US Compounding has a documented, ongoing quality assurance program intended to ensure that compounded sterile drug products have identity, strength, purity, and quality that they are represented to possess.  The most important component of this program is independent lab testing of every batch of sterile product.  At US Compounding each batch is sampled according to batch size and tested by Analytical Research Laboratories ( www.arlok.com ) of Oklahoma City, OK (ARL) is a DEA and FDA registered lab.  US Compounding has ARL test each batch for sterility, the presence of fungus, and endotoxins.  The batch is then held in quarantine in identified storage areas until results are received and reviewed by the compounding pharmacist for release.  The program complies with all applicable federal, state, and local laws and regulations.  It also includes up-to-date policies and procedures for compounding sterile products focusing on compliance with USP Guidelines on Pharmaceutical Compounding - Sterile Preparations.

Our sterile compounding is performed by qualified, licensed pharmacists and technicians.  All are trained according to ASHP guidelines for aseptic technique and are routinely validated for performance.

Products are prepared in a Class 100 environment using HEPA-filtered air.  Cleanrooms and laminar airflow hoods are certified regularly for operational efficiency.

Bulk pharmaceuticals used to compound sterile products are purchased from Professional Compounding Centers of America (PCCA) located in Houston, Texas. ( www.pccarx.com)  PCCA determines the products to be stable, compatible and appropriate for product preparation, according to USP guidelines.