Current through Register 1527, August 2, 2024
Section 21.12 - Application for Relocation of an Outsourcing Facility to a New Address(1) A outsourcing facility registered by the Board shall apply to the Board for approval to relocate to a new address prior to relocating and may not relocate until it receives approval from the Board.(2) An outsourcing facility shall submit an application at least 90 days prior to its desired date of relocation, unless otherwise approved by the Board. In support of an application to relocate, an outsourcing facility shall submit: (a) a complete application;(b) a written plan to maintain security of controlled substances during transportation, if the outsourcing facility is located in Massachusetts; and(c) any other information, as required by the Board.(3) An outsourcing facility may compound sterile drug preparation at the new location, but may not distribute or dispense a sterile drug preparation within or outside the Commonwealth until the new location has been inspected by the FDA.Adopted by Mass Register Issue 1305, eff. 1/29/2016.