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Fingerprinting Requirements in Michigan Change for Pharma Companies

Wednesday, November 18, 2015   (0 Comments)
Posted by: Kate Oesterle
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Requirements related to fingerprinting and criminal history checks have changed for applicants seeking a pharmacy, drug manufacturer or wholesale distributor license in Michigan. Currently, any such applicants, regardless of location, must be licensed under Part 177 in order to do business in the state. 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 such a broad group is a herculean task by any measure. The legislation amended Part 177 (Pharmacy Practice and Drug Control) of the Michigan Public Health Code, which eliminated the need to provide fingerprints for the aforementioned individuals. It now requires fingerprints only for an individual who manages the day-to-day operations of a new pharmacy, drug manufacturer or wholesale distributor, when the application is from a privately held corporation. 

This removes a major regulatory hurdle for manufacturers and distributors.

Additional changes to the Pharmacy Practice law are forthcoming and MichBio is actively monitoring those for their impacts on both pharmaceutical and medical device manufacturers.

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