From Whoop to Watchdog: A Health Attorney's Dive into the Peptide Gray Market
Marc Goldsand
Partner and Co-Founder
Goldsand Friedberg LLP
I am 46 years old. I am a Florida-board certified health attorney and specialize in digital and related technologies. I have access to a lot of cutting-edge health care companies and products.
About three years ago, I had my own version of a mid-life crisis, an episode no doubt prompted by my exposure to the offerings of some of my cutting-edge clients. My version of a mid-life crisis? I fell hard for the longevity craze. I started lifting heavy weights in my newly-upgraded home gym. I integrated “Zone 2 workout” and “Zone 5 workout” into my lexicon. I joined a longevity medical practice, getting quarterly labs and dexa scans. I became keenly aware of my VO2 max. I seriously boosted my protein intake and I started taking all sorts of supplements and prescription drugs. I quit drinking. And I became obsessed with my Whoop.
Over the last 6 months, peptides arrived hard onto my personal radar. They are everywhere. The New York Times is writing about them. I read about the Peter Thiel-backed Enhanced Games, which could easily be called the “Peptide Olympics.” There, athletes previously viewed as mid-tier in their fields are now breaking world records.
In recommending various peptides, “experts” ranging from longevity doctors to wellness influencers (and a coterie of people in between) touted both cosmetic benefits and physiological returns on the investment of working out: increased strength and speed, improved recovery, faster muscle gain, more efficient and targeted fat burning, and amazing sleep. This sounded amazing.
I zeroed in on tesamorelin, CJC-1295. ipamorelin, and BPC-157. These peptides are widely-cited and apparently widely-utilized. But here is what I quickly learned. It is illegal under Federal law for any pharmacy to manufacture most of these products and a long list of other commonly promoted peptides – in the United States.
So where is all this stuff coming from? Below, I attempt to explain.
My intention in writing this article was to give a high-level primer on pharmacy compounding, particularly with respect to peptides. But as I was researching and considering recent news, I added the Codas at the bottom to give some real-time intelligence commentary.
A quick primer on 503A and 503B
The Drug Quality and Security Act (DQSA) of 2013 created two distinct regulatory frameworks for compounding pharmacies.
503A pharmacies are traditional patient-specific compounding pharmacies. They compound drugs pursuant to a valid prescription for an identified individual patient.
503B outsourcing facilities register with the FDA, operate under Current Good Manufacturing Practice (CGMP) standards, and may produce larger batches without patient-specific prescriptions.
a. 503A Pharmacies have three pathways to legal compounding.
Under Section 503A of the Federal Food, Drug, and Cosmetic Act, a traditional compounding pharmacy may use a bulk drug substance — a raw active ingredient rather than an FDA-approved finished product — only if the substance qualifies under one of three pathways. Pathways 2 and 3 are most applicable to the peptide conversation.
Pathway 1 requires that the substance have an applicable United States Pharmacopeia (USP) or National Formulary (NF) drug monograph. Dietary supplement monographs do not qualify.
Pathway 2 requires that the substance be an active ingredient in a currently or formerly FDA-approved drug product, provided that any prior discontinuation was for commercial reasons rather than safety or efficacy concerns. Where the approved product remains commercially available, the compounder must also satisfy the “essentially a copy” restriction — meaning there must be a documented, patient-specific clinical reason why the commercial product is unsuitable for that individual patient.
Pathway 3 requires that the substance appear on FDA's 503A Bulks List, see here and here (updated September 27, 2024). This is a residual pathway, available only where Pathways 1 and 2 cannot be met. The primary operative document is FDA's interim Category 1 list, last updated September 27, 2024, which is linked above and governs under enforcement discretion while formal rulemaking is completed. Notably, substances that are components of currently marketed FDA-approved drugs are ineligible for placement on the Bulks List, as they already qualify under Pathway 2.
b. 503B Manufacturing Facilities have two pathways to legal compounding.
Pathway 1 — 503B Bulks List The bulk drug substance appears on FDA's 503B Bulks List, where FDA has determined there is a clinical need for outsourcing facilities to compound using that substance.
Pathway 2 — FDA Drug Shortage List The drug product compounded from the bulk drug substance appears on FDA's active drug shortage list at the time of compounding, distribution, and dispensing.
2. Peptides That Can Be Compounded
Several peptides have either been nominated for, or placed on, the FDA's bulks lists, or may otherwise lawfully be compounded in appropriate settings. For example:
Oxytocin can be compounded under 503A because it is a component of an FDA-approved drug (Pitocin). However, because Pitocin is currently commercially available, a 503A pharmacy cannot simply produce a personalized version for any patient — the compounder must have a documented, patient-specific clinical reason why the commercial product is unsuitable (i.e., the "essentially a copy" restriction).
Tesamorelin can be compounded under 503A because it is the active component of an FDA-approved drug (Egrifta SV). However, because Egrifta SV is currently commercially available, a 503A pharmacy cannot simply produce a personalized version for any patient — the compounder must have a documented, patient-specific clinical reason why the commercial product is unsuitable (i.e., the “essentially a copy” restriction). Notably, tesamorelin compounding has also been supported at times by the drug shortage pathway, as Egrifta SV has experienced availability and access limitations — but compounders relying on that rationale must ensure the shortage designation remains current and applicable.
Sermorelin can be compounded under 503A because it is the active ingredient in Geref, a formerly FDA-approved drug that was discontinued for commercial reasons — not safety or efficacy. Because no commercially available product exists, the essentially-a-copy restriction does not apply.
Glutathione can be compounded under 503A because it appears on the interim Category 1 Bulks List, subject to enforcement discretion. It does not qualify under Pathway 1 (its USP monograph is dietary supplement grade, not a drug monograph) or Pathway 2 (not a component of an FDA-approved drug). The API used must meet pharmaceutical-grade standards.
During the period of active shortage listings, semaglutide and tirzepatide GLP-1 receptor agonists were eligible for compounding at both 503A and 503B facilities, though FDA has moved to wind down those allowances as shortages were resolved.
The key takeaway: compounding is permissible when the peptide appears on the appropriate bulks list or meets statutory criteria, and when the compounder complies with all applicable requirements.
3. Peptides That Cannot Be Compounded: The Category 2 Problem
This is where things get significantly more complicated.
In recent years, FDA has finalized guidance placing a number of widely popular peptides into what is commonly called the “Category 2“ classification — substances that FDA has determined present significant safety risks or that lack sufficient evidence of clinical utility to justify bulk compounding. Once placed in Category 2, a peptide may not be compounded at either a 503A or 503B facility.
Many of these peptides have passionate clinical advocates, and some have meaningful preclinical and even limited clinical evidence behind them. Nevertheless, FDA's position at least at present is that they do not meet the criteria for lawful bulk compounding.
To that end, it is at least technically possible for items on the Category 2 List to move off it. For example the following Peptides were on the Category 2 list because they were withdrawn by their nominators and removed from the list in September 2024:
BPC-157 (Body Protection Compound-157)
CJC-1295 (a GHRH analog)
Ipamorelin (a ghrelin mimetic)
Selank and Semax (nootropic peptides of Russian origin)
Thymosin Alpha-1 (under review)
So far, none of these has been added to Category 1 list, which is not a surprise considering the FDA’s January 7, 2025 guidance discussed below. Indeed, most of the peptides that I follow – and that RFK appears to follow – cannot be permissibly compounded. As discussed in Coda 1 below, by all indications, the nominators likely had intel that they would be recommended to be added to Category 1 by PCAC in late 2025.
RFK has since publicly promised to create a legal pathway for a cadre of peptides. The pathway of least resistance is likely additions to the Interim Category 1 List, or some other modified version where the FDA takes a public non-enforcement position with respect to that list. This is also discussed below.
4. So How Are People Currently Getting Peptides?
This is the question the industry is quietly (and sometimes not so quietly) wrestling with. There are several pathways currently in use each with its own legal and ethical complexities.
The hard truth is that because it is illegal to produce them in a regulated facility, almost everything in the consumer market is produced in a U.S.-based unregulated facility, or from an overseas factory and imported in through the gray market.
a. Research Use Only (RUO) Suppliers
Perhaps the most common current pathway: chemical supply companies sell many of these peptides labeled “For Research Use Only - Not for Human Use.” These are marketed to laboratories, universities, and researchers, and are not subject to the same regulatory requirements as pharmaceutical-grade compounds.
The legal and ethical problem is significant: a meaningful portion of what is sold under the “research” label is, in practice, being purchased and used by individuals for personal administration or by clinicians for off-label therapeutic use. The labeling does not change the underlying legal reality that administering such compounds to humans without FDA authorization is unlawful. Quality and purity are also major concerns as RUO products are not manufactured under pharmaceutical GMP standards, meaning contamination, mislabeling, and dosing errors are real risks.
Because it is actually illegal for either a 503A or 503B facility to manufacture Category 2 products – and there is no clear regulatory scheme governing research only products – these products are manufactured in totally unregulated facilities.
b. International and Gray-Market Pharmacies
Some peptides that are restricted in the U.S. are legally manufactured and dispensed in other jurisdictions. Patients and practitioners sometimes obtain compounds through foreign pharmacies which, depending on the country, may or may not be operating under rigorous regulatory oversight. Importing these substances for personal use exists in a legal gray area; importation for commercial distribution is generally unlawful.
c. Physician-Directed Use Under Investigational Frameworks
In limited circumstances, physicians may be able to access investigational compounds through formal FDA mechanisms such as an Investigational New Drug (IND) application or under expanded access (compassionate use) protocols. These pathways are real, but they are administratively demanding and rarely used in routine clinical practice.
d. The “Master Formulator” or Custom Synthesis Route
Some practitioners have attempted to work with specialty chemical synthesis laboratories to create custom batches of restricted peptides outside the pharmacy regulatory framework entirely. This approach is legally hazardous and does not provide the quality assurances that pharmaceutical compounding is designed to ensure.
5. Why This Matters
Millions of people are injecting themselves with these products for their health benefits. They are everywhere. Many clients have approached me about getting into the game on this. Without a clear understanding of the current rules and the perspective of where the market and regulations are going, short-term success and positive press might very well be followed by FDA enforcement. On the other hand, making the right calls now could lead to first mover status as new guidance emerges.
Coda 1
The PCAC and the RFK Joe Rogan Appearance
The Pharmacy Compounding Advisory Committee (PCAC) is an independent federal advisory body that provides recommendations to the FDA on which bulk drug substances should be permitted for use in compounding. When the FDA evaluates whether a substance belongs on the 503A Bulks List, it typically presents its analysis to the PCAC, which then votes on whether to recommend inclusion. While PCAC votes are advisory only — meaning the FDA is not legally bound to follow them — they carry significant weight and in practice have closely tracked the FDA's own recommendations. The committee is composed of pharmacists, physicians, and other subject matter experts, and its meetings are public.
The PCAC became a flashpoint in the peptide compounding debate after the FDA used it to formalize the rejection of several popular peptides. Following the withdrawal of nominations for CJC-1295, ipamorelin, AOD-9604, thymosin alpha-1, and Selank in late 2024, those substances were referred to the PCAC for review — and the committee voted against including all of them on the final 503A Bulks List.
That trajectory may now be shifting. On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced on The Joe Rogan Experience podcast that approximately 14 of the 19 peptides previously placed on the FDA's Category 2 restricted list would be moved back to Category 1 status, restoring legal access through licensed compounding pharmacies under a physician's prescription (RFK did not identify the specific peptides that he was referring to). Kennedy argued that the FDA banned these peptides over efficacy concerns rather than genuine safety signals — which he characterized as an improper basis for restriction — and acknowledged that the compounding ban had backfired by driving patients toward unregulated gray-market sources. He indicated a formal FDA announcement could come within weeks. Separately, the PCAC itself is expected to be reconstituted with a Kennedy-friendly composition by April 2026, which could further soften the committee's posture toward peptide compounding going forward.
As of the date of this writing, no formal FDA action has been published. The announcement remains a public statement of intent, not a regulatory change. Pharmacies and prescribers should continue to monitor official FDA communications before acting on Kennedy's remarks.
Coda 2
The Peptide Sciences Shut-down
Peptide Sciences — one of the largest and most recognizable gray-market research peptide vendors — voluntarily shut down in early March 2026. Their website went dark around March 6th with a brief statement saying the decision to “voluntarily shut down operations and discontinue the sale of research products” had been made, with no further explanation.
The closure was widely attributed to escalating regulatory pressure rather than any single event. The trajectory was clear: in December 2024, the FDA issued warning letters to several competing vendors for selling GLP-1 peptides like semaglutide and retatrutide as unapproved drugs. See here, here, and here.
It has also reported that due to the increased regulatory scrutiny, payment processors were not working with Peptide Sciences and people were purchasing through Venmo. In short, Peptide Sciences appears to have chosen a voluntary exit over a forced one.
Coda 3
Novo v. Hims – Not a Peptide Story
The media reported on March 9, 2026 that Hims and Novo settled yet another dispute about Hims marketing a compounded version of Novo's Semaglutide. What's striking about this saga, and the broader compounding battles playing out across the industry, is where the focus keeps landing: marketing claims. Not the safety or efficacy merits of compounded semaglutide. Not documented patient harms. Marketing claims. Whether it's been private litigants or enforcement agencies, the sharpest arrows have been aimed at what companies said — not what they made or who it helped or hurt. That's a meaningful signal about where the legal and regulatory risk actually lives in this space, and perhaps a quiet acknowledgment that the compounding-vs-brand debate is harder to resolve on the clinical merits than some would like.
Coda 4
FDA's New 2025 Bulk Drug Substance Policy: Transition Away from Categories and My Final Thoughts
On January 7, 2025, in the waning days of the Biden Administration, the FDA issued new guidance documents for both 503A compounding pharmacies and 503B outsourcing facilities, replacing the interim policies that had been in place since 2017.
The most important practical change is how substances are classified. Substances previously listed in Category 1 remain available for use in compounding, but Categories 2 and 3 have been eliminated entirely. For substances not already on the Category 1 list, pharmacies may no longer compound with newly proposed bulk drug substances unless and until the FDA completes its full review process and formally adds the substance to the final bulk drug substances list.
This also means the nomination process has changed. Bulk substance nominations submitted on or after January 7, 2025 will no longer be categorized and published to the FDA website, though FDA will continue to review nominations it receives.
Looking ahead, FDA has stated it will focus its resources on finalizing the 503A and 503B bulk drug lists through formal rulemaking, processed in batches. Until that process is complete, compounders should carefully verify that any bulk drug substance they use is either covered by a USP/NF monograph, is a component of an FDA-approved drug, or appears on the existing Category 1 list.
RFK’s comments on Joe Rogan that he intends to move certain peptides back onto the Category 1 list run contrary to the January 2025 guidance, where FDA had essentially forbid itself from updating the Interim Category 1 list, and limited its own enforcement discretion. My prediction: FDA or HHS will announce imminently that the January 7, 2025 FDA guidance is withdrawn and replaced and that a select cadre of peptides has been added to a refreshed Interim Category 1 list. I would also wager that a re-constituted PCAC will endorse these peptides for this purpose.
The information in this article is for educational purposes only and does not constitute legal or medical advice. Practitioners should consult with qualified legal counsel regarding their specific compounding and prescribing practices.
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As discussed below, there is a legal pathway to compound tesamorelin.
A “monograph” is a essentially an official written standard published in the USP-NF that defines exactly what a bulk drug substance must be — covering its chemical identity, purity, potency, and the validated testing methods used to confirm all of the above. The warning letters were primarily marketing-based, not compounding-based. These were not licensed compounding pharmacies; they were gray-market RUO (Research Use Only) vendors. The FDA's theory wasn't that they were compounding improperly — it was that their marketing crossed the line from "research chemical" into implied human therapeutic use.
Specifically, the FDA reviewed these companies' websites and found they were selling GLP-1 peptides (semaglutide, tirzepatide, retatrutide) while using language that indicated the products were intended to "prevent, treat, or cure disease conditions" or "affect the structure or function of the body" — which is the statutory definition of a drug claim. Once you make a drug claim, the "research use only" label becomes legally meaningless. The FDA's position was that they were introducing unapproved new drugs into interstate commerce in violation of the FDCA, regardless of how the products were labeled.