247 CMR, § 6.07

Current through Register 1536, December 6, 2024
Section 6.07 - 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).
(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.

247 CMR, § 6.07

Amended by Mass Register Issue 1536, eff. 12/6/2024.