Controlled Substances
DEA Schedule II-V
Ensuring that your clinical trial goes smoothly is our priority, particularly when controlled substances are involved. A large part of the complex support required for clinical trials using scheduled drugs is understanding and having the skill to navigate the regulations surrounding them.
Our experience with DEA Schedule II-V controlled substances and Class I and II chemicals will ensure your product’s integrity and security remain intact. We will serve as your partner with reliable supply chain solutions that will ensure compliance in this strict regulatory environment.
Security and storage
Our Ohio location is registered with the DEA to provide labeling, kitting, distribution, and secure storage for schedule II-IV drugs. With a 36-pallet, security- and video-monitored vault, we have the capacity to handle not only your secondary packaging needs, but also returned drugs slated for destruction. Our Burlington, Ontario facility is similarly licensed by Health Canada’s Office of Controlled Substances and has Level 11 capabilities.
We closely follow GMP practices and U.S./Canadian regulations (including 21 CFR section 1300) for controlled substances.
Our secure facility features include:
- Auxiliary gas-powered generators in the event of a power outage
- Continuous monitoring in vaults, packaging and surrounding areas, requiring at least two authorized employees be present when accessing the vault or packaging area with controlled substances
- Required employee background checks, drug testing and ongoing extensive training
Labeling, kitting, and distribution
With experience in labeling and kitting all dosage forms, including bottles, blister packs, and syringes, we can ensure a smooth secondary packaging and logistics experience. Clinical labeling that conveys precise and succinct instructions for study participants which also meets regulatory requirements is critically important. We can design and print single and multi-panel, randomized, multi-language labels using our fully validated and GMP compliant ClinPro® clinical labeling system. All designed so you can rest assured that your labels will meet not only our stringent quality standards but yours as well.
Expedited shipments are no problem. We can assist in ensuring all the required documentation is in place in order to ship schedule II-V controlled substances via domestic overnight when required.
Importing
As drug manufacturing is now global, often drugs must be imported for clinical trials. To accommodate this need, we also hold a DEA importation registration at our Ohio facility and have the ability to import product into our Ontario, Canada facility, giving you greater flexibility.