FDA Calls Meeting on Safe Bulk Drugs for Custom Pharmacy Mixes
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. Anyone interested can join in person or online and share their thoughts by July 22, 2026. This affects pharmacies, patients, and drug makers by helping decide which ingredients are allowed, keeping medicines safe and effective.
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Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
FDA reviews specific peptides for compounding
FDA will consider adding specific bulk drug substances to the Section 503A Bulks List at the July 23–24, 2026 meeting. The substances under review include BPC-157 (for ulcerative colitis), KPV (wound healing/inflammatory conditions), TB-500 (wound healing), MOTS-C (obesity and osteoporosis), Emideltide (opioid withdrawal, chronic insomnia, narcolepsy), Semax (cerebral ischemia, migraine, trigeminal neuralgia), and Epitalon (insomnia). If a substance is added to the 503A Bulks List, licensed pharmacists or physicians may be able to compound it under the section 503A exemptions described in the Federal Food, Drug, and Cosmetic Act.
Public meeting and comment deadlines
You can attend an FDA public meeting on July 23–24, 2026 in person at FDA White Oak or online. The public docket (FDA-2025-N-6895) closes July 22, 2026; comments submitted by July 9, 2026 will be provided to the advisory committee. If you want to make a formal oral presentation you must notify FDA and submit required information on or before June 30, 2026.
How comments are posted and kept confidential
Electronic comments submitted at https://www.regulations.gov will be posted unchanged and publicly viewable; the docket (FDA-2025-N-6895) will close at 11:59 p.m. Eastern Time on July 22, 2026. If you need to submit confidential information, you must send a written/paper submission to the Dockets Management Staff with two copies—one marked confidential and one redacted copy for public viewing—so the confidential material is not posted publicly.
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