APC: HOT Issues

APC Advocacy

Learn more about these hot-button issues in pharmacy compounding

Compounding Peptides and HCG

A current “hot” product in the anti-aging and integrative medicine world is peptides, many of which were reclassified in March 2020 by federal law as biologics. Traditional compounding pharmacies cannot compound substances that are classified as biologics. In addition, most peptides do not meet any of the other legal requirements for compounding.

As a result, most peptides are off limits for traditional compounding, as they are either classified as biologics or don’t meet one of the three criteria above. Unfortunately, that March 2020 law reclassified both tesamorelin and HCG as biologics, so they may no longer be compounded.

However, there are some peptides that, because of their smaller molecule size (specifically, 40 amino acids or fewer), do not meet the definition of a biologic, yet do meet one of the three legal criteria for use in compounding. One is semaglutide base. Others include, for example, sermorelin and bremelanotide. Semaglutide is the active ingredient in an FDA-approved drug product.

The issue is complicated by the fact that a drug manufacturer now markets an FDA-approved semaglutide product, which may be protected by U.S. patents. Thus, compounding using semaglutide API, depending on the formulation, may be considered “essentially a copy” of an FDA-approved drug, and therefore impermissible for compounding. However, the FDA approved semaglutide product has been on the FDA Drug Shortage List since March of 2022, which may render it permissible for use in compounding.

On the other hand, semaglutide sodium does not meet FDA’s criteria for compoundingit’s not a component of an FDA-approved drug, doesn’t have a USP or NF monograph, and isn’t on FDA’s 503A bulks listand therefore it should not be compounded.

If you have prescribers asking questions about peptide compounding, here’s a handy briefing paper you can share with them. (It’s a members-only resource, so you’ll need your APC login and password to access it.)

This slide deck from attorney Karla Palmer of Hyman, Phelps & McNamarafrom a CE webinar she conducted for us in 2021may also be helpful to you.

The La Vita Compounding Pharmacy Matter

At issue: California compounders’ ability to compound glutathione and methylcobalamin. At the center: La Vita Pharmacy in California, which is facing enforcement action from the California Board of Pharmacy.

APC is filing an amicus brief on behalf of La Vita, thanks to funding from our Legal Action Fund. Read our news story about that.