Three Considerations When Prescribing Compounded GLP-1s

Our healthcare and business law firm works with many providers who work with compounded medications. As glucagon-like peptide-1 receptor agonists (“GLP-1s”) continue to be prescribed by providers, including FDA-approved commercial versions and compounded versions, we routinely are asked for guidance by providers around prescribing compounded drugs. This blog identifies three categories of topics that are relevant to prescribing compounded GLP-1s. If you would like to discuss ways to protect your practice in prescribing GLP-1s or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

FDA Requirements:

In sum, unless a drug is on the shortage list, compounding a drug is appropriate only for when a patient requires a modification to the commercial (FDA-approved) drug (such as, due to an allergy or need for some additional/replacement ingredient). The FDA has a lot of concerns with GLP-1 drugs and has created a “green list” of importers based on its evaluation of sites, so a practice should work with compounding pharmacy that only import active pharmaceutical ingredients from importers on the green list.

There are many weight loss drugs that are currently in the FDA-approval process. However, the drugs are not FDA-approved and therefore cannot be used in compounding. See FDA’s Concerns for Unapproved GLP-1s for Weight Loss (“Retatrutide and cagrilintide cannot be used in compounding. Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition. The agency has issued warning letters to companies distributing active pharmaceutical ingredients, such as retatrutide and certain other GLP-1 drugs.”)

Salt forms of semaglutide are not FDA-approved and should not be used in compounding, so practices should ensure any compounding pharmacies they work with do not use salt forms of the active pharmaceutical ingredients. Id. (“Salt forms should not be used to compound semaglutide. The agency is aware that some semaglutide products sold by compounders may be the salt forms. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.”)

Good Clinical Practice and Licensing Boards:

There have been reports of adverse reactions from compounded drugs due to dosage issues, temperature control issues, etc. State licensing boards might have concerns with a prescribing provider if a patient files a complaint based on an adverse reaction to a prescribed compounded GLP-1. Part of the issue would of course be a pharmacy issue, but given how well-known the pharmacy issues are, the licensing board could take disciplinary action against the provider.

Marketing:

Manufacturers like Eli Lilly and Novo Nordisks have brought hundreds of lawsuits against pharmacies and practices. As to the practices, the manufacturers have been alleging false advertising and unfair trade practices when the practice advertises compounded drugs as equivalent to the FDA-approved, commercial drug. Practices may wish to review their websites, pamphlets, consents, etc. to ensure they are not advertising as if compounded drugs are equivalent to the FDA-approved drugs.

If you would like to discuss ways to protect your practice in prescribing GLP-1s or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

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