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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. 


No Surprises Act Update: Federal Judge Strikes Portions of the No Surprises Act

In a win for providers, a Texas federal court granted the Texas Medical Association’s (TMA) motion for summary judgment and struck down portions of a federal rule that establishes a reimbursement rate arbitration process between payors and providers under the No Surprises Act (NSA).

Ohio Modernizes and Improves its Laws Governing Limited Liability Companies

Effective Feb. 11, 2022, the Ohio Revised Limited Liability Company Act (“Revised Act”) now governs all limited liability companies formed under Ohio law. The law updates and replaces the existing LLC Act and has important implications for business owners in Ohio. Passage of the Revised Act makes Ohio one of only 16 states that permits the formation of “Series” LLCs. The legislation is intended to be one of the most progressive LLC acts in the country, but retains the terminology used in Ohio’s current LLC act.

Wondering What’s Happening with Telehealth Legislation in Ohio?

In December 2021, Governor DeWine signed into law HB 122, which will expand telehealth services in Ohio. The law takes effect in March 2022 and is in response to more patients relying on telehealth over the past two years during the height of the COVID pandemic, and more providers becoming comfortable with delivering services virtually. Telehealth is now a normalized healthcare delivery system nationwide. Beyond the safety benefits inherent in telehealth services, telehealth has made healthcare more accessible and more affordable for more people.

Ohio Loan Programs to Boost Minority-Owned Businesses

Ohio has created two new loan programs to enhance growth of minority and women owned businesses in Ohio. The Ohio 2022-2023 operating budget includes the Women’s Business Enterprise Loan Program and Ohio Micro-Loan Program.

Supreme Court Upholds CMS Vaccination Mandate for Health Care Providers

Last week, the U.S. Supreme Court struck down the COVID-19 vaccine-or-test mandate for employers with more than 100 employees (the OSHA ETS) and upheld the COVID-19 vaccination mandate for employees of health care providers who receive Medicaid or Medicare funding (the CMS rule).