requirements Under what conditions can an electronic transfer of original prescription order information occur?

Answer 36

The electronic transfer must be between pharmacies owned by the same company using a common or shared database.

Question 37

# R4-23-407. Prescription Requirements Who can perform the electronic transfer of original prescription order information for a non-controlled substance?

Answer 37

A pharmacist, pharmacy intern, pharmacy technician trainee, or pharmacy technician under the supervision of a pharmacist.

Question 38

# R4-23-407. Prescription Requirements Who must perform the electronic transfer of original prescription order information for a controlled substance?

Answer 38

The transfer must be performed between two licensed pharmacists.

Question 39

# R4-23-407. Prescription Requirements The electronic transfer of original prescription order information for a non- controlled substance drug meets the following conditions: i. The transferring pharmacy’s computer system:

Answer 39

(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

Question 40

# R4-23-407. Prescription Requirements What must the transferring pharmacy's computer system do for a controlled substance transfer?

Answer 40

- Invalidate the transferred original prescription order information. - Record the identification code, number, or address, and DEA number of the receiving pharmacy. - Record the name or identification code of the receiving pharmacist. - Record the date of transfer. - Record the name or identification code of the transferring pharmacist.

Question 41

# R4-23-407. Prescription Requirements The electronic transfer of original prescription order information for a non- controlled substance drug meets the following conditions: ii. The receiving pharmacy’s computer system

Answer 41

(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 42

# R4-23-407. Prescription Requirements What must the transferring pharmacy's computer system do for a controlled substance transfer?

Answer 42

- Invalidate the transferred original prescription order information. - Record the identification code, number, or address, and DEA number of the receiving pharmacy. - Record the name or identification code of the receiving pharmacist. - Record the date of transfer. - Record the name or identification code of the transferring pharmacist.

Question 43

# R4-23-407. Prescription Requirements What must be included in the receiving pharmacy's computer system for a controlled substance transfer?

Answer 43

The information required in subsection (E)(4)(b)(iii) must be included.

Question 44

# R4-23-407. Prescription Requirements What additional documentation is required for a transferred prescription order?

Answer 44

An original prescription order containing the required information must be filed in compliance with A.R.S. § 32-1964, in addition to electronic documentation in the computer system.

Question 45

# R4-23-407. Prescription Requirements E. 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 45

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;

Question 46

# 21 CFR § 1306.25 21 CFR § 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.

Answer 46

The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

Question 47

# R4-23-407. Prescription Requirements C. 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 47

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 48

# R4-23-404. Unethical Practices E. Prohibiting a prescription-only drug or device from being dispensed over the counter. A pharmacist shall ensure that:

Answer 48

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 according to this Chapter; and 3. The prescription order is filed according to this Chapter.

Question 49

# R4-23-404. Unethical Practices Under what circumstances is a pharmacist prohibited from dispensing a drug from a prescription order?

Answer 49

A pharmacist shall not dispense a drug if they have knowledge, or reasonably should know, that the prescription order was issued based on an internet-based questionnaire or consultation without a medical practitioner-patient relationship as defined in R4-23-110.

Question 50

# R4-23-404. Unethical Practices What constitutes unethical conduct for a pharmacist under this Section?

Answer 50

A pharmacist who dispenses a prescription-only drug, prescription-only device, or controlled substance in violation of this Section is engaging in unethical conduct, which is a violation of A.R.S. § 32-1901.01.

Question 51

# R4-23-405. Change of Responsibility A pharmacist designated as the pharmacist-in-charge for a pharmacy, manufacturer, or other establishment shall give immediate notice, as defined in R4-23-110, when:

Answer 51

1. The pharmacist’s responsibility as a pharmacist-in-charge is terminated; or 2. The pharmacist knows of a pending termination of the pharmacist’s responsibility as the pharmacist-in-charge.

Question 52

# R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern Who is authorized to provide oral consultation about a prescription medication to a patient or patient’s caregiver in an outpatient setting?

Answer 52

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.

Question 53

# R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern When is oral consultation required for a prescription medication?

Answer 53

1. The prescription medication has not been previously dispensed to the patient in the same strength or dosage form or with the same directions; 2. The pharmacist, through the exercise of professional judgment, determines that oral consultation is warranted; or 3. The patient or patient’s care-giver requests oral consultation.

Question 54

# R4-23-204. Continuing Education Requirements What is the general continuing education requirement for pharmacy license renewal?

Answer 54

The Board shall not renew a license unless the licensee has participated in 30 contact hours (3.0 CEUs) of continuing education activity sponsored by an Approved Provider during the two years preceding the application for renewal.

Question 55

# R4-23-204. Continuing Education Requirements What are the special continuing education requirements for pharmacists certified to administer immunizations and those authorized to dispense controlled substances?

Answer 55

1. Pharmacists certified to administer **immunizations, vaccines, and emergency medications** must complete **at least two contact hours** related to these topics. 2. Pharmacists authorized to dispense controlled substances must complete **at least three contact hours** related to **opioid use, substance use disorders, or addiction.**

Question 56

# R4-23-204. Continuing Education Requirements When is a pharmacist exempt from continuing education requirements?

Answer 56

A pharmacist is exempt from the continuing education requirements between the time of initial licensure and the first renewal.

Question 57

# R4-23-204. Continuing Education Requirements Under what conditions does the Board accept continuing education units (CEUs)

Answer 57

1. CEUs must be from activities sponsored by an Approved Provider. 2. CEUs must be accrued during the two-year period immediately before licensure renewal. 3. CEUs from one biennial renewal period cannot be carried forward to the next. 4. Pharmacists who lead or lecture at an approved CE activity can receive CEUs for their presentation. 5. Normal teaching duties by a pharmacist whose primary role is educating health professionals are not accepted as CEUs.

Question 58

# R4-23-204. Continuing Education Requirements What are the requirements for maintaining and reporting continuing education records?

Answer 58

1. Pharmacists must maintain records verifying their continuing education activities for the preceding five years, including statements of credit or certificates from Approved Providers. 2. At licensure renewal, pharmacists must attest to their CEUs on the biennial renewal form. 3. Pharmacists must submit proof of continuing education participation within 20 days if requested by the Board.

Question 59

# R4-23-204. Continuing Education Requirements What actions can the Board take against a pharmacist who fails to comply with continuing education requirements?

Answer 59

The Board may revoke, suspend, or place on probation the license of a pharmacist who fails to comply with continuing education participation, recording, or reporting requirements.

Question 60

# R4-23-204. Continuing Education Requirements What can a pharmacist do if they disagree with a Board decision regarding CEUs?

Answer 60

A pharmacist can request a hearing before the Board if aggrieved by any decision concerning continuing education units.

Question 61

# Pharmacist Driven Hormonal Contraception What statutes and regulations allow pharmacists to dispense self-administered hormonal contraceptives?

Answer 61

A.R.S. 32-1979.01, R4-23-204, and R4-23-407.2 allow pharmacists to dispense self- administered hormonal contraceptives pursuant to a standing order.

Question 62

# Pharmacist Driven Hormonal Contraception Can someone simply walk into a pharmacy and pick up a hormonal contraceptive?

Answer 62

It is highly recommended that the patient contact the pharmacy. The state does not have a list of pharmacists that are trained to dispense self-administered hormonal contraceptives, and pharmacies are not required to offer this service.

Question 63

# Pharmacist Driven Hormonal Contraception Are self-administered hormonal contraceptives available over-the-counter (“OTC”) in Arizona?

Answer 63

A: Self-administered hormonal contraceptives may be dispensed by a pharmacist pursuant to a standing prescription order and patient completion of a self-screening risk assessment. Some patients may have health conditions that disqualify them from receiving self-administered hormonal contraceptives dispensed by a pharmacist under the standing order. Please refer to R4-23-407.2 for rules pertaining to dispensing self-administered hormonal contraceptives.

Question 64

# Pharmacist Driven Hormonal Contraception What training is required for a pharmacist to dispense self-administered hormonal contraceptives pursuant to a standing order?

Answer 64

This standing order applies to trained pharmacists licensed in the State of Arizona who dispense self-administered hormonal contraceptives by utilizing the standard of care and acting in compliance with Arizona’s Pharmacy Practice Act. . Pursuant to R4-23-204(A)(2)(c), a pharmacist who dispenses self-administered hormonal contraceptives under a standing prescription order must participate in at least three (3) contact hours of continuing education activity sponsored by an Approved Provider related to self- administered hormonal contraceptives prior to license renewal. . Pursuant to R4-23-110, “Approved Provider” means an individual, institution, organization, association, corporation, or agency that is approved by the Accreditation Council for Pharmacy Education (ACPE) in accordance with ACPE’s policy and procedures or by the Board as meeting criteria indicative of the ability to provide quality continuing education.

Question 65

# Pharmacist Driven Hormonal Contraception I am a pharmacist who has completed the required training. Can I immediately begin to dispense self-administered hormonal contraceptives using the statewide standing order?

Answer 65

Yes. However, some employers may have policies that need to be considered, and it is recommended to validate with your individual employer prior to commencing this practice.

Question 66

# Pharmacist Driven Hormonal Contraception Can a pharmacist refuse to dispense hormonal contraceptives?

Answer 66

Yes, if a pharmacist identifies any concerns during review of the self-screening questionnaire and/or pursuant to R4-23-402(A)(7), specifically, interpreting the prescription order, which includes exercising professional judgment in determining whether to dispense a particular prescription.

Question 67

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions. . A. It is prohibited for:

Answer 67

1. Any commercial entity to knowingly or wilfully sell or trade a finished drug product containing any quantity of dextromethorphan to a person who is under eighteen years of age. 2. Any person who is under eighteen years of age to purchase a finished drug product containing any quantity of dextromethorphan. 3. Any person to possess, receive or distribute unfinished dextromethorphan, unless the person is registered pursuant to the federal food, drug, and cosmetic act or is appropriately licensed with the board.

Question 68

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . What must a person making a retail sale of dextromethorphan products do before completing the sale?

Answer 68

They must require and obtain proof of age from the purchaser unless the seller reasonably presumes the purchaser to be at least twenty-five years old based on the purchaser's outward appearance.

Question 69

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . Does the prohibition on possessing, receiving, or distributing unfinished dextromethorphan apply to common carriers?

Answer 69

No, the prohibition does not apply to common carriers that possess, receive, or distribute unfinished dextromethorphan for the purpose of distributing it between persons registered under section 510 of the federal food, drug, and cosmetic act or appropriately licensed with the board.

Question 70

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . What compliance requirements are not imposed on retail entities by this section?

Answer 70

Retail entities are not required to place products in a specific place within a store, restrict consumer access to finished drug products, or maintain transaction records beyond manually obtaining and verifying proof of age.

Question 71

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . What are the penalties for selling dextromethorphan to a minor (under 18 y/o)?

Answer 71

The seller receives a warning for the first offense and a civil penalty of fifty dollars for the second offense, unless they provide documentation of an employee training program in place.

Question 72

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . Does this section apply to dextromethorphan medications sold by prescription?

Answer 72

The seller receives a warning for the first offense and a civil penalty of fifty dollars for the second offense, unless they provide documentation of an employee training program in place.

Question 73

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . Define "Common carrier"

Answer 73

"Common carrier" means a person providing transportation of merchandise for hire to the general public, whether or not they operate the vehicle.

Question 74

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . Define ""Finished drug product"

Answer 74

"Finished drug product" means a legally marketed drug under the federal food, drug, and cosmetic act in finished dosage form.

Question 75

32-1978. Sale of dextromethorphan; age requirement; exception; violation; civil penalty; definitions . Define "Unfinished dextromethorphan"

Answer 75

"Unfinished dextromethorphan" means dextromethorphan in any form, compound, mixture or preparation that is not a finished drug product.

Question 76

# R4-23-411. Pharmacist-administered or Intern-administered Immunizations What are the age requirements for administering immunizations, vaccines, and emergency medications by a pharmacist or intern?

Answer 76

An "eligible adult patient" is defined as a patient 13 years of age or older, and an "eligible minor patient" is defined as a patient at least three years of age but less than 13 years of age.

Question 77

# R4-23-411. Pharmacist-administered or Intern-administered Immunizations Can a pharmacist or intern administer immunizations without a prescription?

Answer 77

Yes, a pharmacist or an intern under the immediate personal supervision of a pharmacist may administer immunizations, vaccines, and emergency medications to eligible patients without a prescription if certain conditions are met.

Question 78

# R4-23-411. Pharmacist-administered or Intern-administered Immunizations A pharmacist or an intern under the immediate personal supervision of a pharmacist may administer, without a prescription, immunizations, vaccines, and emergency medications to eligible adult and minor patients if the following conditions are met:

Answer 78

1. Both the pharmacist and intern meet the qualifications and standards specified by A.R.S. § 32-1974 and this Section. 2. The Board authorizes both the pharmacist and intern as specified in subsection (D). 3. For an eligible adult patient: - The immunization or vaccine is recommended for adults by the United States Centers for Disease Control and Prevention (CDC), or by the CDC’s Health Information for International Travel. - The immunization or vaccine is not on the Arizona Department of Health Services list specified in A.A.C. R9-6-1301 as required under A.R.S. § 32-1974(I). 4. For an eligible minor patient: - The immunization or vaccine is for influenza or a booster dose as described under A.R.S. § 32-1974(B)(2). - Any immunizations or vaccines other than influenza or a booster dose are administered in response to a public health emergency declared by the Governor under A.R.S. § 36-787.

Question 79

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition . SUBSECTION A: Except as prescribed pursuant to subsection H of this section, a pharmacist who is licensed pursuant to this chapter and who meets the requirements of this section may order and administer all of the following:

Answer 79

1. Immunizations or vaccines recommended by the United States centers for disease control and prevention's advisory committee on immunization practices to a person who is at least six years of age. 2. Immunizations or vaccines recommended by the United States centers for disease control and prevention's advisory committee on immunization practices for international travel to a person who is at least eighteen years of age. 3. Immunizations or vaccines for influenza recommended by the United States centers for disease control and prevention's advisory committee on immunization practices to a person who is at least three years of age.

Question 80

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition . SUBSETION B: When can a pharmacist administer immunizations and vaccines to a person who is at least three years of age, aside from the conditions in subsection A?

Answer 80

A pharmacist who is licensed pursuant to this chapter and meets the requirements of this section may administer immunizations and vaccines to a person who is at least three years of age only pursuant to a prescription order or under a collaborative practice agreement.

Question 81

# R4-23-411. Pharmacist-administered or Intern-administered Immunizations What are the requirements for a pharmacist or intern to administer adult immunizations or vaccines that require a prescription order?

Answer 81

A pharmacist or intern authorized by the Board to administer adult immunizations or vaccines must not administer any immunization or vaccine listed in A.A.C. R9-6-1301 without a prescription order. In addition to filing a prescription order as required in A.R.S. § 32-1964, the pharmacist or pharmacy intern must comply with the recordkeeping requirements of subsection (F)(1).

Question 82

Ariz. Admin. Code § R9-6-1301 Section R9-6-1301 - Immunizations or Vaccines Requiring a Prescription Order for Pharmacist Administration A. In this Section, unless otherwise specified, the following definitions apply: **"Certified pharmacist", "Immunization", "Prescription order"**

Answer 82

"Certified pharmacist" means an individual licensed under A.R.S. Title 32, Chapter 18, who is authorized under A.A.C. R4-23-411 to administer immunizations or vaccines. "Immunization" has the same meaning as in A.R.S. § 36-671.3. "Prescription order" has the same meaning as in A.R.S. § 32-1901.

Question 83

Ariz. Admin. Code § R9-6-1301 Section R9-6-1301 - Immunizations or Vaccines Requiring a Prescription Order for Pharmacist Administration . B. The following immunizations or vaccines require a prescription order before the immunization or vaccine may be administered under A.A.C. R4-23-411 by a certified pharmacist:

Answer 83

1. Japanese Encephalitis vaccine, 2. Rabies vaccine, 3. Typhoid vaccines, 4. Yellow fever vaccine, and 5. Cholera vaccine.

Question 84

# R4-23-415. Impaired Licensees – Treatment and Rehabilitation How does the Board handle treatment and rehabilitation for impaired licensees?

Answer 84

The Board may contract with qualified organizations to operate a treatment and rehabilitation program for licensees impaired due to alcohol or drug abuse, as per A.R.S. § 32-1932.01.

Question 85

# R4-23-415. Impaired Licensees – Treatment and Rehabilitation What are the types of participants in the treatment and rehabilitation program?

Answer 85

Participants in the program are either “confidential” or “known.” Confidential participants are self-referred and may remain unidentified to the Board, subject to maintaining compliance with their program contract. Known participants are under Board order to complete a minimum tenure in the program. After a known participant completes the minimum tenure, the Board may terminate the Board order and reinstate the participant’s license to practice pharmacy.

Question 86

# R4-23-415. Impaired Licensees – Treatment and Rehabilitation The program contract with a qualified organization shall include as a minimum the following

Answer 86

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 87

# R4-23-415. Impaired Licensees – Treatment and Rehabilitation How can the Board or its executive director obtain treatment records for a program participant?

Answer 87

A: The Board or its executive director may request treatment records from the program administrator, who must provide them within 10 working days of the request. Additionally, participants must authorize the release of their records from treatment facilities or private practitioners to the program administrator or the Board upon request.

Question 88

# R4-23-415. Impaired Licensees – Treatment and Rehabilitation What happens if there are compliance issues with a program participant?

Answer 88

The program administrator, a Board member, Board staff, and the program participant may meet informally to discuss compliance issues, by mutual consent.

Question 89

# 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 89

1. Sell a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical in Arizona; or 2. Sell a narcotic or other controlled substance, prescription-only 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 90

# R4-23-601. General Provisions When is a medical practitioner exempt from the requirement to adhere to subsection (A) for administering certain substances?

Answer 90

A medical practitioner is exempt from subsection (A) to administer a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical for the emergency needs of a patient.

Question 91

# R4-23-601. General Provisions What are the conditions for the issuance and refund of permit fees?

Answer 91

Permits are issued biennially on an odd- and even-year expiration based on the assigned permit number. The fee, specified in R4-23-205, is not refundable unless the Board fails to comply with the permit time frames established in R4-23-602.

Question 92

# R4-23-601. General Provisions What are the recordkeeping requirements for narcotics and other controlled substances?

Answer 92

1. **Manufacturing, Repackaging, or Relabeling:** - Every person manufacturing, repackaging, or relabeling narcotics, controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals must prepare and retain records for no fewer than three years. This includes recording the date of manufacturing, repackaging, or relabeling. 2. **Receiving, Selling, Delivering, or Disposing:** - Every person receiving, selling, delivering, or disposing of these substances must record and retain for no fewer than three years: - Name, strength, dosage form, and quantity of the substance. - Name, address, and license or permit number of the person from whom the substance is received. - Name, address, and license or permit number of the person to whom the substance is sold, delivered, or who disposes of it. - Date of receipt, sale, delivery, or disposal. 3. **Availability for Inspection:** - Records must be available for inspection by the Board or its compliance officer during regular business hours. 4. **Centralized Recordkeeping:** - If records are stored in a centralized recordkeeping system and are not immediately available, a 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 93

# R4-23-601. General Provisions What are the regulations regarding the sale of damaged narcotics and other controlled substances?

Answer 93

A person shall not sell or offer to sell any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical that has been damaged by water, fire, or from human or animal consumption or use.

Question 94

# R4-23-601. General Provisions What is required before changing ownership of a license or permit?

Answer 94

At least 14 days before a change in ownership occurs, as defined at R4-23-110, the new licensee or permittee must apply to the Board for a new license or permit.

Question 95

# R4-23-606.Resident-Pharmacy Permit: Community, Hospital, Limited Service What is required to operate a pharmacy in Arizona?

Answer 95

must have a current Board-issued pharmacy **permit** to operate a pharmacy in Arizona

Question 96

# R4-23-606.Resident-Pharmacy Permit: Community, Hospital, Limited Service To obtain a permit to operate a pharmacy in Arizona, a person shall submit a completed application, on a form available from the Board, and the fee specified in R4- 23-205. .... Before issuing a pharmacy permit, the Board shall:

Answer 96

a. Receive and approve a completed permit application; and b. Receive a satisfactory compliance inspection report on the facility from a Board compliance officer. . 3. Before issuing a pharmacy permit, the Board may interview the applicant and the pharmacist-in-charge, if different from the applicant, at a Board meeting based on the need for additional information.

Question 97

# R4-23-606.Resident-Pharmacy Permit: Community, Hospital, Limited Service What changes must a pharmacy permittee notify the Board office about, and what is the time frame for each

Answer 97

- **Type of Pharmacy Operated, Telephone or Fax Number, E-mail or Mailing Address, Business Name, or Staff Pharmacist:** Notify the Board office within 10 days. - **Change of Pharmacist-in-Charge:** Provide immediate notice to the Board office.

Question 98

# R4-23-606.Resident-Pharmacy Permit: Community, Hospital, Limited Service Relocation or remodel: what are some rules

Answer 98

1. No fewer than 30 days before the relocation or remodel of an existing pharmacy, the pharmacy permittee shall submit, electronically or manually, a completed application for remodel or relocation using the form specified under subsection (B). A fee is not required with an application for remodel or relocation. 2. The new or remodeled facility shall pass a final inspection by a Board compliance officer before operations begin.

Question 99

# R4-23-609. Pharmacy Area of Community Pharmacy B. Compounding and dispensing counter requirements

Answer 99

On or after January 6, 2004, a pharmacy permit applicant or remodel or relocation applicant shall provide a compounding and dispensing counter that provides a **minimum of three square feet of pharmacy counter working area of not less than 16 inches in depth and 24 inches in length** for the practice of one pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee. . For each additional pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee practicing simultaneously, **there shall be an additional three square feet of pharmacy counter working area of not less than 16 inches in depth and 24 inches in length**. The Board shall determine a pharmacy’s total required compounding and dispensing counter area by multiplying the maximum number of personnel allowed in the pharmacy area using the requirements specified in subsection (A) **by three square feet per person**. A pharmacy permittee or pharmacist- in-charge may operate the pharmacy with a total pharmacy counter working area specified in subsection (A) that is equal to the actual maximum number of pharmacists, graduate interns, pharmacy interns, pharmacy technicians, and pharmacy technician trainees, working simultaneously in the pharmacy area times three square feet per person. . Calculating Total Space: To figure out how much counter space you need, multiply the number of people working at the same time by 3 square feet each. So, if you have 5 people working, you need 15 square feet of counter space (5 people × 3 square feet each).

Question 100

# R4-23-609. Pharmacy Area of Community Pharmacy C. Working area for compounding and dispensing counter requirements

Answer 100

The aisle floor area used by the pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee at the compounding and dispensing counter shall extend the full length of the counter and be clear and continuous for a **minimum of 36 inches** from any counter, fixture, or structure.

Question 101

# R4-23-609. Pharmacy Area of Community Pharmacy D. Area for patient counseling requirements

Answer 101

On or after April 1, 1995, a pharmacy permit applicant or remodel or relocation applicant shall provide a separate and distinct patient counseling area that provides patient privacy. This subsection does not apply to a pharmacy exempt from the requirements of R4-23-402(B).

Question 102

# R4-23-609. Pharmacy Area of Community Pharmacy E. Narcotic cabinet or safe. To prevent diversion, narcotics and other controlled substances may be:

Answer 102

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

Question 103

# R4-23-609. Pharmacy Area of Community Pharmacy F. Building security standard of community pharmacy area requirements

Answer 103

The pharmacy area must be enclosed by a permanent barrier or partition that extends from the floor or counter to the structural ceiling or roof and includes securely lockable entry doors. The barrier must ensure that only a pharmacist can access the area where prescription-only drugs, narcotics, and controlled substances are stored, compounded, and dispensed. The barrier can be made of materials other than solid, but any openings must be small enough to prevent removal of items through them. 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 104

# R4-23-609. Pharmacy Area of Community Pharmacy G. Drug storage and security requirements

Answer 104

General Storage: Drugs and devices must be stored in a dry, well-lit, ventilated, clean, and orderly area. The storage area must be maintained at temperatures that preserve the drugs' integrity, as specified in the official compendium or the manufacturer's/distributor’s labeling. Restricted Storage Area: For drugs that require a pharmacist's oversight, the storage area must be enclosed by a permanent barrier from floor or counter to ceiling. All doors and gates must be locked, and only a pharmacist with a key is allowed entry, except in extreme emergencies.

Question 105

# R4-23-609. Pharmacy Area of Community Pharmacy What are the requirements for protecting the pharmacy working counter area from unauthorized access?

Answer 105

A pharmacy permittee or pharmacist-in-charge must ensure that the pharmacy working counter area is protected from unauthorized access while the pharmacy is open for business. This protection can be provided by a barrier that is not less than 66 inches in height or by another method approved by the Board or its designee.

Question 106

# R4-23-609. Pharmacy Area of Community Pharmacy F. Building security standard of community pharmacy area requirements

Answer 106

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 must be designed to allow only a pharmacist access to the area where prescription-only drugs, narcotics, and other controlled substances are stored, compounded, and dispensed. - **Material Requirements:** - The permanent barrier can be made of materials other than solid, but any openings or interstices must be small enough to prevent removal of items through the barrier. - The material must be strong and thick enough that it cannot be easily removed, penetrated, or bent. - **Approval Process:** - The pharmacy permittee must submit plans and specifications of the permanent barrier to the Board for approval.

Question 107

# R4-23-609. Pharmacy Area of Community Pharmacy G. Drug storage and security requirement

Answer 107

1. **General Storage Requirements:** - Drugs and devices must be stored in a dry, well-lit, ventilated, and clean area. - The drug storage area must be maintained at temperatures that ensure the drugs' integrity before dispensing, as specified in the official compendium (A.R.S. § 32-1901(55)) or the manufacturer's or distributor’s labeling. 2. **Restricted Storage Area:** - For drugs restricted to sale by a pharmacist, the storage area 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 access this area, except in extreme emergencies.

Question 108

# R4-23-609. Pharmacy Area of Community Pharmacy 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 108

1. **Refrigeration:** Adequate refrigeration equipment dedicated to storing drugs and biologicals. 2. **Controlled Substance Register:** A C-V controlled substance register if C-V controlled substances are sold without a medical order. 3. **Graduates:** Assorted sizes of graduates. 4. **Mortar and Pestle:** One mortar and pestle (not required if compounding will not be performed). 5. **Spatulas:** Assorted sizes of spatulas, including one nonmetallic. 6. **Prescription Balance:** A Class A prescription balance with weights or an electronic balance of equal accuracy (not required if compounding will not be performed). 7. **Ointment Tile:** One ointment tile or equivalent (not required if compounding will not be performed). 8. **Pharmacy Acts and Rules:** Current hard-copy or access to a current electronic copy of the Arizona Pharmacy Act and administrative rules, and the Arizona Controlled Substance Act. 9. **Professional Reference Library:** At least one current reference or text (hard-copy or electronic) covering: - Pharmacology or toxicology, - Therapeutics, - Drug compatibility, - Drug product equivalency. 10. **Labels:** An assortment of labels including prescription, transfer, cautionary, and warning labels. 11. **Red C Stamp:** A red C stamp if C-III, C-IV, and C-V controlled substance invoices are not filed separately (as defined in R4-23-110). 12. **Antidote and Drug Interaction Info:** Current antidote and drug interaction information. 13. **Poison Control Number:** Regional poison control phone number prominently displayed in the pharmacy area. . ...NOTE: A professional security video recording system is NOT REQUIRED

Question 109

R4-23-614. Automated Storage and Distribution System 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 109

1. **Security:** The system must ensure: - **Authorized Access:** Only licensed personnel with proper authorization can access drugs or devices based on a valid prescription or medication order. - **Adequate Security:** The system must prevent unauthorized individuals from accessing or obtaining drugs or devices. 2. **Handling Drugs and Devices:** - **Authorized Personnel:** Only Board licensees or other authorized licensed personnel are allowed to fill, stock, or restock drugs or devices in the system. 3. **Quality Assurance:** - **Ongoing Program:** Implement a quality assurance program to monitor and ensure compliance with both the pharmacy’s policies and procedures and federal and state laws. . . . NOTE: THERE ARE NO electronic dating system is in place to identify expired drugs contained therein

Question 110

36-2525. Prescription orders; labels; packaging; definition . What are the requirements for prescription orders for controlled substances? What changes cannot be made?

Answer 110

1. **Prescription Order Requirements:** - **Controlled Substances:** Must include the prescriber’s name, address, and federal registration number. - **Schedule II Controlled Substances:** Each prescription order must be on a separate prescription blank. Hospital drug orders for inpatients are exempt from this rule. 2. **Changes to Prescription Orders:** - **Verbal Authorization:** A pharmacist can make changes to a written or electronic schedule II prescription order if authorized verbally by the prescriber, except for the following: - Patient’s name - Prescriber’s name - Drug name 3. **Documentation of Changes:** - **Record Changes:** The pharmacist must document the changes on the original prescription order and include the time and date the verbal authorization was granted.

Question 111

# R4-23-653. Personnel: Professional or Technician What are the responsibilities and requirements for personnel in a hospital pharmacy?

Answer 111

1. **Director of Pharmacy:** - **Role:** Must be a licensed pharmacist in Arizona, serving as the Director of Pharmacy. The Director can also appoint a separate pharmacist-in-charge. - **Responsibilities:** 1. Oversee all activities of the hospital pharmacy and ensure compliance with the Arizona Pharmacy Act and rules. 2. Prepare, implement, and ensure compliance with required policies and procedures. 3. Review and revise these policies biennially, if necessary. 4. Document the policy review. 5. Maintain the policies in a written manual or an approved format. 6. Make the policies available in the pharmacy for employee reference and Board inspection. 2. **Pharmacy Services:** - **Pharmacist Presence:** A pharmacist must be present during all hours of pharmacy operation, except in extreme emergencies. - **Service Hours:** Pharmacy services must be provided for at least 40 hours per week unless an exception is granted by the Board or its designee. 3. **On-Call Pharmacist:** - **Requirement:** In hospitals where the pharmacy is not open 24/7, a pharmacist must be "on-call" when the pharmacy is closed. 4. **Additional Personnel:** - **Assistance:** The Director of Pharmacy can be assisted by additional personnel as needed to ensure safe and competent pharmacy operation.

Question 112

# R4-23-654. Absence of Pharmacist What must the Director of Pharmacy or Pharmacist-in-Charge do if a pharmacist will not be on duty in the hospital?

Answer 112

If a pharmacist will not be on duty, the Director of Pharmacy or Pharmacist-in-Charge must: - Arrange, before the absence, for the medical staff and other authorized personnel to have access to drugs in the remote drug storage area defined in R4-23-110. - If a required drug is not available in the remote storage area, ensure access to the hospital pharmacy. Ensure a pharmacist is on-call during all absences.

Question 113

# R4-23-654. Absence of Pharmacist What must the Director of Pharmacy or pharmacist-in-charge arrange if a pharmacist will not be on duty in the hospital pharmacy?

Answer 113

The Director of Pharmacy or pharmacist-in-charge must arrange for the medical staff and other authorized personnel of the hospital to have telephone access to an on-call pharmacist before the pharmacist’s absence.

Question 114

# R4-23-654. Absence of Pharmacist What is the maximum period for which a hospital pharmacy can be without a pharmacist on duty?

Answer 114

The hospital pharmacy permittee must ensure that the hospital pharmacy is not without a pharmacist on duty for more than 72 consecutive hours.

Question 115

# R4-23-654. Absence of Pharmacist What responsibilities does the Director of Pharmacy or pharmacist-in-charge have regarding a remote drug storage area in a hospital

Answer 115

The Director of Pharmacy or pharmacist-in-charge must: 1. Develop and maintain an inventory listing of the drugs in the remote drug storage area. 2. Develop, implement, review, and revise policies and procedures to ensure proper storage, access, and accountability for the drugs in the remote drug storage area.

Question 116

# R4-23-654. Absence of Pharmacist What are the requirements for accessing the hospital pharmacy during a pharmacist’s absence when a drug is needed for immediate patient care?

Answer 116

During a pharmacist's absence, access to the hospital pharmacy must adhere to the following: 1. **Policies and Procedures:** - The Director of Pharmacy or pharmacist-in-charge must develop, implement, review, and revise policies and procedures to ensure proper access. This includes: - Delegating access to only one supervisory nurse per shift. - Communicating the policy and the name of the supervisory nurse to the medical staff in writing. - Ensuring the delegated nurse has received proper training on access procedures, drug removal, and recordkeeping. - Allowing the supervisory nurse to delegate access only in emergencies. 2. **Drug Removal Recording:** - When a nurse removes a drug, they must: - Record the patient’s name, drug name, strength, dosage form, quantity removed, and date/time of removal. - Sign or initial the form, with a corresponding signature on file if necessary. - Attach the original or a copy of the medication order to the form. - Place the form conspicuously in the hospital pharmacy. 3. **Post-Absence Verification:** - Within four hours of the pharmacist’s return, they must verify all records of drug removal that occurred during their absence.

Question 117

# R4-23-658. Drug Distribution and Control A. General. -What responsibilities does the Director of Pharmacy or Pharmacist-in-Charge have regarding the drug distribution system?

Answer 117

The Director of Pharmacy or Pharmacist-in-Charge, in consultation with the medical staff, must: - Develop, implement, review, and revise written policies and procedures for the effective operation of a drug distribution system that optimizes patient safety. - Follow the same manner described in R4-23-653(A) for these tasks. - Ensure compliance with these written policies and procedures.

Question 118

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

Answer 118

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 119

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

Answer 119

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, except as specified in R4-23-653(E)(1).

Question 120

# 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:.... . **1. For use inside the hospital.** a. Labels for all single unit packages contain at a minimum, the following information:

Answer 120

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

Question 121

# 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:.... . **1. For use inside the hospital** b. Labels for repackaged preparations contain at a minimum the following information:

Answer 121

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 122

# 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:.... . **1. For use inside the hospital** c. Labels for all intravenous admixture preparations contain at a minimum the following information:

Answer 122

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 123

# 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:.... . **2. For use outside the hospital.**

Answer 123

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 124

# R4-23-658. Drug Distribution and Control E. Controlled sub. accountability

Answer 124

The Director of Pharmacy or Pharmacist-in-Charge must ensure that effective policies and procedures are developed, implemented, reviewed, and revised in the same manner described in R4-23-653(A). These policies and procedures must be complied with and cover the use, accountability, and recordkeeping of controlled substances, including the use of locked storage areas when controlled substances are stored in patient care areas.

Question 125

# R4-23-659. Administration of Drugs A. Self-administration in hospital.. When is self-administration of medications by a patient allowed in a hospital?

Answer 125

Self-administration of medications by a patient is allowed only if the Director of Pharmacy or Pharmacist-in-Charge, in consultation with the appropriate department personnel and medical staff committee, develops, implements, reviews, and revises policies and procedures for self-administration of medications in the same manner described in R4-23-653(A). The policies and procedures must specify that self-administration occurs only when: 1. Specifically ordered by a medical practitioner, and 2. The patient is educated and trained in the proper manner of self-administration.

Question 126

# R4-23-659. Administration of Drugs Drugs brought in by patient - What are the criteria for a patient-owned drug brought into the hospital?

Answer 126

If a hospital allows a patient to bring a drug into the hospital, the Director of Pharmacy or Pharmacist-in-Charge must, in consultation with the appropriate department personnel and medical staff committee, develop, implement, review, and revise policies and procedures for patient-owned drugs as described in R4-23-653(A). The policies and procedures must specify the following criteria: 1. **Administration of Patient-Owned Drugs:** - The drug is not administered to the patient unless: - A pharmacist or medical practitioner identifies the drug. - A medical practitioner writes a medication order specifying administration of the identified patient-owned drug. 2. **Handling of Unused Patient-Owned Drugs:** - If the drug will not be used during the patient’s hospitalization, hospital pharmacy personnel must either: - Package, seal, and give the drug to the patient’s agent for removal from the hospital. - Package, seal, and store the drug for return to the patient at the time of discharge from the hospital.

Question 127

# R4-23-659. Administration of Drugs Drug Samples Who is responsible for drug samples within the hospital and what are their responsibilities?

Answer 127

The Director of Pharmacy or Pharmacist-in-Charge is responsible for the receipt, storage, distribution, and accountability of drug samples within the hospital. They must develop, implement, review, and revise policies and procedures regarding drug samples in the same manner described in R4-23-653(A) and comply with these specific policies and procedures.

Question 128

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 128

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 media-fill test to validate proper aseptic technique.

Question 129

# 36-2525. Prescription orders; labels; packaging; definition In an emergency, how can a pharmacist dispense schedule II controlled substances, and what steps must be followed?

Answer 129

In an emergency, a pharmacist may dispense schedule II controlled substances on an oral prescription order from a medical practitioner. The emergency prescription order must be immediately reduced to writing by the pharmacist and contain all the required information except the manual signature of the practitioner. Within seven days, the medical practitioner must provide a written prescription order manually signed or transmit an electronic prescription order to the pharmacist. This prescription must indicate "authorization for emergency dispensing" and the date of the oral order. If the practitioner fails to provide the written or electronic order within seven days, the pharmacist must notify the board. Failure to notify the board voids the authority to dispense without a written or electronic prescription order.

Question 130

# Emergency Oral Schedule II Prescriptions What are the requirements for dispensing schedule II controlled substances in an emergency situation?

Answer 130

1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period. 2. The prescription order must be immediately reduced to writing by the pharmacist and contain all required information, except for the prescribing practitioner’s signature. 3. Within seven days after authorizing an emergency oral prescription, the prescribing practitioner must furnish the pharmacist with a written, signed prescription for the emergency quantity of the controlled substance prescribed.

Question 131

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy What are the responsibilities of a limited-service pharmacy permittee or pharmacist-in-charge regarding compliance with standards?

Answer 131

The limited-service pharmacy permittee or the pharmacist-in-charge must ensure that the limited-service sterile pharmaceutical products pharmacy complies with the standards for area, personnel, security, sanitation, equipment, sterile pharmaceutical products, and limited-service pharmacies as established in R4-23-608, R4-23-609, R4-23-610, R4-23-611, R4-23-612, R4-23-670, and R4-23-671.

Question 132

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy Who may be authorized to be in a limited-service sterile pharmaceutical products pharmacy?

Answer 132

The pharmacist-in-charge of a limited-service sterile pharmaceutical products pharmacy shall authorize only pharmacists, interns, compliance officers, peace officers acting in their official capacities, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel to be in the limited-service sterile pharmaceutical products pharmacy.

Question 133

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy What must the pharmacist-in-charge ensure regarding the delivery and storage of prescription medication when a pharmacist is not present in a limited-service sterile pharmaceutical products pharmacy?

Answer 133

The pharmacist-in-charge must ensure that: - Prescription medication is delivered to the patient. - If delivery is not possible, the medication is securely locked in the dispensing area.

Question 134

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy The pharmacist-in-charge of a limited-service sterile pharmaceutical products pharmacy shall ensure that. . .

Answer 134

The pharmacist-in-charge of a limited-service sterile pharmaceutical products pharmacy shall ensure that prescription medication is delivered to the patient or locked in the dispensing area when a pharmacist is not present in the pharmacy.

Question 135

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy What are the requirements for toll-free telephone service at a limited-service sterile pharmaceutical products pharmacy?

Answer 135

The limited-service pharmacy permittee must: - Provide toll-free telephone service during regular hours of operation, but not less than 40 hours per week. - Ensure that this service allows communication between patients and a pharmacist with access to patient records. - Disclose the toll-free number on a label affixed to each container dispensed from the pharmacy.

Question 136

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy What are the requirements for policies and procedures at a limited-service sterile pharmaceutical products pharmacy?

Answer 136

The limited-service pharmacy permittee or pharmacist-in-charge must: - Develop, implement, review, and revise policies and procedures in the same manner described in R4-23-671(E). - Ensure compliance with policies and procedures for pharmacy operations, including: - Pharmaceutical product compounding - Dispensing - Distribution - Adhere to the requirements of R4-23-402, R4-23-410, R4-23-670, and R4-23-671.

Question 137

# R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy What are some non-dispensing roles of a pharmacist?

Answer 137

The non-dispensing roles of a pharmacist may include: - Chart reviews - Audits - Drug therapy monitoring - Committee participation - Providing drug information - In-service training for pharmacy and other health professionals

Question 138

32-3248. Health professionals; controlled substances; initial prescriptions; limits; exceptions; definition . Subsec A - What are the limitations on initial prescriptions for schedule II controlled substances that are opioids?

Answer 138

An initial prescription for a schedule II controlled substance that is an opioid is limited to: - **Five-day supply** for most patients. - **Fourteen-day supply** if the prescription follows a surgical procedure.

Question 139

32-3248. Health professionals; controlled substances; initial prescriptions; limits; exceptions; definition . B. Subsection A (previous slide) of this section does not apply to initial prescriptions if the patient:

Answer 139

1. Has an active oncology diagnosis. 2. Has a traumatic injury, not including a surgical procedure. 3. Is receiving hospice care. 4. Is receiving end-of-life care. 5. Is receiving palliative care. 6. Is receiving skilled nursing facility care. 7. Is receiving treatment for burns. 8. Is receiving medication-assisted treatment for a substance use disorder. 9. Is an infant who is being weaned off opioids at the time of hospital discharge.

Question 140

32-3248. Health professionals; controlled substances; initial prescriptions; limits; exceptions; definition . How is an initial prescription for a schedule II controlled substance that is an opioid handled if it is written for more than a five-day supply?

Answer 140

If an initial prescription for a schedule II controlled substance that is an opioid is written for more than a five-day supply, it is considered to meet the exemption requirements when presented to the dispenser. The pharmacist is not required to verify with the prescriber whether the prescription complies with the five-day supply limit.

Question 141

32-3248. Health professionals; controlled substances; initial prescriptions; limits; exceptions; definition . What is the definition of an "initial prescription" for a schedule II controlled substance that is an opioid?

Answer 141

An "initial prescription" for a schedule II controlled substance that is an opioid refers to a prescription that has not covered any portion of the past sixty days before the date the pharmacy dispenses the current prescription. This is evidenced by the controlled substance's prescription history.

Question 142

# R4-23-701. LTCF Pharmacy Services: Consultant Pharmacist C. The long-term care consultant pharmacist shall:

Answer 142

1. **Ensure Availability of Records and Reports:** - **Provider Pharmacy Patient Profiles** and **Long-Term Care Facility Medication Administration Records** - **Reports of Suspected Adverse Drug Reactions** - **Inspection Reports** of drug storage areas, focusing on outdated drugs - **Accountability Reports** including: - Date and time of administration - Name of the person who administered the drug - Documentation and verification of wasted or partial doses - Exception reports for refused doses - All drug destruction forms 2. **Identify and Report Drug Irregularities and Dispensing Errors** to: - The prescriber - The director of nursing of the facility - The provider pharmacy . . NO need to document: Route of administration of the medication

Question 143

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

Answer 143

1. Is stored in an area that: a. Is temperature controlled; and b. Prevents unauthorized access; . 2. Contains on the exterior of the emergency drug supply unit a label to indicate that the contents are for emergency use only; 3. Contains on the exterior of the emergency drug supply unit a complete list of the contents of the unit by drug name, strength, dosage form, and quantity and the provider pharmacy’s name, address, and telephone number; 4. Contains on the exterior of the emergency drug supply unit a label that indicates the date of the earliest drug expiration date; 5. Contains on the exterior of the emergency drug supply unit a label that indicates the date of and pharmacist responsible for the last inspection of the emergency drug supply unit; and 6. Is secured with a tamper-evident seal, or is locked and sealed in a manner that obviously reveals when the unit has been opened or tampered with.

Question 144

# R4-23-701.04. LTCF Pharmacy Services: Automated Dispensing Systems C. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

Answer 144

1. **Ensure** that policies and procedures for the use of the automated dispensing system are prepared, implemented, and complied with. 2. **Review biennially** and, if necessary, revise the policies and procedures required. 3. **Document** the review required under subsection (C)(2). 4. **Assemble** the policies and procedures as a written or electronic manual. 5. **Make available** for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside of the pharmacy where the automated dispensing system is used.

Question 145

# R4-23-701.04. LTCF Pharmacy Services: Automated Dispensing Systems D. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure the written policies and procedures include:

Answer 145

1. **Drug Removal Procedures**: - **Valid Prescription**: A drug is provided only by a valid prescription order for an individual long-term care facility resident. - **Pharmacist Review**: The drug is dispensed only after a pharmacist has: - Reviewed and verified the resident’s prescription order. - Electronically authorized access for that drug for the resident. - **Labeling**: Each drug packet must have a resident-specific label with the resident’s room number or facility ID. 2. **Security Procedures**: - **User Access**: The pharmacy permittee or pharmacist-in-charge is responsible for authorizing, adding, removing, and modifying user access. - **Authorized Users**: Each user must be a Board licensee or authorized licensed personnel of the long-term care facility. - **Securing the System**: The automated dispensing system must be secured with electronic or mechanical means to prevent unauthorized access.

Question 146

# R4-23-704. Customized Patient Medication Packages What are the requirements for providing a customized patient medication package instead of separate containers?

Answer 146

A pharmacist may provide a customized patient medication package with the consent of: - The patient - The patient’s caregiver - The prescriber - The facility caring for the patient **Guidelines for preparing a customized patient medication package include:** 1. **Consent**: Obtain consent from the patient, caregiver, prescriber, or facility. 2. **Compliance**: Follow the guidelines in the current edition of the official compendium for: - Labeling - Packaging - Recordkeeping 3. **Legal Requirements**: Adhere to state and federal law.

Question 147

# R4-23-1104. Pharmacy Technicians and Pharmacy Technician Trainees A. What tasks can a **pharmacy technician trainee** perform under the supervision of a pharmacist?

Answer 147

A pharmacy technician trainee may assist with the following tasks when applicable to the pharmacy practice site: 1. **Prescription Recording**: Record the serial number and date dispensed on the original prescription order. 2. **Refill Authorization**: Initiate or accept verbal or electronic refill authorizations from a medical practitioner or their agent, and record: - Medical practitioner’s name - Patient’s name - Name and quantity of prescription medication - Specific refill information - Name of medical practitioner’s agent, if applicable 3. **Record Keeping**: Record information in the refill record or patient profile. 4. **Prescription Entry**: Enter information for new or refill prescription medications as required under A.R.S. § 32-1964. 5. **Labeling**: Type and affix labels for prescription medications. The accuracy of the label must be verified by a pharmacist or a graduate or pharmacy intern under the pharmacist’s supervision. 6. **Reconstitution**: Reconstitute prescription medications, with ingredients and procedure checked by a pharmacist before and after reconstitution. 7. **Medication Handling**: Retrieve, count, or pour prescription medications. A pharmacist must verify the contents against the original prescription container or by an alternative drug identification method. 8. **Prepackaging**: Prepackage drugs according to R4-23-402(A). 9. **Hospital Inpatient Preparation**: Measure, count, pour, prepare, and package drugs for hospital inpatient dispensing, with accuracy and safety verified by a pharmacist before delivery to a patient care area.

Question 148

# R4-23-1104. Pharmacy Technicians and Pharmacy Technician Trainees B. What tasks can a **licensed pharmacy technician** perform under the supervision of a pharmacist?

Answer 148

1. **Perform Tasks Listed for Trainees**: Complete all tasks allowed for pharmacy technician trainees. 2. **Drug Compounding**: After completing a pharmacy technician drug compounding training program developed by the pharmacy permittee or pharmacist-in-charge: - Assist in compounding prescription medications and sterile or nonsterile pharmaceuticals. - Ensure that the preparation, accuracy, and safety of the final product is verified by a pharmacist before dispensing. 3. **Technology-Assisted Verification**: Perform final technology-assisted verification of the product if qualified under R4-23-1104.01(D). 4. **Labeling**: If technology-assisted verification is performed: - Type and affix a label for the prescription medication. - Ensure the accuracy of the label is verified by a pharmacist or graduate or pharmacy intern as described under R4-23-402(A)(12).

Question 149

R4-23-1105. Pharmacy Technician Trainee Training Program, Pharmacy Technician Drug Compounding Training Program, and Alternative Pharmacy Technician Training . What is required for a pharmacy technician trainee training program?

Answer 149

1. **Development and Compliance**: - The pharmacy permittee or pharmacist-in-charge must develop, implement, review, and revise the training program based on the pharmacy's needs. - The program should include training guidelines that define tasks, assessment methods, and relevant policies and procedures. 2. **Documentation**: - The pharmacist-in-charge must document the completion date of the training program for each trainee and maintain this documentation for Board inspection. 3. **Trainee Tasks**: - Pharmacy technician trainees can only perform tasks listed in R4-23-1104(A) for which they have demonstrated training and competency.

Question 150

R4-23-1105. Pharmacy Technician Trainee Training Program, Pharmacy Technician Drug Compounding Training Program, and Alternative Pharmacy Technician Training . What is required for a pharmacy technician drug compounding training program?

Answer 150

1. **Development and Compliance**: - The pharmacy permittee or pharmacist-in-charge must develop, implement, review, and revise the compounding training program based on the pharmacy's needs. - The program must include guidelines for tasks, assessment methods, and procedures for area preparation, component preparation, aseptic technique, packaging, labeling, and cleanup. 2. **Documentation**: - The pharmacist-in-charge must document the completion date of the training program for each technician and maintain this documentation for Board inspection.

Question 151

R4-23-1105. Pharmacy Technician Trainee Training Program, Pharmacy Technician Drug Compounding Training Program, and Alternative Pharmacy Technician Training . How can an individual obtain a pharmacy technician license through alternative training?

Answer 151

1. **Board-Approved Examination**: - Individuals who have passed the required Board-approved pharmacy technician examination but did not follow the normal licensing path may obtain a license by completing an on-the-job training program during employment orientation. This includes reading and discussing Board rules, job descriptions, and the pharmacy's policies and procedures. 2. **Pharmacy Technician Certificate Program**: - Individuals with a pharmacy technician certificate and Board-approved examination may also obtain a license through an on-the-job training program as described above. 3. **Documentation**: - The pharmacist-in-charge must document the completion date of the on-the-job training program and maintain this documentation for Board inspection.

Question 152

R4-23-1105. Pharmacy Technician Trainee Training Program, Pharmacy Technician Drug Compounding Training Program, and Alternative Pharmacy Technician Training . What should be done if a pharmacy technician leaves a training program before completion?

Answer 152

The pharmacist-in-charge must provide written documentation of the hours of training completed and the tasks for which competence was demonstrated.

Question 153

A Physician’s Assistant (PA) may issue prescriptions for:

Answer 153

- Opioids or Benzodiazepines in Schedule IV or V for up to a 30-day supply - Schedule IV or V controlled substances for non-opioids and non-Benzodiazepines for up to a 90 day supply

Question 154

# 36-2525. Prescription orders; labels; packaging; definition What are the requirements and exceptions for dispensing a Schedule II controlled substance?

Answer 154

- **General Requirements**: Schedule II controlled substances require either a written prescription (ink or indelible pencil) signed by the medical practitioner or an electronic prescription order, starting January 1, 2020, specifically for opioids. **Prescriptions cannot be dispensed more than 90 days after issuance and cannot be refilled**. **A prescription order for a schedule II controlled substance shall not be refilled** - **Interstate Prescriptions**: Schedule II prescriptions from out-of-state practitioners can be dispensed if they comply with the laws of both the prescribing state and federal law. - **Exceptions**: 1. If an electronic or pharmacy management system is down, a written prescription can be dispensed, with a record of the system's downtime. 2. Written prescriptions are allowed if the prescribing medical practitioner works in specific facilities like veterans' hospitals, military bases, Indian health services, or tribal clinics.

Question 155

# 36-2525. Prescription orders; labels; packaging; definition What labeling requirements apply to containers of controlled substances that are not for immediate use by the patient?

Answer 155

**Label Requirements**: The label must include: - Name and address of the dispensing medical practitioner or pharmacist - Serial number and date of dispensing - Name of the prescriber and the patient (or owner and species if an animal) - Directions for use and cautionary statements required by law **Additional Requirements for Schedule II, III, IV**: - Include a transfer warning: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." **Specific Requirement for Schedule II Opioids**: - Containers must have a red cap and a warning label about addiction. The board may waive the red cap requirement if not feasible due to dosage form or packaging.

Question 156

# 36-2525. Prescription orders; labels; packaging; definition Controlled substances in schedules II, III, IV and V may be dispensed as electronically transmitted prescriptions if the prescribing medical practitioner is all of the following:

Answer 156

1. Properly registered by the United States drug enforcement administration. 2. Licensed in good standing in the United States jurisdiction in which the medical practitioner practices. 3. Authorized to issue such prescriptions in the jurisdiction in which the medical practitioner is licensed.

Question 157

# 32-3248.02. Health professionals; substance use/ addiction CE What are the continuing education requirements for health professionals authorized to prescribe or dispense schedule II controlled substances?

Answer 157

- **Requirement**: Health professionals with a valid DEA registration or authorization to dispense controlled substances must complete at least **three hours** of continuing education related to opioid use, substance use disorder, or addiction each license renewal cycle. - **Accreditation**: The education must be accredited and approved by the relevant health profession regulatory board and count towards the total continuing education requirements for the health professional.

Question 158

# Drug Schedule Nalorphine

Answer 158

Lethidrone, Nalline - III

Question 159

# Drug Schedule Alprazolam

Answer 159

Xanax - IV

Question 160

# Drug Schedule Oxycodone

Answer 160

OxyContin - II

Question 161

# Drug Schedule Testosterone

Answer 161

III

Question 162

# Drug Schedule Zaleplon

Answer 162

Sonata - IV

Question 163

# Drug Schedule Ezogabine

Answer 163

Retigabine - V

Question 164

22. When compounding immediate-use CSPs, may more than three individual containers of a sterile products be used?

Answer 164

- **Limit**: Immediate-use CSPs must not involve more than **three different sterile products**. - **Examples**: - Using two vials of the same drug and two vials of Sterile Water for Injection to prepare a single IV bag. - Combining four vials of the same drug into one IV bag, as long as only two different sterile components are used. - **Criteria**: The preparation must meet all the criteria specified for immediate-use CSPs.

Question 165

24. Can a single-dose container be used to prepare doses for more than one patient when compounding an immediate-use CSP?

Answer 165

No. One of the conditions of the immediate-use CSP provision specifies that any unused starting components from a single- dose container must be discarded after preparation for the individual patient is complete. Single-dose containers must not be used for more than 1 patient when used for preparing immediate-use CSPs.

Question 166

25. Why does the immediate-use CSP provision allow for administration to begin within 4 hours following the start of the preparation?

Answer 166

- **Time Limit**: Immediate-use CSPs can be administered within **up to 4 hours** after preparation. - **Reason**: This revision balances CSP quality with timely access to medication, accounting for the 4-to-6-hour lag phase in microbial growth. During this phase, bacterial cells adjust to their environment and do not immediately reproduce, allowing a window for safe administration even if bacterial contamination occurs.

Question 167

38. Do facilities have to change their standard operating procedures (SOPs) and practices for immediate-use from 1 h to 4 h?

Answer 167

No, facilities may choose to maintain the 1-hour limit for administration of immediate-use CSPs, however increasing the time to 4 hours would be considered acceptable.

Question 168

186. Is a conventionally manufactured single-dose container required to be stored in an ISO Class 5 PEC in order for it to be allowed to be used for up to 12 hours?

Answer 168

No, single-dose containers do not need to be stored in an ISO Class 5 PEC for up to 12 hours. However, they must be entered or punctured within an ISO Class 5 PEC. After initial entry or puncture, they can be used for up to 12 hours if stored according to their specific storage requirements. Single-dose ampules must not be stored after opening.

Question 169

187. When determining the BUD for a single-dose vial after puncture, how long can the single-dose vial be stored if the package insert states “use immediately”?

Answer 169

If a single-dose vial's package insert states "use immediately," it typically implies immediate use is preferred. However, if punctured within an ISO Class 5 or cleaner air environment, the vial may be used up to 12 hours after initial entry or puncture, provided that labeled storage requirements are maintained. For products with "use immediately" instructions, microbiological principles suggest a 4-hour use window may apply. For specific stability information, consult the manufacturer.

Question 170

# Section 8 – Dispensing Requirements What are the rules for partially filling a Schedule II prescription for a patient in a long-term care facility (LTCF) or with a terminal illness?

Answer 170

A Schedule II prescription for a patient in an LTCF or with a terminal illness can be partially filled in individual dosage units. The pharmacist must confirm the patient’s status with the practitioner if there is any doubt about their terminal condition. The prescription must be marked with "terminally ill" or "LTCF patient" and is **valid for up to 60 days from the issue date**, unless discontinued sooner.

Question 171

APPENDIX D Identifying Out of Scope Prescriptions The following criteria may indicate that a prescription was not issued for a legitimate medical purpose:

Answer 171

* The prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in the same specialty in the area. * The patient appears to be returning too frequently. A prescription which should last for a month in legitimate use is being refilled on a biweekly, weekly, or even a daily basis. * The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. * The patient presents prescriptions written in the names of other people. * A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician. * People who are not regular patrons or residents of the community show up with prescriptions from the same physician.

Question 172

The FDA has designated Therapeutic Equivalence codes (TE codes) to compare one drug product to another. Which of the following are true I. “A” drug products are therapeutically equivalent to other pharmaceutically equivalent products II. “B” drug products are not therapeutically equivalent to other pharmaceutically equivalent products III. A product with TE code: AB1 , can be substituted for a product with TE code: AB2 with the same strength and same dosage form

Answer 172

I. “A” drug products are therapeutically equivalent to other pharmaceutically equivalent products II. “B” drug products are not therapeutically equivalent to other pharmaceutically equivalent products

Question 173

Which of the following are true for regarding Dietary Supplements? I. The disclaimer “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” is required on all Dietary Supplements II. The manufacturer is responsible for ensuring the accuracy and truthfulness of claims made on its products III. Manufacturers may make 3 types of claims: health claims, structure/function claims, and nutrient content claims

Answer 173

II. The manufacturer is responsible for ensuring the accuracy and truthfulness of claims made on its products III. Manufacturers may make 3 types of claims: health claims, structure/function claims, and nutrient content claims

Question 174

Who validates claims and what kinds of claims can be made on dietary supplement labels?

Answer 174

Claims on dietary supplement labels are validated by the manufacturer, the FDA, and, for advertising claims, the Federal Trade Commission. Manufacturers can make three types of claims: 1. **Health Claims**: Describe the link between a food substance and a disease or health-related condition. 2. **Structure/Function Claims**: Describe the intended benefits of using the product on the body’s structure or function. 3. **Nutrient Content Claims**: Describe the amount of a nutrient or dietary substance in the product. Different requirements apply to each type of claim.

Question 175

Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

Answer 175

This disclaimer is required by law (DSHEA) when a dietary supplement makes a structure/function claim about its role in affecting body structure or function. It informs consumers that the FDA has not evaluated these claims, and that the product cannot legally claim to diagnose, treat, cure, or prevent any disease, as only drugs can make such claims. The manufacturer is responsible for the accuracy and truthfulness of these claims.

Question 176

§352. Misbranded drugs and devices A drug or device shall be deemed to be misbranded— (x) Nonprescription drugs

Answer 176

A nonprescription drug marketed in the U.S. is considered misbranded if its label does not include a domestic address or phone number for the responsible person to receive reports of serious adverse events.

Question 177

Under what conditions is a drug or device considered adulterated according to §351(a) and §351(b)?

Answer 177

- **§351(a):** A drug or device is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance. - **§351(b):** A drug or device is adulterated if it is represented as a drug recognized in an official compendium but its strength differs from, or its quality or purity falls below, the standard set in the compendium.