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# FDA Adds 1 Bulk Drug for Compounding, Rules Out 4 Drugs
- URL: https://www.fdaweb.com/fda-adds-1-bulk-drug-for-compounding-rules-out-4-drugs/
- Published: 2021-03-23T12:00:00.000Z
- Updated: 2026-09-14T16:51:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148943

FDA is proposing to include quinacrine HCl on the list of bulk drug substances (active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. A *Federal Register* [notice](https://www.federalregister.gov/public-inspection/2021-06060/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-the-federal-food-drug-and?ref=fdaweb.com) says the substance is not a component of an FDA-approved drug and was nominated by the agency to compound oral products to treat cutaneous lupus erythematosus. The notice solicits public comments before a final decision is made.

FDA also identified four drug substances — bromfenac sodium, mitomycin-C, nepafenac, and hydroxychloroquine sulfate — that it has considered and proposed not to include on the bulks list. “Based on the information reviewed, the agency did not find a clinical need for an outsourcing facility to compound drugs starting from these bulk drug substances…,” the notice says.