Short answer: A US compounding pharmacy can only make a drug from a bulk ingredient that has a USP monograph, is part of an FDA-approved drug, or is on FDA's "503A bulks list". Most popular peptides meet none of those three. In 2026, nominations for many of them were withdrawn, FDA moved them off its category 2 table into a "withdrawn" list, and on July 23-24, 2026 its advisory committee reviewed seven peptides (BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax). FDA staff recommended against adding all seven. Press reports say the committee voted to back BPC-157 and KPV. As of October 22, 2026, no final rule has been issued, so none of the seven is on the list.
"Is BPC-157 legal now?" "Can my clinic still get ipamorelin?" Most of the confusion about peptides in 2026 comes from one area of law: the rules on what pharmacies may compound. This guide explains those rules in plain words, then walks through what changed in 2026, using only FDA's own pages and documents. All dates are as of October 22, 2026.
Compounding means a pharmacist or doctor mixes a drug for a specific patient, usually from raw ingredients called "bulk drug substances." FDA's own slide deck for the July 2026 meeting sums up the basics: compounded drugs are not FDA-approved, which means FDA does not review them "for safety, efficacy, or manufacturing quality before marketing," and compounding under section 503A is "primarily overseen by state regulators."
Section 503A of the Food, Drug, and Cosmetic Act lets a licensed pharmacist or physician skip the normal approval, labeling and manufacturing rules if certain conditions are met. Section 503B covers larger "outsourcing facilities" and has its own, separate process. This article is about 503A, which is how most patient-specific peptide prescriptions are filled.
Under 503A, a bulk ingredient must pass through one of three doors. It must:
FDA also requires that bulk ingredients come with a valid certificate of analysis and from an FDA-registered establishment. Most popular "research" peptides, including BPC-157, TB-500, KPV and MOTS-c, have no monograph and are not in any approved drug. FDA's July 2026 briefing documents say so for each one. That leaves only door three.
FDA started taking nominations in 2015. A 2019 final rule set four criteria FDA weighs together for each substance:
FDA consults its Pharmacy Compounding Advisory Committee (PCAC) on each substance and then adds or rejects it through notice-and-comment rulemaking. The list is built slowly. FDA's page notes that the 2019 rule placed six substances on the list, and a proposed rule that year would add five and reject 26.
Because the list is slow, FDA has an interim enforcement policy that sorts nominated substances into three categories:
FDA's guidance states it does not intend to place substances nominated on or after January 7, 2025 into these categories. So the category system only covers older nominations.
FDA's page on category 2 substances (content current as of April 22, 2026) now has a section titled "Bulk drug substances nominated but withdrawn." It says these substances were "previously in category 2" and that "the nominators" withdrew them. The table includes AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide (DSIP), epitalon, GHK-Cu for injectable routes, ipamorelin acetate, KPV, PEG-MGF, melanotan II, MOTS-c, selank acetate, semax, thymosin alpha-1 and the thymosin beta-4 fragment known as TB-500. FDA kept a summary of the safety concerns for each. The most common wording: a risk of immune reactions to injected peptides, problems with impurities, and little or no human safety data.
Being off the category 2 table does not make a substance allowed. With no nomination, it is not in category 1 either, and it still has no monograph, no approved drug and no place on the list. FDA's July briefing documents repeatedly note the nominations were withdrawn and that FDA chose to evaluate the substances "at its discretion."
FDA's category document, updated May 14, 2026, says GHK-Cu (except for injectable routes) was removed from category 1 on April 22, 2026 because the nominations were withdrawn. On May 5, 2026, one nominator said it wanted to keep its nomination for non-injectable routes, so GHK-Cu for non-injectable routes is being added back to category 1.
As of the May 14, 2026 update, category 1 includes nicotinamide adenine dinucleotide (NAD), NADH and enclomiphene citrate, among others. That means FDA is still evaluating them and its interim policy currently applies. See our posts on NAD+ injections and enclomiphene.
FDA announced the meeting in the Federal Register on April 16, 2026, with public docket FDA-2025-N-6895. The committee reviewed seven peptides, each in both free-base and acetate forms, for one proposed use each:
| Peptide | Day | Use FDA evaluated | FDA staff position |
|---|---|---|---|
| BPC-157 | July 23 | Ulcerative colitis | Against listing |
| KPV | July 23 | Wound healing and inflammatory conditions | Against listing |
| TB-500 | July 23 | Wound healing | Against listing |
| MOTS-c | July 23 | As nominated | Against listing |
| Emideltide (DSIP) | July 24 | As nominated | Against listing |
| Epitalon | July 24 | As nominated | Against listing |
| Semax | July 24 | As nominated | Against listing |
Each FDA evaluation ends with the same finding: "a balancing of the criteria weighs against" placing the substance on the list. For BPC-157 and TB-500, the detail is in our posts on BPC-157's human evidence and TB-500. FDA also gave a talk on "conflated bulks": many nominations did not say which salt form they meant, and FDA treats a free base and its acetate salt as two different ingredients.
The votes. FDA had not posted minutes on its meeting page when we checked on October 22, 2026. Trade press (RAPS) reported that the committee voted 8 to 6, with one abstention, to recommend BPC-157 for ulcerative colitis and also backed KPV, against the staff recommendation. We could not verify vote counts for the other five peptides from a primary source, so we do not report them.
The committee advises. FDA decides, and it does so through rulemaking with public comment. FDA's briefing says it "will not issue a final determination" until the advisory process and its reviews are finished. Even if a peptide is eventually added, FDA's own slides list what that means: the compounded drug is still not FDA-approved, is not required to carry a label telling patients how to use it, does not have to follow manufacturing (CGMP) rules, and the pharmacy does not have to report adverse events to FDA. Unless the listing says otherwise, it could be compounded for any use by any route.
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Every number in this article comes from one of these sources, checked on October 22, 2026. This article is for education. It is not medical or legal advice, and nothing here is a dose recommendation.