HR 8269
Clear labels act
Clear Labels Act
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Bill overview
This bill, the CLEAR LABELS Act, aims to improve drug labeling requirements by mandating that finished drug products and active pharmaceutical ingredients include information about their original manufacturer and the entire supply chain. Specifically, labels must now display the name, place of business, and unique facility identifier of the original manufacturer and any subsequent manufacturers involved in the drug’s production. The bill also establishes a process for accessing this information electronically and ensures paper copies are available upon request.
Key provisions
- Requires drug labels to include information about the original manufacturer of active pharmaceutical ingredients and finished drug products.
- Mandates the inclusion of the manufacturer’s place of business and unique facility identifier on labels.
- Allows for electronic access to supply chain information via a searchable portal.
- Requires manufacturers to provide paper copies of labeling information upon request.
- Defines ‘original manufacturer’ as the last establishment to conduct substantial manufacturing before the drug enters interstate commerce.
- Exempts finished drug products marked in accordance with Section 502(b)(3)(A) from customs country of origin marking requirements.
Who is affected
- Pharmaceutical manufacturers
- Drug distributors
- Drug packaging companies
- Healthcare providers
- Patients
Notable changes
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Primary sponsor
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119th CONGRESS — 2d Session
H. R. 8269
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information.
This Act may be cited as the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act CLEAR LABELS Act
or the
.
Section 502(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)) is amended to read as follows:
the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor or a link, barcode, QR code, or other means to access a searchable electronic portal containing such information; and
an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that under this clause reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
or a link, barcode, QR code, or other means to access a searchable electronic portal containing such information.
A manufacturer, packer, or distributor required to furnish information under subparagraphs (1), (2), and (3), in addition to making such information available electronically, as applicable, shall make such information available through a package insert, or in paper copy to any individual who requests such a copy.
Section 304 of the Tariff Act of 1930 (19 U.S.C. 1304) is amended by adding at the end the following:
The marking requirements of subsections (a) and (b) shall not apply to articles that are finished drug products and are marked in accordance with the requirements of section 502(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act.