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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. 


Enhancing Privacy Protections for Substance Use Disorder Patient Records

On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) finalized updated rules to 42 CFR Part 2 (“Part 2”) for the protection of Substance Use Disorder (“SUD”) patient records. The updated rules reflect the requirement that the Part 2 rules be more closely aligned with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) privacy, breach notification, and enforcement rules as mandated by the Coronavirus Aid, Relief, and Economic Security Act of 2020.

Columbus, Ohio Ordinance Prohibits Employers from Inquiries into an Applicant’s Salary History

Effective March 1, 2024, Columbus employers are prohibited from inquiring into an applicant’s salary history. Specifically, the ordinance provides that it is an unlawful discriminatory practice to:

The Ohio Chemical Dependency Professionals Board’s Latest Batch of Rules: What Providers Should Know

The Ohio Chemical Dependency Professionals Board has introduced new rules and amendments, covering various aspects such as CDCA certificate requirements, expanded services for LCDCs and CDCAs, remote supervision, and reciprocity application requirements. Notable changes include revised criteria for obtaining a CDCA certification, expanded services for LCDCs and CDCAs, and updated ethical obligations for licensees and certificate holders, including non-discrimination, confidentiality, and anti-sexual harassment measures.

Governor Mike DeWine and The Ohio State University Introduce the SOAR Study on Ohio Mental Illness

On January 19, Ohio Gov. Mike DeWine and The Ohio State University announced a new research initiative, the State of Ohio Adversity and Resilience (“SOAR”) study, which will investigate all factors influencing Ohio’s mental illness and addiction epidemic.

CHANGING TIDES: Summary and Effects of Burnett et. al. v. National Ass’n of Realtors, et. al.

In April 2019, a class-action Complaint was filed in federal court for the Western District Court for Missouri arguing that the traditional payment agreements employed by many across the United States amounted to conspiracy resulting in the artificial increase in brokerage commissions. Plaintiffs, a class-action group comprised of sellers, argued that they paid excessive brokerage commissions upon the sale of their home as a result of the customary payment structure where Sellers agree to pay the full commission on the sale of their property, with Seller’s agent notating the portion of commission they are willing to pay to a Buyer’s agent at closing on the MLS or other similar system.