# Which peptides can a pharmacy compound?

> A pharmacy may compound with a raw peptide only if it meets an official quality standard, is in an FDA-approved drug, or is on an FDA list that names no peptide. Peptides that pass none of these, such as BPC-157, can rely at most on nonbinding FDA or HHS policies of not taking action, which are not approvals.

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- Topic: Regulation
- Web page: https://roverehealth.com/journal/which-peptides-can-be-compounded

## Key points

- A pharmacy may compound from a raw ingredient only if it meets an official quality standard (a monograph), is in an FDA-approved drug, or is on the FDA’s 503A bulks list. That list names six substances, none a peptide.
- The FDA sorted substances nominated for its 503A bulks list before January 7, 2025, into three categories, under a nonbinding guidance, not a law or regulation. Only Category 1 marks substances the FDA does not intend to act against.
- The FDA lists BPC-157, TB-500, epitalon, MOTS-c and 13 other substances as withdrawn from Category 2, its safety-risk group. Withdrawal did not move them into Category 1, so the FDA’s interim policy of not acting does not cover them.
- In a nonbinding draft, HHS says it does not intend to take enforcement action against 503A compounding with BPC-157, TB-500, epitalon, MOTS-c, KPV or semax, under ten conditions. FDA staff opposed listing them; HHS says FDA advisers voted in favor.
- An FDA rule in effect since 2020 treats more than 40 amino acids in a defined sequence as a protein, counting together chains that join in nature. Protein medicines, including tesamorelin and hCG, cannot be compounded under 503A or 503B.

A pharmacy may compound a drug from a raw peptide only if that ingredient passes one of three tests in federal law. It must meet an official quality standard (a monograph), be part of an FDA-approved drug, or be on the FDA’s 503A bulks list. No peptide is on that list. Peptides in FDA-approved drugs, such as oxytocin and semaglutide, can qualify. BPC-157 and TB-500 pass none of the three, FDA staff reported in 2026. For peptides like these, any room to compound rests on FDA or HHS statements of intent not to take action, which are not approvals. [1, 2, 3, 4, 5, 6, 7, 25]

## The three ways a substance qualifies

Section 503A of the Federal Food, Drug, and Cosmetic Act covers compounding by state-licensed pharmacies and physicians. Its tests apply to the bulk drug substance, the raw active ingredient in the finished drug. The ingredient must pass at least one: [1, 2]

- It meets an official drug substance monograph in the United States Pharmacopeia or National Formulary (USP or NF). Monographs for dietary supplements don’t count.
- If no monograph exists, it is a component of an FDA-approved drug.
- If neither applies, it is on the 503A bulks list, which the FDA builds by regulation with advice from an advisory committee and the USP.

Sources for the list above: [1, 2]

Every bulk ingredient must also come from an FDA-registered manufacturer, with a valid certificate of analysis, the supplier’s test results for that batch. A drug made from an ingredient that fails all three tests gets none of the law’s exemptions, including from FDA approval, and “may violate” the law, the FDA says. Another condition bars a pharmacy from compounding, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available drug. [1, 2, 8]

A February 2019 rule put six substances on the 503A bulks list. In September 2019 the FDA proposed adding five more and leaving out 26 others, including vasoactive intestinal peptide (VIP). It has not finalized either part. [1, 3, 37]

Outsourcing facilities, compounders registered with the FDA under section 503B, face a different test. They may use a bulk ingredient only if it is on the FDA’s 503B list of substances with a clinical need, or if the drug is on the FDA’s shortage list. The 503B list holds five substances, none a peptide. In May 2026 the FDA proposed keeping semaglutide, tirzepatide and liraglutide off it. [9, 10, 11, 12]

## The FDA’s categories for nominated substances

While it builds the 503A bulks list, the FDA applies an interim policy, set out in a nonbinding guidance, to nominated substances that pass neither of the first two tests. It sorts them into three categories that reflect the FDA’s enforcement intentions, not what the law allows: [1, 2]

- Category 1, substances under evaluation: the FDA does not intend to act against compounding with them, if the guidance’s other conditions are met.
- Category 2, substances that the FDA says “may present significant safety risks”: the FDA would consider taking action under its general enforcement policies.
- Category 3, substances nominated without enough information for the FDA to evaluate them: the FDA would also consider taking action.

Sources for the list above: [1, 2, 14]

Since January 7, 2025, the FDA no longer categorizes new nominations, so they fall outside the Category 1 policy. A substance leaves its category once every nominator has withdrawn it, which the FDA says reflects no judgment on the nomination. Category 1 includes a few peptides, such as the copper peptide GHK-Cu other than by injection, and VIP, which stays there because the 2019 proposal is not final. A separate interim policy sorts substances nominated for the 503B list into the same three categories. [2, 10, 13, 37]

## Peptides the FDA has flagged

The FDA’s 503A and 503B Category 2 lists now include four peptides, plus one non-peptide, ibutamoren (MK-677). For each peptide, the FDA’s first concern is immunogenicity, the chance that the body mounts an immune response against the drug. It ties that risk to clumping (aggregation) and to impurities, near-copies of the peptide formed during synthesis that can be hard to detect. Injected forms may carry a particular risk, the FDA says. Its other concerns: [5, 13, 14, 15]

- Kisspeptin-10: impurities, and little or no safety information for the proposed routes.
- Ipamorelin: amino acids that the body does not use to build proteins, which complicate testing. In a 2014 placebo-controlled trial in 114 adults after bowel surgery, two patients given it into a vein died; the FDA says it is unclear whether ipamorelin caused the deaths.
- Growth hormone-releasing peptide-2 (GHRP-2), by injection or nose: reports of serious adverse events including pancreatitis (inflammation of the pancreas) and deaths of critically ill study subjects, though the FDA says no causal link has been shown.
- GHRP-6: limited safety information, a possible effect on the stress hormone cortisol, and raised blood sugar.
- Ibutamoren: possible congestive heart failure in some patients. A 2011 placebo-controlled trial in 123 older adults after hip fracture was stopped early over that concern.

Sources for the list above: [14, 16, 17, 39]

The FDA’s Category 2 page also gives risk summaries for 17 substances withdrawn by their nominators. For TB-500, MOTS-c, KPV, dihexa and pegylated mechano growth factor (PEG-MGF), it found no data on any human exposure. For BPC-157, epitalon, semax, emideltide and selank, it says it lacks the information to judge whether they would harm people. [14]

Case reports on melanotan II describe melanoma, prolonged erections, a brain-swelling disorder and a toxic overstimulation of the nervous system. Lab and animal findings suggest cathelicidin LL-37 may harm male reproduction and promote tumors in some tissues. [14]

## Committee reviews and the 2026 changes

The FDA consults its Pharmacy Compounding Advisory Committee, a panel of outside experts, before deciding on the 503A bulks list. It reviews each form of a peptide as a separate ingredient, such as the peptide alone (the free base) or paired with acetate (the acetate salt). In 2024 the committee voted against adding all five peptides it reviewed: ipamorelin, kisspeptin-10, CJC-1295, AOD-9604 and thymosin alpha-1. [2, 4, 16, 18, 19, 20, 21]

On July 23 and 24, 2026, the committee took up seven more peptides with withdrawn nominations: BPC-157, KPV, TB-500, MOTS-c, emideltide (also called DSIP), semax and epitalon. In reviews dated May 2026, FDA staff proposed adding none of them. As of November 14, 2026, the FDA had posted neither results nor minutes, but HHS says the committee voted for the six its draft policy covers. The FDA generally follows its advisory committees but is not legally bound to. [4, 21, 22, 23, 24, 38]

## The HHS draft policy for six peptides

On October 30, 2026, the Department of Health and Human Services (HHS), which oversees the FDA, announced a draft enforcement discretion policy. Enforcement discretion is a choice not to enforce the law in some cases. HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding with six peptides under section 503A. They are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. No other peptide is covered, nor are 503B outsourcing facilities. [25, 38]

Forms and routes covered by HHS’s draft policy. [38]

| Peptide | Form named | Routes covered |
| --- | --- | --- |
| BPC-157 | Acetate salt | Injection under the skin or into a muscle; by mouth; on the skin |
| Epitalon | Acetate salt | Injection under the skin or into a muscle, “dispensed in intermittent courses” |
| KPV | Acetate salt | On the skin; by mouth |
| MOTS-c | Acetate salt | Injection under the skin or into a muscle |
| Semax | Free base | In the nose only |
| TB-500 | Acetate salt | Injection under the skin or into a muscle |

The policy applies only if all ten conditions are met, including: [38]

- One active ingredient, with no blends.
- A valid prescription for an individual patient.
- An ingredient from an FDA-registered manufacturer, tested and documented on a certificate of analysis.
- Serious health problems and quality problems reported to the FDA and the states involved.
- The label line “This is a compounded drug product. Not for resale.”
- An FDA-cleared syringe as the only device.
- For anything taken by mouth, documented adequate absorption in people.

Sources for the list above: [38]

HHS says the policy will “discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients”. It calls this “a more controlled alternative”, meant to expand access while the FDA reviews the six. For each, it says FDA staff opposed listing and the committee voted in favor. HHS cites newer supplier test results and documented past use. For TB-500, epitalon, semax and KPV, it says FDA staff’s safety concerns rest on theory or missing data, not observed harm. [38]

HHS’s Federal Register notice says the draft “is not binding on HHS or the public”. HHS “may revisit” the policy if, among other things, an early sign of harm (a safety signal) or a product quality problem arises. It is not an approval, adds no peptide to the 503A bulks list and lasts until a final FDA rule decides each peptide’s listing. HHS took comments for two weeks after publication. [25, 38]

## Peptides that count as biologics

Under an FDA rule in effect since March 23, 2020, a chain of more than 40 amino acids with a defined sequence is a protein. Chains that join in nature count together. A protein used as a medicine is a biological product. On that date, approved drugs that met the definition became licensed biologics, which the FDA says are not eligible for the 503A and 503B exemptions. [26, 27]

One example is tesamorelin, a lab-made version of the 44-amino-acid chain of human growth hormone-releasing factor. On March 23, 2020, it became a licensed biologic, as did human chorionic gonadotropin (hCG), a pregnancy hormone, and growth hormone (somatropin). [28, 29]

Shorter chains, such as the 15 amino acids reported for BPC-157, are not proteins under the rule. TB-500 is a seven-amino-acid fragment of thymosin beta-4, which has 43 amino acids, above the cutoff. [4, 5, 26]

## Where each peptide stands today

Federal status of selected peptides as of November 13, 2026. [4, 5, 6, 13, 14, 16, 18, 19, 23, 28, 29, 30, 31, 32, 33, 34, 35, 38]

| Peptide | FDA-approved? | Federal compounding status |
| --- | --- | --- |
| BPC-157, TB-500 (a thymosin beta-4 fragment), MOTS-c, KPV, epitalon, semax | No | Withdrawn from 503A Category 2; FDA staff advised against listing them, but HHS says the committee voted in favor; named in HHS’s draft enforcement policy |
| Emideltide (DSIP) | No | Withdrawn from 503A Category 2; FDA staff advised against listing it; not named in HHS’s draft enforcement policy |
| LL-37, melanotan II, PEG-MGF, dihexa | No | Withdrawn from 503A Category 2; committee review planned before the end of February 2027 |
| CJC-1295, AOD-9604, thymosin alpha-1 | No | Withdrawn from 503A Category 2; committee voted against them on December 4, 2024; thymosin alpha-1 is in 503B Category 3 |
| Selank | No | Withdrawn from Category 2 |
| GHK-Cu | No | 503A Category 1 except by injection; injectable form withdrawn from Category 2; committee review planned before the end of February 2027 |
| Ipamorelin | No | 503B Category 2 since September 29, 2023; 503A nomination withdrawn; committee voted against it on October 29, 2024 |
| Kisspeptin-10 | No | 503A Category 2 since September 29, 2023; committee voted against it on October 29, 2024 |
| GHRP-2 | No | 503B Category 2 by injection or nose since September 29, 2023, and Category 1 by other routes; 503A Category 3 |
| GHRP-6 | No | 503B Category 2 since September 29, 2023; 503A Category 3 |
| Ibutamoren (MK-677), not a peptide | No | 503B Category 2 since December 29, 2022, and 503A Category 2 since September 29, 2023; committee voted against it on October 29, 2024 |
| Sermorelin | No longer: its approvals were withdrawn in 2009, not for safety or effectiveness reasons | Not in the 503A categories; 503B Category 1, where the FDA marks sermorelin acetate as a component of FDA-approved drugs |
| Tesamorelin | Yes, since 2010, for excess abdominal fat in adults with HIV and lipodystrophy, a condition that changes where the body stores fat | Biological product since March 23, 2020, so outside 503A and 503B compounding |
| Elamipretide (SS-31) | Yes, since 2025, to improve muscle strength in some people with Barth syndrome, a rare genetic disorder | Only the hydrochloride salt is in an FDA-approved drug; other forms count as separate ingredients |

## What this means if you’re offered a peptide

A peptide’s status depends on the exact substance, salt form and route. Questions to ask the clinician or pharmacy: [4, 13, 38]

- Which test does this ingredient pass: a USP or NF monograph, an FDA-approved drug, or the 503A bulks list?
- If none, which FDA category or HHS policy is the pharmacy relying on, and does it cover this exact form and route?
- Is the compounder a state-licensed 503A pharmacy or a 503B outsourcing facility?
- Is the bulk ingredient from an FDA-registered manufacturer, with a certificate of analysis, and not dietary supplement grade?
- Is it exactly the substance the FDA or HHS lists, or a similarly named relative?

Sources for the list above: [1, 2, 5, 36, 38]

## Sources

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