Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 21.00 - Registration Of Outsourcing Facilities
Section 21.09 - Notifications

(1) any change in the d/b/a name of the entity accompanied by appropriate authorizing documentation;

(2) any change in the names of its officers or directors;

(3) any change in the ownership of the outsourcing facility representing more than 5% interest;

(4) an inspection by the FDA;

(5) receipt of an FDA Form 483 or Warning Letter; and

(6) any disciplinary or adverse action taken by the FDA or a state licensing or registering authority.