Application for a Sterile Compounding Pharmacy License

(1) In support of an application for a license to operate a sterile compounding pharmacy, the applicant shall submit: (a) all documentation identified in 247 CMR 6.04(2); (b) certified blueprints of the compounding area(s) depicting the location and identifying the ISO classification for each primary and secondary engineering control; (c) detailed HVAC design plan and written description; and (d) attestation of intent to engage in compounding, signed by the Manager of Record, pharmacist in charge of sterile compounding, as applicable, and applicant(s). The applicant shall achieve a satisfactory Board inspection of the proposed sterile compounding pharmacy prior to the issuance of an original sterile compounding pharmacy license. (3) Renewal of a sterile compounding pharmacy license (a) Each sterile compounding pharmacy license issued by the Board shall expire on December 31st of each year following the date of its issuance. (b) In connection with an application to renew a sterile compounding pharmacy license, a licensee shall submit copies of all reports or correspondence pertaining to all inspections by any state or federal agency, or any entity inspecting on behalf of a state or federal agency, occurring within the pending licensing period.