Applications for Non-Resident Drug Store Pharmacy, Non-Resident Sterile Compounding Pharmacy,

and Non-Resident Complex Non-Sterile Compounding Pharmacy Licenses (1) Non-Resident Drug Store Pharmacy (a) In support of an application for a license to operate a non-resident Drug Store Pharmacy, the applicant(s) shall submit: 1. all documentation identified in 247 CMR 6.04(2); 2. proof of good standing from the state where the pharmacy is located dated within three months of the application submission date; and 3. inspection report from a Board approved inspector, conducted within two years of the application submission date. (b) The Board may require an additional inspection of a non-resident Drug Store Pharmacy before granting final approval of an application. The Board may require the inspection to be performed by an agent of the Board or by a Board approved inspector. All costs associated with third party inspectors shall be paid by the applicant. (c) A pharmacy located outside of Massachusetts seeking to dispense or ship any controlled substance into Massachusetts shall have a designated Massachusetts licensed pharmacist in charge. (d) Renewal of a non-resident Drug Store Pharmacy license 1. Each non-resident Drug Store Pharmacy license issued by the Board shall expire on December 31st of each odd numbered year following the date of its issuance. 2. In connection with an application to renew a non-resident Drug Store 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. (2) Non-Resident Sterile Compounding Pharmacy License (a) In support of an application for a license to operate a non-resident sterile compounding pharmacy, the applicant shall submit: 1. all documentation identified in 247 CMR 6.04(2); 2. certified blueprints of the compounding area(s) depicting the location and identifying the ISO classification for each primary and secondary engineering control; 3. detailed HVAC design plan and written description; and 4. attestation of intent to engage in compounding, signed by the Massachusetts licensed designated pharmacist in charge, pharmacist in charge of sterile compounding, as applicable, and applicant(s). (b) An applicant shall achieve a satisfactory Board inspection of the proposed non-resident sterile compounding pharmacy prior to the issuance of a non-resident sterile compounding pharmacy license. The Board may require the inspection to be performed by an agent of the Board or by a Board approved inspector. All costs associated with third party inspectors shall be paid by the applicant. (c) Renewal of a non-resident sterile compounding pharmacy license 1. Each non-resident sterile compounding pharmacy license issued by the Board shall expire on December 31st of each year following the date of its issuance. 2. In connection with an application to renew a non-resident 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. (3) Non-Resident Complex Non-Sterile Compounding (a) In support of an application for a license to operate a non-resident complex non-sterile compounding pharmacy, the applicant shall submit: 1. all documentation identified in 247 CMR 6.04(2); 2. certified blueprints of the dedicated compounding room, including placement of containment hood(s); 3. detailed HVAC design plan and written description; and 4. attestation of intent to engage in compounding, signed by the Massachusetts licensed designated pharmacist in charge, pharmacist in charge of complex non-sterile compounding, as applicable, and applicant(s). (b) An applicant shall achieve a satisfactory Board inspection of the proposed non-resident complex non-sterile compounding pharmacyprior to the issuance of a non-resident complex non-sterile compounding pharmacy license. The Board may require the inspection to be performed by an agent of the Board or by a Board approved inspector. All costs associated with third party inspectors shall be paid by the applicant(s). (c) Renewal of a non-resident complex non-sterile compounding pharmacy license 1. Each non-resident complex non-sterile compounding pharmacy license issued by the Board shall expire on December 31st of each year following the date of its issuance. 2. In connection with an application to renew a non-resident 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. (4) A non-resident pharmacy shall submit an application to the Board for approval whenever there is a change of a Massachusetts licensed designated pharmacist in charge. The application shall be made on forms prescribed by, and available from, the Board. The application must be submitted within 90 days of the termination or resignation of the previous pharmacist in charge.