Which peptides can a compounding pharmacy legally use?

The four ways a 503A pharmacy can use a bulk substance

A state-licensed 503A pharmacy compounds for individual patients with a prescription. Under federal law it may compound from a bulk drug substance only if the substance fits one of these routes:

1. Component of an FDA-approved drug. Tesamorelin (Egrifta WR) and levocarnitine (CARNITOR) have approved products. Sermorelin is argued to qualify through the discontinued Geref, but FDA has not confirmed that on the pages we read.
2. USP monograph. The substance has an official United States Pharmacopeia monograph. We did not check USP monographs for the peptides in this guide.
3. The 503A bulks list. A final list FDA builds by rulemaking, with advice from its Pharmacy Compounding Advisory Committee. None of the peptides here has been added.
4. Interim Category 1. While the bulks list is built, FDA does not intend to act against pharmacies using Category 1 substances.

FDA’s interim categories

FDA sorts nominated bulk substances into three interim categories while it decides what goes on the 503A bulks list (page current as of May 14, 2026):

• Category 1: “These substances may be eligible for inclusion on the 503A bulks list.” FDA does not intend to act against licensed pharmacies compounding them while it evaluates them. Examples: NAD, NADH, glutathione, methylcobalamin, acetyl-L-carnitine and non-injectable GHK-Cu.
• Category 2: “FDA has identified significant safety risks relating to the use of these substances in compounding.” As of the May 14, 2026 PDF the 503A Category 2 list is cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10 and quinacrine for intrauterine use.
• Category 3: substances that “may be eligible” but “were nominated with insufficient supporting information for FDA to evaluate them.”

FDA also says it “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.” A substance in no category — BPC-157, TB-500, CJC-1295, ipamorelin and AOD-9604 since April 2026 — gets none of that enforcement discretion.

Where each substance stands

503B outsourcing facilities

503B outsourcing facilities register with FDA, follow current good manufacturing practice and can compound without patient-specific prescriptions. They work from a separate 503B bulks list and their own interim categories. Ipamorelin, for example, left 503A Category 2 in April 2026 but is still in 503B Category 2. For the difference in oversight, see 503A vs 503B.

State law: Louisiana Act 374

Louisiana’s SB 253, “Provides relative to peptides”, became Act 374 and took effect on August 1, 2026 (Louisiana Legislature). Secondary summaries, which we have not confirmed against the enrolled text, say it bars state licensing boards from disciplining prescribers who provide peptides from FDA-registered 503B outsourcers or 503A pharmacies that comply with federal law. It does not change federal status: the pharmacy still has to comply with section 503A or 503B.

What the interim access policy might change

On October 7, 2026 the Washington Post reported the administration was drafting a temporary way to let compounding pharmacies sell some previously restricted peptides while new rules are written; it was “not immediately clear which peptides” and “timing was unclear” (via ADN). On October 15 Reuters reported that HHS and FDA had sent an “interim access policy for compounding using certain peptides” to White House review (Reuters).

If published, a policy like this could work the way Category 1 does — FDA choosing not to act against pharmacies compounding named peptides under set conditions. That is our reading of the mechanism, not a description of the policy, whose content is not public. It would not be FDA approval, and it would not make research-use-only sellers lawful.

October 2026: what changed

• April 2026 — Category 2 withdrawals. FDA moved BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, injectable GHK-Cu and other peptides off its Category 2 list after the nominators withdrew them. FDA lists them as “nominated but withdrawn” (page current as of April 22, 2026). They were not moved into Category 1.
• July 23–24, 2026 — advisory committee. FDA’s Pharmacy Compounding Advisory Committee reviewed BPC-157, KPV, TB-500, MOTs-C, emideltide (DSIP), Semax and Epitalon. FDA staff proposed not adding BPC-157 or TB-500. A law-firm account reports the committee voted 8–6 (one abstention) to recommend BPC-157, KPV and TB-500 (McDermott, July 27, 2026). A vote is advice; FDA has taken no final action.
• October 14–15, 2026 — interim access policy under White House review. The OIRA review site lists “Interim Access Policy for Compounding Using Certain Peptides” from HHS/FDA (RIN 0910-ZD94, stage: Notice), received October 14, 2026 and pending review; no text has been published (reginfo.gov). Reuters reported the filing on October 15 (Reuters), and the AP, citing two people, said it would let pharmacies make some popular peptides, including BPC-157. Which peptides, on what terms and from when are not public. Our running table: peptide legal status 2026.

In short: on October 15, 2026, the legal answer for BPC-157, TB-500, CJC-1295 and ipamorelin is still “no established route”, and for NAD, glutathione and non-injectable GHK-Cu it is still “Category 1”.

New this month: what is known about FDA’s peptide interim access policy · a status table for 16 peptides (FDA and WADA).