Michigan’s Attorney General, Republican State Senator Joe Hune, and Steve Arwood, Director of the Michigan Department of Licensing and Regulatory Affairs announced that they would collaborate on a Michigan bill to tighten regulations on compounding pharmacies. Over the past two years, compound pharmacies have been the subject of increasing controversy as these pharmacies create medications for an individual patient by mixing medications together or turning certain pill-form drugs into liquid form and shipping them to hospitals and clinics across the country. Historically, compounding facilities have been minimally regulated. Recent legislation to establish requirements and oversight for these entities is spurred by growing concern that many compounding pharmacies do not have proper safety and cleanliness policies in place. In 2012, one such facility, the New England Compounding Center in Massachusetts, was responsible for a fungal meningitis outbreak caused by medicines compounded in unsanitary conditions which resulted in 750 illnesses and 64 deaths, according to the Centers for Disease Control. This facility distributed tainted injectable steroids to providers in over 20 states, including Michigan, whose residents experienced a high percentage of the impact. The steroids were given to over 264 Michigan patients resulting in 19 deaths.
The proposed legislation will increase the amount of oversight over compounding facilities by permitting the State Licensing and Regulatory Affairs Department to have expanded inspection authority over there entities. The bill also requires that each facility employs an on-site, licensed pharmacist who has undergone a criminal background check. The pharmacist will also be responsible for all record-keeping activities in the facility and must indicate the name of the person who prepares each compounded product. Additionally, each facility will be required to undergo an inspection to attain re-licensure every two (2) years. Sponsors of the bill hope that increased oversight and adequate record-keeping will allow the State to identify non-compliant facilities and to avoid future widespread outbreaks.
