Section 6.15 - Duty to Report Certain Factors of Pharmacy Operations(1)Definitions.(a) Abnormal Results means results of viable and nonviable testing, such as for environmental contaminants and potency, that are not within acceptable United States Pharmacopeia General Chapter 797 standards or criteria.(b) Accreditation means a process by which a professional association or non-governmental agency grants recognition to a pharmacy for demonstrated ability to meet certain pre-defined criteria.(c) Disciplinary actions means actions including, but not limited to revocation, suspension, probation, censure, reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for renewal, denial or restriction of privileges or termination from Medicare or Medicaid programs including any adverse actions or fines imposed by a state or federal agency.(d) Federal agency means any U.S. Government agency that has regulatory purview over the clinical practice of pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice.(e) State agency means any U.S. State or Territory that licenses or otherwise regulates pharmacies or pharmacist practice.(f) Sterile compounding means the preparation, mixing, assembling, packaging, and labeling of a drug or device that is required to be prepared in accordance with United States Pharmacopeia General Chapter 797 and dispensed pursuant to a valid prescription as defined by 247 CMR 2.00.(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: (a) total number and type of prescriptions dispensed, distribution data identifying the states in which the prescriptions were distributed, status of any non-resident licenses issued by other states, hood certifications required by 247 CMR 6.01(5)(c)5., and all International Organization for Standardization (ISO) certifications in the pharmacy, status of CIVAS approval(s) where applicable, and any other information required by the Board.(b) All such reports shall be accurate and comply with the Board's reporting requirements.(c) All reports shall be accompanied by an affidavit attesting compliance with all laws and regulations pertinent to sterile compounding and United States Pharmacopeia General Chapter 797. This attestation shall be made under pains and penalties of perjury, and include attestation to the following "this registrant/licensee only dispenses medication pursuant to a valid prescription as defined in M.G.L. c. 94C for a single patient, regardless of whether the medication is prepared for a Massachusetts or out-of-state patient."(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).