PharmLaw Set #4 (AZ)

Question 1

32-1922. Qualifications of applicant; reciprocity; preliminary equivalency examination; honorary certificate; fee

A. An applicant for licensure as a pharmacist shall:

Answer 1

1. Education: Graduate from a recognized pharmacy school or qualify under specific conditions.
2. Practical Experience: Complete a supervised practical experience program as verified by affidavits.
3. Examinations: Pass both the pharmacist licensure and jurisprudence examinations. After three failed attempts, petition the board for permission to retake the exam, which may involve additional training.
4. Application Fee: Pay up to $500 for the application. Reciprocal licensure applicants pay a different fee as specified in section 32-1924, subsection D.

Question 2

R4-23-202. Licensure by Examination
A. Eligibility. To be eligible for licensure as a pharmacist by examination, a person shall:

Answer 2

1. Education: Obtain a pharmacy degree from a Board-approved and Accreditation Council for Pharmacy Education (ACPE)-accredited school.
2. Alternate Qualification: Meet the requirements specified in A.R.S. § 32-1922(D).
3. Intern Training: Complete at least 1500 hours of intern training as detailed in R4-23-303.

Question 3

Q: What are the responsibilities and requirements for the proprietor, manager, and pharmacist in charge of a pharmacy regarding drug and device quality?

Answer 3

1. Responsibility for Quality: The proprietor, manager, and pharmacist in charge are responsible for the quality of drugs and devices sold or dispensed, except those in original manufacturer packages.
2. Standards Compliance: No drug or device should be manufactured, compounded, dispensed, or sold if it does not meet the official standards for strength, purity, and quality.
3. Documentation Requirement: Within four working days of a request by an authorized board agent, provide documents related to the acquisition or disposal of prescription-only and controlled substances, including:
   
   • Invoices
   • Stock transfer documents
   • Merchandise return memos
   • Other related documentation

Question 4

What are the purchase limits for ephedrine or pseudoephedrine products?

Answer 4

A person cannot purchase more than 3.6 grams per day or 9 grams per 30 days of base ephedrine or pseudoephedrine.

Question 5

How should products containing pseudoephedrine or ephedrine be stored?

Answer 5

These products must be kept behind the counter or in a locked case where customers do not have direct access.

Question 6

What identification is required when purchasing these products?

Answer 6

Purchasers must present valid government-issued photo identification.

Question 7

32-1977. Sale of methamphetamine precursors by a pharmacy permittee; electronic sales tracking system; violation; classification; state preemption

Answer 7

32-1977: Sale of Methamphetamine Precursors

A. Purchase Limits:
- No more than 3.6 grams per day or 9 grams per 30 days of ephedrine or pseudoephedrine (base) may be sold to the same person.

B. Storage:
- Products containing pseudoephedrine or ephedrine must be kept behind the counter or in a locked case.

C. Identification and Recordkeeping:
- Require valid photo ID for purchase.
- Record:
1. Purchaser’s name and address
2. Product name and quantity
3. Date and time of purchase
4. ID type and number

D. Electronic Sales Tracking:
- Use an electronic tracking system to submit information to the national precursor log exchange if available at no charge.
- The system must be able to:
- Generate stop sale alerts for quantity limit violations.
- Include an override function for safety with log entries.

E. System Failure:
- Maintain a written log or alternative electronic recordkeeping during system failure or if internet access is unavailable.

F. Information Sharing:
- The national association of drug diversion investigators will provide transaction records weekly to the board of pharmacy and real-time access to law enforcement.

G. Violations:
- Class 3 misdemeanor, punishable by a fine.

H. Exemptions:
- Does not apply to products obtained with a valid prescription.

I. State Preemption:
- Sales regulation is a statewide concern and not subject to local regulations.

Question 8

What are the requirements and procedures for pharmacist licensure and reinstatement in Arizona?

Answer 8

A: To practice as a pharmacist in Arizona, you must have a valid license issued by the Board, which can be obtained through practical examination or reciprocity. If your license is delinquent for five or more years:
- For practicing pharmacists: You need to pass the MPJE or another Board-approved jurisprudence exam, pay all delinquent renewal fees, and any penalty fees.
- For non-practicing pharmacists: In addition to the above, you must appear before the Board and prove fitness to be licensed. Before allowing someone to practice, a pharmacy permittee or pharmacist-in-charge must verify their current licensure with the Board.

Question 9

Pharmacists licensed in Arizona (Select all that apply)

Choose ALL answers that apply.

A
Must renew their license on time or else it becomes delinquent

B
Must renew their license on time or else it becomes suspended

C
Must renew their license on time or else it becomes revoked

D
May apply for license renewal as early as 30 days before the expiration date

E
May apply for license renewal as early as 60 days before the expiration date

F
May apply for license renewal as early as 90 days before the expiration date

Answer 9

B and E

Question 10

What are the renewal requirements and penalties for pharmacists, interns, and pharmacy technicians in Arizona?

Answer 10

1. License Renewal Groups:
   
   • Licenses are assigned to renewal groups based on whether they are designated as “even” or “odd” in the licensing database.
   • Even-numbered licenses: Renew biennially on or before November 1 of even-numbered years.
   • Odd-numbered licenses: Renew biennially on or before November 1 of odd-numbered years.
2. Failure to Renew:
   
   • Failure to renew and pay required fees by November 1 results in license suspension.
   • The suspension is vacated once past due fees and reinstatement penalties, which do not exceed $350, are paid.
   • The Board may waive fees or penalties under certain conditions.
3. Renewal Application Timing:
   
   • Applications for renewal cannot be made more than 60 days before the license expiration date.

Question 11

A pharmacist preceptor

I. Must have a minimum of 2 years of experience as an actively practicing pharmacist before acting as a pharmacist preceptor
II. Is responsible for the pharmacy-related actions of an intern during the training period and responsible for giving the intern timely and realistic feedback regarding progress
III. May delegate supervision of technicians to an intern

Answer 11

II ONLY

Question 12

Q: What are the requirements for a pharmacist to become a pharmacy intern preceptor according to R4-23-302?

Answer 12

A: To be a pharmacy intern preceptor, a pharmacist must:

• Hold a current unrestricted pharmacist license.
• Have a minimum of one year of experience as an actively practicing pharmacist.
• If found guilty of violating any federal or state law related to pharmacy practice, drug or device distribution, or recordkeeping, enter into an agreement satisfactory to the Board that places restrictions on the pharmacist’s license.

Question 13

Q: What are the responsibilities of a pharmacy intern preceptor?

Answer 13

A: The responsibilities of a pharmacy intern preceptor include:

• Acting as a teacher and mentor in addition to fulfilling their role as a pharmacist.
• Thoroughly reviewing pharmacy policy and procedure with each intern.
• Being responsible for the pharmacy-related actions of an intern during the specific training period.
  Providing opportunities for skill development and giving timely and realistic feedback regarding the intern’s progress.

Question 14

Q: What should be done if an intern completes more than the specified number of training hours under R4-23-202(A)(3)?

Answer 14

A: The pharmacist acting as the pharmacy intern preceptor must report the total number of training hours to the other jurisdiction.

Question 15

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern
9. Prepackage or supervise the prepackaging of drugs by a pharmacy technician or pharmacy technician trainee under R4-23-1104. For drugs prepackaged by a pharmacy technician or pharmacy technician trainee, a pharmacist shall:

Answer 15

a. Verify the drug to be prepackaged;
b. Verify that the label meets the official compendium’s standards;
c. Check the completed prepackaging procedure and product; and
d. Manually initial the completed label; or
e. For automated packaging systems, manually initial the completed label or a written log or initial a computer-stored log;

Question 16

R4-23-404. Unethical Practices
B. Prescription order-blank advertising prohibited. A pharmacist or pharmacy permittee shall not:

Answer 16

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

Question 17

R4-23-404. Unethical Practices: Q: What constitutes a fraudulent claim for service?

Answer 17

A: A fraudulent claim for service occurs when a pharmacist or pharmacy permittee:

• Claims the performance of a service that was not actually performed.
• For example, claiming to dispense a prescription medication that was not actually dispensed.
• This applies to claims that the pharmacist or pharmacy permittee knows or should know are false.

Question 18

R4-23-404. Unethical Practices: D. Fraudulent claim for a fee. A pharmacist or pharmacy permittee:

Answer 18

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

Question 19

R4-23-407. Prescription Requirements
B. Prescription refills. A pharmacist shall ensure that the following information is recorded on the back of a prescription order when it is refilled:

Answer 19

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

Question 20

Q: What are the requirements for the transfer of prescription order information according to R4-23-407?

Answer 20

A: For a transfer of prescription order information to be valid, the following conditions must be met:

1. Retention:
   
   • Both the original and transferred prescription orders must be maintained for seven years after the last dispensing date.
2. Controlled Substances (Schedule III, IV, V):
   
   • The transfer of original prescription order information must comply with 21 CFR 1306.25.
3. Noncontrolled Substances:
   
   • Transfer is limited to the number of originally authorized refills.
4. Transfers within Arizona:
   
   • For non-controlled substances, the transfer of information can be communicated electronically, verbally, or by fax directly between:
     
     • Two licensed pharmacists,
     • A licensed pharmacist and a licensed intern, or
     • Two licensed interns.
5. Electronic Transfers:
   
   • For pharmacies owned by the same company:
     
     • The electronic transfer must use a common or shared database.
   • For non-controlled substances:
     
     • The transfer may be performed by a pharmacist or intern, pharmacy technician trainee, or pharmacy technician under the supervision of a pharmacist.
6. Controlled Substances (21 CFR § 1306.25):
   
   • The transfer of prescription information for Schedules III, IV, and V controlled substances is permissible on a one-time basis only for refill purposes.
   • Pharmacies sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.

Question 21

Q: What are the requirements for transferring prescription order information for Schedule III, IV, or V controlled substances within Arizona according to R4-23-407?

Answer 21

A: The transfer of prescription order information for Schedule III, IV, or V controlled substances must meet the following conditions:

1. Communication:
   
   • The transfer must be communicated directly between two licensed pharmacists or interns, either electronically or verbally.
2. Information Recorded by the Transferring Pharmacist or Intern:
   
   • Write “void” on the face of the invalidated original prescription order, unless it is an electronic or oral transfer, in which case, the transferred prescription order information must be invalidated in the transferring pharmacy’s computer system.
   • Record the following information:
     
     • Name, address, and DEA number of the pharmacy to which the prescription is transferred.
     • Name of the receiving pharmacist.
     • Date of transfer.
     • Name of the transferring pharmacist.
3. Information Recorded by the Receiving Pharmacist:
   
   • Write “transfer” on the transferred prescription order.
   • Record the following details:
     
     • Date of issuance of the original prescription order.
     • Original number of refills authorized on the original prescription order.
     • Date of original dispensing.
     • Number of valid refills remaining and date of the last refill.
     • Name, address, DEA number, and original prescription number of the pharmacy from which the prescription was transferred.
     • Name of the transferring pharmacist.
     • Name of the receiving pharmacist.

Question 22

R4-23-407. Prescription Requirements

Q: What are the rules for faxing prescription orders and refill authorizations for Schedule II controlled substances?

Answer 22

1. Faxing Schedule II Prescription Orders:
   
   • A medical practitioner or their agent may fax a prescription order for a Schedule II controlled substance for information purposes only unless it meets the specific requirements of A.R.S. § 36-2525(F) and (G).
   • A pharmacy may receive a faxed prescription order for a Schedule II controlled substance for information purposes only. If the fax meets the requirements of A.R.S. § 36-2525(F) and (G), it can serve as the original written prescription.
2. Record Retention:
   
   • To meet the seven-year record retention requirement of A.R.S. § 32-1964, a pharmacy must either receive the faxed prescription order on plain paper or make a photocopy of it.
3. Faxing Refill Authorizations:
   
   • A medical practitioner or their agent can fax refill authorizations to a pharmacy if the fax includes:
     
     • The medical practitioner’s telephone and fax numbers.
     • The medical practitioner’s signature or the name of their agent.
     • The date of authorization.

Question 23

Q: Under what circumstances can a Schedule II controlled substance prescription be faxed to a pharmacy according to A.R.S. § 36-2525(F)?

Answer 23

A Schedule II controlled substance prescription can be faxed to a pharmacy under the following conditions:

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

Question 24

Q: What definitions are provided in R4-23-407.1 regarding the dispensing of opioid antagonists?

Answer 24

1. Community Member:
   
   • Any person in a position to assist someone at risk of an opioid-related overdose. This includes:
     
     • Emergency first responders
     • Peace officers or other law enforcement personnel
     • Fire department personnel
     • School district employees
     • Personnel from facilities or centers serving individuals at risk of an opioid-related overdose
2. Opioid Antagonist:
   
   • A drug approved by the U.S. Food and Drug Administration that binds to opioid receptors, blocking or inhibiting the receptor and preventing opioid effects. Example: Naloxone hydrochloride.
3. Opioid-Related Overdose:
   
   • An acute condition caused by excessive opioid use, identified by a triad of symptoms:
     
     • Decreased level of consciousness
     • Pinpoint pupils
     • Respiratory depression
   • Additional symptoms may include seizures, muscle spasms, coma, or death. Medical assistance is required.

Question 25

Q: What education must a pharmacist or pharmacy intern provide when dispensing an opioid antagonist under A.R.S. § 32-1979?

Answer 25

When dispensing an opioid antagonist, the following education must be provided:

1. Prevention:
   
   • How to prevent an opioid-related overdose.
2. Recognition:
   
   • How to recognize an opioid-related overdose.
3. Administration:
   
   • How to safely administer an opioid antagonist to someone experiencing an opioid-related overdose.
4. Precautions:
   
   • Potential side effects.
   • Possible adverse events associated with the administration of the opioid antagonist.
5. Emergency Assistance:
   
   • The importance of seeking emergency medical assistance for the individual experiencing an opioid-related overdose, both before and after administering the opioid antagonist.

Question 26

Q: What are the rules for pharmacists dispensing opioid antagonists under A.R.S. § 32-1979?

Answer 26

• Authority to Dispense:
  
  • A pharmacist can dispense naloxone hydrochloride or any FDA-approved opioid antagonist.
• Conditions:
  
  • Dispensing must be done pursuant to a standing order issued under A.R.S. § 36-2266.
  • The dispensing must follow protocols adopted by the board.
• Recipients:
  
  • The opioid antagonist can be dispensed to:
    
    • A person at risk of experiencing an opioid-related overdose.
    • A family member or community member who can assist the person at risk.

Question 27

B. A pharmacist who dispenses naloxone hydrochloride or any other opioid antagonist pursuant to subsection A of this section shall:

Answer 27

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 28

R4-23-409. Returning Drugs and Devices
A. After a person for whom a drug is prescribed or the person’s agent takes the drug from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the drug for return or exchange for the purpose of resale unless the pharmacist determines that:

Answer 28

1. The drug is in its original, manufacturer’s, unopened container; and
2. The drug or its container has not been subjected to contamination or deterioration.

Question 29

B. The provisions of subsection (A) - previous notecard- of this Section do not apply to a drug dispensed to:

Answer 29

1. A hospital inpatient; or
2. A resident of a long-term care facility where a licensed health care professional administers the drug, and the pharmacist ensures and documents that the drug:
   a. Has been stored in compliance with the requirements of the official compendium; and
   b. Is not obviously contaminated or deteriorated.

Question 30

C. After a person for whom a device is prescribed or the person’s agent takes the device from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the device for return or exchange for the purpose of resale or reuse unless the pharmacist determines that:

Answer 30

1. The device is inspected and is free of defects;
2. The device is rendered incapable of transferring disease; and
3. The device, if resold or reused, is not claimed to be new or unused.

Question 31

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

Q: What are the qualifications required for a pharmacist or intern to administer immunizations, vaccines, and emergency medications to eligible patients under A.R.S. § 32-1979?

Answer 31

1. Current License:
   
   • Must have a current license to practice pharmacy in the state of AZ.
2. Training Program:
   
   • Successfully complete a Board-approved training program on immunizations
3. CPR Certification:
   
   • Must have a current certificate in basic cardiopulmonary resuscitation (CPR).

Question 32

Q: What are the requirements for dispensing emergency quantities of Schedule II controlled substances under A.R.S. § 32-1979?

Answer 32

1. Emergency Oral Prescription:
   
   • In emergencies, a pharmacist can dispense Schedule II controlled substances based on an oral prescription from a medical practitioner.
   • The oral prescription must be immediately written down by the pharmacist and include all required information except for the manual signature of the practitioner.
2. Written Prescription Requirement:
   
   • Within seven days, the prescribing medical practitioner must deliver a written prescription manually signed or an electronic prescription order to the dispensing pharmacist.
   • The prescription must indicate “authorization for emergency dispensing” and the date of the oral order.
3. Pharmacist’s Responsibility:
   
   • If the written or electronic prescription is not received within seven days, the pharmacist must notify the board.
   • Failure to notify the board within this timeframe will void the authority to dispense the emergency prescription without a properly signed order.

Question 33

36-2606. Registration; access; requirements; mandatory use; annual user satisfaction survey; report; definitions
.
Q: What are the requirements for obtaining a patient utilization report before dispensing a Schedule II controlled substance?

Answer 33

1. General Requirement:
   
   • Before dispensing a Schedule II controlled substance, a pharmacist, pharmacy technician, or pharmacy intern must obtain a patient utilization report from the controlled substances prescription monitoring program’s central database tracking system for the preceding twelve months at the beginning of each new course of treatment.
2. Exceptions:
   
   • Hospice or Palliative Care: The patient is receiving hospice or palliative care for a serious or chronic illness.
   • Cancer or Dialysis: The patient is receiving care for cancer, a cancer-related illness, or dialysis treatment.
   • Medical Practitioner Administration: A medical practitioner will administer the controlled substance.
   • Inpatient or Residential Treatment: The patient is receiving the controlled substance during inpatient or residential treatment in a hospital, nursing care facility, assisted living facility, correctional facility, or mental health facility.
   • Short-Term Prescription: The controlled substance is prescribed for not more than a five-day period for:
     
     • An invasive medical or dental procedure, or
     • A patient who has suffered an acute injury or medical or dental disease process diagnosed in an emergency department setting that results in acute pain (excluding back pain).

Question 34

Q: What are the requirements for obtaining and maintaining a pharmacy permit in Arizona? / important dates/ timelime!

Answer 34

1. Permit Requirement:
   
   • A pharmacy must have a current Board-issued pharmacy permit to operate in Arizona.
2. Application Process:
   
   • Submission: Submit a completed application form and fee (specified in R4-23-205).
   • Approval: The Board must receive and approve the completed permit application and a satisfactory compliance inspection report.
   • Interview: The Board may interview the applicant and the pharmacist-in-charge if additional information is needed.
3. Notification:
   
   • Notify the Board within 10 days of changes to:
     
     • Type of pharmacy operated
     • Telephone or fax number
     • E-mail or mailing address
     • Business name
     • Staff pharmacist
   • Provide immediate notice of a change of pharmacist-in-charge.
4. Nonprescription Drugs:
   
   • If nonprescription drugs are sold outside the pharmacy area when closed, ensure a current nonprescription drug permit is obtained (see R4-23-603).
5. Relocation or Remodel:
   
   • Application: Submit a completed application for remodel or relocation at least 30 days prior to the change. No fee is required.
   • Inspection: The new or remodeled facility must pass a final inspection by a Board compliance officer before operations begin.

Question 35

Q: What are the minimum area requirements for a community pharmacy in Arizona?

Answer 35

1. Minimum Area:
   
   • The primary area devoted to stocking drugs, compounding, and dispensing prescription medications must be at least 300 square feet. This excludes office and other support areas.
2. Personnel Capacity:
   
   • Up to three pharmacy personnel may work simultaneously in this minimum area (300 sqft).
3. Additional Space:
   
   • Provide an additional **60 square feet **for each extra pharmacist, graduate intern, pharmacy intern, pharmacy technician, pharmacy technician trainee, or support personnel working simultaneously.
4. Design Requirements:
   
   • The space must include adequate shelving and be designed for efficient pharmaceutical practice.
   • The layout should allow free movement and enable visual surveillance of personnel by the pharmacist.

Question 36

Q: What are the requirements for maintaining a supply of drugs and chemicals in a pharmacy according to R4-23-606?

Answer 36

1. Stock Requirements:
   
   • Sufficiency: Maintain a stock sufficient to meet the normal demands of the area or patient base served.
   • Standards: Drugs and chemicals must meet standards of strength and purity as established by official compendiums.
2. Contamination:
   
   • Ensure all stock, materials, drugs, and chemicals are not contaminated.
3. Policies and Procedures:
   
   • Preventive Measures: Develop and implement policies to prevent:
     
     • Sale or use of drugs/chemicals past their expiration date.
     • Use of deteriorated or damaged drugs/chemicals (due to age, heat, light, moisture, etc.).
     • Sale of improperly labeled drugs/chemicals.
     • Use of drugs/chemicals with defective containers.
     • Use of drugs/chemicals not complying with federal law.
   • Availability: Make policies and procedures available in the pharmacy for employee reference and inspection by the Board.
   • Reviews and Quarantine:
     
     • Review expiration-dated drugs/chemicals regularly.
     • Move expired, deteriorated, damaged, improperly labeled, or non-compliant drugs/chemicals to a quarantine area.
     • Ensure quarantined items are either properly destroyed or returned to their source of supply.

Question 37

R4-23-614. Automated Storage and Distribution System

Q: What are the requirements for using an automated storage and distribution system in a pharmacy according to R4-23-606?

Answer 37

1. Compliance:
   
   • Ensure that the automated storage and distribution system, along with the policies and procedures, comply with the relevant regulations.
2. Notification:
   
   • Notify the Board in writing of the intent to use the automated system, including the type or name of the system.

Question 38

R4-23-614. Automated Storage and Distribution System

Q: What policies and procedures must a pharmacy permittee or pharmacist-in-charge establish for the use of an automated storage and distribution system according to R4-23-606?

Answer 38

1. System Maintenance and Security:
   
   • Ensure the system is in good working order with appropriate recordkeeping and security safeguards.
2. Patient Access:
   
   • Prescription Requirements:
     
     • Only contain prescriptions that do not require oral consultation (as specified in R4-23-402(B)).
     • Ensure prescriptions are properly labeled and verified by a pharmacist before placement and release.
   • Patient Choice: Allow patients to choose whether to use the system.
   • Location:
     
     • System must be located in a wall of a properly permitted pharmacy or within 20 feet of the pharmacy, secured to prevent unauthorized removal.
   • Patient Identification: Provide a method to identify the patient and release only their prescriptions.
   • Security: Ensure the system is secure from unauthorized access and removal of drugs or devices.
   • Consultation: Provide a method for patients to obtain a consultation with a pharmacist if requested.
   • Counseling Requirement: Prevent the system from dispensing refilled prescriptions if oral counseling is required.
3. Authorized Personnel Access:
   
   • Security: Ensure the system provides adequate security to prevent unauthorized access to drugs or devices.
   • Authorized Handling: Only authorized licensed personnel may fill, stock, or restock the system.
4. Quality Assurance:
   
   • Implement an ongoing quality assurance program to monitor compliance with established policies, procedures, and applicable laws.

Question 39

R4-23-614. Automated Storage and Distribution System

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

Answer 39

1. Preparation and Compliance:
   
   • Ensure that the policies and procedures required under subsection (B) are prepared, implemented, and complied with.
2. Biennial Review:
   
   • Review the policies and procedures biennially and revise them if necessary.
3. Documentation:
   
   • Document the biennial review of the policies and procedures.
4. Manual Assembly:
   
   • Assemble the policies and procedures into a written or electronic manual.
5. Availability:
   
   • Make the policies and procedures available for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside the pharmacy where the system is used.

Question 40

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

Answer 40

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

Question 41

Q: What are the requirements for a pharmacy permittee engaged in shared services according to R4-23-621?

Answer 41

1. Record Maintenance:
   
   • Order Processing: Maintain manual or electronic records identifying each individual involved in order interpretation, entry, verification, drug utilization review, drug compatibility and allergy review, final verification, therapeutic intervention, or refill authorization.
   • Order Filling/Dispensing: Maintain records identifying each individual involved in filling, dispensing, and counseling functions.
2. Reporting and Tracking:
   
   • Disciplinary Actions: Report to the Board any disciplinary actions taken by other states’ pharmacy regulatory agencies regarding shared services.
   • Order Tracking: Maintain a mechanism for tracking orders throughout the processing and filling procedures.
3. Security and Inspection:
   
   • Confidentiality: Provide adequate security to protect patient information confidentiality and integrity.
   • Inspection: Provide any required records or information to the Board or its designee within 72 hours of request.
4. Policies and Procedures:
   
   • Develop, implement, review, revise, and comply with joint policies and procedures for shared services, including:
     
     • Responsibilities of each pharmacy.
     • Contact details and license numbers of participating pharmacies.
     • Policies for:
       
       • Notifying patients if their orders are processed or filled by another pharmacy and providing that pharmacy’s name.
       • Protecting patient information confidentiality and integrity.
       • Handling situations where the filled order is not received or the patient arrives before the order is received.
       • Maintaining records of each individual’s activities in shared services.
       • Compliance with federal and state laws.
       • Continuous quality improvement for shared services to monitor and improve patient care.

Question 42

Q: What conditions must be met for an individual pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technician trainee to access a pharmacy’s electronic database from inside or outside the pharmacy?

Answer 42

• Confidentiality Controls: The pharmacy must establish controls to protect the confidentiality and integrity of patient information.
• Database Protection: No part of the database may be duplicated, downloaded, or removed from the pharmacy’s electronic database.

Question 43

Q: What are the security requirements for a hospital pharmacy

Answer 43

1. Personnel Security:
   
   • Pharmacist Presence: No one is allowed in the pharmacy unless a pharmacist is present, except as specified in this Section and R4-23-654. If the sole pharmacist must leave the pharmacy for emergencies or patient care, non-pharmacist personnel may remain to perform duties, provided:
     
     • C-II controlled substances are secured and accessible only by a pharmacist.
     • The pharmacist remains available in the hospital.
   • Locked Areas: All hospital pharmacy areas must be kept locked with either a key or programmable lock to prevent unauthorized access.
   • Identification Badges: All pharmacists, pharmacy or graduate interns, pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel must wear identification badges with their name and position whenever on duty.
2. Prescription Blank Security:
   
   • Policies and Procedures: The Director of Pharmacy must develop, implement, review, and revise policies and procedures for the safe distribution and control of prescription blanks that bear the hospital’s identification.

Question 44

Q: What are the requirements for emergency services dispensing of drugs in a hospital when the pharmacy is unable to provide this service, according to R4-23-658(F)

Answer 44

1. Patient Eligibility: Drugs are dispensed only to patients who have been admitted to the emergency services department.
2. Authorized Personnel: Only an authorized medical practitioner can dispense drugs; designees or agents are not permitted to dispense.
3. Drug Selection: The nature and type of drugs available are designed to meet the immediate needs of patients treated within the hospital.
4. Quantity Limits: Drugs are dispensed in quantities sufficient to meet patient needs until outpatient pharmacy services become available.
5. Packaging and Labeling:
   
   • Drugs must be prepackaged by a pharmacist, pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist.
   • Containers must be suitably labeled with drug name, strength, dosage form, quantity, manufacturer, lot number, beyond-use date, and any appropriate auxiliary labels.
6. Label Completion: Upon dispensing, the authorized medical practitioner must complete the label on the prescription container in accordance with R4-23-658(D).
7. Record Keeping: The hospital pharmacy must maintain a dispensing log, hardcopy prescription, or electronic record approved by the Board or its designee, which includes:
   
   • Patient name and address
   • Drug name, strength, dosage form, quantity
   • Directions for use
   • Medical practitioner’s signature or identification code
   • DEA registration number, if applicable

Question 45

Q: What are the requirements for equipment and procedures for compounding sterile pharmaceutical products according to R4-23-670?

Answer 45

Equipment Requirements:
1. Environmental Control Devices:
- Must maintain an “ISO class 5 environment” as defined in R4-23-110.
- Acceptable devices include laminar airflow hoods, HEPA-filtered zonal airflow devices, glove boxes, pharmaceutical isolators, barrier isolators, and biological safety cabinets.

2. Disposal Containers:
   
   • For needles, syringes, and other materials used in compounding.
   • Separate containers for cytotoxic, chemotherapeutic, and infectious waste products if applicable.
3. Freezer Storage Units:
   
   • Must have thermostatic control and a thermometer if applicable.
4. Packaging or Delivery Containers:
   
   • Must maintain official compendial drug storage conditions.
5. Infusion Devices and Accessories:
   
   • If applicable to the compounding process.
6. Reference Library:
   
   • Must include a current reference pertinent to the preparation of sterile pharmaceutical products in addition to other required references.

Procedures:
1. Policies and Procedures:
- Prepare, implement, and comply with written policies and procedures for compounding and dispensing sterile pharmaceutical products.

2. Review and Revision:
   
   • Review policies and procedures biennially and revise if necessary.
   • Document the review process.
3. Documentation:
   
   • Assemble policies and procedures as a written manual or approved method.
   • Make policies and procedures available for employee reference and inspection by the Board or its designee.

Question 46

R4-23-409. Returning Drugs and Devices
A. After a person for whom a drug is prescribed or the person’s agent takes the drug from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the drug for return or exchange for the purpose of resale unless the pharmacist determines that:

Answer 46

1. The drug is in its original, manufacturer’s, unopened container; and
2. The drug or its container has not been subjected to contamination or deterioration.
   B. The provisions of subsection (A) of this Section do not apply to a drug dispensed to:
3. A hospital inpatient as defined in R4-23-651; or
4. A resident of a long-term care facility where a licensed health care professional administers the drug, and the pharmacist ensures and documents that the drug:
   a. Has been stored in compliance with the requirements of the official compendium; and
   b. Is not obviously contaminated or deteriorated.
   C. After a person for whom a device is prescribed or the person’s agent takes the device from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the device for return or exchange for the purpose of resale or reuse unless the pharmacist determines that:
5. The device is inspected and is free of defects;
6. The device is rendered incapable of transferring disease; and
7. The device, if resold or reused, is not claimed to be new or unused.

Question 47

R4-23-1104. Pharmacy Technicians and Pharmacy Technician Trainees

Q: What tasks can a pharmacy technician trainee perform under the supervision of a pharmacist?

Answer 47

Assist with Refill Authorizations:
- Initiate or accept verbal or electronic refill authorizations from a medical practitioner or their agent.
- Record the following information on the original prescription order or by an alternative approved method:
- Medical practitioner’s name
- Patient’s name
- Name and quantity of the prescription medication
- Specific refill information
- Name of the medical practitioner’s agent, if applicable

Note: All tasks must be performed in compliance with applicable statutes and rules, and under the supervision of a pharmacist….They cannot counsel or Accept a new prescription order from a prescriber over the phone

Question 48

Q: How should a registered practitioner dispose of controlled substances in their inventory?

Answer 48

Disposal Process:

1. Request Assistance:
   
   • Submit a DEA Form 41 to the Special Agent in Charge of the Administration in your area. The form should list the controlled substances you wish to dispose of.
2. Instructions from the Special Agent in Charge:
   
   • Transfer: Move the controlled substances to a registrant authorized to transport or destroy them.
   • Delivery: Deliver the substances to an agent of the Administration or the nearest office of the Administration.
   • Destruction: Destroy the substances in the presence of an agent of the Administration or another authorized person.

Question 49

Long-term care facilities (LTCF) may employ a consultant pharmacist to provide resident evaluations relating to medication therapy. The consultant pharmacist

I. Must ensure Schedule II controlled substances are stored in a locked and permanently affixed compartment
II. Is not required to report dispensing errors to the director of nursing, but must report dispensing errors to the prescriber
III. Must ensure that the emergency drug supply at the facility staff is accessible to residents in the event of an emergency

Answer 49

I ONLY

Question 50

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

Answer 50

1. Therapeutic Needs:
   
   • Drugs in the unit must meet the immediate and emergency therapeutic needs of residents.
   • Determined by the provider pharmacy’s pharmacist-in-charge in consultation with the facility’s medical director and nursing director.
2. Purpose and Responsibility:
   
   • The unit is not a substitute for the provider pharmacy’s responsibility to provide routine drugs.
   • Its purpose is to ensure immediate access to emergency therapeutic drugs for facility residents.
3. Packaging and Labeling:
   
   • Drugs must be in a manufacturer’s unit of use package or prepackaged.
   • Labeling must include:
     
     • Drug name
     • Strength
     • Dosage form
     • Manufacturer
     • Lot number
     • Expiration date
     • Provider pharmacy’s name, address, telephone number
     • Pharmacist’s initials

Question 51

Q: What additional requirements must be met for using an automated emergency drug supply unit in long-term care facilities?

Answer 51

1. Notification to the Board:
   
   • The pharmacy permittee or pharmacist-in-charge must notify the Board or its staff in writing of the intent to use the automated unit, including its name and type.
2. Access Notification:
   
   • The provider pharmacy must be notified electronically whenever the automated emergency drug supply unit is accessed.
3. Event Recording:
   
   • All access events must be recorded electronically and maintained for at least two years.
4. Transaction Reporting:
   
   • The provider pharmacy must be capable of producing a report of all transactions and a single drug usage report on inspection by the Board or its staff.
5. Policies and Procedures:
   
   • Written policies and procedures must be developed for:
     
     • Accessing the unit during system malfunctions or downtime.
     • Authorizing and modifying user access.
     • An ongoing quality assurance program that includes:
       
       • Training all authorized users in the use of the unit.
       • Maintenance and calibration as recommended by the manufacturer.
6. Documentation:
   
   • Documentation of the ongoing quality assurance program must be maintained for at least two years for Board inspection.

Question 52

R4-23-701.04. LTCF Pharmacy Services: Automated Dispensing Systems

Q: What are the requirements before using an automated dispensing system in a long-term care facility?

Answer 52

1. Notification to the Board:
   
   • The pharmacy permittee or pharmacist-in-charge must notify the Board or its staff in writing of the intent to use the automated dispensing system, including the name and type of the system.
2. Controlled Substances Registration:
   
   • Obtain a separate controlled substances registration for each long-term care facility location where the system will be used, as required by federal law.
3. Documentation Maintenance:
   
   • Maintain copies of the controlled substances registrations at the provider pharmacy for inspection by the Board or its staff.

Question 53

Q: What responsibilities does a pharmacy permittee or pharmacist-in-charge have regarding an automated dispensing system?

Answer 53

1. Ownership of Drugs:
   
   • Ensure that drugs in the automated dispensing system remain the property of the provider pharmacy.
2. Inventory Requirements:
   
   • Include controlled substance drugs in all required inventories, as per A.R.S. § 36-2523(B) and R4-23-1003(A).
3. Restriction on Schedule II Drugs:
   
   • Ensure that Schedule II drugs are not stocked in the automated dispensing system.
4. Emergency Drug Supply:
   
   • Provide a separate emergency drug supply unit in the long-term care facility to meet the requirements of R4-23-701.02.

Question 54

R4-23-703. Assisted Living Facilities

Q: What must a pharmacy permittee verify before dispensing a drug to an assisted living facility resident?

Answer 54

Verify that the assisted living facility has a current and active license issued by the Arizona Department of Health Services.

Question 55

R4-23-703. Assisted Living Facilities

What are the requirements for dispensing a controlled substance prescription drug to an assisted living facility resident?

Answer 55

• Valid Prescription:
  Ensure the controlled substance prescription drug is dispensed only after receiving a valid prescription order from the resident’s medical practitioner.
• Labeling:
  Label the controlled substance prescription drug in accordance with A.R.S. §§ 32-1963.01, 32-1968, and 36-2525, including the beyond-use date.

Question 56

R4-23-703. Assisted Living Facilities

Under what conditions can a pharmacy permittee dispense Schedule III, IV, or V controlled substances to an assisted living facility resident?

Answer 56

Prescription Order:
Receive a written or oral prescription order from:
- The resident’s medical practitioner,
- An individual licensed by the Arizona Board of Nursing within their scope of practice, or
- The manager or a caregiver of the assisted living facility if authorized by the resident’s medical practitioner.

Question 57

R4-23-703. Assisted Living Facilities

What are the requirements for dispensing non-controlled substances to an assisted living facility resident?

Answer 57

Prescription Order:
1. Receive a written or oral prescription order from:
- The resident’s medical practitioner,
- An individual licensed by the Arizona Board of Nursing within their scope of practice, or
- An assisted living facility manager or caregiver acting under the authority of a licensed medical practitioner.
.
2. Order Verification:
Ensure the prescription order meets R4-23-407 requirements and includes the name and title of the individual transmitting the order.
.
3. Labeling:
Label the non-narcotic prescription or non-prescription drug in accordance with A.R.S. §§ 32-1963.01 and 32-1968, including the beyond-use date.

Question 58

R4-23-703. Assisted Living Facilities

What should be done if the label on a drug container for an assisted living facility resident becomes damaged or soiled?

Answer 58

A pharmacist employed by the pharmacy permittee may relabel the drug container using professional judgment. Only a pharmacist is allowed to label or alter the label of a drug container.

Question 59

R4-23-703. Assisted Living Facilities

Can a pharmacist assist in developing policies for drug management in an assisted living facility?

Answer 59

Yes, a pharmacist can help develop written policies and procedures for procuring, administering, storing, controlling, keeping records, and disposing of drugs in the facility and provide information on safe and effective drug self-administration supervision.

Question 60

R4-23-703. Assisted Living Facilities

Are emergency drug supply units or automated dispensing systems allowed in assisted living facilities?

Answer 60

No, a pharmacy permittee shall not place an emergency drug supply unit or an automated dispensing system in an assisted living facility.

Question 61

R4-23-703. Assisted Living Facilities

Can a pharmacist repackage a drug previously dispensed to an assisted living facility resident?

Answer 61

No, a pharmacist shall not repackage a drug previously dispensed to an assisted living facility resident.

Question 62

What is required for an individual to work as a pharmacy technician or pharmacy technician trainee in Arizona?

Answer 62

The individual must possess a pharmacy technician or pharmacy technician trainee license issued by the Board.

Question 63

What are the eligibility requirements for licensure as a pharmacy technician trainee?

Answer 63

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

Question 64

What are the eligibility requirements for licensure as a pharmacy technician?

Answer 64

• Meet the requirements for a pharmacy technician trainee.
• Complete a pharmacy technician training program that meets the standards prescribed in R4-23-1105.
• Pass the Pharmacy Technician Certification Board (PTCB) examination or another Board-approved pharmacy technician examination.

Question 65

What is required for the reinstatement of a pharmacy technician license that has been delinquent for five or more consecutive years?

Answer 65

1. For a person practicing as a pharmacy technician out-of-state:

Provide proof of current, unrestricted pharmacy technician licensure in another jurisdiction.
Provide proof of employment as a pharmacy technician during the last 12 months.
.

2. For a person who has not practiced as a pharmacy technician within the last 12 months:

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

Question 66

R4-23-1104.01 Technology-assisted Verification of Product

What is required before implementing a technology-assisted verification of product program in a pharmacy?

Answer 66

Prepare a written program description including:
- Responsibility of the pharmacist in charge and permittee.
- Design, implementation, and monitoring of the accuracy and safety process.
- Duties and qualifications of a verification technician.
- Training requirements for verification technicians.
- Monitoring and evaluation procedures for technician competency.
- Prohibition of verification technicians performing final accuracy checks.

Question 67

R4-23-1104.01 Technology-assisted Verification of Product

What should be included in the written program description for a technology-assisted verification of product program?

Answer 67

• Responsibilities of both the pharmacist in charge and permittee.
• Process for ensuring product accuracy and safety.
• Duties and qualifications of a verification technician.
• Necessary training and continuing education for verification technicians.
• Procedures for monitoring and evaluating technician competency.
• Prohibition of verification technicians from performing final accuracy checks.

Question 68

R4-23-1104.01 Technology-assisted Verification of Product

What are the requirements for posting and maintaining the written program description in a pharmacy implementing a technology-assisted verification program?

Answer 68

• Post the description in the pharmacy area.
• Provide a copy to the pharmacist in charge and verification technician.
• Obtain and file signed copies from the pharmacist in charge and verification technician.
• Ensure scanning technology captures both product and patient information.
• Update and repeat the posting and filing process after updates.

Question 69

R4-23-1104.01 Technology-assisted Verification of Product

What qualifications must a pharmacy technician have to perform as a verification technician in a technology-assisted verification program?

Answer 69

• Be licensed under R4-23-1102.
• Have at least 1,000 hours of work experience in the same type of pharmacy practice site.
• Complete a training program covering:
  Role and legal requirements of a verification technician.
  Use of the verification system.
  Causes of medication errors.
  Identifying and resolving dispensing errors.
• Complete at least four hours of continuing education on patient safety.

Question 70

R4-23-1104.01 Technology-assisted Verification of Product

What can a verification technician verify using the technology-assisted verification system?

Answer 70

• Products with scanning technology that identifies the product.
• Robotically prepared unit-dose products.
• A Schedule III – V controlled substance

Question 71

R4-23-1104.01 Technology-assisted Verification of Product

What are the restrictions on what a verification technician can verify in a technology-assisted verification program?

Answer 71

• Products resulting from compounding or mixing ingredients.
• Products involving alteration of a drug.
• DEA Schedule II controlled substances.

Question 72

A Physician’s Assistant (PA) may issue prescriptions for (Select all that apply)

Choose ALL answers that apply.

A
Opioids in Schedule II or III for up to a 30-day supply

B
Opioids in Schedule II or III for up to a 90-day supply

C
Schedule II or III controlled substances for non-opioids for up to a 30 day supply

D
Schedule II or III controlled substances for non-opioids for up to a 90 day supply

Answer 72

A and D

Question 73

How must prescription orders for controlled substances listed in schedules I and II be maintained?

Answer 73

Prescription orders must be kept in a separate prescription file specifically for controlled substances listed in schedules I and II only.

Question 74

How can prescription orders for controlled substances listed in schedules III, IV, and V be maintained?

Answer 74

A:
- In a separate prescription file specifically for controlled substances listed in schedules III, IV, and V only.
- Alternatively, in a form that allows them to be readily retrievable from other prescription records.
Definition of “readily retrievable”:

When initially filed, the prescription must have a red “C” stamped in the lower right corner of the face of the prescription, at least one inch high.
The prescription must be filed in the consecutively numbered prescription file for noncontrolled substances.
Note: The requirement to stamp the hard copy prescription with a red “C” is waived if an electronic data processing system is used that allows retrieval by prescription number, prescriber’s name, patient’s name, and drug dispensed.

Question 75

Q: What are the requirements for dispensing a controlled substance listed in schedules III, IV, or V without a prescription at retail?

Answer 75

A:
1. Legitimate Medical Purpose: The controlled substance must be for a legitimate medical purpose.
2. Quantity Limits:
- Opium-containing substances: No more than 240 cc (8 oz) in any 48-hour period.
- Other substances: No more than 120 cc (4 oz) in any 48-hour period.
- Dosage units:
- Opium-containing substances: No more than 48 dosage units in any 48-hour period.
- Other substances: No more than 24 dosage units in any 48-hour period.
3. Ephedrine Preparations: No more than 100 dosage units of any single active ingredient ephedrine preparation may be sold in a 30-day period.
4. Identification: The pharmacist or pharmacy intern must require suitable identification from every purchaser not known to them, including proof of age if appropriate.
5. Recordkeeping: A bound record book must be maintained with:
- Name and address of the purchaser
- Name and quantity of the controlled substance
- Date of purchase
- Name or initials of the pharmacist or pharmacy intern who dispensed the substance
- Compliance with the recordkeeping requirements of section 36-2523.

Question 76

For dietary supplements, it is legal to market a product as

I. A treatment for a specific disease or illness
II. A prevention for a specific disease or illness
III. Alleviating the symptoms of a disease

Answer 76

NONE OF THESE!!!
.
It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.Unlike drugs, supplements are not permitted to be marketed for the purpose of treating, diagnosing, preventing, or curing diseases. That means supplements should not make disease claims, such as “lowers high cholesterol” or “treats heart disease.” Claims like these cannot be legitimately made for dietary supplements.

Question 77

In general, outpatient prescriptions for an opioid that is a Schedule II Controlled Substance is limited to no more than ____ how many meq of morphine QD?

Answer 77

90 morphine milligram equivalents per day

Question 78

What are the requirements for ensuring the labeled strength of compounded sterile preparations (CSPs)?

Answer 78

Compounding supervisors must ensure that:
1. Strength Maintenance: CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% of the labeled strength if not specified, until their Beyond-Use Dates (BUDs).
2. Verification Method: This must be verified through either direct measurement or appropriate information sources.

Question 79

Q: What are the requirements for handling and storing hazardous drugs as compounded sterile preparations (CSPs)?

Answer 79

1. Preparation Conditions: Hazardous drugs must be prepared in conditions that protect healthcare workers and other personnel. This includes using appropriate chemotherapy gloves during all stages of handling—receiving, distribution, stocking, inventorying, preparation, and disposal.
2. Storage: Hazardous drugs should be stored separately from other inventory to prevent contamination and exposure. Preferably, they should be kept in a containment area such as a negative pressure room with sufficient general exhaust ventilation, providing at least 12 air changes per hour (ACPH).
3. Handling: Hazardous drugs must be handled with caution using protective measures to minimize risk.
4. Preparation Environment: Hazardous drugs must be prepared in an ISO Class 5 environment with appropriate protective engineering controls and aseptic practices, as specified for the relevant contamination risk levels.
5. Access Control: Access to areas where hazardous drugs are stored and prepared should be restricted to personnel involved in drug preparation to protect others.

Question 80

Q: What are the requirements for partial dispensing of Schedule II controlled substances?

Answer 80

​
A:
1. Partial Dispensing Conditions: A Schedule II controlled substance prescription may be partially dispensed if the full quantity cannot be supplied. The pharmacist must:
- Note the quantity supplied on the front of the written prescription, on a written record of an emergency oral prescription, or in the electronic prescription record.
- Dispense the remaining portion within 72 hours of the first partial dispensing.
​
2. Notification and New Prescription: If the remaining quantity cannot be dispensed within 72 hours, the pharmacist must notify the prescribing practitioner. No further dispensing is allowed beyond 72 hours without a new prescription.
​
3. DEA Position: The pharmacy must have the balance of the prescription ready within 72 hours, but the patient is not required to pick it up within that time frame.

Question 81

Adalat ® CC and Procardia XL ® both contain the active ingredient nifedipine. If Adalat ® CC has been assigned the TE code AB1, which of the following statements are true (select all that apply)

Choose ALL answers that apply.

A
A drug with the TE code AB1 is bioequivalent

B
A drug with the TE code AB2 is bioequivalent

C
A drug with the TE code AB is bioequivalent

D
A drug with the TE code B is bioequivalent

E
A drug with the TE code C is bioequivalent

Answer 81

A

Question 82

Q: What are the record-keeping requirements for retail pharmacies using central fill pharmacies?

Answer 82

1. Record Maintenance: Every retail pharmacy that uses central fill pharmacies must keep records of all central fill pharmacies authorized to fill prescriptions on its behalf. This record must include:
   
   • Name
   • Address
   • DEA number of each central fill pharmacy.
2. Verification: The retail pharmacy must verify the registration of each central fill pharmacy it uses.
3. Availability for Inspection: These records must be available for inspection by the DEA upon request.

Question 83

You are the pharmacist-in-charge at a community pharmacy in Flagstaff, AZ, and you are preparing to dispense Hydrocodone+Acetaminophen to a patient. You

I. Must check the patient’s PMP utilization report for the preceding 12 months if this is a new course of treatment for the patient

II. Are not required to check the PMP if this patient is receiving hospice care, palliative care, cancer care, or is inpatient at a hospital, nursing care facility, or assisted living facility

III. Are not required to check the PMP if the prescribed day supply is not more than 5 days

Choose ALL answers that apply.

A
I only

B
II only

C
I and II

D
II and III

E
I, II, and III

Answer 83

E!
.
Here’s a simplified version of the rules for dispensing Schedule II controlled substances:

G. Before Dispensing Schedule II Drugs:
- Pharmacists, pharmacy technicians, or pharmacy interns must check a patient’s usage history for the past year from the central database tracking system before starting a new treatment course.

H. Exceptions to Checking the Database:
- You don’t need to check the database if:
1. Hospice or Palliative Care: The patient is in hospice or receiving palliative care for a serious or chronic illness.
2. Cancer Care or Dialysis: The patient is getting treatment for cancer, a related illness, or dialysis.
3. In-Office Administration: A medical practitioner will administer the controlled substance directly.
4. Inpatient Care: The patient is receiving the substance while in a hospital, nursing home, assisted living facility, correctional facility, or mental health facility.
5. Short-Term Prescription: The controlled substance is prescribed for no more than five days for a procedure causing acute pain.
6. Emergency Prescription: The controlled substance is prescribed for no more than five days for an acute injury or emergency condition causing acute pain (excluding back pain).