The peptide vote is two weeks behind us and Washington has gone quiet. The FDA has already posted the next slate. Meanwhile CMS proposed the deepest 340B payment cut in the program's history, HRSA restarted its rebate pilot, and PBM reform cleared its first committee. Here is what you should not have missed.

Compounding & FDA

The Quiet After the Peptide Vote

On July 23 and 24, the FDA's Pharmacy Compounding Advisory Committee recommended six of seven peptides for the section 503A bulk drug substances list. BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon cleared. Only Emideltide, also known as DSIP, fell short. Since then there has been no proposed rule, no Federal Register notice, no interim enforcement policy and no guidance document. The agency has said it will review the record, and that is where matters stand.

Source: FDA, PCAC 2026 Meeting Materials

Boesen & Snow Perspective

Three separate events are being collapsed into one almost everywhere we look. Removal from Category 2 is one event. A favorable PCAC recommendation is a second. Actual placement on the 503A Bulks List is a third, and only the third changes what a pharmacy may lawfully compound. Section 503A(b)(1)(A) has not moved, and as of today none of the six recommended peptides complies with a USP or NF monograph, is a component of an FDA-approved drug product, or appears on the Bulks List. Compound on the strength of the July votes alone and you are compounding at your own enforcement risk. The more useful point is this: building a defensible file takes months, and the rulemaking will take longer. That makes the quiet an opportunity rather than a problem.

Next Up at PCAC: Five More Peptides Before the End of February

The FDA has announced that it will hold another Pharmacy Compounding Advisory Committee meeting before the end of February 2027, and it has already published the agenda. The committee will take up five more bulk drug substances for possible inclusion on the 503A Bulks List: cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II, and pegylated mechano growth factor (PEG-MGF). Time and location have not been set. A Federal Register notice establishing the public docket, along with instructions for requesting open public hearing presentation slots, is still to come.

Source: FDA, Meeting of the Pharmacy Compounding Advisory Committee

Boesen & Snow Perspective

This is the item to calendar. The July slate showed that a balanced committee will vote yes when the record in front of it is developed, and the record is built in the docket, not at the microphone. Anyone with a commercial or clinical interest in these five substances should be assembling chemical characterization data, identity and purity methods, and human use evidence now, so it lands before the FDA writes its briefing package rather than after. Melanotan II arrives with a documented adverse event history and will need a direct answer on safety, not an appeal to popularity. And note what the agenda tells you about the agency's thinking: the FDA is continuing to move peptides through the process it already has, which is not the posture of an agency about to shortcut anything.

Retatrutide, the BLA, and the 40 Amino Acid Line

On July 23, Eli Lilly reported positive topline results from TRIUMPH-2 and TRIUMPH-3 and, notably, announced that it plans to submit a Biologics License Application for retatrutide in the first quarter of 2027. The application has not been filed and the FDA has not accepted anything for review. The classification question that Lilly litigated in the Southern District of Indiana therefore remains open, but the company's choice of pathway is the loudest signal yet about where it thinks the molecule sits.

Source: Eli Lilly and Company investor release, July 23, 2026

Boesen & Snow Perspective

This is not a weight loss story for our readers. It is a compounding eligibility story. Under the BPCIA, a polypeptide of more than 40 amino acids is a biological product, and biologics cannot be compounded under section 503A at all. If retatrutide is ultimately licensed under a BLA, the 503A door closes on it before it ever opens, and the shortage-driven duplication fights we watched over semaglutide and tirzepatide will not repeat here. Every pharmacy weighing a peptide program should be running the amino acid count as a threshold question, before the classification question and well before the sourcing question.

340B

HRSA Restarts the 340B Rebate Pilot, With Plans Due August 24

HRSA has announced a revised 340B Rebate Model Pilot Program, giving qualifying manufacturers a voluntary route to deliver the 340B ceiling price through post-transaction rebates instead of upfront discounts. The pilot is limited to drugs on the Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027, regardless of payer or indication. Covered entities would purchase at wholesale acquisition cost and receive a rebate for the difference. Manufacturers must submit plans to HRSA by August 24, 2026, with approvals expected by September 24 and an effective date of January 1, 2027. Approved plans must give covered entities at least 90 days notice, and manufacturers bear the cost of the claims submission platform. The revision follows a request for information that drew more than 2,400 comments and the nationwide injunction that halted the 2025 pilot.

Source: 91 Fed. Reg. (Aug. 3, 2026), Notice Regarding 340B Rebate Model Pilot Program

New Registration, Recertification and Shipping Address Rules for Covered Entities

Effective with the changes announced July 29, covered entities must specify the relationship of every shipping address to the entity, whether pharmacy, health care delivery site or other receiving location, at registration, at recertification, or when submitting a change request. For any shipping address identified as an entity-owned pharmacy, HRSA now wants supporting ownership documentation such as a pharmacy license or a listing on the entity's Medicare Cost Report. A pharmacy not owned by the covered entity must instead be registered as a contract pharmacy. HRSA says the change is meant to streamline OPAIS review.

Source: HRSA Office of Pharmacy Affairs; Office of Management and Budget

Boesen & Snow Perspective

This reads like a paperwork change and is not one. Entities that have been shipping to affiliated but not actually owned pharmacies under an entity-owned address will have to produce ownership documentation or convert those locations to contract pharmacy registrations, and a contract pharmacy registration brings a written agreement, a compliance obligation, and a very different audit posture with it. Pull your OPAIS shipping address records and test each one against the ownership standard before your recertification window opens, not during it.

CMS Would Make Part D 340B Claims Reporting Mandatory

Through the CY 2027 Physician Fee Schedule proposed rule, CMS proposes to convert the voluntary Medicare Part D 340B claims data repository into a mandatory one for claims dated on or after January 1, 2027. Covered entities, their contract pharmacies or their third-party administrators would submit five data elements for every 340B Part D claim: date of service, prescription or service reference number, fill number, dispensing pharmacy NPI, and 11-digit NDC. Submissions would be quarterly, due by the end of the quarter following the quarter of service, and CMS proposes to make compliance a condition of Medicare participation. The repository is intended to test whether actual claims data can eventually replace the agency's Prescriber-Pharmacy Methodology. Comments are due September 14, 2026.

Source: CMS, CY 2027 PFS Proposed Rule (CMS-1848-P)

CMS Proposes ASP Minus 33.4 Percent for 340B Drugs

The CY 2027 Hospital Outpatient Prospective Payment System proposed rule would overhaul how Medicare pays for 340B-acquired drugs, cutting reimbursement from ASP plus 6 percent to ASP minus 33.4 percent, roughly a 37 percent reduction, based on the acquisition cost survey CMS fielded between January 1 and April 7, 2026. Rural sole community hospitals, children's hospitals and PPS-exempt cancer hospitals would be exempt. CMS proposes new billing modifiers, JG for non-exempt 340B drugs, TB for exempt 340B drugs, and XX for non-340B drugs. Because outpatient payments must remain budget neutral, CMS would offset roughly $4.55 billion in drug savings by raising non-drug outpatient payments by about 8.44 percent. Separately, the rule accelerates the 340B remedy clawback tied to American Hospital Association v. Becerra, raising the annual conversion factor reduction from 0.5 percent to 3 percent so the roughly $7.8 billion owed for 2018 through 2022 is recouped by about 2029 rather than the 2040s. Comments are due August 31, 2026.

Source: CMS, CY 2027 OPPS and ASC Proposed Rule (CMS-1850-P)

Boesen & Snow Perspective

Becerra held that HHS could not vary 340B payment by hospital group without first conducting the acquisition cost survey the statute requires. CMS has now run the survey, which cures the specific defect the Supreme Court identified and forecloses a facial challenge on that ground. Any litigation over a finalized rule will have to be fought over the survey's methodology and the reasonableness of what CMS drew from it, which is a harder and more technical case than the last one. Given the size of the cut and the AHA's track record, we would expect that case to be filed. In the meantime, the August 31 comment window is where the methodology record gets made, and comments filed now are what a court will be reading later.

PBM Reform & Congress

Pharmacists Fight Back Act Clears House Oversight

The House Committee on Oversight and Government Reform passed H.R. 6610, the Pharmacists Fight Back [in Federal Employee Health Benefit Plans] Act, on July 22. The bipartisan bill from Chairman James Comer and Representative Jake Auchincloss would require market-based reimbursement in the Federal Employees Health Benefits Program using the NADAC benchmark plus the state's Medicaid fee-for-service dispensing fee, ban patient steering to PBM-affiliated pharmacies, require pass-through of a portion of manufacturer rebates at the counter, and establish penalties for noncompliance. Sister legislation, H.R. 6609, would apply the same protections to Medicare and Medicaid plans and sits with House Energy and Commerce and House Ways and Means. Both speak broadly to network requirements, including specialty network requirements. The House is in recess from July 27 through August 31.

Source: House Committee on Oversight and Government Reform; Congress.gov

Boesen & Snow Perspective

The reimbursement floor is the headline, but the network language is the provision worth reading closely if you run a specialty or limited distribution pharmacy. Anti-steering and network adequacy text drafted with retail in mind can reach specialty network design in ways nobody intended, and the fix is easier before markup than after. Recess is the window. Committee staff are available, the text is not final, and specialty-specific comments carry more weight now than they will in conference.

How We Can Help

Our attorneys are also pharmacists. We work through substance-level classification, API supplier diligence, master formulation records and SOPs, USP readiness, multi-state board alignment, marketing and website review, 340B registration and contract pharmacy structure, and the fraud and abuse analysis behind telehealth and marketing arrangements. If any item in this issue touches your operation, we are glad to talk it through. Ready To Talk To An Attorney? CLICK HERE

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The FOMO Files is provided for general informational purposes, does not constitute legal advice, and does not create an attorney-client relationship. The regulatory status of the matters discussed is current as of publication and is subject to change. This may be considered legal services marketing.