Prescription Freedom Act of 2025
The Prescription Freedom Act of 2025 would halt the FDA’s long-standing rule that many drugs must be dispensed only with a prescription. Specifically, it repeals the prescription requirement in the Federal Food, Drug, and Cosmetic Act (FDCA) at FDCA §503(b), with the repeal taking effect six months after enactment. After that date, references to prescriptions and prescription drugs in federal law would be treated as references to what is allowed under each state’s laws, effectively shifting control over whether a drug requires a prescription from the federal level to state governments. The bill preserves a carve-out: the Secretary of Health and Human Services may continue to enforce the federal prescription requirement for any drug intended to terminate a pregnancy, as it existed on the day before the effective date. The sponsor and status indicate it was introduced in the House (H.R. 89) and referred to the Committee on Energy and Commerce. In short, if enacted, the federal government would no longer mandate prescriptions for most drugs; instead, states would decide dispensing rules, with an explicit exception to allow federal authority to remain in place for abortion-related medications.
Key Points
- 1Repeal of the federal prescription requirement: Effective six months after enactment, the FDA’s authority to require that drugs be dispensed only upon a prescription (FDCA §503(b)) would be repealed.
- 2State-law framework takeover: After the effective date, references to prescription, prescribing, and prescription drugs in federal statutes/regulations would be interpreted as referring to state-law equivalents, shifting dispensing rules from federal to state authority.
- 3Abortion-drug carve-out: The Secretary of Health and Human Services may continue to exercise the pre-repeal federal authority over any drug intended for terminating a pregnancy, as of the day before the effective date.
- 4Transition and interpretation: Federal officials responsible for administering the relevant statutes would determine how state law applies to drug-dispensing requirements, creating a potential patchwork of rules across states.
- 5Introduction and oversight: The bill was introduced in the House as H.R. 89 by Mr. Biggs of Arizona and referred to the Committee on Energy and Commerce; it is in the introduction stage and has not yet become law.