Peptide API testing standard: a public comment to HHS
HHS issued an enforcement discretion policy for six peptides in 503A compounding: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. Its Appendix B testing standard is ambiguous in places where the ambiguity decides whether a lot passes. My comment, submitted 30Oct2026, the day the notice was published in the Federal Register, asks HHS to clarify five points.
The gap
The policy’s goal is moving patients from research-use-only material to characterized, CGMP-sourced API. That only works if suppliers, compounders and inspectors read the testing standard the same way. As drafted, the same chromatogram can pass under one reading and fail under another.
What I asked HHS to clarify
- Impurity limits. State the reporting, identification and qualification thresholds for peptide-related impurities, or confirm that ICH Q3A(R2) applies as written. Appendix B cites Q3A, which excludes peptides.
- Aggregates, higher order structure, biological activity. Confirm these may be established by characterizing at least three representative batches, repeated on significant change, rather than tested on every lot, consistent with USP <1503>.
- Conditional tests. Confirm that residual fluoride and elemental impurities apply when their USP <1503> conditions are met, and that a documented justification satisfies them otherwise.
- “Intended dosage form.” Confirm that a bulk supplier meets this by stating the dosage forms the lot’s testing supports; the supplier can’t know which one a given lot will become.
- Immunoassay row and Appendix B footnote 1. State what evidence satisfies the immunoassay row, and where each footnote 1 information item is expected to live: on the COA, in qualification documents, or in records available on request.
The docket
- Policy notice: Federal Register document 2026-22192, published 30Oct2026. Comments close 13Nov2026; submit one from that page.
- Docket HHS-OASH-2026-0496 on regulations.gov. Submitted comments appear there once posted.
- The policy and Appendix B (HHS, primary source). HHS may update this file; my comment addresses the version published 30Oct2026.
If this is useful to you
If these questions match what you see in your own work, comment in your own words, with your own data. Agencies tend to group near-identical comments as one voice; distinct voices on the same gap carry more weight.
Submitted by Radkeland Applied on its own behalf; not written for, funded by or on behalf of any client or former employer.
Questions or disagreement welcome: info@radkeland.com