“To amend the Federal Food, Drug, and Cosmetic Act with respect to homeopathic drug products, and for other purposes.”
No CRS summary available for this bill.
This section designates the Act as the "Homeopathic Drug Product Safety, Quality, and Transparency Act" and sets forth the table of contents.
This section states that the purpose of the Act is to address consumer and practitioner needs for continued access to homeopathic drug products that meet requirements for safety, quality, and transparency. It expresses the sense of Congress that (1) homeopathic medicines are important to millions of American consumers, and continued access to safe homeopathic products is best ensured by enacting a distinct statutory pathway for their regulation; and (2) while the Federal Government should continue to take appropriate action against adulterated or misbranded products, federal agencies should not impose regulatory barriers that unreasonably limit or prevent consumer and health care provider access to safe products and accurate information.
This section amends definitions in the Federal Food, Drug, and Cosmetic Act (FDCA) by (1) expanding exceptions to the "new drug" definition to exclude homeopathic drug products (in addition to new animal drugs and animal feeds bearing or containing them); (2) clarifying in the "new animal drug" definition that a homeopathic drug product is not a new animal drug; and (3) adding definitions of "homeopathic drug product" as a drug containing one or more homeopathic ingredients and no other active ingredient, and "homeopathic ingredient" as one listed in the Homeopathic Pharmacopoeia of the United States (HPUS), a state homeopathic formulary, or prepared under specified HPUS or consensus standards. (As background, new drug status under the FDCA generally requires premarket approval; thus, qualifying homeopathic drug products are exempt from such requirements for human and animal use.)
This section establishes safety, quality, and transparency requirements for homeopathic drug products (i.e., remedies prepared according to standards in the Homeopathic Pharmacopoeia of the United States (HPUS)) by inserting new section 503E in the Federal Food, Drug, and Cosmetic Act. Specifically, the section (1) limits applicability of chapter V provisions to this section and sections 501 (adulteration), 502 (misbranding), and 510 (new drugs); (2) exempts homeopathic drug products from any other law, regulation, or guidance that conflicts with this section or imposes standards conflicting with HPUS or accredited voluntary consensus standards; (3) deems such products adulterated if they fail to comply with HPUS or consensus standards (or, if none apply, good manufacturing practice (GMP) regulations under section 501(a)(2) or new GMP regulations specific to homeopathic products, promulgated after public comment and recommendation from the Homeopathic Drug Product Advisory Committee); (4) authorizes manufacturers to petition for GMP exemptions, variances, or alternatives (referred to the advisory committee for a recommendation within 60 days, with Secretary decision within 180 days or deemed approved, allowable only if safety is unaffected, and subject to judicial review); and (5) exempts finished products from certain identity and strength testing under 21 CFR 211.165(a) while requiring other specifications (e.g., contaminants), and requires intermediate testing of certain risky starting materials to ensure levels at or below safe thresholds defined by HPUS, consensus standards, or analytic detectability.
This section makes conforming amendments related to homeopathic drug products. (1) In the pharmaceutical distribution supply chain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), revises a definition by replacing “homeopathic drugs marketed in accordance with applicable guidance under this Act” with “homeopathic drug products marketed in accordance with this Act”. (2) In the serious adverse event reporting requirements for nonprescription drugs under the FD&C Act, redefines “nonprescription drug” to mean a drug that is not subject to prescription requirements under section 503(b) or approval under section 505 and to include a homeopathic drug product. (3) In the Public Health Service Act, amends the definition of biological product to exclude a homeopathic drug product (as defined in section 201 of the FD&C Act).
This section withdraws the Food and Drug Administration's guidance document titled “Homeopathic Drug Products; Guidance for Food and Drug Administration Staff and Industry; Availability” (87 Fed. Reg. 75054, Dec. 7, 2022), rendering it without force or effect with respect to homeopathic drug products (as defined in 21 U.S.C. 321, as amended by section 3(3)). (Thus, the guidance's risk-based enforcement approach for such products—which are drugs recognized in the official Homeopathic Pharmacopoeia of the United States—does not apply.)
This section includes a severability clause providing that the invalidity of any provision of the Act or its amendments—or its applicability to any person or circumstance—does not affect the remainder of the Act or its amendments or their applicability to other persons or circumstances.