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# FDA Revises Bulk Drug Substances Listing
- URL: https://www.fdaweb.com/fda-revises-bulk-drug-substances-listing/
- Published: 2021-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:52:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148948

*Federal Register* notice: FDA has revised its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need in drug compounding. The notice identifies one bulk drug substance that FDA has considered and proposes to include on its list — quinacrine hydrochloride. Additionally, FDA has identified four bulk drug substances that it has considered and proposes not to include on the list — bromfenac sodium, mitomycin-C, nepafenac, and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion are under consideration and may be identified in future notices. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-24/pdf/2021-06060.pdf?ref=fdaweb.com).