The policy, in brief
It is a policy of enforcement discretion. Until a final rule settles each peptide's place on the 503A bulks list, HHS says it "does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance" outside 503A's usual bulk-substance routes "when all of the following circumstances are present:"
There are ten of them. The first is that the peptide appears in Appendix A, which names six: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. Appendix B then sets each one's identity and the dosage forms the policy covers, shown in the grid at the top of this page. A preparation outside those lines is outside the policy.
Section 503A already asks, for any bulk drug substance, that it be "manufactured by an establishment that is registered under section 510 and accompanied by valid certificates of analysis (COAs) for each bulk drug substance". Conditions 3 and 4 say what that means for these six.
The ten conditions, and the record behind each
Open a condition for the policy's own words and the record we would keep, so that the line can be shown when someone asks. The record is our reading, not the policy's.
The substance and its COA: conditions 1 to 4
01On Appendix AThe peptide is one of the six Appendix A names.
"The peptide bulk drug substance appears in Appendix A to this policy."
The formulation record, naming one of the six.
02Identity and routeIt matches Appendix B's identity, in a dosage form Appendix B covers.
"The peptide bulk drug substance has the identity and limitations in route of administration described in Appendix B." "The identity includes but is not limited to amino acid sequence, chemical structure, molecular weight, and molecular formula."
The COA's sequence, formula and weight beside Appendix B's, and the dosage form on the formulation record beside the forms Appendix B covers.
03A registered facility and a valid COAFrom a registered facility, with a COA whose results are consistent with Appendix B.
"The bulk drug substance is from a facility registered under section 510 (21 U.S.C. § 360) and characterized and identified in a valid certificate of analysis (COA) that includes test results consistent with existing guidance-based criteria described by FDA (see Appendix B)."
The facility's registration, looked up in the FDA's records and dated (how to look it up), and the lot's COA, read against Appendix B.
04The original manufacturerThe maker is registered and named on the COA with its plant's location. A reseller has validated the maker.
"The original manufacturer of the bulk drug substance (not a subsequent packer, repacker, labeler, or distributor) is registered with FDA under section 510, is in compliance with CGMP and other FD&C requirements and the physical location of the facility is listed on the COA provided to the 503A compounder." "If the peptide bulk drug substance is obtained through an FDA-registered repacker, relabeler, or reseller, that entity has itself performed and documented appropriate vendor validation of the bulk drug substance manufacturer and validation of the manufacturer's COA."
The COA naming the company that made the API, with its FEI number and plant address. Where the lot came through a repacker, relabeler or reseller, that firm's documented validation of the manufacturer and of its COA (what that COA names).
The preparation and its reporting: conditions 5 to 10
05ReportingProducts, serious adverse events and quality issues go to the FDA and the states.
"Report products compounded, serious adverse events, and product quality issues to FDA and to the States where the products are compounded and sent (if different)." The policy lists what product reporting includes: "Active ingredient and strength of active ingredient per unit"; "Original manufacturer of the active ingredient, including unique facility identifier for the manufacturing facility"; and "Dosage form and route of administration".
Those three items held against every preparation, so a report can be written the day it is needed, and the reporting procedure on the labeling the patient receives.
06The labelThe labeling says it is a compounded drug product, not for resale.
Product labeling carries the statement "This is a compounded drug product. Not for resale."
The label proof for each preparation.
07One active ingredientEach preparation holds a single Appendix A API.
"The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A."
The formulation record, with one API on it.
08Oral formsAn oral form has documented oral bioavailability in humans.
If a peptide is compounded in an oral dosage form, "the compounder is expected to maintain documentation confirming that the specific formulation provided to a patient achieves an adequate level of oral bioavailability in humans."
That documentation, filed with the formulation. Appendix B covers oral forms for two of the six, BPC-157 and KPV.
09The deviceThe only device is a 510(k)-cleared syringe.
"The only drug delivery device co-packaged or containing the compounded drug is an FDA 510(k)-cleared syringe."
The 510(k) clearance for the syringe you co-package.
10The rest of the ActEverything else in the Act still applies, the prescription included.
"The drug product is compounded in compliance with all other applicable requirements of the FD&C Act including that the drug product not be compounded under insanitary conditions (21 U.S.C. § 351(a)(2)(A)) and section 503A's (21 U.S.C. 353a) patient specific prescription requirement."
The patient-specific prescription, and the records you already keep for every 503A preparation.
What the COA carries
Appendix B asks for more than test results. Its first note lists what the certificate itself states. Grouped, it comes to five things.
Who made it. The manufacturer's corporate name, FEI number and address, any firm involved in processing, and any repacker or reprocessor and the laboratory that performed the analysis.
Which lot. The batch number, the date of synthesis, the date of release, and an expiration or retest date.
What it is. The name, chemical structure, amino acid sequence, molecular formula and molecular weight.
What it is for. The grade "Intended for human drug compounding", the intended dosage form, and the storage conditions.
Who stands behind it. A CGMP statement, and a date and signature from the quality unit that identify the original manufacturer.
Each line, laid out on a certificate and quoted, is on the Appendix B page, with the 20 tests and how each result is identified.
One lot, seven questions
Our practice at receiving, built from the conditions above. It is not a rule of HHS or the FDA.
- The peptide
Is it one of the six, in the form Appendix B names?
- The maker
Does the COA name the company that made it, with its FEI number and plant address?
- Registration
Is the facility's registration on file, with the date it was looked up?
- Identity
Do the sequence, formula and weight on the COA match Appendix B?
- The tests
Does the COA report each test that applies, with its method number?
- Signature
Has the manufacturer's quality unit dated and signed it?
- The route
Does Appendix B cover the dosage form you are making?
Where the policy stands
As of November 11, 2026.
HHS announced the policy in the Federal Register on October 30, 2026, in FR Doc. 2026-22192. The notice says "HHS is announcing the availability of a draft" policy, and that "Written comments can be submitted until 2 weeks after date of publication in the Federal Register via regulations.gov on Docket No. HHS-OASH-2026-0496". It also says the policy "does not establish any rights for any person and is not binding on HHS or the public."
The policy calls itself an interim policy, and says: "HHS may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises with a compounded drug product within the scope of this policy."
It does not put the six peptides on the 503A bulks list. The notice says the FDA's future rulemakings "may propose adding some or all of these peptides to the 503A bulks list based on the available evidence." For the current text, the notice points to the HHS website "to find the most current version of the policy."
Sources
Every source below was opened and read for this page. Last reviewed: November 11, 2026.
- HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. The policy, with Appendix A (the six peptides) and Appendix B (their identities, the dosage forms it covers and the testing standard). 16 pages. PDF. Quotations not otherwise marked come from it.
- Notice of availability, FR Doc. 2026-22192. HHS, Office of the Secretary. Federal Register, Volume 91, Number 209, pages 68526 to 68527, October 30, 2026. Docket No. HHS-OASH-2026-0496. Quotations marked as the notice's come from it.
We read documents. We do not test material.