Peptide guide
Every peptide your clients will ask about, and where it stands
The six covered peptides are one part of a bigger picture. This page puts them next to the approved ones, the ones still under review and the ones no licensed pharmacy may compound, so you can answer the question honestly when it comes up.
Regulatory status, as of October 29, 2026
Check the date. The next advisory committee meeting changes this table.
Sermorelin
Growth hormone releasing hormone analogue, 29 amino acids
Nominated to the 503A bulks list and placed in Category 1, where FDA does not intend to take action. The approved product (Geref) was withdrawn in 2008 for commercial, not safety, reasons. Available through Local Healthcare programs now.
The six covered peptides
BPC-157, TB-500, Epitalon, Semax, KPV, MOTS-c
Compoundable by 503A pharmacies and physicians that meet every condition of the policy. Not FDA-approved, and not yet on the final 503A bulks list. See the policy page.
Semaglutide, tirzepatide
GLP-1 receptor agonists, FDA-approved as branded drugs
These are peptides too, but a different world: approved medicines with full trials. Compounded copies are allowed only in narrow circumstances now that shortages have ended. Offered through the medical weight loss program on every Local Healthcare domain.
Tesamorelin
GHRH analogue, 44 amino acids, FDA-approved as Egrifta
Over 40 amino acids, so it is regulated as a biological product and cannot be compounded by a 503A pharmacy. Named in FDA warning letters to grey-market sellers in 2026.
PT-141 (bremelanotide)
Melanocortin agonist, FDA-approved as Vyleesi
An approved product exists, which removes the usual basis for compounding. Research-use-only PT-141 was named in August 2026 FDA warning letters.
CJC-1295, ipamorelin
Growth hormone secretagogues
Placed in Category 2 (significant safety risks identified) in September 2023 and not part of the October 2026 policy. FDA has said it would consider taking action against compounding.
GHK-Cu, LL-37, dihexa, melanotan II, PEG-MGF
Five further nominated peptides
Announced for advisory committee review in April 2026. A favourable vote does not itself make them compoundable; it took a further HHS policy to open the first six. This table will be updated when the committee meets.
DSIP (emideltide)
Delta sleep-inducing peptide
The committee voted 7 to 6 with one abstention against recommending it. Not covered by the policy.
Retatrutide
Triple agonist, investigational
Still in clinical trials. Named in three FDA warning letters to online sellers in 2026.
NAD+, glutathione
Not peptides
Often sold alongside peptides but chemically unrelated. NAD+ is a coenzyme and glutathione a tripeptide antioxidant with its own regulatory history. Available on some Local Healthcare storefronts as recovery programs.
The basics
What is a peptide?
A short chain of amino acids, the building blocks of protein. Insulin is a peptide. So are semaglutide and tirzepatide. Chains of 40 amino acids or fewer are regulated as drugs; longer chains are biological products under a separate law that a compounding pharmacy cannot operate under, which is why tesamorelin and hCG are off the table.
Why were peptides a grey market?
Few have an approved product and none of the popular ones had a USP monograph, so a 503A pharmacy had no lawful basis to compound them once FDA placed them in Category 2 in 2023. Demand went to online sellers labelling vials "research use only". FDA treats that label as meaningless when the website plainly markets to people, and has said so in warning letter after warning letter.
What makes a peptide compoundable?
One of three things: a USP or NF monograph, being a component of an FDA-approved drug, or appearing on the 503A bulks list. The October 2026 policy adds a fourth, temporary route for six peptides: HHS enforcement discretion while the bulks list rulemaking catches up. Sermorelin reached Category 1 by the ordinary route, which is why it has been available all along.
Approved, compoundable, or neither?
Three different things. Approved means FDA has reviewed trials and licensed a product. Compoundable means a pharmacy may prepare it for an individual patient under a prescription. The six are compoundable, not approved. BPC-157 bought from a website is neither.
This page describes regulatory categories and the research literature. It is not medical advice and not an offer of treatment. No compounded peptide is FDA-approved. Regulatory sources are listed on the policy page.