A1 Pre-planning Activities

Once your application is submitted to the IBPE, there are a number of activities you need to complete in preparation for your site inspection and to obtain approval to receive and work with controlled substances.  The activities include:

  1. Write a brief description of the research that will be conducted (typically 100 words or less), a list of controlled substances that will be used to conduct research/testing, and the approximate quantities that will be used per year.
  2. Identify the primary responsible person that supervises use of controlled substances at the facility.  The "Responsible Person" is the principal investigator (known as ‘Researcher’ and ‘Registrant’ in the DEA registration) and has a faculty-rank appointment (i.e., faculty or administrative professional such as laboratory director). This person is ultimately responsible for obtaining approval to use a controlled substance, and is responsible for the safe use, secure storage, and recordkeeping requirements of that controlled substance. The responsible person certifies that the legally required records of receipts and disbursements of the controlled substances listed on the application will be maintained for inspection, and security measures will meet those required by federal and state law.
  3. Determine the type of safe/cabinet where you plan to secure the controlled substances and the exact location in which they will be stored:
  • Cabinet/safe must be capable to be securely locked and is substantially constructed, where access is limited to only authorized agents. 
  • Location of room where cabinet/safe is located (name of the building and room number).
  1. Identify the supplier and vendors from whom controlled substances for the research will be obtained (name, address, phone number, and registration number of the supplier)
  2. Develop laboratory policies and procedures for use and disposal of outdated/unwanted controlled substances.
  3. Develop and document procedures for delivery and receipt of controlled substances. The items must be hand-delivered to the person responsible for the order or an individual designated by the responsible person.
  4. Develop recordkeeping procedures and maintain records for every controlled substance brought into the registered location.  Recordkeeping is required at the site of storage for controlled substances. See Appendices B1-B5 for examples of the types of records that are required.