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ARIZONA STATE SENATE
Fifty-Fifth Legislature, First Regular Session
AMENDED
pharmacy; compounding; terminally ill patients
Purpose
Establishes the right for individuals who are chronically or terminally ill to determine courses of treatment through the use of medications and treatments obtained from compounding pharmacies.
Background
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).
The Right to Try Act, signed into law in 2018, provides a pathway for specified patients who: 1) have been diagnosed with life-threatening diseases or conditions; 2) have tried all approved treatment options; and 3) are unable to participate in a clinical trial to access certain eligible investigational drugs and treatments (H.R. 878, 115th Congress, 2017).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Establishes the right for chronically and terminally ill patients to determine, with assistance from and guidance of their health care providers, individual courses of treatment through the use of medications and treatments obtained from a compounding pharmacy.
2. Grants licensed compounding pharmacies access to active pharmaceutical ingredients, including medications, dietary supplements and amino acids, that meet U.S. pharmacopeia monographs and that may be restricted by the FDA, in order to provide chronically and terminally ill patients with a prescribed individual course of treatment.
3. Applies federal reporting requirements prescribed in the Right to Try Act to compounding pharmacies that operate in Arizona.
4. Specifies that the use of a treatment or medication that is intended to cause death is prohibited.
5. Defines relevant terms.
6. Becomes effective on the general effective date.
Amendments Adopted by Committee
· Prohibits the use of a medication or treatment that is intended to cause death.
Senate Action
HHS 2/18/21 DPA 7-0-1
Prepared by Senate Research
February 19, 2021
CRS/kja