FDA Meeting Seeks Input on Safe Bulk Drug Ingredients
Published Date: 4/16/2026
Notice
Summary
The FDA is holding a public meeting on July 23-24, 2026, to talk about which bulk drug ingredients can be safely used by pharmacies to make custom medicines. They want input from everyone before July 22, 2026, so your voice can help shape the list that affects pharmacists and patients. This is a big deal for anyone involved in making or using compounded drugs, with no direct costs but important safety and access impacts.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
503A Bulks List Controls Compounding Rights
If a bulk drug substance appears on the Section 503A Bulks List, licensed pharmacists or physicians can use it when compounding and the compounded product may qualify for exemptions from current good manufacturing practice requirements (section 501(a)(2)(B)), certain labeling requirements (section 502(f)(1)), and new drug approval requirements (section 505). Whether a substance is placed on the 503A Bulks List therefore affects whether compounders can legally rely on those exemptions.
Which Substances Could Change Access
The FDA Advisory Committee will review specific nominated bulk drug substances at the July 23–24, 2026 meeting. On July 23, FDA will discuss BPC-157 (free base and acetate) for ulcerative colitis; KPV (free base and acetate) for wound healing and inflammatory conditions; TB-500 (free base and acetate) for wound healing; and MOTS-C (free base and acetate) for obesity and osteoporosis. On July 24, FDA will discuss Emideltide/DSIP (free base and acetate) for opioid withdrawal, chronic insomnia, and narcolepsy; Semax (free base and acetate) for cerebral ischemia, migraine, and trigeminal neuralgia; and Epitalon (free base and acetate) for insomnia.
Public Comment and Participation Deadlines
The FDA established docket FDA-2025-N-6895 and will accept public comments through 11:59 p.m. Eastern Time on July 22, 2026; comments received on or before July 9, 2026 will be provided to the Advisory Committee. Individuals who want to request time for an oral presentation must notify FDA and submit required information on or before June 30, 2026.
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