Application for an Institutional Sterile Compounding Pharmacy License

(1) In support of an application for a license to operate an institutional sterile compounding pharmacy, the applicant shall submit: (a) all documentation identified in 247 CMR 6.04(2); (b) a copy of the institution's pharmacy-related license(s) and registration(s); (c) certified blueprints or equivalent architectural drawing of the compounding area(s) depicting the location and identifying the ISO classification for each primary and secondary engineering control; (d) detailed HVAC design plan and written description; and (e) attestation of intent to engage in compounding, signed by the Manager of Record, pharmacist in charge of sterile compounding, as applicable, and applicant(s). (2) The applicant shall achieve a satisfactory Board inspection of the proposed institutional sterile compounding pharmacy prior to the issuance of an initial institutional sterile compounding pharmacy license. (3) Renewal of an institutional sterile compounding pharmacy license (a) Each institutional sterile compounding pharmacy license issued by the Board shall expire on December 31st of each year following the date of its issuance. (b) A licensee shall submit with an application to renew an institutional sterile compounding pharmacy license copies of all reports or correspondence pertaining to all pharmacy-related 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.