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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. 


Puerto Rico Is Open For Business

Puerto Rico has the highest vaccination in the nation. More than 73% of the total population is fully vaccinated. The U.S. national average is just over 57%. The ports opened in June 2020 and San Juan held it first live concert this past summer. It is important to remember that Puerto Rico is a U.S. territory and there is no need for visas, the banking systems is almost identical to the mainland and the Island uses the U.S. postal service and U.S. dollar as its currency. There are thousands of flights from the U.S. to Puerto Rico daily and all main airlines fly to the Island.

Ohio Medical Board Changes Telemedicine Rules

A SCMS News Article by Scott Sandrock.

The Rising Threat from Insiders – Get Your House in Order

As its name implies, an ‘Insider Threat’ originates inside an organization. An ‘insider’ is any person who has or had authorized access to or knowledge of an organization’s resources, including personnel, facilities, information, equipment, networks, and systems. ‘Insider threat’ can manifest from malicious, complacent, negligent or unintentional acts that negatively affect the integrity, confidentiality, and availability of the organization, its data, personnel, or facilities. Certainly, ‘Insider Threat’ can be an activity by a bad actor employee, but can also arise from an inadvertent or unknowing action inside an organization (such as an employee who unintentionally opens a phishing email or clicks on a malicious link).

In Cybersecurity– A Good Offense is the Best Defense

2021 has been a watershed moment for cybersecurity incidents as cybercrime has become a frequent headline and cyber criminals have thrived on unsuspecting and/or unprepared businesses and institutions. For example, the Solar Winds attack exposed sensitive data from top companies like Microsoft as well government agencies[1] and the Colonial Pipeline attack substantially disrupted the petroleum supply chain[2]. We have seen an almost 20% increase in data breaches and attacks since last year.

Changes to Medicare’s Physician Fee Schedule and Outpatient Prospective Payment System

Come the beginning of 2022, both the Medicare Physician Fee Schedule (“MPFS”) and Outpatient Prospective Payment System (“OPPS”) will look a little different. As a refresher, the MPFS lists the fees associated with reimbursement of services to providers at certain facilities, taking into account geography and costs. By contrast, OPPS sets reimbursement rates for hospitals and community mental health centers for outpatient services, which are determined in advance. A summary of some of the more pertinent changes to each rule will be outlined below.