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Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective

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Public Citizen petitioned the Food and Drug Administration (FDA) to promptly add the weight loss drug lorcaserin and injectable forms of the antibiotic bacitracin to its official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective, in order to prevent pharmacy compounding of these banned drugs. We also urged the agency to implement a new policy of simultaneously initiating the process for updating the list of withdrawn drugs whenever the agency announces that a drug was removed from the market because of safety or effectiveness concerns.

April 13, 2021, FDA acknowledgment letter.

October 8, 2021, FDA interim response letter.

May 6, 2022, FDA final response letter.

View our other work related to pharmacy compounding