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Controlled Substance Information

 

Controlled Substance Guidelines


Guidelines for the Ordering and Use of Prescription Drugs and Devices and Controlled Substances for Non-Clinical Laboratory Research

Required Biennial Inventory of Controlled Substances

The principal investigator/DEA registration holder shall ensure that a DEA-required and compliant, biennial (i.e., every 2 years) inventory is performed1 of all controlled substances being stored for laboratory research use under his/her direction

  1. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form by the responsible principal investigator.
  • The inventory record for Schedule I and II controlled substances shall be maintained separate from all other records maintained by the principal investigator.
  • The inventory record for Schedule III-V controlled substances shall be maintained in such a manner that it is readily retrievable from other records of the principal investigator
  1. For controlled substances in finished form the inventory record shall include:
  • the identity (name) of the controlled substance;
  • the strength (e.g., mg/mL; mg/tablet) of each finished form of the controlled substance;
  • the number of commercial containers of each such finished form of the controlled substance; and
  • the number of units or volume of each finished form present in each commercial container (e.g., 3 mL container, 100 tablet container) of the controlled substance.
  • In determining the number of units of each finished form of a controlled substance in a container that has been opened:
  • If a Schedule I or II controlled substance, make an exact count or measure of the contents; or
  • If a Schedule III-V controlled substance, make an estimated count or measure of the content, unless the container holds more than 1000 tablets or capsules in which case an exact count of the contents must be made.
  1. For controlled substances awaiting disposal, held for quality control purposes, or maintained for extemporaneous compounding the inventory shall include:
  • the identity (name) of the controlled substance;
  • the total quantity of the controlled substance to the nearest metric unit weight or the total number of units of finished form; and
  • the reason for the controlled substance being maintained by the principal investigator/DEA registrant and whether such narcotic is capable of use in the manufacture of any controlled substance in finished form.

1 The biennial inventory may be taken on any date which is within two years of the previous biennial inventory