Mich. Admin. Code R. 338.535 - Discontinuing, starting, or resuming sterile compounding services; requirements to resume sterile compounding services
Rule 35.
(1) A
sterile compounding pharmacy or outsourcing facility that ceases to provide
sterile compounding services in this state shall notify the department within
30 days after ceasing to provide sterile compounding services.
(2) A pharmacy shall apply for approval to
start or resume sterile compounding services by submitting to the department an
application on a form provided by the department together with the requisite
fee.
(3) A pharmacy shall not start
or resume sterile compounding services in this state until the pharmacy submits
to the department an inspection report, as required in
R 338.534(2), is
approved by the department, and is accredited, or an organization satisfying
the requirements of R
338.532(1) verifies that the pharmacy
is USP compliant.
(4) An outsourcing
facility shall not start or resume providing sterile compounding services in
this state until the outsourcing facility is approved by the department, and
the department verifies that it is compliant with the requirements of
R 338.533(4) to
(7).
Notes
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