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# FDA Proposes Banning 3 Bulk Drugs from Compounding
- URL: https://www.fdaweb.com/fda-proposes-banning-3-bulk-drugs-from-compounding/
- Published: 2018-08-27T12:00:00.000Z
- Updated: 2026-09-15T00:28:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142200

FDA is proposing to ban three [bulk drug substances](http://email.prnewswire.com/wf/click?upn=jxvag0QJiYRem0F0ujAq9kCBr3u2CG3l0py14PpiS-2BYHbv2jX3iRiNIok5HLb2z-2FIii9l2XUFJvG0vdfa8-2BNpU-2B7IL7Hf9Q3Ya5AvU3f6itF0-2B1UsIy1nX6r4j0sYkhHEm7v3Oq8UgE7ltkIvxPq66akcjqgh6-2BAi7xVLh4WFj64qbZaeBBk35WXpDB-2B6D92LrHIb1SyxOZXtR4KzADvvx05zeIbUTOcP7IjLtPsO95looBVC-2B86020Q-2FKw2iItvZcd5jCT0FlgonsLmm9DyLrYyRMUX2AbPwvi6qiNN2O8-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RutTfViXZ1YNgyW3kwJ9FNcYKdwyUt29LOB2HNK3p-2Fl-2FKKZ0emNZ98IbP3cKRsu21Iy2a0i7LMTV-2B0Vw7bD5yShZEMKNATwUv2uTULuDCXw49olBVYMK21FM2LjQgkERTSoy-2Fqjjiu5El0azQJXpeQnZsjTYzImrOqIugI-2BKmI4eY6BVZPz-2BJjmXwtnsAkLrHUFfBtRVRFNNxSo8oCAz174eHNEo5EQ-2FnQcX1urzT-2FOR1-2F5AdDjV4IXpmDzghJVifK&ref=fdaweb.com) — bumetanide, nicardipine hydrochloride, and vasopressin — from its list of bulk drug substances (active pharmaceutical ingredients) [that outsourcing facilities](http://email.prnewswire.com/wf/click?upn=jxvag0QJiYRem0F0ujAq9kCBr3u2CG3l0py14PpiS-2BYHbv2jX3iRiNIok5HLb2z-2FIii9l2XUFJvG0vdfa8-2BNpU-2B7IL7Hf9Q3Ya5AvU3f6itF0-2B1UsIy1nX6r4j0sYkhHEm7v3Oq8UgE7ltkIvxPq66akcjqgh6-2BAi7xVLh4WFj64qbZaeBBk35WXpDB-2B6D92LrHIb1SyxOZXtR4KzADvvx05zeIbUTOcP7IjLtPsO967hgR2V7kB5c2anpaNY9lRyzkg7FVHPN2lH8td2zhIU4Ent5soTxifesIz5zr8tWA-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RutTfViXZ1YNgyW3kwJ9FNcYKdwyUt29LOB2HNK3p-2Fl-2FKKZ0emNZ98IbP3cKRsu21Iy2a0i7LMTV-2B0Vw7bD5ySheuxeq6TluAGeHWdsg68em45ET6veBN1kxwu2sNCGYYBwMk9xY2SHAhTbEEk6HQjNCWqOLr4cROkmicfi4pCEOpXLzlt-2FuiRPG9bH3zUBO9XOJ-2B96wZyfgWpiR-2BZGv7e8jdbS9SNzpuLuhj5zFrKQYgbT0bjavkrk6TP59SRY2lp&ref=fdaweb.com) may use in compounding. This is the first time that FDA has issued a proposal regarding whether to include bulk drug substances to its bulk drugs listing. “Our preliminary assessment is that the FDA-approved drug products containing these substances can either be used or adapted to treat patients instead of compounding new drugs from bulk drug substances as proposed by the nominations,” FDA commissioner **Scott Gottlieb** is quoted in a [release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=128994&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=d3bf2724cf9d4a2198af12ac0d046d51&elqaid=4791&elqat=1&ref=fdaweb.com) as saying. “So, at this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances. Consistent with the DQSA ( Drug Quality and Security Act), we’re issuing a *Federal Register* notice outlining our proposal and seeking comments from the public before making a final decision. As we’ve said in guidance, once we make a final decision, the interim enforcement policy currently in place will no longer apply to these substances.”