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Mandatory Recall of Unsafe Drugs: Enhanced Patient Safety

New rules grant officials more power to order the recall of drugs that may be harmful to health. Pharmaceutical companies will need to report problems faster and have recall plans in place. This aims to increase the safety of drugs available on the market.
Key points
Authorities can now order immediate cessation of distribution and recall of drugs if there is a risk of serious health consequences or death.
Drug manufacturers must report when they suspect their product is adulterated or misbranded and poses a threat.
Companies are now required to have a recall plan, which should streamline the process if needed.
In cases of imminent threat, authorities can immediately order a drug recall without a prior hearing.
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Additional Information
Recall Unsafe Drugs Act of 2023
Print number: HR 3688
Sponsor: Rep. DeLauro, Rosa L. [D-CT-3]
Process start date: 2023-05-25