ARIZONA HOUSE OF REPRESENTATIVES Fifty-fifth Legislature First Regular Session
	Senate: GOV DP 5-3-0-0 | 3^rd Read 16-14-0-0

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SB 1353: anti-rabies vaccination; rabies titer

S/E: terminally ill patients; compounding; pharmacy

Sponsor:  Senator Barto, LD 15

Committee on Commerce

Summary of the Strike-Everything Amendment to SB 1353

Overview

Asserts chronically and terminally ill patients have the right to determine treatment by medications obtained from a compounding pharmacy.

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 through the use of 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 arrives with a certificate of analysis detailing quality specifications; and

c) Is deemed safe for compounding by the FDA and placed on the federal 503A Category II Bulk Drug Substance List. (Sec. 1)

3. Stipulates the compounding pharmacy requirements do not allow any treatment or use of the medication that is intended to cause the death of the patient. (Sec. 1)

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

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8.                   SB 1353

9. Initials PRB           Page 0 Commerce

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