A peptide is a short chain of amino acids; FDA treats chains of 40 or fewer amino acids as peptides, and whether a given peptide is legal depends on whether it is an FDA-approved drug or a substance FDA allows pharmacies to compound [23][7].
At a glance
6 of the 27 peptide entries we track are legal to get today; BPC-157 is not one of them [2].
FDA status of every peptide we trackRemoval from Category 2 in April 2026 did not make any peptide legal to compound [3].
What changed in 2025 and 2026FDA has rejected "research use only" labels in warning letters through Aug 24, 2026 [32][37].
What "research use only" means, and who FDA and DOJ have acted againstFDA-approved GLP-1 drugs such as Wegovy and Zepbound are peptides [24][25].
Peptides for weight loss
- Not allowed, no review scheduled or a no vote
- 8 entriesIncluding CJC-1295 and ipamorelin [2]
This page tracks the legal status of 27 peptide entries people search for, from BPC-157 to retatrutide. Each row is dated and sourced to FDA's own lists, advisory committee records and drug labels. When FDA acts, the row changes. The status box on each peptide's page reads from the same file, so the tracker and the pages never disagree. For prices of the options that are legal, see our legal peptide price tracker.
FDA status of every peptide we track
Status labels: FDA-approved drug means a brand you can fill at a pharmacy for its approved use. Can be compounded means the substance is in FDA's Category 1, so a 503A pharmacy may make it for one patient with a prescription [7]. Waiting on FDA means an advisory committee voted yes but FDA has not acted, so it is still not legal to compound [5]. Under FDA review means a committee review is planned before the end of February 2027 [2]. Not allowed means FDA's committee voted no, or the substance sits outside every category with no review scheduled, or, for a blend, its ingredients cannot be compounded.
| Peptide | Status | Where it stands | Checked |
|---|---|---|---|
| PT-141 (bremelanotide) | FDA-approved drug | FDA-approved as Vyleesi in 2019 for low sexual desire in premenopausal women only [19] [18]. | Oct 19, 2026 |
| SS-31 (elamipretide) | FDA-approved drug | FDA accelerated approval as Forzinity on Sept 19, 2025, for Barth syndrome only [20]. | Oct 19, 2026 |
| Tesamorelin | FDA-approved drug | FDA-approved as Egrifta for HIV lipodystrophy only. A biologic since 2020, so not eligible for compounding [17] [21]. | Oct 19, 2026 |
| Glutathione | Can be compounded with a prescription | Category 1: may be compounded with a prescription. CDC linked 2026 illnesses to compounded glutathione injections made with supplement-grade ingredients [2] [43]. | Oct 19, 2026 |
| NAD | Can be compounded with a prescription | Category 1: a 503A pharmacy may compound it with a prescription. No FDA-approved NAD drug [2]. | Oct 19, 2026 |
| GHK-Cu (topical) | Sold as a cosmetic (topical) | Non-injectable forms are Category 1 and may be compounded with a prescription. Injectable GHK-Cu is not allowed [2]. | Oct 19, 2026 |
| BPC-157 | Waiting on FDA after a favorable vote | Favorable 8-6-1 committee vote July 23, 2026; nonbinding. Not legal to compound until FDA acts [4] [1]. | Oct 19, 2026 |
| Epitalon | Waiting on FDA after a favorable vote | Favorable committee vote July 24, 2026 (reported as 7-4-1 or 7-5-1); nonbinding. Not legal to compound until FDA acts [12] [59] [1]. | Oct 19, 2026 |
| KPV | Waiting on FDA after a favorable vote | Favorable 8-6-1 committee vote July 23, 2026; nonbinding. Not legal to compound until FDA acts [4] [1]. | Oct 19, 2026 |
| MOTS-c | Waiting on FDA after a favorable vote | Favorable 7-5-2 committee vote July 23, 2026; nonbinding. Not legal to compound until FDA acts [4] [1]. | Oct 19, 2026 |
| Semax | Waiting on FDA after a favorable vote | Favorable 8-5-1 committee vote July 24, 2026; nonbinding. Not legal to compound until FDA acts [12] [1]. | Oct 19, 2026 |
| TB-500 | Waiting on FDA after a favorable vote | Favorable 8-6-1 committee vote July 23, 2026; nonbinding. Not legal to compound until FDA acts [4] [1]. | Oct 19, 2026 |
| Dihexa | Under FDA review | Waiting for a committee review planned before the end of February 2027. Not legal to compound [10] [2]. | Oct 19, 2026 |
| GHK-Cu (injectable) | Under FDA review | Injectable form waiting for a committee review planned before the end of February 2027; not legal to compound. Topical forms are Category 1 [2]. | Oct 19, 2026 |
| LL-37 | Under FDA review | Waiting for a committee review planned before the end of February 2027. Not legal to compound [10] [2]. | Oct 19, 2026 |
| Melanotan II | Under FDA review | Waiting for a committee review planned before the end of February 2027. Not legal to compound [10] [2]. | Oct 19, 2026 |
| PEG-MGF | Under FDA review | Waiting for a committee review planned before the end of February 2027. Not legal to compound [10] [2]. | Oct 19, 2026 |
| Retatrutide | Not approved: trials only | Not approved anywhere; in trials. Cannot be compounded. Lilly plans to file with FDA in early 2027 [30] [31] [29]. | Oct 19, 2026 |
| AOD-9604 | Not allowed in compounding | Committee voted 0-12 against Dec 4, 2024. Not legal to compound; no review scheduled [16] [2]. | Oct 19, 2026 |
| CJC-1295 | Not allowed in compounding | Committee voted against all forms Dec 4, 2024. Not legal to compound; no review scheduled [16] [2]. | Oct 19, 2026 |
| DSIP | Not allowed in compounding | Committee voted 6-7-1 against on July 24, 2026. Not legal to compound [12] [2]. | Oct 19, 2026 |
| Ipamorelin | Not allowed in compounding | Committee voted 0-12-1 against Oct 29, 2024. Not legal to compound; no review scheduled [15] [2]. | Oct 19, 2026 |
| Kisspeptin-10 | Not allowed in compounding | Still in Category 2. Committee voted 0-11 against Oct 29, 2024. Not legal to compound [2] [15]. | Oct 19, 2026 |
| KLOW | Not allowed in compounding | Blend reported to contain GHK-Cu, BPC-157, TB-500 and KPV (low-confidence source). No ingredient is legal to compound for injection today [69] [2]. | Oct 19, 2026 |
| Selank | Not allowed in compounding | Not legal to compound. Listed as nominated but withdrawn; not among the 12 peptides removed in April 2026; no review scheduled [8] [3]. | Oct 19, 2026 |
| Thymosin alpha-1 | Not allowed in compounding | Committee voted 4-17 against Dec 4, 2024. Not legal to compound; no review scheduled [16] [2]. | Oct 19, 2026 |
| Sermorelin | Not confirmed | Brand Geref was discontinued and its approval withdrawn in 2009. Not on any 503A category list. FDA has not said clearly whether it may be compounded [61] [2]. | Oct 19, 2026 |
| Status | Entries | Which ones |
|---|---|---|
| FDA-approved drug | 3 | Tesamorelin, PT-141 (bremelanotide) and SS-31 (elamipretide) |
| Can be compounded with a prescription | 2 | NAD and Glutathione |
| Non-injectable or cosmetic only | 1 | GHK-Cu (topical) |
| Waiting on FDA after a favorable vote | 6 | BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon |
| Under FDA review | 5 | GHK-Cu (injectable), LL-37, Dihexa, Melanotan II and PEG-MGF |
| Not approved: trials only | 1 | Retatrutide |
| Not allowed in compounding | 8 | Selank, DSIP, CJC-1295, Ipamorelin, AOD-9604, Thymosin alpha-1, Kisspeptin-10 and KLOW |
| Not confirmed | 1 | Sermorelin |
| All entries | 27 | GHK-Cu has two entries (injectable and topical); KLOW is a blend, not a single peptide |
How FDA decides whether a pharmacy may compound a peptide
A 503A compounding pharmacy may make a drug from a bulk ingredient only if one of three things is true: the ingredient meets a USP or NF monograph, it is a component of an FDA-approved drug, or it is on FDA's 503A bulks list [7]. Most peptides sold for wellness meet none of these. While FDA builds the bulks list, it sorts nominated substances into interim categories [7]:
- Category 1: nominated with enough information for FDA to evaluate. FDA does not intend to act against pharmacies that compound with these while it decides [7]. This is the only category with that protection.
- Category 2: FDA has identified significant safety risks, and it may take enforcement action [7].
- Category 3: nominated with too little information to evaluate; not covered by the Category 1 policy [7].
- Nominated but withdrawn: where 17 of the peptides in our tracker now sit. These substances are in no category, so no interim protection applies [8].
FDA also said it does not intend to place substances nominated on or after Jan 7, 2025 into these interim categories [7]. To add a substance to the bulks list, FDA asks its Pharmacy Compounding Advisory Committee for advice. The committee's votes are not binding. FDA then has to go through notice-and-comment rulemaking, starting with a proposed rule [5]. FDA could instead place a peptide in Category 1 or announce enforcement discretion in the meantime, and one law firm says there is no reliable timetable for any of it [5].
503B outsourcing facilities follow a separate list. They may use a bulk substance only if it is on the 503B bulks list or the drug is on FDA's shortage list [54]. FDA has not said whether the 2026 peptide actions will extend to 503B [10]. Ipamorelin acetate is still in Category 2 for 503B [8].
Peptides that are legal to get today
These are the routes that exist as of Oct 19, 2026. Each one is limited: an FDA approval covers one use, and Category 1 compounding requires a prescription for an individual patient [3].
| Peptide | Legal route | Approved or allowed for | Source |
|---|---|---|---|
| Tesamorelin (Egrifta WR, Egrifta SV) | FDA-approved drug, first approved 2010 | Reducing excess abdominal fat in adults with HIV who have lipodystrophy; not for weight loss | [17] |
| Bremelanotide (Vyleesi) | FDA-approved drug, approved June 21, 2019 | Premenopausal women with acquired, generalized hypoactive sexual desire disorder; not for men or postmenopausal women | [19][18] |
| Elamipretide (Forzinity) | FDA accelerated approval, Sept 19, 2025 | Barth syndrome in patients weighing at least 30 kg | [20] |
| NAD | Category 1: 503A compounding with a prescription | No FDA-approved NAD drug; compounded NAD is not FDA-approved. The NAD disodium salt form is Category 3 | [2] |
| Glutathione | Category 1: 503A compounding with a prescription | No FDA-approved glutathione drug; CDC linked 2026 illnesses to compounded glutathione injections made with supplement-grade ingredients | [2][43] |
| GHK-Cu, non-injectable | Category 1 for creams and other non-injectable forms; also sold as cosmetics | Injectable GHK-Cu is not allowed | [2][53] |
| Semaglutide, tirzepatide and other GLP-1 drugs | FDA-approved drugs | Wegovy and Zepbound for chronic weight management; Ozempic and Mounjaro for type 2 diabetes | [26][27][24][57] |
Sermorelin is sold by clinics as a compounded drug, but we found no FDA statement on whether that is lawful, so we list it as not confirmed. Its only brand, Geref, is no longer sold. See sermorelin cost and status.
How to check a clinic or online peptide program
- Ask which peptide, in which form. Only the routes in the table above are legal today; BPC-157, TB-500 and the other peptides that lack Category 1 status cannot be compounded by a 503A pharmacy [2].
- Ask which pharmacy makes it. In our October 2026 price check, only one telehealth seller of compounded peptides named its dispensing pharmacy on its site. A compounded drug is made for you by a licensed pharmacy on a prescription, and it is not FDA-approved.
- Ask whether the price includes the prescriber visit, labs, supplies and shipping. Our peptide price tracker shows what each seller says its price covers.
- Check the seller's FDA record. FDA has sent warning letters to telehealth companies over compounded drug claims; see FDA warning letters.
What changed in 2025 and 2026
Newest first. Each peptide's own page carries its own dated history.
- Oct 14 or 15, 2026: HHS sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget. Holland & Knight dates it Oct 14; the AP reported it appeared on a government website Oct 15. Its text is not public and it has not been issued [1][6]. The AP, citing two unnamed people familiar with the plan, reported it is meant to let pharmacies temporarily compound some of the most popular peptides, including BPC-157 [6]; Holland & Knight says the details are unknown [1].
- Oct 1, 2026: FDA's page on unapproved GLP-1 drugs, updated this date, says retatrutide cannot be used in compounding under federal law [31].
- Sept 15, 2026: CDC's outbreak page, updated this date, reported more than 25 people sick in at least four states, at least three hospitalized, after compounded glutathione injections made with ingredients intended for dietary supplements; CDC says the illnesses are likely linked to high endotoxin levels [43].
- Aug 24, 2026: FDA sent warning letters to online sellers of "research use only" peptides, citing products including tirzepatide, semaglutide, retatrutide, SS-31, PT-141 and tesamorelin [37][38]. None of the six peptides the committee had favored was cited [39].
- Aug 12, 2026: Lilly announced six lawsuits against retatrutide sellers [30].
- July 30, 2026: The owner of Paradigm Peptides, an Indiana seller, was sentenced to 5 years 10 months [40].
- July 24, 2026: The committee voted 8 yes, 5 no and 1 abstain for Semax, voted for epitalon (reported as 7-4-1 or 7-5-1), and voted 6 yes, 7 no and 1 abstain against DSIP [12][4][59].
- July 23, 2026: The committee voted 8 yes, 6 no and 1 abstain for BPC-157, TB-500 and KPV, and 7 yes, 5 no and 2 abstain for MOTS-c [4][13]. FDA staff had recommended against all seven peptides on the agenda [11].
- July 23, 2026: Lilly said it plans to submit a Biologics License Application for retatrutide in the first quarter of 2027 [29].
- May 21, 2026: Lilly reported topline TRIUMPH-1 results for retatrutide [28].
- May 14, 2026: FDA's updated categories document put non-injectable GHK-Cu back in Category 1 and said FDA intends to consult the committee on injectable GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF before the end of February 2027. Kisspeptin-10 is the only peptide in our tracker still in Category 2 [2].
- May 11 to 15, 2026: FDA posted staff briefing documents recommending against adding BPC-157, TB-500, KPV, MOTS-c, Semax, epitalon and DSIP to the bulks list [11][45].
- April 22, 2026: The removal took effect. FDA now lists these peptides as nominated but withdrawn, which does not allow compounding [8][3].
- April 15, 2026: FDA gave seven days' notice that it would remove 12 peptides from Category 2 because the nominators withdrew their nominations [9]. Removal from Category 2 does not make them eligible for 503A compounding [3].
- April 1, 2026: A federal grand jury in Utah indicted an osteopathic physician on charges of receiving and delivering misbranded drugs from China, including BPC-157, TB-500, ipamorelin and CJC-1295. These are allegations only [41].
- March 31, 2026: FDA sent warning letters to sellers of "research" retatrutide and other coded GLP-1 products [34][35].
- Sept 19, 2025: FDA granted accelerated approval to Forzinity (elamipretide) for Barth syndrome [20].
- March 25, 2025: Theratechnologies announced FDA approval of Egrifta WR (tesamorelin) [55].
- Feb 26, 2025: FDA warned an online seller that "research use only" labels did not change its products' status as unapproved drugs [32].
- Jan 7, 2025: FDA says it does not intend to place substances nominated on or after this date into the interim categories [7].
Before that: FDA placed 18 peptides and ibutamoren in Category 2 on Sept 29, 2023, citing significant safety risks [14]. A lawsuit over those placements settled in September 2024, and FDA scheduled committee meetings [56]. The committee voted against ipamorelin and kisspeptin-10 on Oct 29, 2024 [15], and against CJC-1295, AOD-9604 and thymosin alpha-1 on Dec 4, 2024 [16].
What "research use only" means, and who FDA and DOJ have acted against
Many online sellers label peptide vials "research use only" or "not for human consumption." FDA does not accept that label as a legal workaround. In a 2025 warning letter it wrote: "Despite statements on your product labeling and website such as 'research use only,'" the products were unapproved new drugs [32]. We do not link to these sellers. They appear on this page only where FDA or the Justice Department named them.
| Date | Recipient | What FDA or DOJ cited | Source |
|---|---|---|---|
| Dec 10, 2024 | Summit Research Peptides | Semaglutide, retatrutide, cagrilintide, tirzepatide and mazdutide labeled research use only; unapproved new drugs | [33] |
| Feb 26, 2025 | USApeptide.com | Semaglutide, tirzepatide, bacteriostatic water and syringes; unapproved and misbranded drugs | [32] |
| Mar 31, 2026 | Prime Sciences | Cagrilintide, retatrutide sold as "GLP1-R", mazdutide; "laboratory research purposes only" rejected | [34] |
| Mar 31, 2026 | Mile High Compounds LLC | Retatrutide sold as "GLP-3 RT" and other coded GLP-1s | [35] |
| Apr 1, 2026 | Utah physician (DOJ indictment) | Charged with receiving misbranded drugs from China, including BPC-157, TB-500, ipamorelin, CJC-1295, GHK-Cu and NAD+, given to more than 200 patients. Allegations only | [41] |
| Jun 17, 2026 | Wholesale Peptide | Prostamax and gonadorelin; research use only labeling contradicted | [36] |
| July 30, 2026 | Paradigm Peptides owner (DOJ sentencing) | Sentenced to 5 years 10 months; products sold as SARMs contained testosterone, and prosecutors described its peptides as believed to be unapproved new drugs | [40] |
| Aug 24, 2026 | Royal Peptides LLC | Tirzepatide, semaglutide, retatrutide, SS-31, PT-141, tesamorelin | [37] |
| Aug 24, 2026 | Peptide Partners LLC | Semaglutide, tirzepatide, retatrutide, SS-31, tesamorelin, PT-141 | [38] |
For retatrutide and other research-use GLP-1s, including Lilly's lawsuits, see research-use-only GLP-1s. For telehealth companies FDA has warned, see the FDA warning letter tracker.
What peptides are
A peptide is a short chain of amino acids. FDA's rules define a protein as a chain of more than 40 amino acids [22]. When it proposed that rule in 2018, FDA said it would treat a chain of 40 or fewer amino acids as a peptide, and that a peptide is regulated as a drug unless it otherwise meets the definition of a biological product [23]. Tesamorelin, the active ingredient in Egrifta, is regulated as a biologic rather than as a drug [21].
"Peptide" says nothing about whether a product is legal, safe or useful. Some peptides are FDA-approved drugs with full labels. Others have never been tested in a published human trial. Legal status depends on the specific substance, its form and how it is sold, which is why this tracker lists each one separately.
Peptides for weight loss
The FDA-approved GLP-1 weight loss drugs are peptides. The Ozempic label says semaglutide is a GLP-1 analog whose peptide backbone is produced by yeast fermentation [24]. The Zepbound label says tirzepatide is based on the sequence of the GIP hormone, with modified amino acids and a fatty acid attached [25]. FDA approved Wegovy for chronic weight management on June 4, 2021 [26] and Zepbound on Nov 8, 2023 [27]. See semaglutide, tirzepatide and what each costs on the GLP-1 cost tracker.
Retatrutide is not approved anywhere [30]. In Lilly's TRIUMPH-1 trial in adults with obesity or overweight without diabetes, people on the 12 mg dose lost an average of 28.3% of body weight at 80 weeks, compared with 2.2% on placebo, by the trial's efficacy estimand [28]. Lilly plans to file with FDA in the first quarter of 2027 [29], and FDA says retatrutide cannot be compounded [31].
Two other peptides sold for fat loss have no legal route. FDA's committee voted 0 to 12 against AOD-9604 in December 2024 [16], and FDA says it identified serious adverse events that may be linked to it, though cause is not clear [8]. MOTS-c went to the committee for obesity and osteoporosis; FDA's briefing found no clinical studies, only rodent and lab data [47]. For FDA-approved options and clinics, see medical weight loss.
Muscle, skin, healing and anti-aging claims compared with the evidence
Sellers market peptides for muscle growth, healing, skin and longevity. None of the FDA-approved peptide drugs in our tracker is approved for any of those uses [17][18][20]. The table reports what FDA reviewers and published reviews found about human evidence and safety. It does not show that any peptide works.
| Peptide | Human evidence found | Safety concerns FDA named | Source |
|---|---|---|---|
| BPC-157 | Five small clinical studies and one Phase 1 trial with no posted results. An orthopedic review of 36 studies found 35 were preclinical | Not enough clinical safety information to describe its safety profile; possible immunogenicity; clotting and liver signals in rat and dog studies; no carcinogenicity studies | [11][44] |
| TB-500 | None: no clinical studies, no human pharmacokinetic data and no published case reports | FDA staff recommended against listing it | [45] |
| KPV | None: lab and animal anti-inflammatory data only | FDA is "particularly concerned about the lack of any human data" | [46] |
| MOTS-c | None: rodent and lab data only | Breaks down quickly in human blood in lab tests; no human data | [47] |
| Epitalon | Three small human studies; none measured sleep outcomes | Telomerase activation flagged as a theoretical cancer concern | [48] |
| Semax | Mostly Russian-language studies; a registered drug in Russia as nasal drops | Bleeding risk and possible abuse potential | [49] |
| DSIP | Small IV studies only, none by injection under the skin | Immunogenicity cannot be ruled out | [50] |
| GHK-Cu (injectable) | Limited human data | Immunogenicity risk from aggregation and impurities | [8] |
| LL-37 | Insufficient safety information, per FDA | Animal findings suggest harm to male reproduction | [8] |
| CJC-1295 | Limited clinical data | Serious adverse events, including increased heart rate and vasodilatory reactions | [8] |
| Ipamorelin | Committee found a lack of safety and efficacy information | A published study identified serious adverse events, including death | [15][8] |
| Melanotan II | Case reports | Case reports of melanoma, a brain swelling syndrome (PRES) and priapism | [8] |
| Dihexa, PEG-MGF | FDA found no human exposure data | Both placed in Category 2 in 2023 for significant safety risks | [8][14] |
Skin: GHK-Cu creams can be compounded with a prescription because non-injectable GHK-Cu is in Category 1 [2], and copper peptide serums are sold over the counter as cosmetics [53]. We found no FDA review of whether these products change skin. Healing blends: "Wolverine" is a marketing name for BPC-157 plus TB-500, which Healthline notes has not been tested in humans for safety or effectiveness [51]. An analysis of more than 15 million medical records found 1,039 patients with documented BPC-157 use, with new users up 33-fold from 2020 to 2026; the study is not yet peer reviewed [52]. See KLOW and Wolverine blends.
Dosing questions
There is no FDA-reviewed dose for any unapproved peptide. Doses posted online come from research-chemical marketing, not from a reviewed trial or label. For FDA-approved peptide drugs, the prescriber and the product label are the only dosing sources. Signs of a severe allergic reaction after an injection, such as swelling of the face or throat or trouble breathing, need emergency care: call 911.
Peptides and sports drug testing
WADA's 2026 Prohibited List bans BPC-157 at all times under its S0 class for non-approved substances, TB-500 and other thymosin beta-4 derivatives under S2, MOTS-c under S4 as an AMPK activator, and CJC-1295, sermorelin, tesamorelin, ipamorelin, AOD-9604 and mechano growth factors under S2 [42]. Peptides that are not named, such as KPV, Selank or GHK-Cu, may still fall under S0, which covers substances with no approval by any government health authority. Athletes should ask their anti-doping agency. IV infusions of more than 100 mL in 12 hours, such as large NAD or glutathione drips, are prohibited outside hospital treatment, surgery or clinical diagnostics [42].
How we check
We check every row against FDA's 503A categories document (updated May 14, 2026) [2], FDA's safety page for withdrawn nominations [8], committee briefing documents and minutes, and FDA-approved labels. Where FDA has not posted its own record, such as the July 2026 vote counts, we use law firm reports and say so. Where sources conflict, as on the epitalon vote count and the date the interim policy reached the White House, we show both. We do not use seller websites for legal status. This tracker was last checked Oct 19, 2026. Report a change or an error through our contact page; see also our editorial standards.
Questions people ask
Are peptides legal in the US?
Some are. As of Oct 19, 2026, 6 of the 27 entries in our tracker are legal to get: 3 FDA-approved drugs (Egrifta, Vyleesi and Forzinity), 2 substances a pharmacy may compound with a prescription (NAD and glutathione), and non-injectable GHK-Cu [2][17][18][20]. Another 20, including BPC-157 and TB-500, cannot be legally compounded or sold as drugs [2][3].
Did FDA legalize peptides in April 2026?
What did the FDA advisory committee vote on peptides in July 2026?
On July 23 and 24, 2026, FDA's Pharmacy Compounding Advisory Committee voted to recommend six peptides for the 503A bulks list: BPC-157, TB-500 and KPV (8-6-1 each), MOTS-c (7-5-2), Semax (8-5-1) and epitalon (reported as 7-4-1 or 7-5-1). It voted 6-7-1 against DSIP [4][12][59]. The votes are not binding; FDA must still issue a rule or another policy before pharmacies may compound them [5].
What is the FDA interim access policy for peptides?
HHS sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House budget office for review around Oct 14 or 15, 2026 [1][6]. As of Oct 19, 2026 it has not been issued and its text is not public [1]. The AP, citing two unnamed people, reported it is meant to let pharmacies temporarily compound some popular peptides, including BPC-157 [6].
Which peptides are FDA-approved?
Among the peptides in our tracker, tesamorelin (Egrifta, for excess abdominal fat in adults with HIV and lipodystrophy), bremelanotide (Vyleesi, for low sexual desire in premenopausal women) and elamipretide (Forzinity, for Barth syndrome) are FDA-approved [17][18][20]. GLP-1 drugs such as semaglutide (Wegovy, approved for weight management June 4, 2021) and tirzepatide (Zepbound, Nov 8, 2023) are also peptides [26][27][24].
Are research peptides legal?
Selling them for people to use is not. FDA has told sellers that "research use only" labels do not change their products' status as unapproved new drugs, in letters from Dec 2024 through Aug 24, 2026 [33][32][37]. The Justice Department has also prosecuted peptide sellers, including a 2026 sentence of 5 years 10 months for the owner of Paradigm Peptides [40].
What are peptides?
Peptides are short chains of amino acids. FDA defines a protein as more than 40 amino acids [22] and, in its 2018 proposal, said it would treat 40 or fewer as a peptide, regulated as a drug unless it meets the biological product definition [23]. Semaglutide, the ingredient in Wegovy and Ozempic, is a peptide [24].
Which peptides are approved for weight loss?
We do not rank peptides. The FDA-approved peptide drugs for chronic weight management include Wegovy (semaglutide, approved June 4, 2021) and Zepbound (tirzepatide, approved Nov 8, 2023) [26][27]. Retatrutide is not approved; in the TRIUMPH-1 trial the 12 mg dose averaged 28.3% weight loss at 80 weeks versus 2.2% on placebo [28]. AOD-9604 received a 0-12 committee vote against in Dec 2024 [16].
Can you take peptides without needles?
Some legal options are not injected. Non-injectable GHK-Cu, such as a cream, is in FDA's Category 1 and may be compounded with a prescription [2], and copper peptide serums are sold as cosmetics [53]. Semaglutide is FDA-approved as a Wegovy tablet as well as an injection [58]. Oral and nasal forms of BPC-157 and other unapproved peptides are not legal to compound [2].
Sources
69 cited
- Peptides at a crossroads: what wellness providers need to know. Holland & Knight, Oct 16, 2026.
- Bulk drug substances nominated for use in compounding under section 503A (categories document). FDA, May 14, 2026.
- FDA peptides do-not-compound list update (2026). Frier Levitt, Apr 2026.
- Bulk list bound: PCAC backs majority of peptides in two-day public meeting. McDermott Will & Emery, Jul 27, 2026.
- FDA voted yes on six peptides. Now what? The regulatory road ahead. Buchanan Ingersoll & Rooney, Aug 18, 2026.
- AP report on FDA interim peptide compounding policy. STAT / Associated Press, Oct 15, 2026.
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA, May 14, 2026.
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. FDA, Apr 22, 2026.
- FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings. Orrick, Apr 16, 2026.
- FDA's peptide rally: what compounders and industry need to know (post 1 of 2). Hyman, Phelps & McNamara (FDA Law Blog), Apr 21, 2026.
- PCAC briefing document: BPC-157. FDA, May 11, 2026.
- The peptide wave rolls on: PCAC adds two more bulk drug substances for the 503A list. Hyman, Phelps & McNamara (FDA Law Blog), Jul 24, 2026.
- FDA advisory committee backs two controversial peptides. RAPS Regulatory Focus, Jul 23, 2026.
- 503A categories update, September 2023. FDA (hosted by Alliance for Pharmacy Compounding), Sep 29, 2023.
- PCAC final summary minutes, Oct 29, 2024. FDA, Oct 29, 2024.
- PCAC final summary minutes, Dec 4, 2024. FDA, Dec 4, 2024.
- Egrifta WR prescribing information. FDA, Mar 2025.
- Vyleesi prescribing information. FDA Label (Palatin Technologies), Jan 10, 2025.
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- FDA grants accelerated approval to first treatment for Barth syndrome. FDA, Sep 19, 2025.
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This page is general information, not medical advice. Talk with a licensed clinician about your own care.