Controlled Substance Manufacturing
Developing and manufacturing active pharmaceutical ingredients (APIs) controlled by the United States Drug Enforcement Agency (DEA) requires a specific set of regulatory and operational controls that go above and beyond those required by the Food and Drug Administration (FDA). The additional layers of regulatory and operational complexity limit the number of companies that are able to work with these substances. Critical considerations include controlled substance manufacturing registrations, security systems and regulatory knowledge.
Cedarburg Pharmaceuticals is registered with the DEA to handle Schedule II-V controlled substances and perform the following functions:
- Research & Development
- Analytical Analysis
- Commercial Manufacturing
Controlled Substance Manufacturing Experience
Cedarburg Pharmaceuticals has experience working with diverse classes of controlled substances including:
- Anabolic Steroids
The DEA requires robust security systems for manufacturers working with controlled substance. Security requirements are outlined in the Title 21 Code of Federal Regulations (CFR). Cedarburg Pharmaceuticals has systems in place that exceed those required by the CFR. Security highlights include:
Live Video Feed
Video cameras have been installed in the manufacturing suites, storage areas and labs where controlled substances are handled. Live feeds from these cameras can be monitored from remote desktop locations, allowing real-time monitoring of the controlled substance manufacturing process and chain of custody. This feature adds both security and safety.
Access to areas where controlled substances are manufactured and handled is strictly controlled per DEA requirements. Access is regulated with both code access and key access. No employee has both forms of access, requiring them to be accompanied when accessing controlled substance storage areas and helping prevent diversion.
Controlled Substance Storage Facilities
There are approximately 400 ft2 of controlled substance storage space at Cedarburg Pharmaceuticals. The storage space is equipped with both motion and seismic detectors for added security, and in accordance with the CFR. The storage area also has validated freezer and refrigeration units that allow for the storage of controlled substances in a range of temperature controlled conditions. Our stability chambers are also housed within the controlled substance storage area, providing necessary security for controlled substance stability chambers.