Peptides are short chains of amino acids. A few are FDA-approved drugs, but many prescribed peptides are compounded, which means they are not FDA-approved. FDA rules decide which peptide ingredients pharmacies may use, and those rules shifted between 2023 and 2026.
Peptides are short chains of amino acids, the same building blocks that make up proteins. Some peptides are FDA-approved medicines that went through clinical trials and FDA review. Many others reach patients through compounding pharmacies, and compounded drugs are not FDA-approved. Which peptide ingredients a pharmacy may legally use depends on a set of FDA rules and interim policies that changed noticeably between 2023 and 2026, so it helps to understand how the system works before you consider any peptide.
A peptide therapy is a medicine whose active ingredient is a chain of amino acids. Many peptides copy or adjust a signal the body already uses. For example, bremelanotide, the drug also known as PT-141, is a melanocortin receptor agonist; a 2022 review by Edinoff and colleagues explains that activating one of these receptors (MC4R) modifies brain pathways involved in sexual response.
Being a peptide does not tell you whether a product has been tested. Bremelanotide, under the brand name Vyleesi, received FDA approval in June 2019 after clinical trials. Sermorelin was once FDA-approved as the brand Geref, but those approvals were withdrawn in 2009 at the manufacturer's request, and the FDA later determined the products were not withdrawn for reasons of safety or effectiveness. Many other peptides have been nominated for use in compounding, as the FDA lists described below show.
State-licensed pharmacists and physicians can compound under section 503A of the federal Food, Drug, and Cosmetic Act. The FDA explains that 503A compounders may use a bulk drug substance (the raw active ingredient) only if it meets one of these conditions:
Whatever the pathway, the ingredient must come with a valid certificate of analysis and be made by an FDA-registered establishment. The 503A bulks list itself is short: a final regulation in February 2019 placed six substances on it, and the FDA continues to evaluate nominated substances through notice-and-comment rulemaking.
While nominations for the bulks list are evaluated, the FDA uses an interim policy that sorts nominated substances into categories:
| Category | What it means |
|---|---|
| Category 1 | May be eligible for the list and nominated with enough supporting information. FDA does not intend to take action against compounders using it if the policy's conditions are met. |
| Category 2 | Nominated with enough information, but FDA has identified significant safety risks. FDA would consider enforcement action. |
| Category 3 | Nominated with insufficient information. Not covered by the category 1 policy; can be renominated with more support. |
A category is a temporary enforcement position, not an approval. Even a substance in category 1 is still used to make compounded drugs that are not FDA-approved.
2023. The FDA's list of substances that may present significant safety risks shows several peptides added to category 2 on September 29, 2023. The page explains that substances placed in category 2 are ones for which FDA has identified significant safety risks in compounding.
2024. On December 4, 2024, the FDA's Pharmacy Compounding Advisory Committee met to discuss three groups of peptide substances being considered for the 503A bulks list.
2025. According to the FDA's 503A page, a January 7, 2025 guidance revising the interim policy states that FDA "does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories."
2026. The FDA's category 2 page, current as of April 2026, now includes a separate table of peptide substances whose nominations were withdrawn by the nominators. In July 2026 the advisory committee met again, on July 23 and 24, to discuss seven peptides being considered for inclusion on the 503A bulks list. The meeting page does not record a final FDA decision. Because this area is moving, ask your prescriber how the current FDA status applies to any peptide you are offered.
NewDay Wellness offers the peptide programs below. Each is prescribed by a licensed provider after an online visit, and each is compounded, which means none of them is FDA-approved.
The FDA states plainly that compounded drugs are not FDA-approved and that the agency does not review their safety, effectiveness or quality before marketing. It also notes that compounded drugs can meet real medical needs, and that poor-quality compounding, such as contamination or too much active ingredient, can cause serious harm. That is why the pharmacy's licensing, the ingredient's source and your prescriber's reasoning all matter. Dosing is set by your prescriber.
Not automatically. Whether a product has been tested depends on whether it went through FDA review, not on its structure. The FDA has placed some nominated peptides in category 2 because it identified significant safety risks with their use in compounding.
No. Vyleesi is the FDA-approved brand of bremelanotide, reviewed for a specific use in premenopausal women. Compounded PT-141 contains the same named ingredient but is a different product that has not gone through FDA approval, and its use outside the approved indication is off-label.
It means the FDA has identified significant safety risks with using that substance in compounding and would consider enforcement action against compounders who use it. It is a signal of regulatory concern, not a finding about any one patient.
No. Under section 503A, the bulk ingredient must meet one of three FDA conditions, such as being a component of an FDA-approved drug or appearing on the 503A bulks list, and it must come from an FDA-registered source with a certificate of analysis.
A licensed provider can explain whether a peptide is FDA-approved or compounded, what evidence exists for your specific goal, and whether an approved alternative is available. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
In published studies, the most commonly reported sermorelin side effects were brief facial flushing and pain at the injection site. Long-term safety data in adults are limited, and related drugs carry warnings about blood sugar, fluid retention and active cancer.
Read articleSermorelin is a lab-made copy of the first 29 amino acids of growth hormone-releasing hormone. It signals the pituitary to release its own growth hormone rather than supplying the hormone directly. The US brand was discontinued, and compounded sermorelin is not FDA-approved.
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Off-label prescribing means using an FDA-approved drug for a condition, dose, form or population that is not in its label. It is legal and common, but the FDA has not reviewed that use, and the supporting evidence ranges from strong to thin.
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