247 CMR, § 6.15

Current through Register 1536, December 6, 2024
Section 6.15 - Application for Remodeling, Change in the Configuration, or Change in Square Footage of a Pharmacy
(1) A Drug Store pharmacy, sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, and a non-resident sterile compounding pharmacy shall apply to the Board for approval to remodel or to change the configuration or square footage of the pharmacy and may not commence any construction work or remodeling until it receives approval from the Board.
(2) A sterile compounding pharmacy, non-resident sterile compounding pharmacy, and institutional sterile compounding pharmacy shall apply to the Board for approval to remodel or to change the configuration or square footage of the pharmacy prior to moving, adding, modifying, removing, or replacing any secondary engineering control and may not move, add, modify, remove, or replace any secondary engineering control until it receives approval from the Board.
(3) In support of an application to change the configuration or square footage of a pharmacy, the applicant shall submit to the Board:
(a) blueprints or equivalent architectural drawings depicting the pharmacy layout, prescription area, and counseling area;
(b) a written plan to maintain security of controlled substances during any transportation, if the pharmacy is located in Massachusetts; and
(c) any other information, as required by the Board.
(4) A sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, and non-resident sterile compounding pharmacy shall submit the following in support of an application to remodel or to change the configuration or square footage of a pharmacy:
(a) certified blueprints depicting compounding area(s) and the location and ISO classification of each primary and secondary engineering control, and placement of containment hood(s), as applicable;
(b) containment strategy;
(c) environmental monitoring plan, if applicable;
(d) plan to re-certify primary and secondary engineering controls and containment hoods, if applicable;
(e) continuity of care plan, if applicable; and
(f) any other information, as required by the Board.

247 CMR, § 6.15

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