Research and Development
For researchers and developers working with controlled substances, security is critical. Safe storage impacts employees and staff at every level.
The DEA includes researchers and developers under its practitioner category. Practitioners include a variety of medical professionals, like physicians, dentists, veterinarians, researchers and pharmacists, as well as researchers and developers.
The Controlled Substances Act allows for legitimate research with controlled substances in Schedule I, with two provisions:
- The FDA must approve the researcher or developer as qualified and competent.
- The FDA must approve research protocol and determine its merit.
Researchers who meet these criteria should obtain a separate registration from the FDA to conduct research with these Schedule I controlled substances.
Federal regulations don’t specifically define the construction requirements for security cabinets. But the intent of the law is that controlled substances must be adequately safeguarded. Some factors considered when evaluating a researcher’s controlled substance security include:
- How many employees, customers or patients have access to the substances
- The location
- Use of an effective alarm system
- Quantity of controlled substances kept on hand
- Prior history of theft or loss
The DEA will use these and other indicators to evaluate secure storage. Bottom line: controlled substances must be stored in a securely locked cabinet of substantial construction. Schedule 1 and Schedule 2 substances may require a Class 5 rated safe or a UL Listed burglary safe.
The area where the substance is stored should only be accessible to a minimum of authorized employees. Should a non-authorized person pass through the area, like maintenance staff or a business guest, adequate written observation of the area must be made by an authorized employee.
To minimize the threat of theft, loss or diversion, researchers and developers should implement procedures to keep unauthorized people out and provide an alarm system where necessary. These procedures include:
- Not employing an individual who has had his or her application for registration with the DEA denied or revoked at any time
- Notifying the nearest DEA Field Office upon discovery of loss or theft
- Storing DEA order forms in secure locations to minimize risk of theft
Security matters for those at every point in pharmaceutical operations, beginning at the research and development stage. And with safe practices, developers can conduct their research securely and efficiently.
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