Outsourcing Facility Registration Requirements

(1) Registration under 247 CMR 21.02 is limited to outsourcing facilities located in Massachusetts. Outsourcing facilities located outside Massachusetts shall register in accordance with 247 CMR 21.04. (2) An application for an outsourcing facility registration shall be made on forms prescribed by, and available from, the Board. (3) In support of an application for an outsourcing facility registration, the applicant shall submit: (a) complete application forms; (b) a complete application, available from the Board, for a Massachusetts controlled substance registration; (c) check or money order made payable in the proper amount to the "Commonwealth of Massachusetts Board of Registration in Pharmacy"; (d) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act; (e) proof of an inspection by the FDA in connection with the section 503B of the Federal Food, Drug, and Cosmetic Act registration within the two years immediately preceding the application; (f) if the applicant is an entity: 1. a certificate of good standing and legal existence issued by the Secretary of State, or the equivalent, in the state in which the entity was organized or formed, and other information concerning ownership and control, as the Board may require; 2. a statement of the name and address of each officer, director, or partner of the entity and the position held; 3. the "doing business as" name of the entity; 4. if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s); and (g) any additional information, as required by the Board. (4) The Board may require the applicant(s), interest holder(s), and any other person to personally appear before the Board to answer questions to enable the Board to determine whether issuance of an outsourcing facility registration would be in the best interest of public health, safety, and welfare. (5) All fees submitted to the Board in connection with an application for an outsourcing facility registration are nonrefundable. (MA REG. # 1305, Dated 1-29-16) (6) An outsourcing facility registration shall be non-transferrable.