CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce that it has been granted a Controlled Dangerous Substance license for scheduled drugs under section II through V. The license, granted by the New Jersey Department of Consumer Affairs, in conjunction with the Federal Drug Enforcement Agency, enables CS Analytical to perform testing on controlled and classified drug substances.

“Achievement of a CDS License requires a lengthy and strict adherence to a large number of special requirements and I want to thank the CS Analytical team for their diligence in helping put this program together. The CDS License will allow us to better serve the container testing needs for those manufacturers of controlled drugs,” commented Sandra Cincotta, Director of Quality for CS Analytical.

Controlled drugs utilize a wide variety of container and package configurations that require testing. A number of test protocols require the use of the drug product as part of the test process. For example, dose volume measurements are best performed with actual drug product. The ability to be able to receive, store and perform testing using a controlled drug product allows the CS Analytical Team to meet client and regulatory test requirements in a real-life scenario. CS Analytical has implemented a number of required controls that include the installation of a DEA approved safe, a central station monitored security system and specific and detailed operating procedures around all aspects of handling and using CDS drugs in the testing process.