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Recall Unsafe Drugs Act of 2022

USA117th CongressHR-6834| House 
| Updated: 2/28/2022
Rosa L. DeLauro

Rosa L. DeLauro

Democratic Representative

Connecticut

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Recall Unsafe Drugs Act of 2022 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.
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Timeline

Bill from Previous Congress

HR 116-5578
Recall Unsafe Drugs Act of 2020
Feb 25, 2022
Introduced in House
Feb 25, 2022
Referred to the House Committee on Energy and Commerce.
Feb 28, 2022
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-5578
    Recall Unsafe Drugs Act of 2020


  • February 25, 2022
    Introduced in House


  • February 25, 2022
    Referred to the House Committee on Energy and Commerce.


  • February 28, 2022
    Referred to the Subcommittee on Health.

Health

Administrative remediesConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archives

Recall Unsafe Drugs Act of 2022

USA117th CongressHR-6834| House 
| Updated: 2/28/2022
Recall Unsafe Drugs Act of 2022 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-5578
Recall Unsafe Drugs Act of 2020
Feb 25, 2022
Introduced in House
Feb 25, 2022
Referred to the House Committee on Energy and Commerce.
Feb 28, 2022
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-5578
    Recall Unsafe Drugs Act of 2020


  • February 25, 2022
    Introduced in House


  • February 25, 2022
    Referred to the House Committee on Energy and Commerce.


  • February 28, 2022
    Referred to the Subcommittee on Health.
Rosa L. DeLauro

Rosa L. DeLauro

Democratic Representative

Connecticut

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archives