 |
ARIZONA STATE SENATE
Fifty-Fifth Legislature, Second Regular Session
pharmacies; off-label use; refusal prohibition
Purpose
Prohibits a pharmacy, during a public health state of emergency, from refusing to fill a prescription order for a prescription-only drug prescribed for an off-label use that is potentially lifesaving.
Background
The Governor may declare a state of emergency if the Governor finds conditions of disaster or extreme peril to the safety of persons or property within the state caused by air pollution, fire, flood, epidemic, riot, earthquake or other causes that are likely to be beyond the control of any single county or municipality (A.R.S. § 26-301). During a state of emergency, the Governor has complete authority over all agencies of the state government and the right to exercise all police power vested in the state by the Arizona Constitution. Additionally, the Governor may direct all agencies to utilize and employ personnel, equipment and facilities for the performance of activities designed to prevent or alleviate actual or threatened damage due to the emergency. The Governor's state of emergency powers end when the state of emergency proclamation has been terminated by proclamation of the Governor or Concurrent Resolution of the Legislature (A.R.S. § 26-303).
Before a drug manufacturer can market a drug in the United States, the drug must first be tested and approved for use by the U.S. Food and Drug Administration (FDA). Each drug manufacturer must submit clinical data and other information to the FDA that demonstrates the drug is safe and effective for its intended uses. If it is determined that the drug’s benefits outweigh any potential risks, the drug is approved for sale for designated uses (FDA).
An off-label use drug is an FDA-approved drug, biological product or device utilized in a manner other than the use approved by the FDA (A.R.S. § 32-1997).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Prohibits a pharmacy, during a public health state of emergency, from refusing to fill a prescription order for a prescription-only drug that is prescribed for off-label use and that is potentially lifesaving.
2. Defines off-label use.
3. Becomes effective on the general effective date.
Prepared by Senate Research
February 7, 2022
MM/sr