ARIZONA HOUSE OF REPRESENTATIVES Fifty-fifth Legislature First Regular Session
	Senate: GOV DP 5-3-0-0 | 3^rd Read 16-14-0-0 House: COM DPA/SE 9-0-0-1

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SB 1353: anti-rabies vaccination; rabies titer

NOW: terminally ill patients; compounding; pharmacy

Sponsor:  Senator Barto, LD 15

House Engrossed

Overview

Asserts chronically and terminally ill patients have the right to determine treatment by medications obtained from a compounding pharmacy.  Outlines requirements for accessing active pharmaceutical ingredients.

History

According to the Food and Drug Administration (FDA) compounding is generally a practice in which a licensed pharmacist, a licensed physician or a person under the supervision of a licensed pharmacist combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient (FDA). A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, and practitioners in hospitals, clinics and other health care facilities can provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat the patient. Compounded drugs are not FDA approved and the FDA does not review or evaluate compounded drugs for safety, effectiveness or quality before being offered to patients.

In 2012, the U.S. Congress passed the Drug Quality and Security Act (DQSA) which made various updates to the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding human drug compounding, including eliminating provisions concerning advertising of compounded drugs that had been found to be unconstitutional. Additionally, the FD&C Act describes the conditions under which compounded human drug products are exempt from requirements regarding pre-marketing approval, manufacturing practices and directions for use labeling. Further, the DQSA and FD&C Act outline requirements for compounding in state-licensed pharmacies and by doctors, as well as compounding in outsourcing facilities (P.L. 113-54, 113th Congress, 2013; FD&C Act § 503A).

Statute defines compounding as the preparation, mixing, assembling, packaging or labeling of a drug by a pharmacist or an intern or pharmacy technician under the pharmacist's supervision, for the purpose of dispensing to a patient based on a valid prescription order  (A.R.S. § 32-1901).

Provisions

1. Asserts chronically and terminally ill patients have the right to determine, with assistance from their health care provider, individual courses of treatment using medications and treatments obtained from a compounding pharmacy. (Sec. 1)

2. Grants licensed compounding pharmacies access to active pharmaceutical ingredients for use in compounding that meet U.S. pharmacopeia monographs if the active pharmaceutical ingredient:

a) Is prepared for use by a U.S. FDA-registered manufacturer or packager;

b) Is lawfully shipped into Arizona; and

c) Arrives with a certificate of analysis detailing quality specifications, including any medications, dietary supplements and amino acids that are already in use.

3. Specifies access to active pharmaceutical ingredients do not apply to ingredients that are deemed unsafe or are placed on the interim 503A Category II Bulk Drug Substance List. (Sec. 1)

4. Permits compounding pharmacies to use substances placed on the interim 503A category III Bulk Drug Substance List if the substance meets the requirements for accessing active pharmaceutical ingredients. (Sec. 1)

5. Stipulates the requirements for access to active pharmaceutical ingredients do not allow any treatment or use of the medication that is intended to cause the death of the patient. (Sec. 1)

6. Defines chronically ill patient, compounding pharmacy, monographs and terminally ill patient. (Sec. 1)

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10.                   SB 1353

11. Initials PRB           Page 0 House Engrossed

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