As an FDA Registered Outsourcing Facility and an PCAB Accredited™ Compounding Pharmacy, US Compounding Pharmacy is cGMP compliant with thorough quality
assurance programs and quality control procedures. 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.
US Compounding has a 3rd party FDA registered laboratory test compounded sterile injectables to ensure the highest standards for quality and safety. This includes testing for potency, particulates, endotoxins, and sterility. 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.
Bulk pharmaceuticals used to compound
medications are purchased from FDA-registered chemical suppliers. Our suppliers
go through intense vendor qualification to ensure the quality and integrity of
our bulk ingredients meet are suitable for pharmaceutical preparations.