Monitoring is conducted at least monthly? Draft 247 CMR 17.24 (8)(b) Best Practice Yes No N/A Item# Requirements Yes No N/A Additional Information Frequency of Monitoring (continued) 121 Does the pharmacy ensure that environmental monitoring samples are collected from ISO Class 5, then ISO Class 7, and then ISO Class 8? Draft 247 CMR 17.24 (9) General 122 Does the pharmacy ensure that personnel performing environmental monitoring are qualified and have demonstrated competency and proficiency in all the following sampling techniques? media selection, media preparation, sample collection, incubation protocols, identification of positive results, proper handling of samples for contracted lab distribution, and proper disposal of sampling plates Proper selection and use of equipment Draft 247 CMR 17.24 (10-11) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No 123 If the pharmacy has qualified internal personnel collect environmental monitoring samples, do they validate sampling procedures at least once every six months through a qualified third-party vendor? Draft 247 CMR 17.24 (21) Best Practice 124 Is the equipment used for environmental monitoring maintained and calibrated for use at annually or more frequently in accordance with manufacturer’s specifications? Draft 247 CMR 17.24 (12) Documentation Required 125 Does the pharmacy ensure environmental monitoring samples are incubated at the appropriate temperature and length of time? Draft 247 CMR 17.24 (17) 126 Does the environmental monitoring for viable organisms include negative controls? Draft 247 CMR 17.24 (18) 127 Does the pharmacy ensure that all Staphylococcus organisms are identified as coagulase positive or negative? Draft 247 CMR 17.24 (19) 128 Does the pharmacy utilize a method for collection of viable air and surface samples? Draft 247 CMR 17.24 (20) Best Practice 129 Does the pharmacy obtain a “Growth Promotion Certificate” for environmental monitoring plates to validate that the media can support microbial growth? 247 CMR 17.24 (22) Documentation Required 130 Does the pharmacy utilize plates intended for environmental monitoring? Draft 247 CMR 17.24 (23) Item# Requirements Yes No N/A Additional Information
Allergen Extracts as CSPs 198 Does the pharmacy prepare allergen extracts? If yes… Does the pharmacy prepare allergen extracts in an ISO 5 Classified Area located within an ISO Class 7 buffer room or CAI located within a SCA? Does the pharmacy maintain policy and procedures for proper preparation and assignment of BUD and storage of CSPs with allergen extracts? Draft 247 CMR 17.10 (1 – 3) Yes No Yes No N/A Yes No N/A Sterile Compounding for Veterinary Patients 199 Does the pharmacy separate drugs, ingredients, and components intended for animal use only from drugs, ingredients, and components intended for human use? Draft 247 CMR 17.11 200 Does the pharmacy handle and compounding supplies and equipment in a manner that prevents cross contamination of animal use only and human use drugs, ingredients, and components? Draft 247 CMR 17.11 Item# Requirements Yes No N/A Additional Information Implantable Infusion Pumps 201 Does the pharmacy ensure that BUDs are calculated from the time of compounding and include the time a drug will reside inside an implantable infusion pump reservoir? Draft 247 CMR 17.07 (1) Documentation Required; Best Practice 202 In addition to standard prescription labeling requirements, does the pharmacy include the date of compounding on the for CSPs prepared for administration by an implantable pump? Draft 247 CMR 17.07 (2) CSPs as Stock Solutions 203 Does the pharmacy ensure that BUDs applied to intermediate or stock solutions from commercially available sterile components, excluding the pooling of commercially available single dose vials, do not exceed USP standards for medium risk compounding and Draft 247 CMR 17.41? Draft 247 CMR 17.08 (1) 204 Does the pharmacy ensure that sterilization procedures are conducted immediately when compounding high risk level intermediate or stock solutions? Draft 247 CMR 17.08 (2) CSPs made from Blood-Derived or Biological Material 205 Does the pharmacy maintain a policy and procedure pertaining to compounding that involves blood-derived or other biological material? Draft 247 CMR 17.09 (1) Documentation Required; Best Practice 206 Does the pharmacy maintain procedures for compounding CSPs using blood-derived or other biological material that require compounding to be separate from routine material-handling procedures and define cleaning of PEC and other equipment used in CSP preparation to avoid cross-contamination? Draft 247 CMR 17.09 (2) Documentation Required; Best Practice
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