Regulatory Support

Regulatory Support

Compounding Solutions is committed to assisting our customers in the complex world of regulation. The demand for high quality medical plastics and compounds continues to grow as regulations become more stringent, technology advances, and new, life saving medical devices are developed. Compounding Solutions is dedicated in providing all the necessary components (many listed below) needed for our customers to get through their product approval processes around the world.

     > Animal Content (Bovine Spongiform or Transmissible Spongiform)
     > ASTM / ISO / USP
     > Bisphenol A (BPA)
     > California Proposition 65
     > Cas #s
     > CMA – component material assessment
     > Conflict Minerals (Dodd-Frank Wall Street Reform and Consumer Protection Act)
     > Country of Origin
     > FDA 21 CFR Subpart D
     > FDA Food Allergens
     > Genetically Modified Organisms (GMO)
     > Gluten-Free
     > Halogenated Flame Retardants
     > Human Derivatives
     > Lactose-Free
     > Latex
     > Material containing HAP(s)
     > Medical Substances
     > Melamine
     > Nano-Materials
     > Polyvinyl Chloride (PVC)
     > Reach
     > Restricted Substances
     > ROHS
     > SDS (Safety Data Sheets)

Contact Compounding Solutions Regulatory staff to request documentation that a Compounding Solutions compound has compliance with governing regulations and/or a defined standard. …Contact Us