Two weeks ago we asked you to write one page with three scenarios on it. Scenario A was “the policy publishes.”
It published. On October 30, HHS put an interim policy in the Federal Register covering six of the peptides the compounding advisory committee reviewed in July. That is real news, and it is narrower than the headlines. This issue walks through what it says, what it doesn’t, and how to check your pharmacy against it before anyone at your clinic says yes.
This week in 30 seconds:
HHS published an interim policy on six peptides. It isn’t approval, it isn’t final, and it only applies when about ten conditions are all met.
FDA warned a GLP-1 seller for saying “American made.” FDA’s own records show no registered U.S. maker of the active ingredient.
The lesson: seven questions to put to your pharmacy, in writing, before your clinic touches any of the six.
📡 The Radar
1. HHS published its peptide policy. It covers six peptides, under ten conditions, and it isn’t final. The Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances ran in the Federal Register on October 30 (Federal Register 2026-22192).
It says HHS does not intend to take enforcement action against state-licensed pharmacies, licensed physicians or federal facilities that compound BPC-157, TB-500, epitalon, KPV, MOTS-c or Semax from bulk, but only in specified forms and routes, and only when every condition is met (Baker Hostetler; Hall Render). Three details matter most.
It came from the HHS Secretary, not FDA. Per the policy’s own appendix, FDA’s drug center recommended against listing these peptides, and the advisory committee voted for it. HHS sided with the committee.
It is interim, and the notice calls it a draft. Comments are open through November 13 (docket HHS-OASH-2026-0496). It lasts only until FDA finishes rulemaking on the 503A bulks list, and HHS says it may revise or withdraw it if safety or quality problems appear.
It is not approval, and it is not a safe harbor. That phrase is Hall Render’s, not ours: the policy “does not create a safe harbor.” It does not put these substances on the 503A list. It does not cover 503B outsourcing facilities, research chemicals or supplements. And it covers six substances, not the seven the committee reviewed: emideltide is not in it. (Our stake: BioPeakRx sells two of the six, MOTS-c and KPV, inside its Metabolic Blend and Skin & Repair bundles.)
What it means for your clinic: the question just changed from “is this allowed?” to “does our supply chain meet these specific conditions?” Most of the conditions sit with your pharmacy, not with you, which is exactly why you need them in writing (see the Operator Lesson below). Two cautions. First, neither law firm’s summary says whether HHS is applying the policy now or only after the comment period, so don’t build a launch date on it. Second, the opposition we covered last issue now has a published text to challenge. If you have a view, the comment window is the one place it formally counts, and it closes in eight days.
2. An FDA warning letter that turns on the word “American.” On October 30, FDA warned RonanRx of Elgin, Texas, over its compounded semaglutide and tirzepatide (FDA, MARCS-CMS 737905). The letter cites three things. Its website said “FDA-Approved Compounded Medications.” Its product labels showed the RonanRx name, suggesting it compounded the drugs “when in fact it is not.” And a video called the products “American made,” with a flag on screen. That last one is the new move. FDA said its records show no registered U.S. manufacturer of semaglutide or tirzepatide active ingredient for compounding, so “American made” was false advertising. Disclaimers elsewhere on the site didn’t cure any of it. RonanRx has 15 working days to respond.
What it means for your clinic: FDA is now checking marketing claims against its own registration data. If your site or your partner’s says “made in the USA,” “U.S.-sourced” or anything like it about a compounded GLP-1, ask where the active ingredient was manufactured, and get the answer in writing. If no one can name a registered facility, take the claim down this week. And look at your labels. If your clinic’s name sits where the compounder’s should, that’s the same finding.
🔭 The Watchlist
The peptide policy’s comment window: closes November 13. The next signals are a final version, a revision, or a court challenge. We’ll tell you the week any of them happens.
The Partnership for Safe Medicines petition, which asks FDA to block all seven peptides, is still open. We found no FDA response yet.
Empower Pharmacy: still no posted response. The September 18 warning letter page shows no response or closeout letter.
Compounded glutathione: no CDC update since mid-September (CDC).
PCAC round two: still no date. LL-37, GHK-Cu, dihexa acetate, melanotan II and PEG-MGF remain scheduled for “before the end of February 2027” (FDA PCAC page).
The 503B GLP-1 rule: no final determination.
🔧 The Operator Lesson: turn the conditions into a checklist
If you wrote the Scenario A page from Issue #8, you already decided what you’d need to see. Now there’s a published text to hold it against. Here’s how to turn the policy into a one-page checklist your pharmacy has to fill in before your clinic touches any of the six.
Ask your pharmacy for these, in writing, per substance:
Who made the bulk powder. The original manufacturer’s name and its FDA registration, not the distributor’s or repacker’s. The policy requires an FDA-registered, CGMP-compliant original manufacturer.
A certificate of analysis for each lot, showing the manufacturer’s physical location. If the pharmacy bought through a repacker, ask for its documented validation of that manufacturer and that COA.
The form and route, matched to the policy’s list. BPC-157 covers injectable, oral and topical forms. Semax is intranasal only. KPV is topical and oral only. Anything outside the list isn’t covered.
For anything oral, the documentation that this formulation reaches adequate bioavailability in humans. If they don’t have it, there’s no oral product.
A sample label carrying the exact statement “This is a compounded drug product. Not for resale,” plus the reporting instructions the policy requires.
Single ingredient only. No blends and no stacks in one vial.
The syringe. It must be FDA-cleared, and nothing else can be co-packaged.
Then check your own side:
A patient-specific prescription every time. No office stock and no “standing” supply.
A named person who files MedWatch and state reports for adverse events and quality problems. Write that name on the page.
Your marketing. No “FDA-approved,” no “now legal” and no “made in USA,” for the reasons in Radar item 2. Remember the six substances are still not FDA-approved drugs.
If the pharmacy can’t hand you all seven, the answer is the one you wrote down two weeks ago: “not yet.” That isn’t you being cautious. It’s you reading the policy.
And keep Scenario C on the page. This is interim, it’s being challenged, and HHS says it can withdraw it. Whatever you’d tell a patient if it went away, have it written before you start, not after.
Before you go
We’re turning this lesson into the Peptide Policy Pharmacy Checklist, a fill-in version of the questions above, and adding it to the Clinic Operator’s Toolkit alongside the three-scenario decision page from last issue.
Reply “checklist” and we’ll send it to you when it’s ready.
Still free from Issue #1: the Processor-vs-EMR Reconciliation Worksheet, the monthly pass that surfaced $58,070 in declined charges at one practice, $41,368 of it never recovered. Download it →
In partnership with
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Kalshi opens it up. Contracts on weather, fuel prices, inflation, tariffs and regulation, starting at a few dollars. Take a position on the outcome that would hurt you. If it hits, the payout softens it. If it doesn't, the contract expires and the good month was the point.
And tell us: did your pharmacy call you this week about peptides? What did they say? Hit reply. We read everything.
— Devin & Ryan
Who writes this. Devin Casey, MBA and Ryan Arvizo, FNP-C. We operate Revive Medical Care, a cash-pay practice in Phoenix, and BioPeakRx, a LegitScript-certified telehealth platform. That’s why this brief is about compounding supply chains, payment rails and documentation: we run them, and we usually get the decision wrong once before we write it up. When we have a stake in something we mention, we say so in the same sentence. Who we are, and what we own →
The Clinic Brief is business and regulatory information, not legal or medical advice. Talk to qualified healthcare counsel about your specific situation.