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This bill would remove the Food and Drug Administration’s power to decide that a drug must be sold only with a prescription. In most cases, that means whether a medicine needs a prescription would instead be left to state law rather than federal law. The change would take effect six months after the bill becomes law. The bill also keeps a special federal authority in place for drugs used to end a pregnancy, so those drugs would not be covered by the general repeal in the same way.
- It repeals the part of federal law that lets the FDA require certain drugs to be dispensed only by prescription.
- After the change takes effect, federal references to prescriptions and prescription drugs would generally be treated as references to what state law says.
- Any federal rules, guidance, or statutes that refer to the repealed FDA authority would be read as pointing to the related state law requirement, if one exists.
- The bill makes an exception for drugs intended to end a pregnancy, allowing the Health and Human Services Secretary to keep using the current federal authority for those drugs.
Official Summaries
Prescription Freedom Act of 2025
This bill generally eliminates the authority of the Food and Drug Administration (FDA) to require that a drug be dispensed only with a prescription. However, the FDA may continue to require a prescription for any drug intended for terminating a pregnancy.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 89 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 89
To repeal the authority of the Food and Drug Administration to require
that drugs be dispensed only upon prescription, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 3, 2025
Mr. Biggs of Arizona introduced the following bill; which was referred
to the Committee on Energy and Commerce
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A BILL
To repeal the authority of the Food and Drug Administration to require
that drugs be dispensed only upon prescription, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prescription Freedom Act of 2025''.
SEC. 2. REPEAL OF FDA AUTHORITY TO REQUIRE PRESCRIPTIONS.
(a) Repeal.--Effective as of the date that is 6 months after the
date of enactment of this Act, subsection (b) of section 503 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) is repealed.
(b) References.--Beginning on the effective date described in
subsection (a), any reference in a Federal statute, regulation, or
guidance--
(1) to prescribing, a prescription, a prescription drug, or
a drug subject to section 503(b) of the Federal Food, Drug, and
Cosmetic Act is deemed to be a reference to prescribing, a
prescription, or a prescription drug, respectively, under
applicable State law; and
(2) to any requirement or provision of section 503(b) of
the Federal Food, Drug, and Cosmetic Act is deemed to be a
reference to the corresponding requirement or provision, if
any, in applicable State law, as determined by the Federal
official or officials responsible for administering the
respective Federal statute, regulation, or guidance.
(c) Exception.--Notwithstanding subsections (a) and (b), the
Secretary of Health and Human Services may continue to exercise the
authority vested by subsection (b) of section 503 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353), as in effect on the day before
the effective date described in subsection (a), with respect to any
drug that is intended for use in terminating a pregnancy.
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