State Rules to Change for Pharma Companies
Wednesday, September 23, 2015
The Michigan House Committee on Health Policy voted out unanimously a substitute bill H-1 for SB 195, that would eliminate a requirement that an applicant for a pharmacy, manufacturer, or wholesale distributor license provide his/her fingerprints for a criminal history check. The House issued both legislative and fiscal summaries of the proposed legislation.
The bill would amend Part 177 (Pharmacy Practice and Drug Control) of the Public Health Code. Currently, any aforementioned applicants, regardless of location, must be licensed under Part 177 in order to do business in Michigan. An outsourcing facility also must be licensed in this regard.
Why is this relevant to pharmaceutical manufacturers, including those that make active pharmaceutical ingredients (API) under contract? It’s all wrapped up in the definition of “applicant.” The current definition includes the following:
- An individual, if the person applying is an individual.
- All partners, including limited partners, if the person applying is a partnership.
- All stockholders, officers, and members of the board of directors, if the person applying is a privately held corporation.
As one can imagine, the task of securing fingerprints for partners, directors, officer, and stockholders is a herculean task by any measure.
The proposed rules would require fingerprints only for any individual who manages the day-to-day operations of a new pharmacy, manufacturer, or wholesale distributor, when the application is from a privately held corporation.
Thus, elimination of the requirement would remove a major regulatory hurdle for manufacturers and distributors.
The legislation goes to the full House for second reading.
Other related changes to the Pharmacy Practice law are forthcoming and MichBio is actively monitoring those for their impacts on both pharmaceutical and medical device manufacturers.