Some peptides are FDA-approved medicines: insulin is a peptide, and so are several widely used diabetes and weight-management drugs. But many of the peptides marketed online and in wellness clinics for injury recovery, muscle growth, sleep or aging are not FDA-approved for those uses. In 2023 the FDA restricted a number of them from being compounded, and in 2026 their status is under review but not settled. [1]
What a peptide is
A peptide is a short chain of amino acids. Many of the body’s hormones and signaling molecules are peptides, which is why they interest researchers and drug developers. “Peptide” describes a type of molecule, not a level of safety or evidence: each one has to be judged on its own. Being built from amino acids does not make a peptide natural or harmless at medicinal doses: peptides can have strong effects on hormones, blood sugar, blood pressure and the immune system.
Three very different categories
- FDA-approved peptide medicines have been reviewed for safety, effectiveness and manufacturing quality for specific uses, and are prescribed for those uses.
- Compounded peptides are prepared by a licensed pharmacy for an individual patient on a prescription. Compounded drugs are not FDA-approved, and pharmacies may only compound from bulk substances that meet federal conditions. [3] [4]
- “Research use only” products are sold online with labels such as “not for human consumption.” They are not made or tested to the standards required for medicines, and their contents and purity are unknown.
What the FDA has done since 2023
In 2023 the FDA placed several peptides promoted for wellness uses in “Category 2” of its interim list of bulk substances for compounding, meaning substances that may present significant safety risks. In practice, licensed pharmacies were not to compound them. The concerns included possible immune reactions, impurities and limited safety information in people. [1] An FDA advisory committee reviewed several peptides in 2024 and did not support adding them to the list of permitted substances.
In April 2026 the FDA removed twelve peptides from Category 2 and referred seven of them to its Pharmacy Compounding Advisory Committee. In July 2026 the committee voted, mostly narrowly, to recommend six of the seven for the list of substances pharmacies may use; FDA’s own reviewers had advised against all seven. [2] Those votes are advisory. Removal from Category 2 does not by itself make a peptide eligible for compounding, and the FDA has not yet completed the rulemaking that would change their status. [1] [2] In October 2026 the Department of Health and Human Services sent the White House an interim policy that would reportedly let pharmacies compound some of these peptides for the time being. Its terms have not been published and, as of this article’s date, it has not taken effect. [6]
The picture may change again. What has not changed is that none of these peptides is FDA-approved, and good human evidence for most of their marketed uses is limited.
How we approach peptide therapy
Where peptide therapy is considered at RGH, it is:
- physician-supervised and individualized, after a full history, examination and relevant testing;
- offered only where clinically appropriate and permitted under current federal and state rules;
- prescribed through licensed U.S. pharmacies, never “research” products;
- discussed openly, including what is and is not known, the risks, the alternatives and how progress will be monitored.
For many goals, the measures with the strongest evidence, such as sleep, strength training, nutrition and treating blood pressure and cholesterol, come first.
Questions to ask before any peptide
- Is it FDA-approved for this use? If not, what is its current regulatory status?
- If it is compounded, which licensed pharmacy prepares it?
- What evidence is there in people, not just animals or cells?
- What side effects should I watch for, and how will we monitor them?
- If I compete in a tested sport, is it on the World Anti-Doping Agency’s prohibited list? [5]
Read more about peptide therapy at RGH and what concierge medicine includes.
General information only; not medical advice. In an emergency, call 911.
About the author. Dr. Irfan Siddiqui provides concierge care through Regenerative Health & Wellness. More about Dr. Siddiqui · Explore membership.