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Compounding GLP-1 Drugs - Recent Updates

Client Alert
November 13, 2025

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. 

Health LawHealthcareHealthcare PolicyGLP-1MedSpa
Client Alert

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

May 3, 2022On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.Client Alert

Property Owner Protection from Tax Valuation Challenges

April 29, 2022New legislation provides significant new protections for commercial property owners against challenges to valuation primarily by local school boards and prohibiting side agreements to avoid tax valuation changes. The Ohio Legislature has approved House Bill 126 which will go into effect July 2022 but will effectively apply to the 2023 tax valuation year.Client Alert

No Surprises Act Update: The IDR Portal is Open

April 25, 2022The No Surprises Act (“NSA”) became effective January 1, 2022, and has been the subject of lawsuits and criticisms since its inception. The goals of the No Surprises Act are to shield patients from surprise medical bills, provide to uninsured and self-pay patients good faith estimates of charges, and create a process to resolve payment disputes over surprise bills, which arise most typically in emergency care settings. We have written about Part I and Part II of the NSA previously. This update concerns the Independent Dispute Resolution (“IDR”) procedure created by Part II but applicable to claims covered by Part I. The Centers for Medicare & Medicaid Services (“CMS”) finally opened the Portal for providers to submit disputes to the IDR process following some updated guidance regarding the arbitration process itself.Client Alert

Updated FAQs for the No Surprises Act - Good Faith Estimates

April 7, 2022The No Surprises Act (“NSA”) became effective January 1, 2022. Meant to protect consumers from surprise medical bills, the new law is good for consumers, but vexatious for health care providers and facilities. One particular source of frustration is the operationalization of the Good Faith Estimate (“GFE”) requirement, governed by Part II of the regulations that implement the NSA. The GFE requirements apply broadly to all healthcare providers and facilities that practice within the scope of their state-issued license.Client Alert

IMPORTANT PRF UPDATE! HRSA Allows Providers the Opportunity to Correct Missed Period 1 Reporting

April 7, 2022Late Wednesday, April 6, HRSA announced that it was going to allow providers with extenuating circumstances that prevented them from preventing a completed Period 1 Report to submit a Request to Report Late Due to Extenuating Circumstances.
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