H.R. 3688 · 118th Congress
Recall Unsafe Drugs Act of 2023
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
DeLauroSponsorNo cosponsors.
This bill authorizes the Food and Drug Administration (FDA) to order the recall of certain adulterated or misbranded drugs and contains other related provisions.
What it does: CRS summary · Introduced in House · May 25, 2023
Recall Unsafe Drugs Act of 2023
This bill authorizes the Food and Drug Administration (FDA) to order the recall of certain adulterated or misbranded drugs and contains other related provisions.
A producer of a medication must notify the FDA of the identity and location of a drug if the producer has reason to believe that (1) the drug is adulterated or misbranded, and (2) there is a reasonable probability that the drug will cause a threat of serious adverse health consequences or death to humans or animals.
If use of a drug may cause serious adverse health consequences or death, the FDA may order the producer to immediately cease distribution and notify affected individuals. After issuing such an order, the FDA may also order a recall after affording the producer an opportunity for an informal hearing.
If a drug presents an imminent threat of serious adverse health consequences or death, the FDA may order the producer to immediately recall the drug and notify affected individuals. The distributor may appeal such an order.
An individual or entity required to register as a producer of drugs or medical devices must have a recall plan in effect.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Recall Unsafe Drugs Act of 2023
Latest action (May 26, 2023): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 25, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.