Controlled Substance Manufacturing, Packaging and Handling

Safe, Compliant Handling of DEA-Controlled Substances

Whether your product is oral-solid or semi-solid dose, establishing the appropriate analytical framework and formulation design is vital to ensuring optimal production at clinical and commercial scale. UPM’s R&D and formulation experts have advanced several complex compounds from concept to commercialization, applying multidisciplinary expertise to develop the best processing conditions and formulation solutions for each unique product.

Controlled Substance Handling

UPM has a number of strict controls in place to ensure the safe handling of DEA Schedule I–V controlled substances and listed chemicals—chief among them being customer and staff education. We take very seriously our responsibility to safely develop your product while navigating the regulatory pathway on your behalf. Working in close collaboration with customers, we ensure you not only understand all relevant Controlled Substances Act (CSA) regulations, but also the specific implications of those regulations on your product and market strategy.

All UPM staff involved in the handling of controlled substances must undergo a rigorous training program to maintain compliance with CSA regulations while avoiding diversions and resulting development delays. In addition, we dedicate substantial R&D resources to investigating abuse-deterrence solutions promoted by both the DEA and FDA.

With over 15,800 square feet of DEA Approved vault space, an extensive track record of controlled substance handling and positive, enduring relationships with regulators, UPM is a partner you can trust to safely advance your project from lab to patient.

Controlled Substance Capabilities

  • Approvals for Schedule II–V controlled substances and listed chemicals
  • Formulation, process and method development / validation
  • Stability and degradation testing
  • Offsite Warehousing in 8,300 square feet of DEA Approved vault space
  • Onsite Warehousing in 7,200 square feet of DEA Approved vault space