H.R.1108 - Recall Unsafe Drugs Act of 2017115th Congress (2017-2018)
|Sponsor:||Rep. DeLauro, Rosa L. [D-CT-3] (Introduced 02/16/2017)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 02/17/2017 Referred to the Subcommittee on Digital Commerce and Consumer Protection. (All Actions)|
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Summary: H.R.1108 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in House (02/16/2017)
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.