HR 89 — Prescription Freedom Act of 2025

Summary

Prescription Freedom Act of 2025This 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.

Bill Text

• Introduced Introduced in House Current html January 03, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

This bill repeals the requirement for drugs to be dispensed only upon prescription.

• 21 U.S.C. § 353(b)

  A drug intended for use by man which—(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

  Removes the requirement that certain drugs can only be dispensed with a prescription from a licensed practitioner.

• 21 U.S.C. § 353(b)(2)

  Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 352 of this title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs (g), (h), and (p), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.

  Eliminates the exemption from certain labeling requirements for drugs dispensed under a prescription.

• 21 U.S.C. § 353(b)(3)

  The Secretary may by regulation remove drugs subject to section 355 of this title from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.

  Revokes the authority of the Secretary to remove drugs from prescription requirements for public health purposes.

• 21 U.S.C. § 353(b)(4)(A)

  A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing the label of the drug fails to bear, at a minimum, the symbol “Rx only”.

  Removes the misbranding requirement for drugs that would have been labeled as 'Rx only'.

Action History

1. January 03, 2025

   Introduced in House

2. January 03, 2025

   Introduced in House

3. January 03, 2025

   Referred to the House Committee on Energy and Commerce.

Sponsors

• Andy Biggs · Primary

Subjects