Investing in Quality and Patient Safety
Wells Pharmacy Network operates a 503A compounding pharmacy in Ocala, Florida as well as an FDA Registered 503B Outsourcing Facility in Dyersburg, Tennessee.
503B FDA Registered Outsourcing Facility
In 2017 the 4,000 square foot Wells Pharmacy Network location in Dyersburg, Tennessee became an FDA Registered 503B Outsourcing Facility dedicated to the production of sterile implantable hormone pellets. By registering with the FDA, we are subject and intend to comply with the federal regulations and standards applicable to a 503B outsourcing facility. Compounding sterile implantable hormone pellets in compliance with the FDA’s standards for CGMP (current good manufacturing practices), just like the largest commercial drug manufacturers.
503A Compounding Pharmacy
Our 21,000 square foot compounding pharmacy in Ocala Florida is among the first in the country to build negative pressure hazardous chemical storage rooms and negative pressure hazardous cleanrooms in accordance with the new USP General Chapter guidelines providing standards to protect compounding personnel when handling hazardous drugs.
Wells Pharmacy continues to invest in quality and safety equipment, processes and talent. In addition to our in-house endotoxin, sterility, potency, method suitability, and particulate testing Wells has recently added new state of the art equipment including:
- Biological safety cabinets (BSC) for compounding hazardous materials
- Class 100 laminar airflow hoods inside our cleanrooms
- Most advanced HVAC systems
- Continuous environmental monitoring system
- State of the art motion detector door systems
We continue to utilize:
- Third party independent testing to validate in-house test methods
- Chemicals purchased through FDA registered facilities
- Five-point quality control process
- Images of the contents of every order captured during packing and shipping
- Experienced clinical pharmacists and registered pharmacy technicians to process and verify all prescription orders
- PhD Biochemist on site to manage Quality Control laboratory testing process
- Sterility reports available upon request for every order