NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS
“Pharmacy Compounding” involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet the standards required to produce sterile injectable products. Compounding pharmacies may only perform compounding upon receipt of a patient specified prescription. In addition, these Compounding Pharmacies must comply with United States Pharmacopeia (USP) <797> Pharmaceutical Compounding – Sterile Preparations.
The NECC investigation included DPH investigators obtaining documentary evidence, reviewing and obtaining copies of Standard Operating Procedures (SOPs), observational findings, reviewing batch records, etc. The FDA conducted product testing and investigators took environmental samples of various areas of the facility to test for contaminants.
AMONG THE FINDINGS:
1) NECC distributed batches of compounded sterile products directly to facilities for general use, rather than requiring a prescription for individual patients.
2) Since NECC is not licensed as a manufacturer, manufacturing and distributing of sterile products in bulk is not permitted under state pharmacy license.
3) NECC distributed two of the recalled lots prior to receiving results of sterility tests.
4) Lot 06292012 was prepared on June 29, 2012 and final sterility testing was completed on July 17, 2012. Two product shipments were made prior the final sterility test results were obtained. NECC’s records demonstrated no contamination.
5) Lot 08102012 was prepared on August 10, 2012 and final sterility testing was completed on August 28, 2012. Eleven shipments of product were made prior to the sterility test results being obtained. NECC’s records demonstrated no contamination.
6) NOTE: Sterility Tests (USP<71>) require 14 calendar days and involve a set procedure. DPH currently is examining the testing methods.
7) Final sterilization of product does not follow proper standards for autoclaving as per USP<797> and NECC’s own SOPs. NECC’s records indicated a systemic failure to keep products in the autoclave for the required minimum 20 minute sterilization period –thereby aborting the cycle.
8) NECC did not conduct correct validation of autoclaves as per USP<797>.
9) Powder hoods, intended to protect pharmacists from inhaling substances during medication preparation, within the sterile compounding area were not thoroughly cleaned as per USP<797>.
10) Tacky mats were visibly soiled and did not meet USP<797>.
11) A boiler adjacent to the clean room left a pool of water and culture results are pending.
12) The complete preliminary report may be found at: