Senate Bill 704: What it Means for Pharmacists

Bill: Senate Bill 704

Senate Bill (SB) 704 provides additional regulatory requirements for all pharmacies, but most notably for pharmacies compounding sterile pharmaceuticals. The bill was introduced by Sen. Joe Hune (R-Whitmore Lake), who has worked closely with the office of Michigan Attorney General Bill Schuette, the Michigan Department of Licensing and Regulatory Affairs and Michigan Pharmacists Association (MPA), to ensure that the bill holds pharmacists to fair and appropriate standards that increase patient safety. The bill has been described as introducing “accountability at the top,” and for the first time formally defines the role and responsibilities of the “pharmacist in charge” in the state of Michigan.

This week, the bill was voted out of the House of Representatives and now heads to Michigan Gov. Rick Snyder for his signature. The speed at which the bill is moving is a strong indication of the importance this issue holds in the minds of the stakeholders. SB 704 is the Michigan Legislature’s answer to the New England Compounding Center (NECC) tragedy that began in 2012.  

In 2013, Congress passed legislation related to the registration and inspection of outsourcing facilities. The Michigan bill takes the law one step further to tighten record keeping and accountability requirements for all practices that compound sterile pharmaceuticals. The bill also contains unique provisions for compounding of products for office use, which are geared toward facilities that do not ship across state lines and, therefore, do not wish to register as outsourcing facilities under FDA 503B. 

All facilities that compound sterile pharmaceuticals will be required to receive accreditation from an entity approved by the Michigan Board of Pharmacy. Additionally, sterile compounders who supply pharmaceuticals to patients outside of a hospital or health-system must adhere to more stringent record-keeping requirements that must be held in the same manner that prescription records are currently retained.

 

The bill also introduces criminal penalties for those who willfully and knowingly violate these regulations. Failure to meet appropriate accreditation and record-keeping requirements will result in a misdemeanor charge. This charge escalates to felony in the event that violation of the regulations directly results in the injury or death of a patient. Falsification of a prescription to compound a product in bulk is also considered a felony charge if it results in patient harm. It is important to note that these criminal penalties are all “willful and knowing” violations, which is different from the “willful or reckless” criminalities that currently exist in the Michigan Public Health Code (e.g., adulteration or misbranding of a prescription). These criminal penalties are not intended for individuals who may inadvertently breach the new regulations through activities such as clerical errors.

MPA and several member pharmacists testified in support of SB 704.  The bill will work to increase patient safety provisions in the state of Michigan and provides some much needed clarity as to what is expected of our compounding pharmacists.

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