Allergen Extracts as CSPs Does the pharmacy prepare allergen extracts? Yes No If yes… Does the pharmacy prepare allergen extracts in an ISO 5 Classified Area located Yes No N/A 198 within an ISO Class 7 buffer room or CAI located within a SCA? Does the pharmacy maintain policy and procedures for proper preparation and Yes No N/A assignment of BUD and storage of CSPs with allergen extracts? Draft 247 CMR 17.10 (1 3) – Sterile Compounding for Veterinary Patients Does the pharmacy separate drugs, ingredients, and components intended for animal use only from drugs, 199 ingredients, and components intended for human use? Draft 247 CMR 17.11 Does the pharmacy handle and compounding supplies and equipment in a manner that prevents cross 200 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 Does the pharmacy ensure that BUDs are calculated from the time of compounding and include the time a drug will 201 reside inside an implantable infusion pump reservoir? Draft 247 CMR 17.07 (1) Documentation Required; Best Practice In addition to standard prescription labeling requirements, does the pharmacy include the date of compounding on 202 the for CSPs prepared for administration by an implantable pump? Draft 247 CMR 17.07 (2) CSPs as Stock Solutions 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 203 medium risk compounding and Draft 247 CMR 17.41? Draft 247 CMR 17.08 (1) Does the pharmacy ensure that sterilization procedures are conducted immediately when compounding high risk 204 level intermediate or stock solutions? Draft 247 CMR 17.08 (2) CSPs made from Blood-Derived or Biological Material Does the pharmacy maintain a policy and procedure pertaining to compounding that involves blood-derived or other 205 biological material? Draft 247 CMR 17.09 (1) Documentation Required; Best Practice 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 206 equipment used in CSP preparation to avoid cross-contamination? Draft 247 CMR 17.09 (2) Documentation Required; Best Practice
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
sterile-compounding-inspection.docx