HHS gives compounding pharmacies free rein to make certain peptides

HHS gives compounding pharmacies free rein to make certain peptides

Without finalizing any new approvals or regulatory changes, the Department of Health and Human Services (HHS) on Wednesday gave compounding pharmacies the go-ahead to make and sell six peptides lauded by alternative health enthusiasts for their purported health benefits.

HHS stated in a notice that it would be practicing enforcement discretion when it came to the manufacturing and sale of the peptides BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax.

In its notice, the HHS acknowledged these peptides are not FDA-approved, evaluated for safety and may even “pose risks to patients,” but stated the decision by the Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee (PCAC) indicated “significant interest” in peptide use.

Earlier this year, the PCAC voted in favor adding these peptides to the FDA’s DA’s 503A list of bulk drug substances that can be used in compounding. Prior to the meeting, FDA scientists had concluded in briefing materials that there was not enough evidence to support these peptides being safe and effective.

For a 503A compounding pharmacy to manufacture and sell a substance, the product must either meet quality standards under the United States Pharmacopeia or National Formulary monograph; be a component of an FDA-approved product; or be on the FDA’s 503A compounding list.

Pro-peptide groups welcomed the news on Wednesday.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding , said in a statement, “We’ve said all along that the question isn’t whether patients are using these peptides. They are. The question is where they’re getting them. Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what’s actually in the vial.”

Other groups like the Partnership for Safe Medicines (PSM) pushed back on the decision.

“Today’s decision leaves Americans in a grey area as to whether peptides are safe or not, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence,” PSM Executive Director Shabbir Imber Safdar said in a statement.

“Overlooked in this vote is that many newly appointed PCAC members appear to have conflicts of interest directly related to the peptide substances under consideration. This outcome shreds any sense of credibility and transparency, placing their interests above the safety of the American people,” he added.

Welcome to The Hill’s Health Care newsletter , we’re Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health.

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