It depends on the peptide. It also depends on how it is made and sold. There are three routes. A peptide can be an approved drug. It can be compounded by a pharmacy. Or it can be sold with no approval at all.
This page states what FDA documents list. It is not legal advice. State pharmacy law can add rules on top.
First: is it a drug or a protein?
FDA draws the line at 40 amino acids [1]. A chain longer than 40 is a “protein.” Proteins are regulated as biological products. Chains of 40 or fewer fall outside that definition and are generally regulated as drugs. Every peptide on this page is on the drug side. The basics are in what are peptides.
Route 1: FDA-approved peptides
An approved peptide has passed FDA review for a stated use. Its label sets the dose. Semaglutide, tirzepatide and bremelanotide are examples. A prescriber may prescribe them. The head-to-head trials show what that review rests on.
Route 2: compounding, 503A and 503B
Compounding is a pharmacy making a drug itself. Federal law has two paths [2].
- 503A pharmacies compound from valid patient-specific prescriptions. They are exempt from FDA pre-approval and some labeling rules.
- 503B outsourcing facilities register voluntarily. They must follow federal manufacturing rules. FDA inspects them on a risk-based schedule. They may fill office-stock orders without a named patient.
For raw ingredients, FDA keeps interim lists of bulk substances nominated for 503A compounding [3]. There are three categories.
- Category 1: under evaluation. Examples include NAD, glutathione and GHK-Cu, except by injection.
- Category 2: raises significant safety risks. The May 2026 list includes kisspeptin-10 and ibutamoren.
- Category 3: nominated without adequate support. GHRP-2 and GHRP-6 are here.
July 2026: an advisory vote, not a change
FDA’s compounding advisory committee met July 23–24, 2026 [6]. It reviewed seven peptides for the 503A list. They were BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and epitalon.
FDA’s own briefing on BPC-157 concluded the balance “weighs against” listing it [7]. The committee still voted to recommend six of the seven. It rejected emideltide [8].
The votes are recommendations. They do not bind FDA. Listing needs final rulemaking first. Until then, pharmacies may not compound these peptides, NCPA reports. None of the seven is on the May 14, 2026 list.
Ipamorelin is a split case. It appears among the withdrawn 503A nominations. It is also in 503B Category 2, added September 29, 2023. The ipamorelin evidence explains FDA’s stated concern.
Sermorelin is another special case. Its approved product, GEREF, left the market. In 2013 FDA ruled it was not withdrawn for safety or effectiveness. The sermorelin side effects page covers its record.
Route 3: “research use only”
Many peptides are sold online labeled “for research use only.” The label is not a legal category of its own.
FDA regulation defines intended use by “objective intent” [5]. That intent can be shown by labeling and advertising. It can be shown by statements from the seller. It can also be shown by “the circumstances surrounding the distribution.” Under that rule, the label is not the only thing that counts.
How this site applies the lists
- Each compound’s status is read from an FDA or Federal Register source.
- The read date is recorded beside it.
- A compound with an unread status is treated as research only.
- Research-only compounds get evidence pages only. No sellers, no prices.
The full rules are in the editorial policy.