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| Long title | To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. |
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| Announced in | the 113th United States Congress |
| Sponsored by | Rep. Fred Upton (R, MI-6) |
| Number of co-sponsors | 10 |
| Citations | |
| Public law | Pub. L. 113–54 (text) (PDF) |
| Codification | |
| Acts affected | Federal Food, Drug, and Cosmetic Act, Public Health Service Act, Comprehensive Drug Abuse Prevention and Control Act of 1970, Atomic Energy Act of 1954, and others. |
| U.S.C. sections affected | 21 U.S.C. § 353, 5 U.S.C. § 553, 21 U.S.C. § 353a, 18 U.S.C. § 1365, 21 U.S.C. § 331, and others. |
| Agencies affected | United States Congress, Government Accountability Office, Nuclear Regulatory Commission, Department of Health and Human Services, Food and Drug Administration |
| Authorizations of appropriations | an unlimited amount in fiscal 2014 to be spent at any time |
| Legislative history | |
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The Drug Quality and Security Act (H.R. 3204) is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.[1] The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people.[2] The bill was signed by President Obama on November 27, 2013.
Title I of the DQSA comprises the Compounding Quality Act (CQA), which amends regulations concerning compounding drugs. Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States."[3]
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uptonPRwas invoked but never defined (see the help page). - ^ Research, Center for Drug Evaluation and (2020-05-08). "Drug Supply Chain Security Act (DSCSA)". FDA. Retrieved 2020-08-03.