119 S3788 RS: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act U.S. Senate 2026-07-27 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

Short title

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

Require drug labeling to include original manufacturer and supply chain information

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

;

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

(B)an accurate

;

(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:

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

; 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. (3)(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,

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.

Exemption from customs country of origin marking requirement

Section 304 of the Tariff Act of 1930 (19 U.S.C. 1304) is amended by adding at the end the following:

(m)

Marking of certain finished drug products

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)).

Short title

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

Require drug labels to include original manufacturer and supply chain information

Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) is amended by adding at the end the following —

(i)

Original Manufacturer and Supply Chain Information

(1)

In general

No person shall introduce or deliver for introduction into interstate commerce any drug—(A)if it is an active pharmaceutical ingredient, unless the label and certificate of analysis contain the name and place of business of the original manufacturer; or(B)if it is a finished drug product in a package form, unless the label includes, either printed directly or made available through electronic means, the name and place of business 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.(2)

Multiple original manufacturers

In the case of a finished drug product for which there are multiple different original manufacturers of an active pharmaceutical ingredient, the requirements of paragraph (1)(B)(i) shall be satisfied if the label includes, either printed directly or made available through electronic means, the name and place of business of each applicable original manufacturer of the active pharmaceutical ingredient for the applicable drug product lot.(3)

Effect of noncompliance

In the case of noncompliance with the requirements of paragraph (1), the Secretary shall have discretion to determine that such noncompliance constitutes misbranding and to assess a civil monetary penalty, as described in section 303(f)(10), except that the Secretary may not treat a violation of this subsection as a criminal violation.(4)

Definition of original manufacturer

For purposes of this subsection, the term original manufacturer means the establishment that conducts the majority of the significant phases of manufacturing (chemical, physical, or biological manipulation) to produce the active pharmaceutical ingredient or the finished dosage form.

Penalties

(a)

In general

Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended by adding at the end the following:

(10)(A)Any person who fails to comply with the requirements of section 503(i) shall be subject to a civil monetary penalty in an amount not to exceed 25 percent of the total value of the drug product lot or lots involved. (B)In determining whether to assess a penalty under this paragraph against a person, and the amount of such a penalty, the Secretary shall consider—(i)the size of the business of such person and the gravity of the violation; (ii)whether such person received written notice of the noncompliance in advance of such proceeding and was provided an opportunity by the Secretary to correct the violation following such notice; and (iii)whether such person acted in good faith to correct the violation following any such notice.

(b)

Conforming amendments

Section 303(f)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(5)(A)) is amended by striking (1), (2), (3), (4), or (9) and inserting (1), (2), (3), (4), (9), or (10).

Agency coordination regarding FDA and customs country of origin requirements

In carrying out the amendments made by this Act, the Commissioner of Food and Drugs shall coordinate with the Commissioner of U.S. Customs and Border Protection on efforts to address the potential administrative burden on manufacturers of active pharmaceutical ingredients and finished drug products related to any potential overlap with, or duplication or conflict between, the requirements of such amendments and section 304 of the Tariff Act of 1930 (19 U.S.C. 1304). Such coordination may include the establishment of mechanisms to facilitate the sharing of relevant information between the Food and Drug Administration and U.S. Customs and Border Protection to ensure compliance with such amendments and such section 304, and joint rulemaking, if determined by such commissioners to be appropriate.

Confidentiality

Nothing in the amendments made by this Act shall be construed as authorizing the Secretary of Health and Human Services to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

Effective date

The amendments made by this Act shall apply to active pharmaceutical ingredients and finished drug products that are manufactured and packaged on or after the date that is 5 years after the date of enactment of this Act.

July 27, 2026

Reported with an amendment