Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 21.00 - Registration Of Outsourcing Facilities
Section 21.06 - Grounds for Denial, Revocation, Suspension, and Non-renewal
Current through Register 1518, March 29, 2024
Grounds for denial of a registration, revocation or suspension of a registration, or non-renewal of a registration shall include, but shall not be limited to:
(1) failure to maintain a current, valid registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(2) an inspection by the FDA that results in a warning letter that prohibits commercial distribution by the registered facility of sterile drug preparations within or outside of the commonwealth;
(3) material misrepresentation, omission, or falsification of any information furnished to the Board;
(4) failure to comply with reporting requirements established by the Board with respect to registration with or inspections by the FDA;
(5) failure to adhere to the most current standards established under cGMP;
(6) the lack of suitability of the applicant or registrant; or
(7) in the case of outsourcing facilities located in Massachusetts, the failure to maintain a current, valid Massachusetts controlled substances registration.
