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MI SB0704

Bill

Status

Passed

7/16/2014

Primary Sponsor

Joseph Hune

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Origin

Senate

97th Legislature

AI Summary

  • Requires all pharmacies, manufacturers, and wholesale distributors to designate a pharmacist in charge (PIC) who is responsible for regulatory compliance, with the PIC working an average of at least 8 hours per week at each location.

  • Establishes accreditation requirements for pharmacies providing compounding services for sterile pharmaceuticals, with new applicants required to submit verification of accreditation and existing pharmacies having until September 30, 2015 to achieve accreditation or demonstrate USP standards compliance.

  • Prohibits compounding of commercially available pharmaceuticals except when the compounded version provides significant difference or when the commercial product is unavailable from normal distribution channels, with pharmacist documentation required for unavailability cases.

  • Restricts pharmacies from compounding pharmaceuticals for prescribers or health facilities without a prescription unless specifically authorized by the department, with authorization limited to 2-year periods and subject to monthly record-keeping and adverse event reporting.

  • Creates criminal penalties ranging from misdemeanors to felonies punishable by up to 15 years imprisonment for knowing or willful violations of compounding requirements, with enhanced penalties if violations result in personal injury, serious bodily impairment, or death.

Legislative Description

Health; pharmaceuticals; compounding pharmacies; regulate, require all pharmacies, manufacturers, and wholesale distributors to designate a pharmacist in charge, and provide remedies and penalties. Amends secs. 16233, 16241, 17702, 17704, 17706, 17707, 17709, 17742 & 17748 of 1978 PA 368 (MCL 333.16233 et seq.) & adds secs. 17748a, 17748b, 17748c & 17748d.

Health, occupations

Last Action

Assigned Pa 0280'14 With Immediate Effect

7/16/2014

Committee Referrals

Regulatory Reform5/13/2014
Health Policy12/3/2013

Full Bill Text

No bill text available