FDA list of compounded peptide safety risks cites GHRP 2 and ipamorelin deaths

SILVER SPRING, MD. An FDA list of compounded peptide safety risks cites deaths in people who received GHRP 2 or ipamorelin in studies. A 2 Minute Medicine brief highlighted the list on November 2, but the FDA dated both entries September 29, 2023, and marks its page current as of April 22, 2026. The record matters now because the same page carries risk language for BPC 157 and five other peptides that a new federal policy lets pharmacies compound.

What the FDA says about GHRP 2 and ipamorelin

The FDA places GHRP 2 in category 2 for injectable and nasal use under its Section 503B interim policy. The agency gives three reasons. First, compounded versions may trigger an immune response, because the peptide can clump together, a process called aggregation, and can carry peptide related impurities. Second, GHRP 2 contains an unnatural amino acid, which the FDA says makes the peptide harder to characterize. Third, the agency says it knows of serious adverse events in patients who received GHRP 2. Those reports include a higher insulin need to keep blood glucose in range, infection, pancreatitis and death among critically ill study subjects. The FDA adds a caveat in the same entry: causality has not been established for any of these events.

The ipamorelin entry follows the same pattern. The FDA lists ipamorelin acetate in category 2 under Section 503B, again citing a possible immune response from aggregation or impurities and the unnatural amino acids in its structure. The agency points to one published study in which serious adverse events, including death, occurred when ipamorelin was given intravenously to improve gastric motility. For certain other injectable routes, the FDA says it has found no safety information. It concludes that it lacks enough data to know whether those routes would harm people. That is a statement about missing evidence, not proof of safety or of harm. The table below sets out the five active entries most relevant to peptide compounding, as the FDA page lists them.

What FDA category 2 means for compounders

Category 2 sits inside the FDA's review of bulk drug substances that people have nominated for the 503A or 503B bulks lists. Section 503A covers state licensed pharmacies, and Section 503B covers outsourcing facilities. Under interim policies, the agency sorts nominated substances into categories, and category 2 holds those it says may present significant safety risks. The FDA category 2 page now shows 14 active entries, from cesium chloride to tranilast. Five of them sit close to the peptide market: GHRP 2, GHRP 6, ipamorelin acetate, kisspeptin 10 and ibutamoren mesylate. Each gained at least one listing on September 29, 2023, according to the agency. None of these compounded peptide safety risks is a new finding this month.

It notes that a randomized, placebo controlled trial in people recovering from hip fracture was stopped early over a possible heart failure signal.

The other entries near the peptide market add different concerns. For GHRP 6, the FDA says safety data are limited but point to possible effects on cortisol and a rise in blood glucose from lower insulin sensitivity. For ibutamoren mesylate, the agency cites a risk of congestive heart failure in certain patients. It notes that a randomized, placebo controlled trial in people recovering from hip fracture was stopped early over a possible heart failure signal. For kisspeptin 10, the FDA says it has no or only limited safety information for the proposed routes. The page does not describe what enforcement follows a listing. It does show pharmacists, prescribers and patients which risks the agency has on record for each ingredient.

BPC 157 and five HHS peptides sit on the withdrawn list

The same FDA page carries a second table of 17 substances that were in category 2 until the people who nominated them withdrew the nominations. All six peptides in the interim HHS compounding policy appear there: BPC 157, TB 500, epitalon, KPV, MOTS c and Semax. The FDA still prints its risk language next to each name. For BPC 157, the agency says compounded forms may provoke an immune response and pose impurity and characterization problems, and that it has little or no safety information for the proposed routes. For KPV, MOTS c and TB 500, the FDA says it found no human exposure data at all. The page does not say the withdrawals changed the agency's view of these risks.

That record now sits beside a federal policy that points the other way. AJMC reported that HHS filed the policy with the Federal Register on October 28, 2026. Under it, HHS does not intend to take enforcement action against state licensed pharmacies, federal facilities or licensed physicians that compound the six peptides while the FDA works on rulemaking for its 503A bulks list. Compounders must meet 10 conditions, AJMC said. The HHS peptide compounding policy followed a July vote by the FDA's Pharmacy Compounding Advisory Committee, which backed six of the seven peptides it reviewed. According to AJMC, career FDA scientists had recommended against all seven. A JAMA Viewpoint has warned that the vote could weaken drug approval.

What remains unknown about the reported deaths

The FDA entries leave large gaps. The agency does not give the number of deaths linked to GHRP 2 or ipamorelin, the years in which they occurred or the amounts given. For GHRP 2, it says the deaths happened among critically ill study subjects and that causality has not been established, so the patients' underlying illness may explain some or all of those outcomes. For ipamorelin, the FDA cites a single published study of intravenous use for gastric motility. The agency does not say whether any of the reported events involved compounded products. Readers should treat these compounded peptide safety risks as signals that call for more study, not as measured death rates. The FDA describes them as potential risks, and its wording stays cautious throughout.

Several steps are still pending. CNN reported that the HHS draft policy opened a 14 day comment period, after which HHS is expected to issue a final policy. The FDA's separate rulemaking will decide whether any of the six HHS peptides gain a formal listing for pharmacy use. The FDA page may also change, since its content is marked current as of April 22, 2026. AJMC describes all six HHS peptides as unapproved, and CNN noted that many users have obtained such products from unregulated websites without seeing a doctor. This site's review of the evidence found that support for those six comes mostly from animal or cell studies. Anyone considering these compounds should speak with a licensed clinician first.

Conclusion

The FDA record of compounded peptide safety risks is older than the coverage it drew this month, but it remains the agency's current word. It cites deaths with GHRP 2 and ipamorelin without proven cause and reports little or no safety data for BPC 157 and the other HHS peptides. The distance between that record and the new HHS policy is the point to watch as HHS finalizes its policy and the FDA continues rulemaking. This report is for research and news purposes only and is not medical advice.