Rick Snyder today signed legislation that updates pharmacy safety standards and strengthens oversight.
The bills are a result of a 2012 fungal meningitis outbreak from contaminated steroid injections distributed by the New England Compounding Center in
Massachusetts. More than 260 Michigan patients were affected by the outbreak including 22 deaths. The compounding center was only licensed as a compounding facility but acted as a drug manufacturer which contributed to the contamination of the injections.
"These bills will help establish additional safeguards between patients and pharmacists helping ensure Michiganders remain safe and healthy," Snyder said. "Consumers need and deserve to have confidence in any product they receive, especially medical ones. These changes put patient safety first and are designed to help prevent future tragedies."
Senate Bill 704, sponsored by state Sen.
Joe Hune, provides safeguards for Michigan patients and pharmacy customers. The bill ensures that pharmacies are operating under their scope of service and requires each pharmacy to have a licensed "pharmacist-in-charge" who is responsible for ensuring the facility follows state laws and regulations. It also requires compounding pharmacies to maintain accurate records for all compounded drug sales including the name of the person who prepared and approved the compound. Pharmacies, manufacturers and wholesalers engaged in compounding must submit to at least one state inspection every two years.
SB 904, also sponsored by Hune, establishes felony and penalty provisions for violations of SB 704. Violations that cause personal injury, serious impairment of a bodily function or death can result in four to 15 years' imprisonment.
"We owe it to the hundreds of
Michigan victims of the NECC meningitis tragedy to ensure a disaster of this magnitude does not strike twice," said Attorney General Bill Schuette. "This legislation signed by Governor Snyder today will hold every compounding pharmacy responsible for the drugs they distribute and ensure pharmacists always put patient safety first."