The Food and Drug Administration has granted enforcement discretion, allowing 503A compounding pharmacies to compound six peptide bulk substances: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. For more details, see here. No timeframe was given as to how long this enforcement discretion will last.
In July, the FDA’s Pharmacy Compounding Advisory Committee voted to recommend these six peptides be added to the 503A Bulks List, which outlines the bulk drug substances that compounding pharmacies can use in creating medications. The committee also rejected adding emideltide to the list. For details on the meeting, including links to the full video recordings, click here.
Pharmacies are still awaiting final rulemaking on these peptides, and NCPA will keep members apprised of developments.
