Are peptides FDA approved?

The clinical detail.

"FDA approved" sounds like a binary, but for therapeutic peptides the picture is more nuanced. A peptide can be: (1) FDA-approved for a specific indication; (2) FDA-approved for one indication but used off-label for others; (3) not FDA-approved, but legally compounded by a 503A or 503B pharmacy under a physician's prescription; or (4) not FDA-approved and not appropriate for clinical use. The category matters because it changes the source, the oversight, and the risk profile.

FDA-approved peptides.

A small set of peptides have full FDA approval for specific indications. Examples relevant to functional and integrative practice include:

• Bremelanotide (Vyleesi) — FDA-approved in 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women. Sold as an autoinjector. PT-141 is the research/development name for the same molecule.
• Semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) — FDA-approved GLP-1 receptor agonists for type 2 diabetes and weight management. THE WELLNESS CO. does not prescribe these.
• Liraglutide (Victoza, Saxenda) — FDA-approved GLP-1 agonist for diabetes and weight management.
• Insulin (all variants) — the original peptide therapeutic, FDA-approved across many formulations.
• Glucagon — FDA-approved for hypoglycemia rescue.
• Octreotide — FDA-approved for acromegaly and certain endocrine tumors.

Off-label use of FDA-approved peptides.

Once a drug is FDA-approved for any indication, licensed clinicians can prescribe it off-label for other clinically appropriate uses. This is a routine, legal practice in U.S. medicine, but it requires the clinician to disclose the off-label status and to base the off-label use on clinical judgment and the available evidence base. Example: PT-141 (Vyleesi) is FDA-approved for HSDD in premenopausal women; clinicians sometimes prescribe it off-label for other sexual-function indications. The patient should know that.

Compounded peptides (503A and 503B pharmacies).

Many therapeutic peptides used in functional medicine are not FDA-approved but are legally compounded by specialty pharmacies. 503A pharmacies compound prescriptions on a per-patient basis under a physician's order. 503B outsourcing facilities compound larger batches under stricter manufacturing standards. Both operate under FDA-overseen frameworks but produce products that have not gone through the full new drug approval process.

Compounded peptides used clinically include sermorelin, CJC-1295, ipamorelin, BPC-157, AOD-9604, and others. Each compounded peptide carries the caveat: it is not FDA-approved for the indication for which it's being prescribed, and the patient should know this before starting.

The 2023 FDA reclassification.

In late 2023 the FDA reclassified several peptides commonly compounded in the functional medicine space, moving some to Category 2 status (presents significant safety risks) which restricts the conditions under which they can be compounded. This affected the availability and prescribing patterns for some peptides previously widely compounded. The regulatory landscape continues to evolve.

At THE WELLNESS CO., we follow FDA guidance on which peptides remain legally compoundable. We source from licensed, audited 503A and 503B pharmacies that follow USP compounding standards. We do not source from research-chemical channels, "buy peptides online" supply, or any source that is not a licensed pharmacy.

What "FDA-approved" doesn't tell you.

FDA approval is one signal among several. A peptide can be FDA-approved for one indication and yet inappropriate for an individual patient because of contraindications, drug interactions, or lack of clinical fit. Conversely, a peptide can lack FDA approval but have substantial international evidence, decades of clinical use, and an excellent safety record. The right question is not "is it FDA-approved?" but "is the evidence base for this use appropriate, is the source legitimate, and is the monitoring discipline in place?"

This is the framework we use. We disclose the regulatory status (FDA-approved on-label, FDA-approved off-label, or compounded). We share the evidence base for the intended use. We monitor structurally. And we don't recommend peptides we don't believe are appropriate for the patient's clinical picture.

Where this fits in our methodology.

Honest regulatory framing is part of the CLARITY methodology. Every peptide we offer is accompanied by its regulatory status, evidence base, source pharmacy, monitoring requirements, and contraindications. Patients should leave a peptide consultation knowing what they're agreeing to, not just hearing claims of benefit. See the methodology in full.

For specific molecules, see PT-141, Sermorelin, BPC-157, CJC-1295/Ipamorelin, NAD+, AOD-9604.