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# Add All Lorcaserin Drugs to List of Drugs Not to Compound: Public Citizen
- URL: https://www.fdaweb.com/add-all-lorcaserin-drugs-to-list-of-drugs-not-to-compound-public-citizen/
- Published: 2021-04-13T12:00:00.000Z
- Updated: 2026-09-14T16:54:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149099

Public Citizen is petitioning FDA to add all drug products containing lorcaserin HCl and all parenteral drug products containing bacitracin to the list of drugs that may not be compounded after being withdrawn from the market for reasons of safety or effectiveness. The advocacy group’s 4/13 [petition](https://downloads.regulations.gov/FDA-2021-P-0378-0001/attachment%5F1.pdf?ref=fdaweb.com) also calls for the agency to implement a policy that whenever it issues a notice announcing a determination that a drug product was withdrawn from sale for reasons of safety or effectiveness, it simultaneously will issue a notice of proposed rulemaking proposing to amend the regulations to include that drug product on the list.

“Such an agency policy would minimize the period during which patients could be potentially harmed by exposure to compounded formulations of FDA-approved drug products previously marketed by traditional drug manufacturers that were determined by the agency to have been withdrawn or removed from the market because they were unsafe or ineffective,” the petition says. “Delaying such regulatory action poses unacceptable and avoidable risks to patients and public health.”

Public Citizen’s petition follows a 3/4 FDA determination that Belviq (lorcaserin HCl) tablets, 10 mg, and Belviq XR extended-release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. It also follows an agency 3/12 notice that requested all holders of ANDAs for bacitracin for injection to voluntarily request withdrawal of approval of their applications specifically because FDA had determined the drug was unsafe.