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Are You Ready For The Peptide Gold Rush?
Whether it’s Robert Kennedy, Jr. on the Joe Rogan podcast, Martin Shkreli debating Superpower’s Max Marchione, the New York Times, Wall Street Journal here, here, and here, or FDA warning letters, it seems like everybody is talking about peptides. After years of murmurs, grey markets and FDA warning letters it seems like the peptide gold rush is upon us.
Why Is Everyone Talking About Peptides?
There are two reasons everyone is talking about Peptides.
First, the success of GLP-1s has brought peptides into the spotlight. The GLP-1 market has experienced explosive growth over the last few years, with an estimated more than $60 billion spent in 2025. That number is expected to grow to $150-$200 billion by the early 2030s according to market reports. The success and growth of GLP-1s has brought attention to other peptides.
Second, Robert Kennedy, Jr., the Secretary of the Department of Health and Human Services, recently went on the Joe Rogan podcast and said the FDA is going to add 14 peptides to the FDA’s interim Category 1 list.
What A Second...GLP-1s Are Peptides And What Is This Category 1 Lists All About?
Ok, ok....one question at a time.
GLP-1s Are Peptides?
Yes, GLP-1 stands for glucagon-like peptide-1 (catchy huh?). This is a naturally occurring peptide hormone found in the lining of your small intestine. But GLP-1 drugs like semaglutide and tirzepatide, which are what most people are talking about, are synthetic peptides. These synthetic peptides are the active ingredients in name brand drugs like Wegovy and Ozempic.
And What About Those Lists?
Peptides, including GLP-1s like semaglutide and tirzepatide, and others like tesamorelin, CJC-1295, ipamorelin, and BPC-157, are commonly prepared by 503A compounding pharmacies. That means they have to comply with Section 503A of the Federal Food, Drug and Cosmetic Act. The FDA's approach to compounding bulk drug substances under 503A has changed over the last 10-15 years. In July 2014, FDA issued a guidance, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, that stated: "Until a bulk drug substances list is published in the Federal Register as a final rule, human drug products should be compounded using only bulk drug substances that are components of drugs approved under section 505 of the FD&C Act, or are the subject of USP or NF monographs." So only three types drug can be compounded:
1. Drugs that have an applicable United States Pharmacopeia or National Formulary drug monograph; or
2. Drugs that are an active ingredient in an FDA approved drug product but not be essentially a copy of the FDA approved drug; or
3. Drugs on the FDA’s 503A Bulks List.
There was considerable push back on this position with health care providers arguing that the policy would disrupt patient treatment while the FDA evaluated whether or not to add a drug to the bulk substance list. As a result, in 2015, the FDA issued new guidance stating it would not take regulatory action for compounding drug products appearing on Category 1 on the FDA's website. If a drug substance is...say...on the Category 2 list, it is illegal to prescribe it or compound it for human use.
What Does This Have to Do With Peptides?
We are getting there. Be patient. Peptides can effectively be put into one of 5 categories: 1) Category 1 substances that are eligible to be included on the 503A or 503B bulk lists; 2) Category 2 substances that present significant safety risks; 3) Category 3 substances without adequate support; and 4) other bulk drug substances that may present significant safety risks (typically these are drugs where the nomination for Category 1 was withdrawn); and 5) peptides that are components of drugs approved by the Secretary of the Department of Health and Human Services. Only peptides that meet #1 or #5 can be legally compounded or prescribed for human use.
Most of the popular peptides wound up in Category 2 or Category 3 and a few ended upon the “other bulk drug substances” list after their nominations for the bulk lists were withdrawn.
How Are These Peptides Popular If They Can’t Be Prescribed Or Compounded?
Some peptides, such as NAD and NADH, are on the Category 1 list. These can legally be prescribed and compounded. The popular GLP-1s can be prescribed and compounded because they are the active ingredient in FDA approved drugs. Other peptides are acquired in a few different ways which are illegal and carry health and legal risks including through Research Use Only (“RUO”) suppliers and through international and grey-market pharmacies.
Some of the peptides which are restricted in the U.S. are legal to manufacture and dispense in other countries. People will sometimes obtain restricted peptides from foreign pharmacies. However, importing drugs from other countries is legally dubious and foreign labs may not be held to the same standards of domestic compounding pharmacies meaning the drugs may contain impurities or be contaminated. Marketing RUO drugs for human use is illegal. Slapping a ROU label on a drug that is intended for human use is not a get out of jail free card. It is illegal and the FDA has sent warning letters to many compounding pharmacies that marketing ROU peptides for human use. Importantly, 503A pharmacies typically are not willing to put their license at risk by manufacturing Category 2 or Category 3 products meaning these products are manufactured at unregulated facilities which may not be following requirements related to sterility, contamination and labeling. One complaint about the FDA’s decision to restrict many of these peptides is that it has forced people to get the peptides from questionable and potentially unsafe sources.
Sounds Bad...But This All Might Change Soon, Right?
Yes. On February 27, 2026, Robert Kennedy, Jr. went on the Joe Rogan podcast and said the expected the FDA to change the status of about 14 peptides that became restricted back in 2023. The most likely path for this would be for the FDA to place these 14 peptides on the Category 1 list. At the time, Kennedy said this would happen in a couple of weeks, but it has been more than a month and there has been no formal announcement from the FDA and there have been no new additions to the Category 1 list.
What Should Wellness and Longevity Providers Do To Get Ready For This Change?
Great Question!
Thanks!
There are lot of things for healthcare providers to do and think about as they get ready for the peptide gold rush.
- Find a licensed 503A compounded pharmacy that you can work with. Perform some due diligence on the pharmacy or pharmacies. Review their licensing history and publicly available inspections or surveys. Search their name to see of they were ever sent an FDA warning letter. Ask the pharmacy how they plan to obtain the peptides once they are moved to the Category 1 list.
- Create new informed consent documents related to the new peptides. Peptides on the Category 2 list were put there because the FDA determined they may present significant safety risk to humans. Peptides on the Category 3 list were put there because there was not enough information for the FDA to evaluate them. Be sure your informed consent language accurately informs patients of these risks or of the lack of supporting information. Consider adopting policies regarding how providers should discuss these risks with patients.
- Related, make sure your marketing information is accurate. If you are making clinical claims about a peptide, be sure you have studies or data to back up those claims. Be sure marketing materials and influencers and affiliates talk about both the benefits and risks of peptides.
- Make sure you are properly set up to prescribe peptides in the states where you plan to see patients. This may require the creation of a new professional corporation and a management service organization.
- Don’t forget the basics! Medical records should justify the prescription and demonstrate patients were aware of any risks. Ensure synchronous visits occur in states where they are required or where medically necessary and ensure asynchronous visits comply with state laws.