What Congress has done on peptides

The 503A bulks list is an FDA regulation, so most of the peptide fight has happened inside the agency. Congress has two kinds of influence. It can press HHS and FDA through letters and hearings, and it can change the law itself. As of 15 October 2026 it has done the first several times and the second only at the edges. Holland and Knight, writing after the July 2026 committee vote, noted that the two routes to listing are FDA rulemaking or Congress amending the Food, Drug, and Cosmetic Act. No bill we found would do the second.

Letters to HHS

Sen. Tommy Tuberville (R-Alabama), 30 July 2025. We have not seen this letter. It is described in a later House letter as warning that "restricting physician-guided compounding risks driving patients into unsafe markets". Associated Press and Undark also report that Tuberville wrote to Kennedy asking for limits on peptides to be lifted.

Rep. Diana Harshbarger (R-Tennessee), 10 November 2025. Writing "as both a pharmacist and a Member of Congress", Harshbarger asked Kennedy to have FDA "exercise enforcement discretion with respect to the compounding of certain peptides". She named six: BPC-157, CJC-1295, ipamorelin, thymosin alpha-1, TB-500 and GHK-Cu. She made two requests:

• Reevaluate the six "through an improved Pharmacy Compounding Advisory Committee (PCAC) process that prioritizes safety and quality over evidence of clinical efficacy", arguing that "there are no double-blind, placebo-controlled studies for these types of personalized therapies".
• In the meantime, allow compounding where active ingredients come only from "FDA-registered, cGMP-compliant facilities", compounding happens only in registered outsourcing facilities or state-licensed 503A pharmacies, and each dispensing requires a prescription for an identified patient.

The letter was copied to Commissioner Makary. Associated Press later reported that her son, Tennessee state Sen. Bobby Harshbarger, a pharmacist, was appointed to the committee that voted in July 2026.

Hearings

At a House Energy and Commerce hearing in 2026, according to the Alliance for Pharmacy Compounding, Rep. Harshbarger pressed Kennedy on repopulating the PCAC before its July meeting and on supply of good-manufacturing-practice ingredients. Kennedy replied: "We need to bring it back into a real marketplace," where "legitimate, honest formulation pharmacies with integrity and ethics are formulating them for Americans." The report does not give the hearing date. At the Senate confirmation hearing of FDA nominee Heidi Overton on 24 September 2026, we found no report that peptides were raised.

Bills

The argument in the Harshbarger letter

The letter's central request goes to the method, not just the outcome. FDA's 2019 rule makes "evidence of effectiveness" one of four criteria it balances for every substance. Harshbarger asked for a process that would weigh "safety profile and suitability for compounding" instead, on the ground that compounded preparations "are inherently individualized and not subject to the same clinical trial models as manufactured drugs." FDA's reviewers took the opposite approach in July 2026: each of their seven briefing documents cited a lack of evidence of effectiveness among the reasons to say no. The committee members who voted yes largely argued from access and supply quality rather than from efficacy data. Changing the criteria themselves would take a new rule or an act of Congress.

Reading the bills

None of the three touches the 503A list. The defence bill provision concerns military supplement rules, not FDA. Its scope depends on the phrase "legally available", which, for most peptides sold online, is the open question FDA has not yet answered. The Department of Defense's prohibited list draws on the WADA Prohibited List among other sources, and many peptides are on it.

The Mace bill would route veterans' access through VA research rather than compounding. Announcing it, Mace said: "Study it. Test it. Follow the evidence. If it works, veterans deserve access."

The Morelle bill is about a different kind of peptide altogether: new oral or inhaled cyclic peptide drugs from industry discovery platforms, and how soon Medicare can negotiate their price. It is the only one of the three that concerns FDA-approved drugs.

What would change things

A statute adding peptides to the 503A list, or changing the PCAC process the way Harshbarger's letter describes, would bypass the rulemaking that has not yet started. No such bill had been introduced in the 119th Congress as of 15 October 2026, based on our search of congress.gov. Members have so far chosen letters and hearings. The timeline places each step in sequence, and the states page shows that one state legislature, Louisiana, has gone further than Congress.

Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.