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Quality Assurance

PCAB Accredited Compounding Pharmacies

As evidenced by our designation as a PCAB Accredited™ Compounding Pharmacy, US Compounding has an unparalleled commitment to quality. To receive accreditation, we had to prove that our compounded preparations meet or exceed the highest standards for quality in the pharmaceutical compounding world. These standards for injectibles and sterile compounding means that patients receive the highest quality medications.

US Compounding has a documented, ongoing quality assurance program intended to ensure that compounded drug products have the 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 injectable compounded at our pharmacy. Every 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.

PCAB Accredited Compounding Pharmacy

US Compounding has ARL test each batch of compounded sterile injectables for sterility and the presence of fungus and endotoxins. The batch is then held in locked quarantine in identified storage areas until the results are received and reviewed by the compounding pharmacist for release. No compounded injectable leaves our pharmacy before documented sterility is on file for that batch. This program exceeds all applicable federal, state, and local laws and regulations.

Our quality assurance program also includes up-to-date policies and procedures for compounding sterile and non-sterile products focusing on stringent compliance with USP Guidelines on Pharmaceutical Compounding: Sterile Compounding (Chapter <797>) and Non-Sterile Compounding (Chapter <795>).

Our compounding is performed by qualified, licensed pharmacists and technicians who have undergone extensive training in the art of pharmacy compounding. All are trained to exceed ASHP guidelines and are routinely validated for performance.

Sterile compounds are prepared in a Class 100 environment using HEPA-filtration. Cleanrooms and laminar airflow hoods are certified regularly for operational efficiency to be ISO Class 5.

PCCA Compounding Pharmacies

Bulk pharmaceuticals used to compound medications are purchased from Professional Compounding Centers of America (www.pccarx.com) located in Houston, TX. PCCA is an FDA-registered chemical supplier and is the industry leader in providing pharmaceutical bulk chemicals and determines the products to be stable, compatible, and appropriate for product preparation according to USP guidelines.