Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.07 - Suitability of Applicant, Registrant, and Interest Holder

Current through Register 1525, July 5, 2024
In its discretion, the Board may determine an applicant or registrant is not suitable to establish or maintain an outsourcing facility, and that it would not be in the interest of public health, safety, and welfare to issue a registration. In making its determination, the Board may consider the following factors:
(1) An applicant, registrant, or interest holder acted in a manner that presented an immediate or serious threat to public health and safety.
(2) An applicant, registrant, or interest holder prevented or attempted to impede the work of any duly authorized representative of the Board or the Department or the lawful enforcement of any provision of M.G.L. c. 112 or M.G.L. c. 94C.
(3) An applicant, registrant, or interest holder plans to assume or has assumed ownership of an outsourcing facility in an effort to circumvent the effect and purpose of 247 CMR 2.00.
(4) An applicant, registrant, or interest holder owned, operated, or held an interest in an outsourcing facility, pharmacy, healthcare facility, or other entity registered by the Federal Food and Drug Administration (FDA) or the Federal Drug Enforcement Administration (DEA), that was the subject of proceedings which resulted in the discipline, suspension, denial, or revocation of the outsourcing facility registration or other professional license or registration.
(5) An applicant, registrant, or interest holder owned, operated, or held an interest in an outsourcing facility, pharmacy, healthcare facility, or other entity registered by the FDA or the DEA, that entered into a consent agreement in resolution of a complaint against an outsourcing facility, pharmacy, healthcare facility, or other entity registered by the FDA or DEA resulting in the imposition of discipline upon the outsourcing facility registration or other professional license or registration.
(6) An applicant, registrant, or interest holder owned, operated, or held an interest in an outsourcing, pharmacy, healthcare facility, or other entity registered by the FDA or the DEA, in such a manner that created an immediate or serious threat to public health and safety.
(7) An applicant, registrant, or interest holder failed to demonstrate that he or she has the competence or experience to operate an outsourcing facility.
(8) An applicant, registrant, or interest holder obtained or attempted to obtain a registration by fraud or misrepresentation or by submitting false information.
(9) An applicant, registrant, or interest holder is licensed and authorized to prescribe controlled substances.
(10) An applicant, registrant, or interest holder held a professional license or registration that was the subject of proceedings which resulted in the discipline, suspension, denial, or revocation of the license or registration.
(11) An applicant, registrant, or interest holder entered into a consent agreement in resolution of a complaint against a professional license or registration resulting in the imposition of discipline upon the professional license or registration.