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.
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