Must-know

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1) Partnership for Safe Medicines citizen petition (filed Oct 16; announced Oct 21) — PSM petitioned FDA to refrain from any action, whether by regulation, Category 1 placement, or enforcement discretion, that would allow compounding of BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax, and epitalon. The petition argues that the July 2026 Pharmacy Compounding Advisory Committee votes recommending six of those peptides were compromised by conflicts of interest and fell short of FACA and Ethics in Government Act standards. FDA staff had recommended against all of them for lack of characterization, safety data, and human evidence. PSM also documents recent purchases of these substances from licensed 503A pharmacies shipping across state lines. That is direct pressure against any near-term pathway, including the pending interim policy. These substances remain unapproved. The petition restates that 503A compounding is unlawful absent a listing or an exercise of discretion.

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2) Interim Access Policy still pending at OMB (received Oct 14; pending through at least Oct 23) — HHS and FDA submitted “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94) to OIRA on October 14. It is a notice, not a proposed rule, and it has no public text, named peptides, conditions, or effective date. Reporting that cites unnamed sources describes possible temporary enforcement discretion for state-licensed 503A pharmacies to compound certain popular peptides, possibly including BPC-157, under a prescription while formal rulemaking continues. Around October 20, HHS Secretary Kennedy said the administration wants a regulated marketplace so products match their claims. Stakeholder meetings with OMB were scheduled for late October. Until the text issues, nothing changes legally. Any discretion would be limited to 503A pharmacies filling prescriptions. It would not cover research-use-only sellers or 503B facilities, and it could be withdrawn. This is not an approval, not a bulks-list addition, and not a green light for non-pharmacy channels.

A systematic review in Acta Orthopaedica Belgica (Vol. 92, Autumn 2026; published October 8 and covered October 19–22) searched human BPC-157 evidence through June 1, 2026. It found three reports and about 30 participants: an intra-articular knee series, an intravesical interstitial-cystitis series, and a small intravenous safety pilot. Each reported improvement and no treatment-related adverse events. The authors rated the work poor and the certainty very low, and said BPC-157 should not be used clinically outside regulated trials. That is the same thin evidence base FDA staff cited against listing. There is no new primary data in this window.

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FDA’s page on unapproved GLP-1 drugs used for weight loss, current as of early October and cited again this week, states that retatrutide and cagrilintide are not components of approved drugs and cannot be used in compounding. The page also updates adverse-event counts for compounded semaglutide and tirzepatide and flags dosing errors and fraudulent products. That draws a hard line between those research-use analogs and compounds that are approved or shortage-eligible.

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ClinicalTrials.gov last updated NCT04689360 on October 16. The intermediate-size expanded-access protocol for subcutaneous elamipretide (SS-31) in genetically confirmed rare mitochondrial diseases remains “Available.” There is no new efficacy result and no status change that moves research-use positioning.