Quality

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

Facility:

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.

Preparations:

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.

*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.