Provisional Outsourcing Facility Registration Requirements

(1) A non-resident outsourcing facility is not eligible for a provisional outsourcing facility registration. (2) In the event an applicant for an outsourcing facility registration was not inspected by the FDA within the two years immediately preceding the application, the Board may issue a provisional outsourcing registration, provided the applicant otherwise submitted a complete application for an outsourcing facility registration. (3) An entity with a provisional outsourcing facility registration may compound sterile drug preparations, but may not distribute or dispense a sterile drug preparation within or outside the Commonwealth until it has been inspected by the FDA and received a Massachusetts outsourcing facility registration. A provisional outsourcing facility registration shall be valid until the earliest of the following events occurs: (a) the Board converts the provisional outsourcing facility registration to an outsourcing facility registration; (b) the provisional outsourcing facility registration is surrendered, suspended, or revoked; or (c) the provisional outsourcing registration expires on December 31st of the first odd numbered year following the date of issuance. (5) The Board may convert a provisional outsourcing facility registration to an outsourcing facility registration upon the applicant's or registrant's submission of proof of an inspection by the FDA in connection with section 503B of the Federal Food, Drug, and Cosmetic Act, provided the Board determines the inspection results do not constitute grounds for denial as set forth in M.G.L. c. 112, § 36E(e). (6) A provisional outsourcing facility registration issued on or after September 1st of an odd numbered year may be renewed. No other provisional outsourcing facility registration may be renewed or extended. (7) A provisional outsourcing facility registration shall be non-transferrable.