Do all master formulation records include? Yes No N/A the risk level of compounding; Yes No N/A all ingredients; Yes No N/A detailed compounding processes; Yes No N/A BUD assignment; Yes No N/A all equipment; Yes No N/A the primary and secondary engineering controls utilized; Yes No N/A product testing including sterility, stability, and potency, as applicable; 328 Yes No N/A quality control procedures including final release checks; Yes No N/A depyrogenation and sterility procedures and validations, as applicable; Yes No N/A compounding personnel; Yes No N/A garbing protocol; Yes No N/A endotoxin limit, as applicable; Yes No N/A storage conditions; and Yes No N/A container closure system. Draft 247 CMR 17.43 (1) Documentation Required Compounding Record Does the compounding record include the following? official or assigned name, strength, and dosage of the preparation; Yes No N/A reference to the master formulation record, if applicable; Yes No N/A any deviation to the master formulation record, if applicable; Yes No N/A and quantities of all ingredients; Yes No N/A all calculations; Yes No N/A sources, lot numbers, and expiration dates of all ingredients and components; Yes No N/A total quantity compounded; Yes No N/A name of the person who prepared the preparation and name of the pharmacist Yes No N/A 329 who verified the preparation; identity of any automated compounding device, if applicable; Yes No N/A date and time of preparation; Yes No N/A lot number, if applicable; Yes No N/A prescription or order number; Yes No N/A assigned BUD; Yes No N/A duplicate container if prepared in a batch; Yes No N/A Yes No identification of the specific PEC where the CSP was compounded. N/A Draft 247 CMR 17.44 (1) Documentation Required Item# Requirements Yes No N/A Additional Information Verification of Compounding Accuracy; Release Checks
328 Do all master formulation records include? the risk level of compounding; all ingredients; detailed compounding processes; BUD assignment; all equipment; the primary and secondary engineering controls utilized; product testing including sterility, stability, and potency, as applicable; quality control procedures including final release checks; depyrogenation and sterility procedures and validations, as applicable; compounding personnel; garbing protocol; endotoxin limit, as applicable; storage conditions; and container closure system. Draft 247 CMR 17.43 (1) Documentation Required Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Compounding Record 329 Does the compounding record include the following? official or assigned name, strength, and dosage of the preparation; reference to the master formulation record, if applicable; any deviation to the master formulation record, if applicable; and quantities of all ingredients; all calculations; sources, lot numbers, and expiration dates of all ingredients and components; total quantity compounded; name of the person who prepared the preparation and name of the pharmacist who verified the preparation; identity of any automated compounding device, if applicable; date and time of preparation; lot number, if applicable; prescription or order number; assigned BUD; duplicate container if prepared in a batch; identification of the specific PEC where the CSP was compounded. Draft 247 CMR 17.44 (1) Documentation Required Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Item# Requirements Yes No N/A Additional Information Verification of Compounding Accuracy; Release Checks
sterile-compounding-inspection.docx