4-23.pdf

4 A.A.C. 23 Supp. 24-1 TITLE 4. PROFESSIONS AND OCCUPATIONS...

4 A.A.C. 23 Supp. 24-1 TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY The table of contents on page one contains links to the referenced page numbers in this Chapter. Refer to the notes at the end of a Section to learn about the history of a rule as it was published in the Arizona Administrative Register. This Chapter contains rules that were filed to be codified in the Arizona Administrative Code between the dates of January 1, 2024 through March 31, 2024 R4-23-101. General................................................................. 4 R4-23-301. Intern Licensure.................................................18 R4-23-119. Subpoenas.......................................................... 13 R4-23-302. Training Site; Intern Preceptors; Training Time 19 R4-23-201. General............................................................... 15 R4-23-303. Repealed.............................................................20 R4-23-202. Licensure by Examination................................. 15 R4-23-304. Repealed.............................................................20 R4-23-203. Licensure by Reciprocity................................... 16 R4-23-305. Repealed.............................................................20 R4-23-205. Fees and Charges............................................... 17 Questions about these rules? Contact: Board: Board of Pharmacy Address: 1110 W. Washington St., Suite 260 Phoenix, AZ 85007 Website: www.azpharmacy.gov Name: Kamlesh Gandhi, Executive Director Telephone: (602) 771-2740 Fax: (602) 771-2749 Email: [email protected] The release of this Chapter in Supp. 24-1 replaces Supp. 23-3, 1-86 pages. Please note that the Chapter you are about to replace may have rules still in effect after the publication date of this supplement. Therefore, all superseded material should be retained in a separate binder and archived for future reference. i  PREFACE Under Arizona law, the Department of State, Office of the Secretary of State (Office), Administrative Rules Division, accepts state agency rule notice and other legal filings and is the publisher of Arizona rules. The Office of the Secretary of State does not interpret or enforce rules in the Administrative Code. Questions about rules should be directed to the state agency responsible for the promulgation of the rule. Scott Cancelosi, Director ADMINISTRATIVE RULES DIVISION RULES HOW TO USE THE CODE The definition for a rule is provided for under A.R.S. § 41-1001. Rules may be in effect before a supplement is released by the “‘Rule’ means an agency statement of general applicability that Office. Therefore, the user should refer to issues of the Arizona implements, interprets, or prescribes law or policy, or describes the Administrative Register for recent updates to rule Sections. procedures or practice requirements of an agency.” ARIZONA REVISED STATUTE REFERENCES THE ADMINISTRATIVE CODE The Arizona Revised Statutes (A.R.S.) are available online at the The Arizona Administrative Code is where the official rules of the Legislature’s website, www.azleg.gov. An agency’s authority note state of Arizona are published. The Code is the official codification to make rules is often included at the beginning of a Chapter. Other of rules that govern state agencies, boards, and commissions. Arizona statutes may be referenced in rule under the A.R.S. acro- nym. The Code is separated by subject into Titles. Titles are divided into Chapters. A Chapter includes state agency rules. Rules in Chapters SESSION LAW REFERENCES are divided into Articles, then Sections. The “R” stands for “rule” Arizona Session Law references in a Chapter can be found at the with a sequential numbering and lettering outline separated into Secretary of State’s website, www.azsos.gov under Services-> Leg- subsections. islative Filings. Rules are codified quarterly in the Code. Supplement release dates EXEMPTIONS FROM THE APA are printed on the footers of each Chapter. It is not uncommon for an agency to be exempt from the steps out- First Quarter: January 1 - March 31 lined in the rulemaking process as specified in the Arizona Admin- Second Quarter: April 1 - June 30 istrative Procedures Act, also known as the APA (Arizona Revised Third Quarter: July 1 - September 30 Statutes, Title 41, Chapter 6, Articles 1 through 10). Other agencies Fourth Quarter: October 1 - December 31 may be given an exemption to certain provisions of the Act. For example, the first supplement for the first quarter of 2022 is An agency’s exemption is written in law by the Arizona State Leg- cited as Supp. 22-1. Supplements are traditionally released three to islature or under a referendum or initiative passed into law by Ari- four weeks after the end of the quarter because filings are accepted zona voters. until the last day of the quarter. When an agency files an exempt rulemaking package with our Please note: The Office publishes by Chapter, not by individual rule Office it specifies the law exemption in what is called the preamble Section. Therefore there might be only a few Sections codified in of rulemaking. The preamble is published in the Register online at each Chapter released in a supplement. This is why the Office lists www.azsos.gov/rules, click on the Administrative Register link. only updated codified Sections on the previous page. Editor’s notes at the beginning of a Chapter provide information RULE HISTORY about rulemaking Sections made by exempt rulemaking. Exempt Refer to the HISTORICAL NOTE at the end of each Section for the rulemaking notes are also included in the historical note at the end effective date of a rule. The note also includes the Register volume of a rulemaking Section. and page number in which the notice was published (A.A.R.) and The Office makes a distinction to certain exemptions because some beginning in supplement 21-4, the date the notice was published in rules are made without receiving input from stakeholders or the the Register. public. Other exemptions may require an agency to propose exempt AUTHENTICATION OF PDF CODE CHAPTERS rules at a public hearing. The Office began to authenticate Chapters of the Code in Supp. 18- PERSONAL USE/COMMERCIAL USE 1 to comply with A.R.S. §§ 41-1012(B) and A.R.S. § 41-5505. This Chapter is posted as a public courtesy online, and is for private A certification verifies the authenticity of each Code Chapter use only. Those who wish to use the contents for resale or profit posted as it is released by the Office of the Secretary of State. The should contact the Office about Commercial Use fees. For informa- authenticated pdf of the Code includes an integrity mark with a cer- tion on commercial use fees review A.R.S. § 39-121.03 and 1 tificate ID. Users should check the validity of the signature, espe- A.A.C. 1, R1-1-113. cially if the pdf has been downloaded. If the digital signature is Rhonda Paschal, rules managing editor, assisted with the invalid it means the document’s content has been compromised. editing of this Chapter. Arizona Administrative Code Published electronically under the authority of Mailing Address: Publisher A.R.S. § 41-1012. Administrative Rules Division Department of State Authentication authorized under Office of the Secretary of State Office of the Secretary of State Arizona Revised Statutes, Chapter 54, 1700 W. Washington Street, Fl. 7 Administrative Rules Division Uniform Electronic Legal Material Act. Phoenix, AZ 85007 ii  Digitally signed Arizona Administrative Code 4 A.A.C. 23 Arizona by Arizona Administrative Rules Division Secretary Secretary State of The Arizona Secretary of State electronically publishes each A.A.C. Chapter with a digital of State Date: 2024.05.29 certificate. The certificate-based signature displays the date and time the document was signed 13:15:15 -07'00' and can be validated in Adobe Acrobat Reader. TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY Authority: A.R.S. § 32-1904 et seq. Supp. 24-1 CHAPTER TABLE OF CONTENTS ARTICLE 1. ADMINISTRATION ARTICLE 4. PROFESSIONAL PRACTICES Section Section R4-23-101. General................................................................. 4 R4-23-401. Time-frames for Board Approvals and Special R4-23-102. Meetings............................................................... 4 Requests............................................................. 20 R4-23-103. Repealed............................................................... 4 R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern R4-23-104. Repealed............................................................... 4............................................................................ 21 R4-23-105. Repealed............................................................... 4 R4-23-403. Repealed............................................................. 22 R4-23-106. Repealed............................................................... 4 R4-23-404. Unethical Practices............................................ 22 R4-23-107. Repealed............................................................... 4 R4-23-405. Change of Responsibility................................... 23 R4-23-108. Repealed............................................................... 4 R4-23-406. Repealed............................................................. 23 R4-23-109. Repealed............................................................... 4 R4-23-407. Prescription Requirements................................. 23 R4-23-110. Definitions............................................................ 4 R4-23-407.1. Dispensing an Opioid Antagonist...................... 26 R4-23-111. Notice of Hearing............................................... 11 R4-23-407.2. Dispensing a Self-administered Hormonal R4-23-112. Ex Parte Communications.................................. 12 Contraceptive..................................................... 27 R4-23-113. Motions.............................................................. 12 R4-23-408. Computer Records............................................. 27 R4-23-114. Computing Time................................................ 12 R4-23-409. Returning Drugs and Devices............................ 29 R4-23-115. Filing Documents............................................... 12 R4-23-410. Current Good Compounding Practices.............. 29 R4-23-116. Continuing or Expediting a Hearing; Reconvening R4-23-411. Pharmacist-administered or Intern-administered a Hearing............................................................ 12 Immunizations................................................... 31 R4-23-117. Vacating a Hearing............................................. 12 R4-23-412. Emergency Refill Prescription Dispensing........ 32 R4-23-118. Prehearing Conference....................................... 13 R4-23-413. Temporary Recognition of Nonresident Licensure R4-23-119. Subpoenas.......................................................... 13............................................................................ 32 R4-23-120. Telephonic Testimony........................................ 13 R4-23-415. Impaired Licensees – Treatment and Rehabilitation R4-23-121. Rights and Responsibilities of Parties................ 13............................................................................ 33 R4-23-122. Conduct of Hearing............................................ 13 R4-23-416. Reserved............................................................. 33 R4-23-123. Failure of Party to Appear for Hearing.............. 14 R4-23-417. Reserved............................................................. 33 R4-23-124. Witnesses; Exclusion from Hearing................... 14 R4-23-418. Reserved............................................................. 33 R4-23-125. Proof................................................................... 14 R4-23-419. Reserved............................................................. 33 R4-23-126. Disruptions......................................................... 14 R4-23-420. Reserved............................................................. 33 R4-23-127. Hearing Record.................................................. 14 R4-23-421. Repealed............................................................. 33 R4-23-128. Rehearing or Review and Appeal of Decision... 14 R4-23-422. Repealed............................................................. 33 R4-23-129. Notice of Judicial Appeal; Transmitting the R4-23-423. Repealed............................................................. 33 Transcript........................................................... 15 R4-23-424. Repealed............................................................. 33 R4-23-425. Repealed............................................................. 33 ARTICLE 2. PHARMACIST LICENSURE R4-23-426. Repealed............................................................. 33 Section R4-23-427. Repealed............................................................. 34 R4-23-201. General............................................................... 15 R4-23-428. Repealed............................................................. 34 R4-23-202. Licensure by Examination................................. 15 R4-23-429. Repealed............................................................. 34 R4-23-203. Licensure by Reciprocity................................... 16 ARTICLE 5. CONTROLLED SUBSTANCES R4-23-204. Continuing Education Requirements................. 17 PRESCRIPTION MONITORING PROGRAM R4-23-205. Fees and Charges............................................... 17 New Article 5, consisting of Sections R4-23-501 through R4- ARTICLE 3. INTERN TRAINING; INTERN PRECEPTORS 23-505, made effective August 2, 2014 (Supp. 14-2). Section Article 5, consisting of Sections R4-23-501 through R4-23- R4-23-301. Intern Licensure................................................. 18 505, expired effective August 30, 2013 (Supp. 14-1). R4-23-302. Training Site; Intern Preceptors; Training Time 19 R4-23-303. Repealed............................................................. 20 Article 5, consisting of Sections R4-23-501 and R4-23-502, R4-23-304. Repealed............................................................. 20 recodified to Article 8 at 9 A.A.R. 4011, effective August 18, 2003 R4-23-305. Repealed............................................................. 20 (Supp. 03-3). Section March 31, 2024 Supp. 24-1 Page 1 4 A.A.C. 23 Arizona Administrative Code TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY R4-23-501. Controlled Substances Prescription Monitoring R4-23-646. Reserved............................................................. 56 (CSPMP) Program Registration and Database R4-23-647. Reserved............................................................. 56 Access................................................................ 34 R4-23-648. Reserved............................................................. 56 R4-23-502. Requirements for Data Format and Transmission R4-23-649. Reserved............................................................. 56............................................................................. 34 R4-23-650. Reserved............................................................. 56 R4-23-503. Access to Controlled Substances Prescription R4-23-651. Definitions......................................................... 56 Monitoring Program Data.................................. 35 R4-23-652. Hospital Pharmacy Permit................................. 56 R4-23-504. Computerized Central Database Tracking System R4-23-653. Personnel: Professional or Technician............... 57 Task Force.......................................................... 36 R4-23-654. Absence of Pharmacist....................................... 58 R4-23-505. Reports............................................................... 36 R4-23-655. Physical Facility................................................. 58 R4-23-506. Repealed............................................................. 36 R4-23-656. Sanitation and Equipment.................................. 59 R4-23-657. Security.............................................................. 59 ARTICLE 6. PERMITS AND DISTRIBUTION OF DRUGS R4-23-658. Drug Distribution and Control........................... 59 Section R4-23-659. Administration of Drugs.................................... 60 R4-23-601. General Provisions............................................. 36 R4-23-660. Investigational Drugs......................................... 61 R4-23-602. Permit Application Process and Time frames.... 37 R4-23-661. Repealed............................................................. 61 R4-23-603. Resident-Nonprescription Drugs, Retail............ 38 R4-23-662. Repealed............................................................. 61 R4-23-604. Resident Drug Manufacturer.............................. 39 R4-23-663. Repealed............................................................. 61 R4-23-605. Resident Drug Wholesaler Permit...................... 40 R4-23-664. Repealed............................................................. 61 R4-23-606. Resident-Pharmacy Permit: Community, Hospital, R4-23-665. Reserved............................................................. 61 and Limited Service........................................... 46 R4-23-666. Reserved............................................................. 61 R4-23-607. Nonresident Permits........................................... 46 R4-23-667. Reserved............................................................. 61 R4-23-608. Change of Personnel and Responsibility........... 48 R4-23-668. Reserved............................................................. 61 R4-23-609. Pharmacy Area of Community Pharmacy......... 48 R4-23-669. Reserved............................................................. 61 R4-23-610. Community Pharmacy Personnel and Security R4-23-670. Sterile Pharmaceutical Products........................ 61 Procedures.......................................................... 49 R4-23-671. General Requirements for Limited-service R4-23-611. Pharmacy Facilities............................................ 50 Pharmacy........................................................... 62 R4-23-612. Equipment.......................................................... 50 R4-23-672. Limited-service Correctional Pharmacy............ 63 R4-23-613. Procedure for Discontinuing a Pharmacy.......... 51 R4-23-673. Limited-service Mail-order Pharmacy............... 64 R4-23-614. Automated Storage and Distribution System..... 52 R4-23-674. Limited-service Long-term Care Pharmacy....... 65 R4-23-615. Mechanical Storage and Counting Device for a R4-23-675. Limited-service Sterile Pharmaceutical Products Drug in Solid, Oral Dosage Form...................... 52 Pharmacy........................................................... 66 R4-23-616. Mechanical Counting Device for a Drug in Solid, R4-23-676. Third-party Logistics Provider Permit................ 66 Oral Dosage Form.............................................. 53 R4-23-677. Automated Prescription-dispensing Kiosk Permit R4-23-617. Temporary Pharmacy Facilities or Mobile............................................................................ 66 Pharmacies......................................................... 54 R4-23-678. Reserved............................................................. 67 R4-23-618. Reserved............................................................. 54 R4-23-679. Reserved............................................................. 67 R4-23-619. Reserved............................................................. 54 R4-23-680. Reserved............................................................. 67 R4-23-620. Continuous Quality Assurance Program............ 54 R4-23-681. General Requirements for Limited-service Nuclear R4-23-621. Shared Services.................................................. 54 Pharmacy........................................................... 67 R4-23-622. Reserved............................................................. 55 R4-23-682. Limited-service Nuclear Pharmacy.................... 68 R4-23-623. Reserved............................................................. 55 R4-23-683. Reserved............................................................. 69 R4-23-624. Reserved............................................................. 55 R4-23-684. Reserved............................................................. 69 R4-23-625. Reserved............................................................. 55 R4-23-685. Reserved............................................................. 69 R4-23-626. Reserved............................................................. 55 R4-23-686. Reserved............................................................. 69 R4-23-627. Reserved............................................................. 55 R4-23-687. Reserved............................................................. 69 R4-23-628. Reserved............................................................. 55 R4-23-688. Reserved............................................................. 69 R4-23-629. Reserved............................................................. 55 R4-23-689. Reserved............................................................. 69 R4-23-630. Reserved............................................................. 55 R4-23-690. Reserved............................................................. 69 R4-23-631. Reserved............................................................. 55 R4-23-691. Repealed............................................................. 69 R4-23-632. Reserved............................................................. 56 R4-23-692. Compressed Medical Gas (CMG) Distributor- R4-23-633. Reserved............................................................. 56 Resident or Nonresident..................................... 69 R4-23-634. Reserved............................................................. 56 R4-23-693. Durable Medical Equipment (DME) and R4-23-635. Reserved............................................................. 56 Compressed Medical Gas (CMG) Supplier- R4-23-636. Reserved............................................................. 56 Resident or Nonresident..................................... 70 R4-23-637. Reserved............................................................. 56 ARTICLE 7. NON-PHARMACY LICENSED OUTLETS – R4-23-638. Reserved............................................................. 56 GENERAL PROVISIONS R4-23-639. Reserved............................................................. 56 R4-23-640. Reserved............................................................. 56 Section R4-23-641. Reserved............................................................. 56 R4-23-701. Long-term Care Facilities Pharmacy Services: R4-23-642. Reserved............................................................. 56 Consultant Pharmacist....................................... 71 R4-23-643. Reserved............................................................. 56 R4-23-701.01. Long-term Care Facilities Pharmacy Services: R4-23-644. Reserved............................................................. 56 Provider Pharmacy............................................. 72 R4-23-645. Reserved............................................................. 56 Page 2 Supp. 24-1 March 31, 2024  Arizona Administrative Code 4 A.A.C. 23 TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY R4-23-701.02. Long-term Care Facilities Pharmacy Services: R4-23-1004. Schedules of Controlled Substances.................. 78 Emergency Drugs............................................... 72 R4-23-1005. Products Excluded or Exempted from the R4-23-701.03. Long-term Care Facilities Pharmacy Services: Schedules of Controlled Substances.................. 78 Emergency Drug Prescription Order.................. 73 R4-23-1006. Substances Excepted from Drug Offenses......... 78 R4-23-701.04. Long-term Care Facilities Pharmacy Services: Automated Dispensing Systems......................... 73 ARTICLE 11. PHARMACY TECHNICIANS R4-23-702. Hospice Inpatient Facilities................................ 75 Article 11, consisting of R4-23-1101 through R4-23-1105, R4-23-703. Assisted Living Facilities................................... 75 made by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 R4-23-704. Customized Patient Medication Packages......... 76 (Supp. 04-1). R4-23-705. Repealed............................................................. 76 R4-23-706. Repealed............................................................. 76 Section R4-23-707. Repealed............................................................. 76 R4-23-1101. Licensure and Eligibility.................................... 78 R4-23-708. Repealed............................................................. 76 R4-23-1102. Pharmacy Technician Licensure........................ 79 R4-23-709. Repealed............................................................. 76 R4-23-1103. Pharmacy Technician Trainee Licensure........... 79 R4-23-1104. Pharmacy Technicians and Pharmacy Technician ARTICLE 8. DRUG CLASSIFICATION Trainees.............................................................. 80 R4-23-1104.01.... Technology-assisted Verification of Product 81 Article 8, consisting of Sections R4-23-801 and R4-23-802, R4-23-1105. Pharmacy Technician Trainee Training Program, recodified from Article 5 at 9 A.A.R. 4011, effective August 18, Pharmacy Technician Drug Compounding Training 2003 (Supp. 03-3). Program, and Alternative Pharmacy Technician Article 8, consisting of Sections R4-23-801 through R4-23- Training.............................................................. 82 804, repealed effective November 4, 1998 (Supp. 98-4). R4-23-1106. Continuing Education Requirements................. 82 Section ARTICLE 12. DONATED MEDICINE PROGRAM R4-23-801. Repealed............................................................. 76 R4-23-802. Veterinary........................................................... 76 Article 12, consisting of R4-23-1201 through R4-23-1211, R4-23-803. Repealed............................................................. 76 made by final rulemaking at 14 A.A.R. 4320, effective January 3, R4-23-804. Repealed............................................................. 76 2009 (Supp. 08-4). ARTICLE 9. PENALTIES AND MISCELLANEOUS Section R4-23-1201. Repealed............................................................. 83 Section R4-23-1202. Repealed............................................................. 83 R4-23-901. Penalty for Violations........................................ 77 R4-23-1203. Repealed............................................................. 83 R4-23-902. Non-disciplinary Civil Penalties........................ 77 R4-23-1204. Repealed............................................................. 83 R4-23-1205. Repealed............................................................. 83 ARTICLE 10. UNIFORM CONTROLLED SUBSTANCES R4-23-1206. Repealed............................................................. 83 AND DRUG OFFENSES R4-23-1207. Repealed............................................................. 83 R4-23-1208. Handling Fee....................................................... 83 Section R4-23-1209. Repealed............................................................. 84 R4-23-1001. Repealed............................................................. 77 R4-23-1210. Repealed............................................................. 84 R4-23-1002. Repealed............................................................. 77 R4-23-1211. Repealed............................................................. 84 R4-23-1003. Records and Order Forms.................................. 77 March 31, 2024 Supp. 24-1 Page 3 4 A.A.C. 23 Arizona Administrative Code TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY ARTICLE 1. ADMINISTRATION Historical Note Former Rules 1.5800 and 1.5900. Section repealed by R4-23-101. General final rulemaking at 10 A.A.R. 1132, effective May 1, A. This Chapter applies to all actions and proceedings of the 2004 (Supp. 04-1); Historical Note updated (Supp. 06-2). Board and shall be deemed part of the record in any Board action or proceeding without formal introduction of, or refer- R4-23-107. Repealed ence to the rules. A party to a Board action is deemed to have knowledge of the rules. Historical Note B. The Board, within its jurisdiction, may, in the interest of jus- Former Rules 1.5910, 1.5920, 1.5921, and 1.5922. tice, excuse the failure of any person to comply with the rules. Section repealed by final rulemaking at 10 A.A.R. 1132, C. The Board, within its jurisdiction, may grant an extension of effective May 1, 2004 (Supp. 04-1); Historical Note time within which to comply with any rule when it deems the updated (Supp. 06-2). extension to be in the interest of justice. R4-23-108. Repealed Historical Note Historical Note Former Rules 1.1000, 1.1200, and 1.1300; Amended Former Rule 1.5930. Section repealed by final effective August 23, 1978 (Supp. 78-4). Amended by rulemaking at 10 A.A.R. 1132, effective May 1, 2004 final rulemaking at 10 A.A.R. 1132, effective May 1, (Supp. 04-1); Historical Note updated (Supp. 06-2). 2004 (Supp. 04-1); Historical Note updated (Supp. 06-2). Amended by final rulemaking at 30 A.A.R. 155 (January R4-23-109. Repealed 26, 2024), effective March 4, 2024 (Supp. 24-1). Historical Note R4-23-102. Meetings Former Rules 1.7100, 1.7200, and 1.7300. Amended A. The Board shall hold not less than four meetings per fiscal effective July 14, 1977 (Supp. 77-4). Amended effective year to conduct general business and interview permit and February 8, 1991 (Supp. 91-1). Section repealed by final license applicants. rulemaking at 10 A.A.R. 1132, effective May 1, 2004 B. A special meeting of the Board may be held at any time sub- (Supp. 04-1); Historical Note updated (Supp. 06-2). ject to the call of the President or a majority of the Board R4-23-110. Definitions members and in compliance with the notification requirements In addition to definitions in A.R.S. § 32-1901, the following of A.R.S. § 38-431.02. definitions apply to this Chapter: Historical Note “Active ingredient” means any component that furnishes Former Rules 1.2100, 1.2200, 1.2300, and 1.2400. pharmacological activity or other direct effect in the diagnosis, Amended by final rulemaking at 7 A.A.R. 2143, effective cure, mitigation, treatment, or prevention of disease or that May 1, 2001 (Supp. 01-2). affects the structure or any function of the body of man or other animals. The term includes those components that may R4-23-103. Repealed undergo chemical change in the manufacture of the drug, that Historical Note are present in the finished drug product in a modified form, Former Rules 1.3100, 1.3200, 1.3300, and 1.3400; and that furnish the specified activity or effect. Amended subsection (C) effective August 9, 1983 “AHCCCS” means the Arizona Health Care Cost Containment (Supp. 83-4). Section repealed by final rulemaking at 10 System. A.A.R. 1132, effective May 1, 2004 (Supp. 04-1); Historical Note updated (Supp. 06-2). “Annual family income” means the combined yearly gross earned income and unearned income of all adult individuals R4-23-104. Repealed within a family unit. Historical Note “Approved course in pharmacy law” means a continuing Former Rules 1.4011, 1.4110, 1.4120, 1.4200, 1.4210, education activity that addresses practice issues related to state 1.4220, 1.4300, 1.4400, 1.5500, 1.5600, 1.5700, and or federal pharmacy statutes, rules, or regulations. 1.4500; Amended effective August 23, 1978 (Supp. 78- 5); Amended by deleting subsection (B) and renumbering “Approved Provider” means an individual, institution, subsections (C) through (J) as subsections (B) through (I) organization, association, corporation, or agency that is effective August 9, 1983 (Supp. 83-4). Amended approved by the Accreditation Council for Pharmacy effective February 8, 1991 (Supp. 91-1). Section repealed Education (ACPE) in accordance with ACPE’s policy and by final rulemaking at 10 A.A.R. 1132, effective May 1, procedures or by the Board as meeting criteria indicative of the 2004 (Supp. 04-1); Historical Note updated (Supp. 06-2). ability to provide quality continuing education. R4-23-105. Repealed “Assisted living facility” means a residential care institution as defined in A.R.S. § 36-401. Historical Note Former Rules 1.5100, 1.5200, 1.5300, and 1.5400; “Authentication of product history” means identifying the Amended subsection (B) effective August 9, 1983 purchasing source, the ultimate fate, and any intermediate (Supp. 83-4). Section repealed by final rulemaking at 10 handling of any component of a radiopharmaceutical or other A.A.R. 1132, effective May 1, 2004 (Supp. 04-1); drug. Historical Note updated (Supp. 06-2). “Automated dispensing system” means a mechanical system R4-23-106. Repealed in a long-term care facility that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing Page 4 Supp. 24-1 March 31, 2024  Arizona Administrative Code 4 A.A.C. 23 TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY of medications, and which collects, controls, and maintains all “Computer system audit” means an accounting method, transaction information. involving multiple single-drug usage reports and audits, used to determine a computer system’s ability to store, retrieve, and “Automated storage and distribution system” means a process original and refill prescription dispensing information. mechanical system that performs operations or activities other than counting, compounding, or administration, relative to the “Contact hour” means 50 minutes of participation in a storage, packaging, or distributing of drugs or devices and that continuing education activity sponsored by an Approved collects, controls, and maintains all transaction information. Provider. “Batch” means a specific quantity of drug that has uniform “Container” means: character and quality, within specified limits, and is produced A receptacle, as described in the official compendium or according to a single manufacturing order during the same the federal act, that is used in manufacturing or cycle of manufacture. compounding a drug or in distributing, supplying, or dispensing the finished dosage form of a drug; or “Beyond-use date” means: A date determined by a pharmacist and placed on a A metal receptacle designed to contain liquefied or prescription label at the time of dispensing to indicate a vaporized compressed medical gas and used in time beyond which the contents of the prescription are manufacturing, transfilling, distributing, supplying, or not recommended to be used; or dispensing a compressed medical gas. A date determined by a pharmacist and placed on a “Continuing education” means a structured learning process compounded pharmaceutical product’s label at the time required of a licensee to maintain licensure that includes study of preparation as specified in R4-23-410(B)(3)(d), R4- in the general areas of socio-economic and legal aspects of 23-410(I)(6)(e), or R4-23-410(J)(1)(d) to indicate a time health care; the properties and actions of drugs and dosage beyond which the compounded pharmaceutical product is forms; etiology, characteristics and therapeutics of disease not recommended to be used. status; or pharmacy practice. “Biological safety cabinet” means a containment unit suitable “Continuing education activity” means continuing education for the preparation of low to moderate risk agents when there obtained through an institute, seminar, lecture, conference, is a need for protection of the product, personnel, and workshop, mediated instruction, programmed learning course, environment, consistent with National Sanitation Foundation or postgraduate study in an accredited college or school of (NSF) standards, published in the National Sanitation pharmacy. Foundation Standard 49, Class II (Laminar Flow) Biohazard “Continuing education unit” or “CEU” means 10 contact hours Cabinetry, NSF International P. O. Box 130140, Ann Arbor, of participation in a continuing education activity sponsored MI, revised June 1987 edition, (and no future amendments or by an Approved Provider. editions), incorporated by reference and on file with the Board. “Continuous quality assurance program” or “CQA program” “Care-giver” means a person who cares for someone who is means a planned process designed by a pharmacy permittee to sick or disabled or an adult who cares for an infant or child and identify, evaluate, and prevent medication errors. includes a patient’s husband, wife, son, daughter, mother, father, sister, brother, legal guardian, nurse, or medical “Correctional facility” has the same meaning as in A.R.S. §§ practitioner. 13-2501 and 31-341. “Change of ownership,” as used in A.R.S. § 32-1901.01(A), “CRT” means a cathode ray tube or other mechanism used to means a change of at least 30 percent in voting stock or vested view information produced or stored by a computer system. interest that has direct operational oversight. “CSPMP” means the Controlled Substances Prescription “Community pharmacy” means any place under the direct Monitoring Program established under A.R.S. Title 36, supervision of a pharmacist where the practice of pharmacy Chapter 28. occurs or where prescription orders are compounded and “Current good compounding practices” means the minimum dispensed other than a hospital pharmacy or a limited service standards for methods used in, and facilities or controls used pharmacy. for, compounding a drug to ensure that the drug has the “Component” means any ingredient used in compounding or identity and strength and meets the quality and purity manufacturing drugs in dosage form, including an ingredient characteristics it is represented to possess. that may not appear in the finished product. “Current good manufacturing practice” means the minimum “Compounding and dispensing counter” means a pharmacy standard for methods used in, and facilities or controls used for counter working area defined in this Section where a manufacturing, processing, packing, or holding a drug to pharmacist, intern, pharmacy technician, or pharmacy ensure that the drug meets the requirements of the federal act technician trainee under the supervision of a pharmacist as to safety, and has the identity and strength and meets the compounds, mixes, combines, counts, pours, or prepares and quality and purity characteristics it is represented to possess. packages a prescription medication to dispense an individual “Cytotoxic” means a pharmaceutical that is capable of killing prescription order or prepackages a drug for future dispensing. living cells. “Computer system” means an automated data-processing “Day” means a calendar day unless otherwise specified. system that uses a programmable electronic device to store, retrieve, and process data. “DEA” means the Drug Enforcement Administration as defined in A.R.S. § 32-1901. March 31, 2024 Supp. 24-1 Page 5 4 A.A.C. 23 Arizona Administrative Code TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY “Declared disaster areas” means areas designated by the Sequential compression devices, governor or by a county, city, or town under A.R.S. § 32-1910 Transcutaneous electrical nerve stimulation (TENS) unit, as those areas that have been adversely affected by a natural and disaster or terrorist attack and require extraordinary measures to provide adequate, safe, and effective health care for the Ventilators. affected population. “Earned income” means monetary payments received by an “Delinquent license” means a pharmacist, intern, or pharmacy individual as a result of work performed or rental property technician license the Board suspends for failure to renew or owned or leased by the individual, including: pay all required fees on or before the date the renewal is due. Wages, “Dietary supplement or food supplement,” as used in A.R.S. § Commissions and fees, 32-1904(B), means a product (other than tobacco) that: Salaries and tips, Is intended to supplement the diet that contains one or more of the following dietary ingredients: a vitamin, Profit from self-employment, mineral, herb or other botanical, amino acid, dietary Profit from rent received from a tenant or boarder, and substance for use by humans to supplement the diet by increasing the total daily intake, or concentrate, Any other monetary payments received by an individual metabolite, constituent, extract, or combinations of these for work performed or rental of property. ingredients; “Electronic signature” has the same meaning as in A.R.S. § Is intended for ingestion in pill, capsule, tablet, or liquid 44-7002. form; “Eligible patient” means a patient who a pharmacist Is not represented for use as a conventional food or as the determines is eligible to receive an immunization using sole item of a meal or diet; and professional judgment after consulting with the patient regarding the patient’s current health condition, recent health Is labeled as a “dietary supplement” or “food condition, and allergies. supplement.” “Emergency drug supply unit” means those drugs that may be “Digital signature” has the same meaning as in A.R.S. § 41- required to meet the immediate and emergency therapeutic 132(E). needs of long-term care facility residents and hospice inpatient “Dispensing pharmacist” means a pharmacist who, in the facility patients, and which are not available from any other process of dispensing a prescription medication after the authorized source in sufficient time to prevent risk of harm to complete preparation of the prescription medication and residents or patients. before delivery of the prescription medication to a patient or “Extreme emergency” means the occurrence of a fire, water patient’s agent, verifies, checks, and initials the prescription leak, electrical failure, public disaster, or other catastrophe medication label, as required in R4-23-402(A). constituting an imminent threat of physical harm to pharmacy “Drug sample” means a unit of a prescription drug that a personnel or patrons. manufacturer provides free of charge to promote the sale of the “Family unit” means: drug. A group of individuals residing together who are related “Durable medical equipment” or “DME” means technologi- by birth, marriage, or adoption; or cally sophisticated medical equipment that may be used by a An individual who: patient or consumer in a home or residence. DME may be pre- Does not reside with another individual; or scription-only devices as defined in A.R.S. § 32-1901. DME includes: Resides only with another individual or group of Air-fluidized beds, individuals to whom the individual is unrelated by birth, marriage, or adoption. Apnea monitors, “FDA” means the Food and Drug Administration, a federal Blood glucose monitors and diabetic testing strips, agency within the United States Department of Health and Continuous Positive Airway Pressure (CPAP) machines, Human Services, established to set safety and quality standards for foods, drugs, cosmetics, and other consumer Electronic and computerized wheelchairs and seating products. systems, “Health care decision maker” has the same meaning as in Feeding pumps, A.R.S. § 12-2291. Home phototherapy devices, “Health care institution” has the same meaning as in A.R.S. § Hospital beds, 36-401. Infusion pumps, “Hospice inpatient facility” means a health care institution licensed under A.R.S. § 36-401 and Article 8 that provides Medical oxygen and oxygen delivery systems excluding hospice services to a patient requiring inpatient services. compressed medical gases, “Immediate notice” means a required notice sent by mail, fax, Nebulizers, or electronic mail to the Board Office within 24 hours. Respiratory disease management devices, Page 6 Supp. 24-1 March 31, 2024  Arizona Administrative Code 4 A.A.C. 23 TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY “Immunizations training program” means an immunization “Long-term care facility” or “LTCF” means a nursing care training program for pharmacists and interns that meets the institution as defined in A.R.S. § 36-401. requirements of R4-23-411(E). “Lot” means a batch or any portion of a batch of a drug, or if a “Inactive ingredient” means any component other than an drug produced by a continuous process, an amount of drug “active ingredient” present in a drug. produced in a unit of time or quantity in a manner that assures its uniformity. In either case, a lot is identified by a distinctive “Internal test assessment” means performing quality assurance lot number and has uniform character and quality with or other procedures necessary to ensure the integrity of a test. specified limits. “ISO Class 5 environment” means an atmospheric “Lot number” or “control number” means any distinctive environment that complies with the ISO/TC209 International combination of letters or numbers, or both, from which the Cleanroom Standards, specifically ANSI/IEST/ISO-14644- complete history of the compounding or manufacturing, 1:1999: Cleanrooms and associated controlled environments-- control, packaging, and distribution of a batch or lot of a drug Part 1: Classification of air cleanliness, first edition dated May can be determined. 1, 1999, (and no future amendments or editions), incorporated by reference and on file in the Board office. “Low-income subsidy” means Medicare-provided assistance that may partially or fully cover the costs of drugs and is based “ISO Class 7 environment” means an atmospheric on the income of an individual and, if applicable, the environment that complies with the ISO/TC209 International individual’s spouse. Cleanroom Standards, specifically ANSI/IEST/ISO-14644- 1:1999: Cleanrooms and associated controlled environments-- “Materials approval unit” means any organizational element Part 1: Classification of air cleanliness, first edition dated May having the authority and responsibility to approve or reject 1, 1999, (and no future amendments or editions), incorporated components, in-process materials, packaging components, and by reference and on file in the Board office. final products. “Licensed health care professional” means an individual who “Mechanical counting device for a drug in solid, oral dosage is licensed and regulated under A.R.S. Title 32, Chapter 7, 11, form” means a mechanical device that counts drugs in solid, 13, 14, 15, 16, 17, 18, 25, 29, or 35. oral dosage forms for dispensing and includes an electronic balance when used to count drugs. “Limited-service correctional pharmacy” means a limited-ser- vice pharmacy, as defined in A.R.S. § 32-1901, that: “Mechanical storage and counting device for a drug in solid, Holds a current Board permit under A.R.S. § 32-1931; oral dosage form” means a mechanical device that stores and counts and may package or label drugs in solid, oral dosage Is located in a correctional facility; and forms for dispensing. Uses pharmacists, interns, and support personnel to “Mediated instruction” means information transmitted via compound, produce, dispense, and distribute drugs. intermediate mechanisms such as audio or video tape or “Limited-service long-term care pharmacy” means a limited- telephone transmission. service pharmacy, as defined in A.R.S. § 32-1901, that holds a “Medical practitioner-patient relationship” means that before current Board-issued permit and dispenses prescription prescribing, dispensing, or administering a prescription-only medication or prescription-only devices to patients in long- drug, prescription-only device, or controlled substance to a term care facilities. person, a medical practitioner, as defined in A.R.S. § 32-1901, “Limited-service mail-order pharmacy” means a limited- shall first conduct a physical examination of that person or service pharmacy, as defined in A.R.S. § 32-1901, that holds a have previously conducted a physical examination. This sub- current Board permit under A.R.S. § 32-1931 and dispenses a division does not apply to: majority of its prescription medication or prescription-only A medical practitioner who provides temporary patient devices by mailing or delivering the prescription medication or supervision on behalf of the patient’s regular treating prescription-only device to an individual by the United States medical practitioner; mail, a common or contract carrier, or a delivery service. Emergency medical situations as defined in A.R.S. § 41- “Limited-service nuclear pharmacy” means a limited-service 1831; pharmacy, as defined in A.R.S. § 32-1901, that holds a current Prescriptions written to prepare a patient for a medical Board permit under A.R.S. § 32-1931 and provides examination; or radiopharmaceutical services. Prescriptions written, prescription-only drugs, “Limited-service pharmacy permittee” means a person who prescription-only devices, or controlled substances issued holds a current limited-service pharmacy permit in compliance for use by a county or tribal public health department for with A.R.S. §§ 32-1929, 32-1930, 32-1931, and A.A.C. R4- immunization programs, emergency treatment, in 23-606. response to an infectious disease investigation, public “Limited-service sterile pharmaceutical products pharmacy” health emergency, infectious disease outbreak or act of means a limited-service pharmacy, as defined in A.R.S. § 32- bioterrorism. For purposes of this subsection, 1901, that holds a current Board permit under A.R.S. § 32- “bioterrorism” has the same meaning as in A.R.S. § 36- 1931 and dispenses a majority of its prescription medication or 781. prescription-only devices as sterile pharmaceutical products. “Medicare” means a federal health insurance program “Long-term care consultant pharmacist” means a pharmacist established under Title XVIII of the Social Security Act. providing consulting services to a long-term care facility. March 31, 2024 Supp. 24-1 Page 7 4 A.A.C. 23 Arizona Administrative Code TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY “Medication error” means any unintended variation from a “Physician” means a medical practitioner licensed under prescription or medication order. Medication error does not A.R.S. Title 32, Chapter 13 or 17. include any variation that is corrected before the medication is “Physician-in-charge” means a physician who is responsible to dispensed to the patient or patient’s care-giver, or any the Board for all aspects of a prescription medication donation variation allowed by law. program required in A.R.S. § 32-1909 and operated in the “Mobile pharmacy” means a pharmacy that is self-propelled or physician’s office or in a health care institution. movable by another vehicle that is self-propelled. “Poverty level” means the annual family income for a family “MPJE” means Multistate Pharmacy Jurisprudence unit of a particular size, as specified in the poverty guidelines Examination, a Board-approved national pharmacy law updated annually in the Federal Register by the U.S. examination written and administered in cooperation with Department of Health and Human Services. NABP. “Precursor chemical” means a precursor chemical I as defined “NABP” means National Association of Boards of Pharmacy. in A.R.S. § 13-3401(26) and a precursor chemical II as defined in A.R.S. § 13-3401(27). “NABPLEX” means National Association of Boards of Pharmacy Licensure Examination. “Prepackaged drug” means a drug that is packaged in a frequently prescribed quantity, labeled in compliance with “NAPLEX” means North American Pharmacist Licensure A.R.S. §§ 32-1967 and 32-1968, stored, and subsequently Examination. dispensed by a pharmacist or intern under the supervision of a “Order” means either of the following: pharmacist, who verifies at the time of dispensing that the drug A prescription order as defined in A.R.S. § 32-1901; or container is properly labeled, in compliance with A.R.S. § 32- 1968, for the patient. A medication order as defined in A.A.C. R4-23-651. “Prep area” means a specified area either within an ISO class 7 “Other designated personnel” means a non-pharmacist environment or adjacent to but outside an ISO class 7 environ- individual who is permitted in the pharmacy area, for a limited ment that: time, under the direct supervision of a pharmacist, to perform Allows the assembling of necessary drugs, supplies, and non-pharmacy related duties, such as trash removal, floor equipment for compounding sterile pharmaceutical maintenance, and telephone or computer repair. products, but does not allow the use of paper products “Outpatient” means an individual who is not a residential such as boxes or bulk drug storage; patient in a health care institution. Allows personnel to don personnel protective clothing, “Outpatient setting” means a location that provides medical such as gown, gloves, head cover, and booties before treatment to an outpatient. entering the clean compounding area; and “Patient profile” means a readily retrievable, centrally located Is a room or a specified area within a room, such as an information record that contains patient demographics, area specified by a line on the floor. allergies, and medication profile. “Primary care provider” means the medical practitioner who is “Pharmaceutical patient care services” means the provision of treating an individual for a disease or medical condition. drug selection, drug utilization review, drug administration, “Proprietor” means the owner of a business permitted by the drug therapy monitoring, and other drug-related patient care Board under A.R.S. §§ 32-1929, 32-1930, 32-1931, and 32- services intended to achieve outcomes related to curing or 1934. preventing a disease, eliminating or reducing a patient’s symptoms, or arresting or slowing a disease process, by “Provider pharmacy” means a pharmacy that contracts with a identifying and resolving or preventing potential and actual long-term care facility to supply prescription medication or drug-related problems. other services for residents of a long-term care facility. “Pharmaceutical product” means a medicinal drug. “Radiopharmaceutical” means any drug that emits ionizing radiation and includes: “Pharmacy counter working area” means a clear and Any nonradioactive reagent kit, nuclide generator, or continuous working area that contains no major obstacles such ancillary drug intended to be used in the preparation of a as a desktop computer, computer monitor, computer keyboard, radiopharmaceutical, but does not include drugs such as external computer drive device, printer, fax machine, carbon-containing compounds or potassium-containing pharmacy balance, typewriter, or pill-counting machine, but salts, that contain trace quantities of naturally occurring may contain individual documents or prescription labels, pens, radionuclides; and prescription blanks, refill log, pill-counting tray, spatula, stapler, or other similar items necessary for the prescription- Any biological product that is labeled with a radionuclide filling process. or intended to be labeled with a radionuclide. “Pharmacy law continuing education” means a continuing “Radiopharmaceutical quality assurance” means performing education activity that addresses practice issues related to state and interpreting appropriate chemical, biological, and physical or federal pharmacy statutes, rules, or regulations, offered by tests on radiopharmaceuticals to determine the suitability of an Approved Provider. the radiopharmaceutical for use in humans and animals. Radiopharmaceutical quality assurance includes internal test “Pharmacy permittee” means a person who holds a current assessment, authentication of product history, and appropriate pharmacy permit that complies with A.R.S. §§ 32-1929, 32- record retention. 1930, 32-1931, 32-1934, and R4-23-606 and R4-23-652. Page 8 Supp. 24-1 March 31, 2024  Arizona Administrative Code 4 A.A.C. 23 TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY “Radiopharmaceutical services” means procuring, storing, penetrating numbers, high-resolution border, high-resolution handling, compounding, preparing, labeling, quality assurance latent images, micro-printing, prismatic printing, embossed testing, dispensing, distributing, transferring, recordkeeping, images, abrasion ink, holograms, and foil stamping. and disposing of radiochemicals, radiopharmaceuticals, and “Shared order filling” means the following: ancillary drugs. Radiopharmaceutical services include quality Preparing, packaging, compounding, or labeling an order, assurance procedures, radiological health and safety or any combination of these functions, that are performed procedures, consulting activities associated with the use of by: radiopharmaceuticals, and any other activities required for the provision of pharmaceutical care. A person with a current Arizona Board license, located at an Arizona pharmacy, on behalf of and at the request of “Red C stamp” means a device used with red ink to imprint an another resident or nonresident pharmacy; or invoice with a red letter C at least one inch high, to make an invoice of a Schedule III through IV controlled substance, as A person, located at a nonresident pharmacy, on behalf of defined in A.R.S. § 36-2501, readily retrievable, as required and at the request of an Arizona pharmacy; and by state and federal rules. Returning the filled order to the requesting pharmacy for “Refill” means other than the original dispensing of the delivery to the patient or patient’s care-giver or, at the prescription order, dispensing a prescription order in the same request of this pharmacy, directly delivering the filled quantity originally ordered or in multiples of the originally order to the patient. ordered quantity when specifically authorized by the “Shared order processing” means the following: prescriber, if the refill is authorized by the prescriber: Interpreting the order, performing order entry verifica- In the original prescription order; tion, drug utilization review, drug compatibility and drug allergy review, final order verification, and when neces- By an electronically transmitted refill order that the sary, therapeutic intervention, or any combination of pharmacist promptly documents and files; or these order processing functions, that are performed by: By an oral refill order that the pharmacist promptly A pharmacist or intern, under pharmacist documents and files. supervision, with a current Arizona Board license, located at an Arizona pharmacy, on behalf of and at “Regulated chemical” means the same as in A.R.S. § 13- the request of another resident or nonresident 3401(30). pharmacy: or “Remodel” means to alter structurally the pharmacy area or A pharmacist or intern, under pharmacist location. supervision, located at a nonresident pharmacy, on “Remote drug storage area” means an area that is outside the behalf of and at the request of an Arizona pharmacy; premises of the pharmacy, used for the storage of drugs, and locked to deny access by unauthorized persons, and secured After order processing is completed, returning the against the use of force. processed order to the requesting pharmacy for order “Resident” means: filling and delivery to the patient or patient’s care- An individual admitted to and living in a long-term care giver or, at the request of this pharmacy, returning facility or an assisted living facility, the processed order to another pharmacy for order filling and delivery to the patient or patient’s care- An individual who has a place of habitation in Arizona giver. and lives in Arizona as other than a tourist, or “Shared services” means shared order filling or shared order A person that owns or operates a place of business in processing, or both. Arizona. “Sight-readable” means that an authorized individual is able to “Responsible person” means the owner, manager, or other examine a record and read its information from a CRT, employee who is responsible to the Board for a permitted microfiche, microfilm, printout, or other method acceptable to establishment’s compliance with the laws and administrative the Board or its designee. rules of this state and of the federal government pertaining to distribution of drugs, devices, precursor chemicals, and “Single-drug audit” means an accounting method that regulated chemicals. Nothing in this definition relieves other determines the numerical and percentage difference between a individuals from the responsibility to comply with state and drug’s beginning inventory plus purchases and ending federal laws and administrative rules. inventory plus sales. “Score transfer” means the process that enables an applicant to “Single-drug usage report” means a computer system printout take the NAPLEX in a jurisdiction and be eligible for licensure of original and refill prescription order usage information for a by examination in other jurisdictions. single drug. “Security features” means attributes incorporated into the “Standard-risk sterile pharmaceutical product” means a sterile paper of a prescription order, referenced in A.R.S. § 32- pharmaceutical product compounded from sterile commercial 1968(A)(4), that are approved by the Board or its staff and drugs using sterile commercial devices or a sterile include one or more of the following designed to prevent pharmaceutical optic or ophthalmic product compounded from duplication or aid the authentication of a paper document: laid non-sterile ingredients. lines, enhanced laid lines, thermochromic ink, artificial “State of emergency” means a governmental declaration watermark, fluorescent ink, chemical void, persistent void, issued under A.R.S. § 32-1910 as a result of a natural disaster March 31, 2024 Supp. 24-1 Page 9 4 A.A.C. 23 Arizona Administrative Code TITLE 4. PROFESSIONS AND OCCUPATIONS CHAPTER 23. BOARD OF PHARMACY or terrorist attack that results in individuals being unable to Disability payments, refill existing prescriptions. Payments from the Social Security Administration, “Sterile pharmaceutical product” means a medicinal drug free Payments from public assistance, from living biological organisms. Periodic insurance or annuity payments, “Strength” means: The concentration of the drug substance (for example, Retirement or pension payments, weight/weight, weight/volume, or unit dose/volume Strike benefits from union funds, basis); or Training stipends, The potency, that is, the therapeutic activity of a drug substance as indicated by bioavailability tests or by Child support payments, controlled clinical data (expressed, for example, in terms Alimony payments, of unity by reference to a standard). Military family allotments, “Substantial-risk sterile pharmaceutical product” means a sterile pharmaceutical product compounded as a parenteral or Regular support payments from a relative or other injectable dosage form from non-sterile ingredients. individual not residing in the household, “Supervision” means a pharmacist is present, assumes legal Investment income, responsibility, and has direct oversight of activities relating to Royalty payments, acquiring, preparing, distributing, administering, and selling prescription medications by interns, pharmacy technicians, or Periodic payments from estates or trusts, and pharmacy technician trainees and when used in connection Any other monetary payments received by an individual with the intern training requirements means that, in a that are not: pharmacy where intern training occurs, an intern preceptor As a result of work performed or rental of property assumes the primary responsibility of teaching the intern owned by the individual, during the entire period of the training. Gifts, “Supplying” means selling, transferring, or delivering to a patient or a patient’s agent one or more doses of: Lump-sum capital gains payments, A nonprescription drug in the manufacturer’s original Lump-sum inheritance payments, container for subsequent use by the patient, or Lump-sum insurance payments, or A compressed medical gas in the manufacturer’s or compressed medical gas distributor’s original container Payments made to compensate for personal injury. for subsequent use by the patient. “Verified signature” or “signature verifying” means in relation “Support personnel” means an individual, working under the to a Board license or permit application or report, form, or supervision of a pharmacist, trained to perform clerical duties agreement, the hand-written or electronic signature of an associated with the practice of pharmacy, including cashiering, individual who, by placing a hand-written or electronic bookkeeping, pricing, stocking, delivering, answering non- signature on a hard-copy or electronic license or permit professional telephone inquiries, and documenting third-party application or report, form, or agreement agrees with and reimbursement. Support personnel shall not perform the tasks verifies that the statements and information within or attached of a pharmacist, intern, pharmacy technician, or pharmacy to the license or permit application or report, form, or technician trainee. agreement are true in every respect and that inaccurate reporting can result in denial or loss of a license or permit or “Temporary pharmacy facility” means a facility established as report, form, or agreement. a result of a declared state of emergency to temporarily provide pharmacy services within or adjacent to declared “Veteran” means an individual who has served in the United disaster areas. States Armed Forces. “Tourist” means an individual who is living in Arizona but “Virtual manufacturer” means an entity that contracts for the maintains a place of habitation outside of Arizona and lives manufacture of a drug or device for which the entity: outside of Arizona for more than six months during a calendar Owns the New Drug Application or Abbreviated New year. Drug Application number, as defined by the FDA, for a “Transfill” means a manufacturing process by which one or drug; more compressed medical gases are transferred from a bulk Owns t