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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. 


Federal and Ohio Laws on Surprise Billing

Beginning in January 2022, Ohio providers and healthcare facilities will need to comply with both the federal No Surprises Act (“NSA”) and the state surprise billing law (HB 388), which are both designed to protect patients from unexpected medical bills.

New Year, New Laws, Old Form Documents? Exhibit A: Changes in Florida’s Real Estate Contracts

Settling into a New Year often brings renewed energy into setting and pushing new goals of building business relationships, increasing sales, and moving Letters of Intent and negotiations into final, signed agreements. It’s all too easy to grab a form document off the Internet (Google, anyone?), or to pull the last document in your files as a template for your next agreement. However, changes in the law can take effect at the beginning of the calendar year, as well as mid-year or fiscal new year, and sometimes on a random date in between. Your awareness – or lack of awareness – in changes in the law can mean the difference between keeping you and your business operating within the law or putting you at great financial and legal risk for not complying with the law. It can also result in financial and time savings or additional burden in time and costs.

Sports Betting Legal in Ohio

Ohio has made sports betting legal with Governor DeWine signing House Bill 29 into law on December 22, 2021. The Casino Control Commission will regulate sports betting in Ohio and estimates that the launch date for sports betting will be January 1, 2023.

Banking and Cannabis: Is it Legal

Marijuana is still a Schedule 1 drug and is illegal under federal law. However, I am not aware of any federal banking law or regulation, or any other federal law or regulation, which explicitly makes it illegal for banks and other financial institutions to provide their traditional services to state legal cannabis businesses.

Protections Under Federal and Ohio Law for Bona Fide Prospective Purchasers of Contaminated Property

Most industrial/commercial property developers are generally aware of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), often also referred to as “Superfund”. CERCLA, a United Stated federal law administered by the U.S. Environmental Protection Agency, was created, in part, because the U.S. Environmental Protection Agency recognized that environmental cleanup could help promote reuse or redevelopment of contaminated, potentially contaminated, and formerly contaminated properties, helping revitalize communities that may have been adversely affected by the presence of the contaminated properties. Commercial property developers should be aware that CERCLA provides for some important liability limitations for landowners that own contaminated property impacted by materials hazardous to the environment. It can also assist with landowners concerned about the potential liabilities stemming from the presence of contamination to which they have not contributed. In particular, CERCLA provides important liability limitations for landowners that qualify as (1) bona fide prospective purchasers (BFPPS), (2) contiguous property owners, or (3) innocent landowners.