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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. 


Is Your Bonus System Creating Wage and Hour Violations? A Hidden Impact of the Labor Shortages

As employers struggle with attracting and retaining talent, many have turned to incentives such as Signing Bonuses and Retention Bonuses. In doing so, employers may be inadvertently exposing themselves to overtime law violations. Employers with non-exempt employees know that the Fair Labor Standards Act (FLSA) requires an overtime premium to non-exempt for work in excess of 40 hours per week. However, all too often, employers miscalculate the “regular rate” of pay, which is used for calculating the “overtime rate.” The miscalculation is becoming more prevalent in today’s market when employers fail to include supplemental compensation, such as certain Signing Bonuses and Retention Bonuses into the regular rate of pay. An example: A non-exempt employee is hired at a rate of $20 per hour, and also receives a retention bonus of $1,200 after working for 12 weeks. In her 11th week of work, employee works 50 hours. In her 14th week of work, employee works 50 hours. What is her paycheck in week 11? What is her paycheck in week 14?

No Surprises Act – Notice Requirements

On July 1, 2021, the Biden Administration passed an interim final rule: Part 1 of the “Requirements Related to Surprise Billing Act,” in an attempt to curb excessive costs patients are required to pay in relation to surprise billing. The rule is set to take affect January 1, 2022, and will only affect those who are enrolled in insurance via their employers, as federal healthcare programs already prohibit this type of billing.[1]

El Contrato Escrito: La Herramienta Predilecta

No existe mejor herramienta a una disputa contractual que un documento firmado por las partes en el cual se expongan las obligaciones y acuerdos entre éstas.

New State Budget Institutes Licensure Requirement for Ohio’s Hospitals

On July 1, 2021, Governor Mike DeWine signed Ohio’s final budget codified at Ohio Revised Code 3722.01 et seq., which includes a new licensing requirement for Ohio’s hospitals. For years, Ohio was the only state in the country that did not license its hospitals. This approach will now be replaced with new, detailed requirements that will require careful review and compliance. Here are some of the highlights concerning these new changes:

Healthcare Provisions in the Ohio FY 22-23 Budget

Governor Mike DeWine signed Ohio’s Fiscal Year 2022-2023 budget bill (HB 110) into law on July 1, 2021. At almost 1,000 pages and 74.1 billion dollars, the budget lays out the State’s spending for the next two years. Below are a few highlighted provisions from the budget that will be important for the healthcare industry in Ohio