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Controlled Substances: Protocol

  1. Contact the CNSM Safety Office (x55623) prior to the initial ordering/use of any controlled substance. No controlled substance may be ordered, used or possessed in the absence of the appropriate Controlled Substances Registration Certificate (Permit) from the Drug Enforcement Administration. Possession of a controlled substance without a current permit is a violation of Federal Law, even if the substance was purchased legally in the past. The CNSM Safety Office will assist in obtaining the correct permit. See if you need to apply for a permit, and for instructions on how to apply.
  2. Only those persons registered with the DEA and authorized by the CNSM Safety Office to conduct research with controlled substances listed in Schedules II through V is permitted to acquire such substances for research purposes (21 CFR, 1301.21).
  3. All registered possessors shall provide effective controls and procedures to guard against theft and diversion of controlled substances (21 CFR, 1301.71). The substances shall be stored in a securely locked, substantially constructed cabinet (21 CFR 1301.72) with limited key distribution. The cabinet shall be located in a room with limited key distribution; the room will be securely locked when left unoccupied.
  4. All pertinent MSDS's and a copy of this protocol shall be kept in the records notebook provided by the CNSM Safety Office.
  5. Every registrant shall maintain a current record of each substance received, delivered, or otherwise used (21CFR 1304.22). Each researcher shall maintain records with the following information for each controlled substance:
    1. the name of the substance
    2. the amount and concentration e.g. a 3-ml vial of a 20% solution
    3. the date received
    4. the supplier.
    Each registrant shall ensure that the following information is recorded each time a controlled substance is used:
    1. the name of the user (registrant or authorized project worker)
    2. the date an aliquot is removed from the stock
    3. the amount taken
    4. the project (instructional course #, research etc.)
    5. the current, amended balance of unused stock.
  6. Each registrant shall perform an inventory of the controlled substance every two years (21CFR 1304.11).
  7. All records shall be kept for at least two years (21CFR 1304.04).
  8. The registrant may only issue a controlled substance to a CNSM researcher/instructor who is working under the supervision of the registrant and who has received written authorization from the registrant to use the substance (21 CFR, 1301.21). Each registrant shall ensure that each authorized project worker fills out the DEA "Security Screening Information" form.
  9. The registrant must immediately report any apparent loss, theft or tampering of the controlled substances to the Campus Police and the CNSM Safety Office.
  10. The registrant must contact the CNSM Safety Office for disposal of the regulated substance. The registrant may NOT dispose of the regulated substance in any manner other than via the CNSM Safety Office. Disposal protocols and forms are on-file in the CNSM Safety Office.
  11. The reference website for the DEA Diversion Control Program is http://www.deadiversion.usdoj.gov/.

Commonly-Encountered Regulated Materials:

  • Sodium Barbital/Barbituric acid (for buffer solution)
  • Chloral Hydrate (animal sedative)
  • Testosterone and related steroids (molecular biology work)
  • Ketamine Solutions (animal sedative)