What does Preamble of Homeopathic Drug Product Safety, Quality, and Transparency Act do?

This bill aims to amend the Federal Food, Drug, and Cosmetic Act The amendment focuses on homeopathic drug products The bill has other purposes beyond homeopathic drug products

What does SHORT TITLE. of Homeopathic Drug Product Safety, Quality, and Transparency Act do?

This bill is formally titled the Homeopathic Drug Product Safety, Quality, and Transparency Act.

What does FINDINGS. of Homeopathic Drug Product Safety, Quality, and Transparency Act do?

This section establishes findings related to homeopathic drug products. Homeopathic drug products have a history of use in the United States and are prepared differently from other drugs. Federal regulation of homeopathic drug products has historically utilized mechanisms other than premarket approval. A clear statutory framework is believed to promote safety, quality, and access, ensure consistent regulation, and reduce uncertainty regarding homeopathic drug products.

What does REGULATION OF HOMEOPATHIC DRUG PRODUCTS. of Homeopathic Drug Product Safety, Quality, and Transparency Act do?

This section amends the Federal Food, Drug, and Cosmetic Act to define and regulate homeopathic drug products. It adds 'homeopathic drug product' as an exception to certain definitions and clarifies that a homeopathic drug product is not a new animal drug. The Act establishes a new category of drugs, homeopathic drug products, which will be regulated by the Secretary in a manner appropriate to their characteristics. Existing sections of the Federal Food, Drug, and Cosmetic Act, primarily sections 501, 502, and 510, will apply to homeopathic drug products, but section 505 (approval application) will not. The Secretary must issue a final rule within three years establishing current good manufacturing practices and labeling requirements for homeopathic drug products. Finished homeopathic drug products are exempt from certain laboratory testing requirements, but must meet other specifications. Labeling requirements are modified to allow for homeopathic attenuations and traditional homeopathic evidence. The Act establishes a Homeopathic Drug Product Advisory Committee to provide recommendations on regulation. Guidance from the Food and Drug Administration entitled “Homeopathic Drug Products; Guidance for FDA Staff and Industry” is withdrawn.

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Homeopathic Drug Product Safety, Quality, and Transparency Act

Last updated: 6/4/2026 · Introduced: 6/4/2026

Author: Tommy Tuberville (R-AL)

TL;DR (AI)

The bill amends the Federal Food, Drug, and Cosmetic Act to define and regulate homeopathic drug products, establishing a new category of drugs with unique characteristics.
The Secretary must issue a final rule within three years establishing current good manufacturing practices and labeling requirements for homeopathic drug products, including exemptions from certain laboratory testing requirements.
The bill establishes a Homeopathic Drug Product Advisory Committee to provide recommendations on regulation and modifies labeling requirements to allow for homeopathic attenuations and traditional homeopathic evidence.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 2 more.

4 sections

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