Section 20.06 - Compounding Pharmacies(1) Each sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, non-resident sterile compounding pharmacy, and non-resident complex non-sterile compounding pharmacy shall report to the Board annually, or upon request by the Board, the following information: (a) a list of sterile and complex non-sterile prescriptions dispensed within and outside of the commonwealth, as well as the volume of these prescriptions;(b) the states in which the sterile and complex non-sterile prescriptions were dispensed and the status of any non-resident licenses issued by other states;(2) Each sterile compounding pharmacy, institutional sterile compounding pharmacy, and non-resident sterile compounding pharmacy shall report, within seven days of identification, any defective compounded sterile preparation dispensed into or from Massachusetts.(3) Each complex non-sterile compounding pharmacy and non-resident complex non-sterile compounding pharmacy shall report, within seven days of identification, any defective complex non-sterile compounded preparation dispensed into or from Massachusetts.(4) Each sterile compounding pharmacy, institutional sterile compounding pharmacy, and non-resident sterile compounding pharmacy shall report above action level environmental monitoring results.(5) Each sterile compounding pharmacy, institutional sterile compounding pharmacy, and non-resident sterile compounding pharmacy shall report failure of certification of primary or secondary engineering control.(6) A Manager of Record of a sterile compounding pharmacy, complex non-sterile compounding pharmacy, or institutional sterile compounding pharmacy shall: (a) disclose to the board the location, name and title of all principal managers and the name and Massachusetts license number of the designated Manager of Record;(b) certify the sterile compounding pharmacy's compliance with reasonable informational requests made by the Board;(c) certify to the Board that the Manager of Record has fulfilled continuing education requirements for sterile compounding and ensured that all pharmacy staff has received the appropriate training and education required by law and regulation before engaging in compounding;(d) submit to the Board the names and titles of all individuals employed by the sterile compounding pharmacy, complex non-sterile compounding pharmacy, or institutional sterile compounding pharmacy; and(e) annually, and within 30 days after any transfer of ownership or change in corporate officers, management personnel or Manager of Record, file a report containing the information disclosed under 247 CMR 20.06(6)(a).Adopted by Mass Register Issue 1536, eff. 12/6/2024.