Recently, the Ohio Board of Pharmacy (Ohio Board) has intensified its oversight and policing of pharmacies compounding GLP-1 products in the State of Ohio. The Ohio Board’s focus extends past Ohio-based pharmacies and also includes nonresident pharmacies that compound GLP-1 products and ship these products into the state of Ohio. This development comes in the wake of the Food and Drug Administration (FDA) removing Semaglutide and Tirzepatide from the FDA Drug Shortage List. In light of this recent development, all compounding pharmacies doing business in Ohio, whether licensed as a resident or non-resident pharmacy, should prioritize compliance with all applicable rules and regulations to avoid possible disciplinary action by the Ohio Board.

Ohio Board’s Enforcement Focus of GLP-1 Drug Products

Last month, the Ohio Board issued a statement notifying compounding pharmacies that retatrutide, a peptide therapy treatment aimed at treating obesity and type 2 diabetes similar to other GLP-1 products, cannot be used in compounding. The Board noted retatrutide is not a component of an FDA-approved drug and has not been found safe and effective for any condition. The Ohio Board warned licensees that if they are found to be compounding, selling, ordering, administering, or otherwise facilitating the distribution of retatrutide, the Ohio Board will take disciplinary action against the licensee, including immediate licensure suspension, also known as summary suspension. 

Although the Board’s statement specifically related to retatrutide, the Ohio Board’s actions reflect a broader initiative to clamp down on what it perceives as unsafe or unlawful compounding activities, especially concerning compounded GLP-1 products. For example, the Ohio Board recently issued multiple summary suspensions aimed at pharmacies compounding GLP-1 products. This again illustrates the Ohio Board’s broader initiative that focuses not only on retatrutide, but on the compounding of GLP-1 products generally. Compounding pharmacies should be aware of the Ohio Board’s initiative to avoid the risk of any potential disciplinary action, including summary suspension. This Ohio Board’s actions in Ohio reflect an environment of heightened scrutiny throughout the entire country related to sterile compounding, especially as it relates to GLP-1 products. 

Conclusion

In light of this enforcement landscape, compounding pharmacies must prioritize strict and complete compliance to avoid regulatory repercussions. Ohio’s stance indicates a clear intent to regulate the compounding of GLP-1 and peptide products, such as retatrutide, rigorously. Pharmacies compounding and dispensing in the State of Ohio must diligently assess their policies and procedures that relate to compounding, with a special focus on the compounding of GLP-1 products. Prompt and proactive action now can help to mitigate the risk of disciplinary actions, including serious actions like summary suspension and other enforcement actions. By implementing vigorous compliance measures, pharmacies can better navigate this challenging regulatory environment and continue to serve patients safely and effectively.