Michigan Attorney General Bill Schuette along with Steve Arwood, Director of the Michigan Department of Licensing and Regulatory Affairs, and State Senator Joe Hune, recently announced their plan to collaborate on a bill designed to strengthen Michigan’s regulation and oversight of compounding pharmacies. Compounding pharmacies have been under increased scrutiny in Michigan and nationally following the 2012 outbreak of fungal meningitis, which was traced by the Centers for Disease Control and Prevention (“CDC”) and the Food and Drug Administration (“FDA”) to unsanitary conditions at a Massachusetts compounding pharmacy. The 2012 outbreak resulted in 64 deaths and nearly 750 illnesses nationally with 19 deaths and at least 264 illnesses in Michigan.
Historically, compounding pharmacies have been minimally regulated. However, since the outbreak, legislators around the country have considered proposals that would increase governmental oversight of compounding pharmacies and establish cleanliness and safety procedures. These proposals have been made in response to the growing concern that such polices are lacking or nonexistent. Further, some regulators have expressed concern that some compounding pharmacies are acting more like manufacturers by providing hospitals with drug preparations without a prior prescription.
The Attorney General and his collaborators hope that through increased oversight by DLARA and more adequate record-keeping by the pharmacies, the state would be able to identify non-compliant facilities and prevent future outbreaks. As proposed, the legislation would impose the following requirements:
• Facilities would be required to employ a licensed “pharmacist-in-charge,” who is responsible for ensuring that the facility complies with all state and federal laws;
• Facilities would have to maintain accurate records for all sterile compounded drugs that includes the product’s name, strength quantity and dosage, formula to compound, date of preparation, identifying prescription number, manufacturer and lot number of each ingredient, name of the person who prepared the compound, and the name of the pharmacist who approved the compound.
• Facility owners would be subject to background checks.
• Facilities would be required to undergo a re-licensure, including an inspection, every two (2) years.
Once introduced, this legislation will join a growing list of measures aimed at increasing governmental oversight of compounding, including a federal measure (H.R. 3204), passed by the House of Representatives, that would clarify the FDA’s role in compounding oversight.
We will continue to monitor this proposal as well as H.R. 3204 and provide updates as they occur. If you have questions about this issue or other related issues, please contact Adrienne Dresevic, Esq., or Clinton Mikel, Esq. at (248) 996-8510, or visit the HLP website.