Are Peptides Legal? Compounding Status by Peptide, September 2026

Some are and most are not. As of September 2026, a US pharmacy has a lawful route to compound sermorelin, glutathione, bremelanotide, and the approved GLP-1s within tight limits. BPC-157, TB-500, CJC-1295 and the rest of the popular injectables have no such route yet, whatever an advisory committee voted in July. Tesamorelin has no compounding route at all, because FDA regulates it as a biologic.

The table

Every row below was read from fda.gov in September 2026. The dates in the status column are FDA's own. "Category 2" means FDA identified significant safety risks and would consider enforcement against a compounder using the substance¹. "Category 1" means the substance is under evaluation and FDA does not intend to act against a 503A pharmacy using it, provided the conditions in its interim policy are met².

The Category 2 rows are the easiest to misread. Ipamorelin, GHRP-2 and GHRP-6 are all still in the live table, with the 503B date September 29, 2023, and kisspeptin-10 is there on the 503A side¹. On the 503A list, GHRP-2 and GHRP-6 also appear in Category 3, meaning they were nominated without enough supporting information for FDA to evaluate them³.

What "removed from Category 2" does not mean

FDA's page keeps a second table under the heading "Bulk drug substances nominated but withdrawn". Its own description is that these substances were "previously in category 2" and "were withdrawn by the nominators"¹. The nominators withdrew. FDA did not clear anything.

That distinction decides whether a pharmacy can use the substance. A 503A pharmacy may compound from a bulk substance only if it has a USP or National Formulary monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list². The withdrawn peptides meet none of those tests. They are not in Category 1 either, so the interim policy that protects Category 1 substances does not reach them³.

FDA also left its safety text in place. For BPC-157 the agency still says it "has identified no, or only limited, safety-related information for the proposed routes of administration." For CJC-1295 it says it "has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction"¹. A seller who says BPC-157 is "no longer restricted" is describing the loss of one label while skipping the absence of any permission. What the human reports on it do show is in BPC-157 side effects.

GHK-Cu shows how fine the lines are. Its nominations were withdrawn and it left Category 1 on April 22, 2026. On May 5, one nominator clarified that it had meant to withdraw only the injectable route, so the non-injectable form went back into Category 1 and the injectable form did not³.

The July 2026 votes

FDA's Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026. On the first day it took up BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis. On the second it took up emideltide (DSIP), Semax and epitalon⁴.

Trade press reported the committee voted 8 to 6 in favor of adding BPC-157, KPV and TB-500 to the 503A bulks list, and 7 to 5 in favor of MOTS-c⁵. A law-firm summary of the second day reported that the committee recommended epitalon and Semax and did not recommend emideltide⁶. FDA's meeting page does not publish the tallies.

None of that changed the law. FDA's own description of its advisory committees is that they "make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so"⁴. A substance reaches the 503A bulks list through notice-and-comment rulemaking², and FDA's 503A page, current as of May 14, 2026, has not been updated since the meeting to announce one for any of the seven². Until a rule is final, the vote is a forecast.

Note what the committee evaluated: BPC-157 for ulcerative colitis, not for tendons, gut repair in general, or recovery⁴. If a rule does follow, it will attach to a nominated use. The claims most sellers make were not the ones on the table.

Why tesamorelin can't be compounded at all

Tesamorelin is FDA-approved, as Egrifta. It is also on FDA's list of approved drugs that were "deemed to be BLAs on March 23, 2020", the date certain protein products moved from drug applications to biologics licenses. The row reads "tesamorelin acetate, Egrifta and Egrifta SV, 022505"⁷.

That move closed the compounding door. FDA's notice to compounders said the transitioning biological products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act"⁸. There is no category tesamorelin could be placed in and no nomination that would change this. Any "compounded tesamorelin" on offer is being made outside both routes. The lawful product is the brand, prescribed. What the label and trials show is on our tesamorelin page and in tesamorelin side effects, and the sermorelin comparison is in sermorelin vs tesamorelin.

GLP-1s and the 503B exclusion proposal

Semaglutide and tirzepatide are approved drugs, which gives a 503A pharmacy a route: they are components of FDA-approved products. That route has two limits.

First, a 503A pharmacy may not compound "regularly or in inordinate amounts" drugs that are essentially copies of a commercially available product. FDA said in April 2026 that it does not intend to act if a pharmacy fills four or fewer prescriptions of such a copy in a calendar month. It gave semaglutide plus vitamin B12 as an example of a combination that can still count as a copy⁹.

Second, outsourcing facilities under 503B need the substance on the 503B bulks list or the drug on FDA's shortage list. FDA's April 2026 statement says "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list"⁹. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, "finding no clinical need for outsourcing facilities to compound these drugs from bulk substances." Comments closed June 29, 2026¹⁰.

For a reader, the practical upshot is that a compounded GLP-1 in late 2026 comes from a 503A pharmacy working under the copy rules, and it is not the product the trials tested. Our compounding explainer covers the two routes, and compounded is not the trial drug covers the second point.

Sermorelin, bremelanotide and the approved-ingredient route

Sermorelin was sold as Geref. The product is discontinued, but in 2013 FDA published a determination that Geref "was not withdrawn from sale for reasons of safety or effectiveness"¹¹. Sermorelin is compounded today as the ingredient of a once-approved drug, not as a bulks-list substance. Our sermorelin page sets out what the trials measured, and sermorelin before and after covers the changes the adult studies recorded.

Bremelanotide is approved as Vyleesi for premenopausal women with hypoactive sexual desire disorder. A pharmacy compounding it is using an approved-drug ingredient, and the same copy limits apply⁹. The bremelanotide page covers what the label does and does not cover.

How to check a status yourself

Four FDA pages answer almost every version of the question.

• The Category 2 page. It lists the live table with dates and a separate withdrawn table, each with FDA's safety text. Check which table a peptide is in, not just whether its name appears¹.
• The 503A categories list. It is a PDF with its own "updated" date and names Category 1, 2 and 3 substances³.
• The 503B bulk substances page for outsourcing facilities¹².
• The advisory committee calendar, for meetings, agendas and briefing documents⁴.

Look for two dates on each: the "content current as of" line at the bottom of the page, and the date FDA gives for the specific action. If a seller's claim about legality cannot be matched to a row on one of those pages, it is marketing. For the related question of what a "research use only" label means, see what "research chemical" actually means.