H.R. 1108 · 115th Congress
Recall Unsafe Drugs Act of 2017
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
DeLauroSponsor4 cosponsors · 4 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require producers of medications to notify the Food and Drug Administration (FDA) of the identity and location of a medication if the producer has reason to believe: (1) that the medication is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption…
What it does: CRS summary · Introduced in House · Feb 16, 2017
Recall Unsafe Drugs Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require producers of medications to notify the Food and Drug Administration (FDA) of the identity and location of a medication if the producer has reason to believe: (1) that the medication is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the medication will cause a threat of serious adverse health consequences or death to humans or animals.
The FDA may: (1) request that the distributor of a medication that is in violation of the FFDCA voluntarily recall the medication; (2) require the distributor of a medication that may cause serious adverse health consequences to immediately cease distribution of the medication; (3) recall a medication for which distribution has been ceased after giving the distributor an opportunity for an informal hearing; and (4) immediately recall a medication that presents an imminent threat of serious adverse health consequences. Distributors may appeal these FDA orders.
In the case of a recall, the FDA must notify consumers and state and local health officials to whom the medication was, or may have been, distributed.
Medication distributors 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 2017
Latest action (Feb 17, 2017): Referred to the Subcommittee on Digital Commerce and Consumer Protection.
Policy area: Health · Origin: House · Introduced: Feb 16, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.