Application for a Complex Non-Sterile Compounding Pharmacy License
Effective Apr 25, 2025Mass. Register #1546MGL c. 112, §§ 38, 39, 39G, 39H, 39I, 39J, and 42A St. 2014, c. 159, § 25Board of Registration in Pharmacy
(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).
- (2) 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.