Controlled Substance Manufacturing, Packaging and Handling

Safe, Compliant Handling of Controlled Drug Product Development

You can be assured that controlled substance manufacturing and packaging at UPM follows all laws and regulations as provided by the DEA. In addition, our experts are well-trained to safely and properly handle such pharmaceutical products to be 100-percent compliant with all government standards.

Controlled Substance Handling

UPM has a number of strict controls in place to ensure safe controlled substance packaging and handling of DEA Schedule I–V controlled substances and listed chemicals — chief among them being customer and staff education. As a controlled substances manufacturer, 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 controlled drug product development and market strategy.

All UPM staff involved in controlled substance packaging and handling 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 manufacturing and positive, enduring relationships with regulators, UPM is a partner you can trust to safely advance your project from lab to
patient.

Controlled Substances Manufacturer 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