AmEx Pharmacy adheres to strict guidelines for the processing of aseptic compounds according Florida pharmacy statutes. These statutes have been harmonized with the United States Pharmacopeia (USP) chapter 797 guidelines.
Internally, AmEx Pharmacy samples each batch of aseptic syringes that are produced and incubated in a soy broth growth medium for 14 days. (Note that each batch may include one or more AmEx Pharmacy assigned lot numbers.) The pharmacist inspects each sample daily for initial signs of growth. If any indications of growth are noted, immediate action is taken to quarantine for further testing and recalls would be conducted as required. External testing is conducted on random syringes by an Analytical Research Laboratory for Sterility and Endotoxin presence according to USP 71 and USP 85 methodologies monthly.
I am pleased to report that all syringes tested have been documented to be Sterile with no endotoxins even approaching the accepted limits.AmEx Pharmacy recognizes the value of independent validation and accreditation. We became accredited by the Pharmacy Compounding Accreditation Board (PCAB) in January 2012. Please feel free to contact us directly for additional information regarding our clean room certifications.