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Compounding GLP-1 Drugs - Recent Updates

Client Alert

More individuals are utilizing weight loss medication than ever before. With the rise in usage, providers must be aware of when, how, and why they are able to prescribe or create compounded GLP-1 drugs.       

Recent guidance from the Ohio Board of Pharmacy (“BOP”) indicates that providers should generally use the FDA approved GLP-1 drug, rather than a non-FDA approved compounded version of the medication. Importantly, if a GLP-1 drug is commercially available, it cannot be copied through compounding. Currently, compounded copies of Tirzepatide and Semaglutide are not permitted.  

There are two exceptions that allow a provider to compound a GLP-1 drug: (1) if the drug is not commercially available, and (2) if the compounded drug “includes a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the commercially available product.” The identified change must be documented appropriately on the prescription or order.

The BOP also prohibits a provider from using certain ingredients in compounding. For example, Retatrutide and Cagrilintide are not permitted to be used in compounding. In addition, providers cannot use salt forms when compounding GLP-1 drugs. 

While compounded GLP-1 drugs do serve a purpose, such as serving an individualized patient need, the United States Food and Drug Administration (“FDA”) has stated its concern with using any non-FDA approved GLP-1 drug. According to the FDA, one of the potential concerns is that the compounded drug may contain the incorrect amount of an active ingredient, leading to adverse effects. If using a compounded GLP-1 medication, providers will want to ensure that they are creating and storing the compounded drugs correctly, that they are not utilizing drugs labeled “for research purposes only,” and that any active ingredients purchased are from an FDA registered and Ohio licensed distributor.

To learn more about how drug compounding regulations can impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001. 


What Inpatient Behavioral Health Providers Need to Know About ODM's New Draft Rule for Reimbursements

Ohio Department of Medicaid (ODM) recently released a draft rule that will transform how inpatient behavioral health services are reimbursed for some hospitals. ODM will migrate inpatient payments for behavioral health and substance use disorder services (BH/SUD) provided by freestanding psychiatric hospitals (FSPs) from the APR-DRG payment methodology to a per diem payment methodology derived from the APR-DRG system.

BMD Named to the 2024 U.S. News – Best Lawyers® “Best Law Firms”

Brennan Manna & Diamond (BMD) is recognized among the leading law firms in the nation according to the 2024 Edition of U.S. News – Best Lawyers®  "Best Law Firms." The firm has ranked in in 13 practice areas and has earned “National Tier 1” rankings in Health Care Law and Litigation-Trusts & Estates.

Friendly Physician Models: The Basics Through 5 Frequently Asked Questions

During the past several years, many health law practices have noticed a dramatic increase in the number of telehealth businesses and private equity backed health care providers. Both of these trends often rely heavily on corporate structures commonly referred to as “friendly physician,” “captive PC” or “MSO” models. Although friendly physician models are used by non-physician health care providers (e.g., physical therapists, psychologists, and dentists), this article focuses on physicians and how the model is used in connection with the provision of professional medical services.

The DOL and EEOC Enter a Partnership to Strengthen Federal Employment Law Enforcement

On September 13, the U.S. Department of Labor’s (DOL) Wage and Hour Division and the Equal Employment Opportunity Commission (EEOC) entered into a Memorandum of Understanding (MOU) agreeing to work together in enforcing federal employment laws. The MOU forms a partnership between the two agencies to encourage coordination through information sharing, joint investigations, training, and outreach.

Proposed Laboratory Arrangement Draws Heightened Scrutiny from the OIG

On September 25, 2023, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO). The Opinion involved a proposed arrangement between an independent laboratory and other physician laboratories for the purchase of the technical component of anatomic pathology services. The OIG ultimately concluded that the arrangement at issue, if it was entered into with the requisite intent, would implicate the Federal Anti-Kickback Statute (AKS) and constitute grounds for sanctions.