S3788-119
ReportedCLEAR LABELS Act
Mr. Armstrong’s recorded connection
Cosponsored this bill
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Potential benefit to Food and Drug Administration
Fewer compliance requirements
Summary unavailable
6. 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.
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Potential burden on Food and Drug Administration
More compliance requirements
Summary unavailable
4. 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 pote…
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Unclear effects on Food and Drug Administration
No material effect identified
Summary unavailable
2. 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— 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 manufact…
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Potential burden on Food and Drug Administration
More compliance requirements
Summary unavailable
2. 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 generalNo person shall introduce or deliver for introduction into interstate commerce any drug—(A)if it is an active pharmaceutical ing…
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Potential burden on Food and Drug Administration
More compliance requirements
Adds or tightens a compliance mandate, definition change, delegation of rulemaking provision: 2. Require drug labeling to include original manufacturer and supply chain information Section 502(b) of the Federal Food,... In practical terms, health care providers and patients face compliance burden up (negative); Federal implementing agencies face compliance burden up (negative).