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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. 


Hurry Up, STOP. . .Has CTA Been Struck Down By Courts?

Following a recent case in Texas, uncertainty has arisen regarding whether clients should file "beneficial owners" reports. This is a result of the Federal Government enjoined from enforcing the CTA. Contact your BMD Member Blake Gerney to find out how this affects you.

DEA and HHS Issue its Third Extension of Telemedicine Flexibilities through 2025

The DEA and U.S. Department of Health and Human Services (HHS) have extended telemedicine flexibilities for prescribing controlled medications through December 31, 2025. This extension builds on temporary exceptions made in 2020 due to COVID-19, allowing providers to prescribe Schedule II-V controlled substances based on a telemedicine evaluation alone. The extension ensures continued patient access to necessary prescriptions and provides time for providers to comply with future regulations.

Medicare Making Changes to Improve Behavioral Health Care Access

The Centers for Medicare & Medicaid Services (CMS) has introduced changes to Medicare’s behavioral health coverage, including allowing Marriage and Family Therapists and Mental Health Counselors to enroll independently, increasing reimbursements for crisis psychotherapy and substance use treatment, and expanding services via community health workers. These updates address gaps in care and improve access to mental health services for Medicare beneficiaries.

The Ohio Department of Medicaid Announces Four Next Generation MyCare Plans

On November 1, 2024, the Ohio Department of Medicaid (ODM) announced four managed care organizations that will become ODM’s Next Generation MyCare plans starting January 2026. MyCare Ohio is a managed care program that supports Ohioans across 29 counties enrolled in both Medicare and Medicaid.

Corporate Transparency Act Reporting Deadline: December 31

The Corporate Transparency Act (“CTA”), which became effective January 1, 2024, imposes strict reporting guidelines on small business owners throughout the country.  The deadline for non-exempt businesses to submit reporting is December 31, 2024.