Michigan Imposing Tighter Regulatory Controls on Compounding Pharmacies
On April 24, 2014, the Michigan Senate Health Policy Committee held its first hearing on Senate Bills 704 and 904, a pair of proposed legislation which will impose additional regulatory controls on compounding pharmacies. The bills, which were introduced and sponsored by State Senator Joe Hune (R-22 Dist.), impose additional compliance requirements on compounding pharmacies and elevate criminal penalties for particular violations.
Bill 704 imposes several new administrative requirements, including a heightened record-keeping requirement for compound recipes and a mandatory bi-annual inspection by Michigan’s Department of Licensing and Regulatory Affairs. Bill 704 requires the designation of a “pharmacist in charge” at every facility. The proposed legislation imposes ongoing licensing and accreditation requirements which will most definitely result in additional costs to compounding pharmacies. Bill 704 also enables the State to immediately suspend a compounding pharmacy license upon notice of an imminent risk to public health or safety by the United States Food and Drug Administration (FDA) or the Centers for Disease Control and Prevention (CDC). Regulatory violations, as defined by Bill 704, are complimented by potential criminal repercussions set forth in Bill 904.
Bill 904 directly amends Michigan’s Code of Criminal Procedure to include in the sentencing guidelines the offenses proposed by Senate Bill 704. Under the proposed sentencing guideline, a civil violation by a compounding pharmacy which results in personal injury to a consumer can result in a four-year prison sentence. A violation that results in a patient death will carry a maximum prison sentence of fifteen years.
The bills come as direct response to a 2012 meningitis outbreak linked to New England Compounding Center (NECC), a now-defunct Massachusetts compounding facility. While the bills have been met with support across the Michigan State Legislature, they will impose additional costs on compounding pharmacies and require additional due diligence.
Frier Levitt can assist pharmacies in meeting various legal standards and can advise clients on compliance with State and Federal laws and regulations. Contact Frier Levitt for help navigating your pharmacy through the evolving regulatory requirements and avoiding potential liability.