Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department
Section 6.15 - Duty to Report Certain Factors of Pharmacy Operations
Current through Register 1531, September 27, 2024
(1) Definitions.
(2) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall report to the Board within seven business days of receipt, in a manner and format determined by the Board, all non-routine notices, correspondence, and disciplinary actions as defined in 247 CMR 6.15.
(3) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall report to the Board any adverse change in status of accreditation, including but not limited to withdrawal, discontinuance, termination, revocation, suspension, probation, or warning. All such reports shall be made within seven business days of an action taken by the accrediting agency, and in a manner determined by the Board.
(4) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, and pharmacist licensed or registered pursuant to M.G.L. c. 112, § 24, shall provide the Board with responsive documents sent from a registrant or licensee to a state or federal agency with respect to reports or responses submitted pursuant to 247 CMR 6.15(2) and (3). All such materials shall be provided to the board within seven business days of response to the aforementioned state or federal agency.
(5) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39, that performs central intravenous admixture services (CIVAS), or engages in sterile compounding, shall report to the Board every six months, or upon request by the Board, at a minimum, the following information:
(6) Every pharmacy engaged in sterile compounding and licensed pursuant to M.G.L. c. 112, § 39 shall report within seven business days of identification all errors relating to the preparation of medications in that pharmacy inconsistent with United States Pharmacopeia General Chapter 797 standards or criteria for factors including but not limited to pyrogenicity, stability, improper composition, mislabeling, or sterility.
(7) Every pharmacy licensed pursuant to M.G.L. c. 112, § 39 shall report within seven business days all abnormal results, including failure of certification as required pursuant to 247 CMR 6.01(5)(c), and identification of environmental contaminants or improper potency in that pharmacy inconsistent with United States Pharmacopeia General Chapter 797 standards or criteria.
(8) Failure to comply with reporting requirements described in 247 CMR 6.15(2) through (7) or to cooperate fully in the Board's investigation of any such report to the Board shall be grounds for disciplinary action pursuant to 247 CMR 10.03: Grounds for Discipline(1)(q).