Section R. 338.535 - Discontinuing, starting, or resuming sterile compounding services; requirements to resume sterile compounding servicesRule 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).Mich. Admin. Code R. 338.535
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024