Park Compounding is committed to delivering high-quality products to our patients. Our formulations are governed by U.S. Pharmacopeia (USP) <795>, <797> and <800> requirements. We operate under the regulatory framework of the Drug Quality & Security Act (2013) and state pharmacy laws.
Our Quality Assurance program:
- Comprehensive environmental monitoring program
- Sterility and potency testing for all sterile formulations
- Required to meet US Pharmacopeia (USP) <795> <800> & <797> requirements
- PCAB Accredited
All sterile products are prepared in State of the Art ISO 7 cleanrooms and inside ISO 5 Laminar Flow Hoods Cleanrooms and hood are certified twice annually by an independent certifier. We have a very rigorous environmental monitoring program where each technician is sampled daily for fingertips and gown to ensure adherence to best aseptic practices. Daily and weekly cleaning is performed with pre-sterile cleaning solutions.
Our sterile compounded preparations are tested for sterility, potency and particulate matter. We perform stability studies for assigning beyond used dates to ensure formulation integrity.
We offer sterile injectables, preservative-free formulations, eye drops, inhalations, intravenous drugs (I.V.), intramuscular drugs (I.M.), subcutaneous (S.C. or S.Q.) and many other sterile compounds.
USP Pharmacopeia <797>
Test Results Included with Order
Beyond Use Dating
QA Program Documentation and Policies
*All formulations dispensed by Park Compounding are compounded products and formulated for individually identified patients pursuant to a prescription from a licensed physician. No compounded medication is reviewed by the FDA for safety and efficacy. Park Compounding does not compound copies of commercially available medications. References available upon request.