In a constantly changing market, healthcare facilities are challenged to reduce costs, while improving performance. Many are finding that outsourcing pharmaceutical services enhances their ability to provide quality products and services more cost-effectively. Cantrell Drug currently serves hospitals and clinics in fourteen states as an out-source specialty pharmacy.
Compounding is an invaluable healthcare service that pharmacists provide. Compounded medications are legal and recognized by the FDA. The philosophy of Cantrell Drug Company is that manufacturers will never be able to supply 100% of pharmaceuticals that patients need and that compounding pharmacists are the specialists that bridge the gap when appropriate manufactured pharmaceuticals are not available.
Through an outsourcing compounding agreement, concerns such as liability and responsibility are addressed. Therefore, a relationship is established, assuring that a healthcare facility will be prepared when out-sourced pharmacy services are required.
Sterile compounding procedures are performed by qualified licensed pharmacists and technicians. The Quality Assurance program at Cantrell Drug Company, focusing on USP guidelines, includes policies and procedures for compounding sterile products which address:
Product acquisition
Product storage and handling
Environmental controls
Personnel controls
Sterilization procedures
End-product evaluation and testing
Quarantine procedures
Quality system controls
DEA Manufacturer
This licensure enables Cantrell Drug to compound and distribute controlled substances to physicians and health care institutions for their office use and administration.
A common misunderstanding in the healthcare community is that a prescription may be utilized to acquire or distribute compounded controlled-drugs from one DEA registrant to another (i.e. pharmacy to physician). This transaction requires the services of a registered DEA manufacturer.
Cantrell Drug Company's compounding and distributions are performed in strict compliance with DEA regulations. Contact us for more information regarding these laws and our services.
Specialized Compounding Pharmacists and Pharmacy Technicians
All compounding procedures are performed by highly trained and qualified licensed pharmacists and technicians. All pharmacy personnel responsible for preparing sterile products receive both didactic and experiential training in pharmacy compounding and are routinely validated for proper aseptic technique. In addition, the compounding staff at Cantrell Drug Company is skilled at performing accurate and aseptic manipulations of drug products to assure their quality.
Risk Level III
Cantrell Drug Company meets or exceeds the requirements necessary to compound high-risk sterile products according to USP Chapter <797>. Quality assurance processes within this risk level are the most stringent of the drug product classifications designated by USP. Documented quality assurance policies and procedures provide the foundation for all sterile compounding performed at Cantrell Drug Company in order to ensure that compounded sterile products have the identity, strength, purity, and quality that they are represented to possess.
Cleanrooms/Compounding Laboratories
All aseptic manipulations are performed in a Class 100 environment using High Efficiency Particulate Air (HEPA). Cantrell Drug Company's state-of-the-art facility includes two certified ISO Class 5 cleanrooms and one certified ISO Class 6 cleanroom. Cleanrooms and laminar airflow hood are certified for operational efficiency every 6 months by an independent certification agency.
Sterility Tests
Each batch of compounded sterile product has a unique lot number. This allows for efficient and rapid retrieval of all records pertaining to a particular batch.
Appropriate end-product testing, including sterility testing, is performed according to USP <797> guidelines. Quantitative analysis is performed on each batch to determine concentration of the active ingredient(s). This testing is performed by an independent laboratory. Copies of this analysis are included with each drug shipment.
Pyrogen Tests
Ingredients used in compounding procedures are determined to be stable, compatible, and appropriate for use, according to manufacturers' and USP guidelines. Certificates of Analysis are received from manufacturers for chemicals used in compounding. Tests are performed according to USP <797> guidelines.
Components and finished products undergoing end-product testing remain in quarantine until testing results are received and reviewed by a compounding pharmacist.
