Grounds for Denial, Revocation, Suspension, and Non-renewal

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; 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.