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ARIZONA STATE SENATE
Fifty-Fifth Legislature, First Regular Session
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. 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 they are offered to patients.
In 2012, 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.
The Right to Try Act, signed into law in 2018, provides a pathway for specified patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain eligible investigational drugs and treatments.
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 United States 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. Defines relevant terms.
5. Becomes effective on the general effective date.
Prepared by Senate Research
February 16, 2021
CRS/kja