ISSUE  BRIEF

Peptides: The Quiet After the PCAC Vote

What Compounders Should Be Doing While the FDA Makes Up Its Mind

Two weeks ago I wrote about what happened at the FDA, where a balanced Pharmacy Compounding Advisory Committee looked at seven peptides and recommended six of them for the section 503A bulk drug substances list. BPC-157, KPV, TB-500, MOTS-C, Semax, and Epitalon all cleared. Only Emideltide, also known as DSIP, fell short.

Since then, nothing. No proposed rule. No Federal Register notice. No interim enforcement policy. No guidance document. The agency has said it will review the record, and that is where matters stand.

I have been asked several times in the last two weeks whether I am hearing anything out of Washington. I am not. It has been remarkably quiet.

That quiet is being read two different ways in our client conversations. Some pharmacies take it as a sign the FDA is preparing to move quickly. Others take it as a sign the agency has no intention of moving at all. Both readings share the same flaw. They treat the FDA’s calendar as the thing that determines whether a pharmacy is ready to compound these substances. It is not. You are.

Three different things the market keeps calling one thing

Before anything else, a distinction that is getting collapsed almost everywhere I look, including in places that ought to know better.

Removal from Category 2 is one event. A favorable PCAC recommendation is a second event. Actual placement on the 503A Bulks List through notice-and-comment rulemaking or agency action is a third. Only the third one changes what a pharmacy may lawfully compound.

Section 503A(b)(1)(A) has not moved. A bulk drug substance still has to comply with an applicable USP or NF drug monograph, be a component of an FDA-approved drug product, or appear on the 503A Bulks List. As of today, not one of the six recommended peptides satisfies any of those three prongs. If you compound them on the strength of the July votes alone, you are compounding at your own enforcement risk, and I would not want to be the one explaining that decision to a board or to a jury.

There is a fourth possibility I argued for in the last article, which is that the FDA extends interim enforcement discretion while the rule works its way through. That would be the sensible move, and this administration has given every public signal that it favors access. But enforcement discretion is a policy posture, not a legal reclassification, and a pharmacy operating under it stands on very different ground than one operating under a final rule. Your documentation needs to make clear which of the two you were relying on and when.

The question I would be asking if I owned the pharmacy

The question is not when you will be allowed to compound BPC-157. The question is whether, on the day after a rule takes effect, an inspector could walk into your pharmacy, ask why you compounded a particular peptide for a particular patient, and get a file rather than a shrug.

Building that file takes months. The rulemaking will take longer. That is the most useful fact available to any compounder right now, and it is the reason the quiet is an opportunity rather than a problem. Here is the work with which you should be engaged, and I want to be clear that none of this is a checklist you can complete on your own in an afternoon. Every item below opens into questions that depend on your licenses, your supply chain, your referral relationships, and your tolerance for risk.

Classify one substance at a time. A peptide program is not a category decision. It is a series of individual determinations, each of which needs a written basis. Which statutory prong does this substance rely on? Free base or acetate salt, and does the authorization cover the form you are actually buying? Has it drawn a warning letter or an import alert? Sermorelin, ipamorelin, CJC-1295, glutathione, and NAD+ all sit in different places on that road, and the map to follow keeps moving.

Know whether you are even looking at a drug. Under the BPCIA transition,1 a polypeptide of more than 40 amino acids is a biological product, and biologics cannot be compounded under 503A at all. That is not an academic point. It is the reason certain longer-chain products are simply off the table for a 503A pharmacy no matter how much demand exists, and it is the question hanging over the next wave of metabolic agents, including retatrutide. Eli Lilly filed a biologics licensing application (BLA) for retatrutide this month. Its unclear at the time of this writing whether the FDA agrees that this molecule meets the legal definition of a biologic.

Qualify the ingredient before you need it. Where is the material coming from, is the facility FDA-registered, and can you actually evaluate the certificate of analysis rather than just file it? Bulk peptide labeled for research use only is not compoundable material, and seeing that language anywhere in your supply chain should end the conversation. Remember that the FDA reviewers spent real time in July on the absence of accepted chemical definitions for several of these substances. If the agency cannot confirm identity at the review level, you need a serious answer at your pharmacy.

Formulate to a standard, not to a demand curve. USP General Chapters <795> and <797> do not relax because a substance is popular. Sterile injectable peptides raise sterility, endotoxin, container closure, and stability questions that require data. Where does your beyond-use date come from, and can you produce the study behind it? Is it stability indicating?

Compound to a prescription, not to a market. A 503A pharmacy compounds pursuant to a valid prescription for an identified individual patient. That means a legitimate prescriber-patient relationship and real limits on anticipatory compounding. If the prescriptions are arriving through a telehealth platform, then the intake design, the patient payment questions, corporate practice of medicine, and the auto-refill mechanics are part of your risk profile, not just the platform’s.

Watch the marketing, because that is where enforcement starts. It always has. A compounded preparation may not be promoted as safe and effective, and nothing in your materials may suggest FDA approval. State and federal advertising rules stack on top of that, and LegitScript, Google Merchant Center, and your payment processor each have policies with their own timelines. An advisory committee vote is not a marketing event. Pharmacies treating it as one are building a documentary record that will not read well later.

Look hard at how the money moves. Where a peptide program involves a telehealth partner, a marketing company, a med spa, or a management services entity, the Anti-Kickback Statute (even “all payor states” that include kickback prohibitions in all cash models) and, in many arrangements, the Eliminating Kickbacks in Recovery Act are squarely in play. Per-prescription compensation, percentage-based marketing fees, and fee splitting all deserve analysis before the agreement is signed rather than after the subpoena arrives.

Do not assume your state follows the FDA. Federal eligibility is a floor, not a ceiling. States regulate compounding independently, several maintain their own restricted-substance lists, and nonresident licensure obligations follow the patient. A substance that becomes federally compoundable may still be unavailable in a state where you hold a license.

Call your carrier. Professional liability and product liability policies sometimes exclude non-FDA-approved substances or sterile compounding. Informed consent for a compounded preparation with limited human data is a different document than the one you use for routine pharmacy care.

The bottom line

The advice I gave after the vote has not changed, because the law has not changed. Compound conservatively, document thoroughly, and resist the temptation to treat a committee’s endorsement as the agency’s authorization.

What I would add is this. The pharmacies that come out of this well will not be the ones that guessed the timing correctly. They will be the ones that used the wait to build a classification record, a qualified supply chain, a validated formulation, a defensible beyond-use date, a reviewed marketing package, and a clean set of financial arrangements, with a name and a date attached to every one of those decisions. When the rule lands, and I believe it eventually will, that work cannot be done retroactively.

The runway is open right now. It will not stay open indefinitely.

How Boesen & Snow Law can help

If you are weighing whether to compound peptides, we can help you build the framework before you need it rather than reconstruct it under pressure. Our attorneys are also pharmacists, which means we can work through substance-level classification, API supplier diligence, master formulation records and SOPs, USP readiness, state board alignment across multiple jurisdictions, marketing and website review, and the fraud and abuse analysis behind your telehealth and marketing arrangements. We have advised 503A pharmacies, 503B outsourcing facilities, prescribers, and manufacturers through every turn of the peptide categorization saga, and we will keep our clients out in front of whatever comes next.