CLEAR LABELS Act

This Act may be cited as the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act.

Section 502(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)) is amended—

(1) by striking containing (1) the name and place of business of the manufacturer, packer, or distributor and inserting the following: “containing—

(A) 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

(1) ;

(2) in clause (A) (as so designated), by striking (2) an accurate and inserting the following:

(B) an accurate

(2) ;

(3) in clause (B) (as so designated), by striking count: Provided, That under clause (2) of this paragraph reasonable variations and inserting count, provided that under this clause, reasonable variations;

(4) by striking (b) If in a package form and inserting the following:

(1) If it is a finished drug product in a package form

(4) ; and

(5) by adding at the end the following:

(2) If it is an active pharmaceutical ingredient, unless any accompanying label and certificate of analysis contains the name, place of business, and unique facility identifier of the original manufacturer.

(A) If it is a finished drug product, unless its labeling contains the name, place of business, and unique facility identifier of—

(i) the original manufacturer of each active pharmaceutical ingredient;

(ii) the original manufacturer of the finished drug product; and

(iii) the packer or distributor, if any,

(A) or a link, barcode, QR code, or other means to access a searchable electronic portal containing such information.

(B) In the case of a finished drug product for which there are multiple potential different manufacturers of the active pharmaceutical ingredient, the requirements of this subparagraph shall be satisfied if all such manufacturers of active pharmaceutical ingredients for the drug product are identified in the labeling or the searchable electronic portal.

(4) A manufacturer, packer, or distributor required to furnish information under paragraphs (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.

(5) For purposes of this subsection, the term original manufacturer, means the single last establishment to conduct substantial manufacturing activities prior to introduction of the active pharmaceutical ingredient or finished drug product into interstate commerce.

(6) The Secretary shall issue regulations to implement subparagraphs (2) and (3) and may provide for reasonable variations in the implementation of, or an alternative placement for, the labeling requirements under such subparagraphs, including by electronic means. Such regulations shall take effect on a date determined by the Secretary and not earlier than 1 year after the date of publication of the final regulations, and shall apply with respect to drugs manufactured on or after the effective date of such regulations.

(5) .

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)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)(2)(A)).

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