Peptide compounding policy: who is lobbying the White House

What reached the White House

On 14 October 2026, HHS and FDA submitted to the White House Office of Management and Budget (OMB) a document titled «Interim Access Policy for Compounding Using Certain Peptides»⁹. The federal regulatory-review record lists it under RIN 0910-ZD94, at the «Notice Stage»¹, and the reviewing office, OIRA, shows it as pending review¹⁰. The text is not public: the record does not say which peptides it covers or under what conditions¹⁰¹¹.

On 12 October we covered the press report that anticipated this shortcut (Peptides without rules). Two things are new. The document now exists in the federal record, and the fight has moved from the advisory committee to the White House, where outside groups are lining up to be heard before it is published.

Six meetings in eight days

Under Executive Order 12866, OIRA meets «with any interested party to discuss issues on a rule under review», and the subject, date and participants are disclosed publicly⁸. For this policy, the record lists six meetings, all with HHS/FDA as the agency¹:

• 21 October, 3:00 PM: American Academy of Peptide Medicine, requested by Lee Rosebush².
• 23 October, 2:00 PM: Hims & Hers Health³.
• 27 October, 2:00 PM: Alliance for Pharmacy Compounding (APC), requested by its CEO, Scott Brunner⁴¹².
• 27 October, 2:30 PM: Center for Science in the Public Interest (CSPI)⁵.
• 28 October, 3:00 PM: Faegre Drinker Consulting, for its client «Collaborative for Evidence-Based Medicines»⁶.
• 28 October, 3:30 PM: Carmen Group, for its client Medivant Healthcare⁷.

For. The American Academy of Peptide Medicine was first through the door; Semafor reported its OMB meeting in advance¹². Its chair, Lee Rosebush, said of the submission: «We are encouraged by this progress and see it as an important step toward safe, regulated access», and urged HHS and FDA «to place these substances on the interim bulk drug substances lists»¹³.

Hims & Hers is a telehealth company that, per Reuters, rose to prominence partly through sales of GLP-1 weight-loss drugs¹⁴. In August its CEO, Andrew Dudum, told investors it would sell already-permitted peptides such as NAD+, sermorelin and glutathione by year-end, and would wait for «full and final rulemaking» from FDA on those still under review; the company has begun stability testing on BPC-157¹⁴. Per the AP, Hims & Hers and Noom plan to offer peptides if access is eased¹¹. The record does not say what the company argued³.

APC, the trade group for 503A compounding pharmacies, had already met FDA twice to request «interim enforcement discretion for state-licensed compounding pharmacies», conditioned on enhanced patient disclosures, serious adverse-event reporting and data collection¹⁶. On the White House filing, Brunner called it «potentially significant, but we don't yet know what the policy says, which peptides it covers»¹².

Against. CSPI is led by Peter Lurie, a former FDA official who in April said that letting peptides onto the market without clinical testing poses a «profound threat» to FDA's drug-review system¹⁵.

Unknown. We found no public statement on this policy from the «Collaborative for Evidence-Based Medicines» or from Medivant Healthcare; the record names only the lobbying firms and their clients⁶⁷.

What an interim policy can and cannot do

Everything points to enforcement discretion. According to two people familiar with the plan cited by the AP, the policy is meant to let pharmacies temporarily compound some of the most popular peptides, including BPC-157, by assuring them they will not be targeted¹¹. Formally adding them to the 503A list would require rulemaking that could take years¹¹¹⁷.

• It is not an approval. Enforcement discretion «does not modify the underlying statutory framework or confer FDA approval on a compounded product», and it can be withdrawn without rulemaking⁹.
• It probably does not reach the gray market. Holland & Knight's reading is that the approach «would not cover research-use-only, supplement or 503B outsourcing facility channels»⁹. Law firm Buchanan Ingersoll & Rooney lists as an open question whether it would apply only to 503A pharmacies¹⁰.
• It does not bind the states. State pharmacy and medical boards are not bound⁹, and state law still governs prescribing, delegation, supervision and administration; while review continues, as AmSpa puts it, «Nothing has changed yet»¹⁷.

The evidence it would rest on

On 29 June 2026, FDA released staff briefing documents recommending against adding any of the seven peptides under review⁹. On 23–24 July, the Pharmacy Compounding Advisory Committee (PCAC) recommended six anyway: BPC-157, KPV and TB-500 passed 8–6 with one abstention; MOTS-c, Epitalon and Semax were also recommended; emideltide (DSIP) failed 6–7 with one abstention⁹. The recommendations are advisory only⁹.

The opposition went on record that week. The Partnership for Safe Medicines called the vote «a serious setback for patient safety» and warned: «Patients won't read the fine print. They will hear one thing: the FDA said yes»¹⁹. Public Citizen told the committee that for BPC-157 «there are still no adequate data about its safety or effectiveness» and that FDA identified only five clinical studies assessing its safety; one trial was completed by only 46 participants and is known only from a meeting abstract²⁰.

PubMed tells the same story. A 2025 systematic review in orthopaedic sports medicine included 36 studies: 35 preclinical and 1 clinical²¹. That clinical study was a retrospective chart review of 17 patients given intra-articular injections for knee pain, 16 reached by phone, with self-rated pain and no validated outcome tools²². The intravenous safety «pilot» published in 2025 enrolled 2 healthy adults over three days²³. The review's authors noted the absence of human safety data and warned of risks from unregulated manufacturing or contamination²¹.

Meanwhile, FDA is going after «research use only» sellers

The same agency drafting the access policy is squeezing the gray market. On 24 August 2026, FDA's CDER issued warning letters to five online vendors (Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations, doing business as Tex Peptides) for selling unapproved new drugs¹⁸. The «research use only» label did not help: FDA cited dosing guidance, reconstitution calculators, bacteriostatic water sold alongside the injectable peptides and the sites' overall impression, and wrote that the websites establish the products «are intended to be drugs for human use»¹⁸.

The next round is also on the horizon: a second advisory committee meeting is expected before the end of February 2027 to consider GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF, with no date set⁹. Holland & Knight expects a lasting federal pathway to be «a 2027-2028 development»⁹.