US Moves to Expand Access to Unproven Peptides Despite FDA Objections

WHO:

CNN - The US Department of Health and Human Services (HHS) issued the draft policy; HHS spokesperson Emily Hilliard said it supports patient-specific compounding under state and federal oversight.

CNN - FDA scientists recommended against supporting the substances, according to Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines.

CNN - The American Peptide Association, co-founded by Jeff Cohen, and the Alliance for Pharmacy Compounding, led by CEO Scott Brunner, welcomed the policy.

CNN - Committee members in favor included Dr. Hal Mohammed, global chief medical officer of Gameday Men’s Health; Dr. Elizabeth Rebello of the University of Texas MD Anderson Cancer Center was among those who opposed easing access.

CNN - Jay Campbell, co-founder of BioLongevity Labs and author of “Optimize Your Health With Therapeutic Peptides,” said prescription access could benefit some patients but raise costs.

NY Post - The Trump administration is easing access to peptides despite FDA opposition; its headline describes the peptides as favored by RFK Jr.

ABC News - HHS said some wellness peptides will be available by prescription.

WHAT:

CNN - HHS posted a draft policy allowing limited access to six injectable peptides through patient-specific prescriptions filled by licensed compounding pharmacies. The policy does not grant FDA approval or establish clinical safety and effectiveness.

CNN - The six peptides are not FDA-approved. Examples discussed in the article include BPC-157, TB-500 and Semax.

ABC News - The department said it will temporarily let compounding pharmacies provide six peptides by prescription.

NY Post - The government will accept comments for two weeks before finalizing the measure.

CNN - HHS says safeguards include patient-specific prescriptions, traceable ingredients, quality testing and safety reporting. The policy says HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding the listed products under the policy.

CNN - Peptides are short chains of amino acids and building blocks of proteins. Insulin and GLP-1 medicines, including Ozempic and Wegovy, are peptides.

CNN - The FDA’s Pharmacy Compounding Advisory Committee narrowly supported allowing compounding of the six peptides. Some members argued regulated pharmacy access could be safer; opponents cited limited evidence and unknown effectiveness and risks.

CNN - The Partnership for Safe Medicines filed a citizen petition asking the FDA to block peptide compounding. Safdar said potential conflicts of interest among newly appointed committee members were overlooked.

CNN - Campbell said pharmacy sourcing and testing could raise prices; he said direct-to-consumer users could face higher costs or reduced access. The Alliance for Pharmacy Compounding said the draft includes extensive testing, documentation and reporting of serious adverse events and product-quality issues.

WHERE:

CNN - The policy concerns compounding in the United States; some consumers currently obtain peptides through unregulated websites and other gray-market suppliers.

WHY:

CNN - HHS said the policy is intended to provide a more controlled alternative to foreign-supplied, research-use-only products and discourage their widespread use.

CNN - Supporters said regulated pharmacy access could reduce risks from products of uncertain contents; critics questioned whether compounding would curb gray-market sales and raised concerns about evidence and safety.

HOW:

CNN - Compounding involves a licensed pharmacist or physician combining, mixing or altering drug ingredients to create medication tailored to an individual patient. Under the draft policy, access would require a physician’s prescription and dispensing by a licensed compounding pharmacy.

CNN - HHS said it would issue a final policy after the draft’s 14-day comment period; the draft is separate from a final rule on whether the peptides may be added to the list of ingredients eligible for compounding.

(UPDATED October 30, 2026 00:02 UTC)

The Department of Health and Human Services has proposed temporarily allowing licensed compounding pharmacies to provide six injectable peptides with patient-specific prescriptions, even though the substances are not FDA-approved. HHS says safeguards would include ingredient tracking, quality testing and safety reporting, while supporters see regulated access as an alternative to products from unregulated suppliers. Critics point to limited evidence and unknown risks, and the proposal does not establish the peptides’ safety or effectiveness; HHS will consider public comments before issuing a final policy.