A headline is not a rule change. This page tracks procedural actions by named agencies: what happened, the date, and a link to the primary source. Newest on top. It picks up where the book's dated snapshot ends.
How to read this pageThree different doors. Off a restricted list. Eligible for compounding. FDA approved. Anyone who blurs them, to hype you or to scare you, has told you something about whether to trust them.A committee recommends. It doesn't flip a switch. Nothing changes until an agency finishes its formal process and publishes the result.Only primary sources. Every entry links to the agency's own page or the Federal Register, not to a news story about it.Educational only. This page describes procedural actions by named institutions. It is not legal, regulatory, or medical advice, and it never says what to take or where to get it.
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FDA's Pharmacy Compounding Advisory Committee met on seven peptide substances nominated for the 503A Bulks List
What happened. The U.S. Food and Drug Administration convened its Pharmacy Compounding Advisory Committee (PCAC) for a two-day public meeting at the FDA White Oak Campus. The committee considered whether seven bulk drug substances should be added to the Section 503A Bulks List, which governs what compounding pharmacies may use. Day one covered BPC-157, KPV, TB-500, and MOTS-c. Day two covered emideltide (DSIP), semax, and epitalon. FDA's own scientific reviewers had recommended against adding all seven, citing a lack of clinical data and insufficient characterization. The committee voted to recommend six of the seven, and voted against emideltide.
What it is not. An advisory committee vote is not an agency action. FDA is not bound by it. Any change to the 503A Bulks List still requires FDA review and formal, public rulemaking. As of this entry, none of these substances has been added to the list, and none has been approved by FDA. The substances remain unapproved drugs.
FDA lists a further PCAC meeting on five additional substances, to be held before the end of February 2027
What happened. FDA's Pharmacy Compounding Advisory Committee page lists an upcoming meeting, with time and location still to be scheduled, to consider five more substances nominated for the 503A Bulks List: cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II, and pegylated mechano growth factor (PEG-MGF).
What it is not. A scheduled meeting is a meeting. It is not a decision about any of these substances. This entry will be updated with the date once FDA publishes it.
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