Application for a Complex Non-Sterile Compounding Pharmacy License

(1) In support of an application for a license to operate a complex non-sterile compounding pharmacy, the applicant(s) shall submit: (a) all documentation identified in 247 CMR 6.04(2); (b) certified blueprints of the dedicated compounding room, including placement of containment hood(s); (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 complex non-sterile compounding, as applicable, and applicant(s). The applicant shall achieve a satisfactory Board inspection of the proposed complex non-sterile compounding pharmacy prior to the issuance of an original complex non-sterile compounding pharmacy license. (3) Renewal of a complex non-sterile compounding pharmacy license (a) Each complex non-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 complex non-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.