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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. 


CMS to Once Again Reprocess Outpatient Clinic Claims

The Hospital Outpatient Prospective Payment System (OPPS) Rule was passed in November 2018, which was intended to prevent the Centers for Medicare and Medicaid Services (CMS) from paying more for services rendered in outpatient settings than what they paid for the same services rendered in physician offices that are simply owned by hospitals or health systems.[1]

New Vaccine Requirement for Select CMS-Participating Facilities

On November 4, 2021, the Centers for Medicare and Medicaid (“CMS”) released a new rule requiring certain healthcare facilities to implement policies requiring employees to be vaccinated against COVID-19. It does not matter if a staff member does not perform patient treatment services, they must still be vaccinated if an employee of an applicable facility.

OSHA COVID-19 EMERGENCY TEMPORARY STANDARD (ETS) Vaccination, Testing, Recordkeeping, and Reporting

The Occupational Safety and Health Administration has issued its long-awaited COVID-19 Emergency Temporary Standard (ETS). Note that the ETS does not apply to employers covered under the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors or Subcontractors (see here), or to settings where employees provide healthcare services subject to OSHA’s ETS for the healthcare industry (see here).

Interesting Trends Revealed in 50-State Medicaid Budget Survey

Results of the KFF annual survey of state Medicaid directors reveal some fascinating trends in Medicaid service delivery and benefit coverage. Read on for a summary of the highlights we find most noteworthy. Background As a preliminary matter, many of the trends KFF identifies and that we highlight below are no doubt a result of the Covid-19 pandemic. The pandemic triggered a public health emergency and economic crisis that resulted in increased Medicaid enrollment, service offerings, and flexibility in service delivery, along with a heightened awareness of disparities in access to care and health outcomes.

Changes to Physician Assistant Statutes in Florida

In the last year, there have been many changes to the scope of practice and collaboration/supervision requirements for advanced practice providers such as APRNs and physician assistants in the state of Florida. In a previous Client Alert we discussed House Bill 607, which expanded the autonomous practice of APRNs providing primary care services in Florida.