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ARIZONA HOUSE OF REPRESENTATIVES57th Legislature, 2nd Regular Session |
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HB4036: bulk drug substances; prohibitions
Sponsor: Representative Peņa, LD 23
Committee on International Trade
Overview
Regulates compounded medications and bulk drug substances.
History
It is unlawful for any person to compound, sell or dispense any drugs or to dispense or compound the prescription orders of a medical practitioner, unless that person is a pharmacist or a pharmacy intern acting under the direct supervision of a pharmacist. A pharmacy technician or support personnel is not prevented from assisting in the dispensing of drugs if this is done pursuant to rules adopted by the Arizona State Board of Pharmacy (Board) and under the direct supervision of a licensed pharmacist or under remote supervision by a pharmacist (A.R.S. § 32-1961).
Compounding pharmacies licensed in this state must have access to active pharmaceutical ingredients for use in compounding that meet United States pharmacopeia monographs, if the active pharmaceutical ingredient: 1) is prepared for use by a United States Food and Drug Administration-registered (FDA) active pharmaceutical ingredient manufacturer or packager; and 2) is shipped into this state in compliance with state law and arrives with a certificate of analysis detailing quality specifications, in order to provide chronically ill patients and terminally ill patients with the prescribed individual course of treatment (A.R.S. § 32-1971).
Provisions
1. Mandates that is it unlawful for any person or entity to engage in the sale, transfer or distribution of a drug compounded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonist used for obesity or weight management or a drug substance component of a similar drug approved by the FDA for obesity or weight management. (Sec. 1)
2. Allows the drug compounder to be sold, transferred or distributed only if the compounder:
a. uses bulk drug substances that comply with the standards of a United States pharmacopoeia or national formulary monograph and the United States pharmacopoeia chapter on pharmacy compounding, as prescribed;
b. confirms that any bulk drug substance used was manufactured according to the process prescribed by federal law;
c. ensures that the bulk drug substance is a pharmaceutical grade product;
d. verifies that the bulk drug substance is accompanied by a valid certificate of analysis;
e. conducts and documents quality control testing of any bulk drug substance before its use in a compounded drug, as outlined;
f. conducts and documents quality control testing of the finished drug product compounded, as prescribed;
g. obtains proof that the manufacture of the bulk drug substance took place in an establishment that meets listed requirements; and
h. complies with the FD&C Act. (Sec. 1)
3. Stipulates that it is unlawful for any manufacturer or wholesaler to sell, transfer or distribute a bulk drug substance for use in compounding without providing to the purchaser written verification that the substance is pharmaceutical grade and meets sourcing requirements and documentation of any quality control testing as outlined. (Sec. 1)
4. Requires any person or entity engaging in the sale, transfer or distribution of compounded drugs to maintain all records related to the acquisition, examination and testing of the bulk drug substance for at least two years after the expiration date of the last lot of drug substance, as prescribed. (Sec. 1)
5. Authorizes the Board or the Board's authorized agent to inspect any person or entity engaging in compounding drugs, as well as any domestic supplier, wholesaler, repackager or other provider of the drug substance. (Sec. 1)
6. Asserts that refusal to allow the Board access to conduct an inspection constitutes a violation. (Sec. 1)
7. Mandates that it is unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading as outlined. (Sec. 1)
8. Subjects a person or entity in violation to a civil penalty of $1,000 per dose of the illegally compounded drug sold, transferred or distributed and a suspension or revocation of the licensee's or permittee's license or permit. (Sec. 1)
9. Allows the Board to adopt rules as necessary to implement regulation on compounded medications. (Sec. 1)
10. Defines pertinent terms. (Sec. 1)
11. Contains legislative findings. (Sec. 1)
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15. Initials LM HB 4036
16. 2/13/2026 Page 0 International Trade
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