Licenses to obtain and use in research drugs that have been scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act (CSA) Regulations are issued to individual investigators. Compliance with CSA regulations is the responsibility of the license holder. The regulations (21CFR, Part 1300) can be found at http://www.usdoj.gov/dea/agency/csa.htm. License holders are subject to audits by the DEA, which may be preceded by an unannounced visit for the purpose of arranging the time of the audit with the license holder.
The JHU Animal Care and Use Committee includes review of secure storage and record-keeping for controlled substances in the semi-annual inspections to assist JHU faculty in assuring that these basic functions are being carried out in their laboratories. JHU license holders should review the regulations to assure themselves that they are meeting other regulatory requirements.
Secure Storage: The license application will have specified the means by which the license holder will assure secure storage of controlled substances. Laboratory members who will make use of the controlled substances need to know the storage and access requirements for the laboratory.
Security requirements are permitted to vary under the CSA depending on the particular schedule of a compound (requirements are highest for Schedule I and II compounds); quantity of controlled substance handled; the type of location and the need for security in such a location; the adequacy of key control and/or combination locks; the extent of unsupervised public access; the procedures for handling visitors, maintenance personnel, and other service personnel; and the availability of security personnel. Thus research laboratories at Johns Hopkins already are relatively secure. The primary concern should be on preventing loss or theft within the laboratory setting.
The stored controlled substances “shall be accessible only to an absolute minimum number of specifically authorized employees” (Part 1301.72 of the CSA regulations). The registrant determines who those individuals are to be. There are no paperwork requirements, however, on specification of those individuals.
Record keeping: The records for researchers need to contain the following information for each drug received: name, form received (e.g., powder; liquid with mg concentration per ml), the amount (e.g., total grams of powder, number of milliliters per vial), number of containers (e.g., two 10-gram bottles of powder, ten 3-ml vials) received at once, the date of receipt, the name and address of the source of the compound, and the registration (license) number of the person from whom the drug was received if it was not received from a commercial source.
Helpful Hint: Since shipments need to be accounted for separately, it is useful to have a system for matching the record to the containers for a particular shipment (e.g,, put the lot number on the record sheet; put the date of receipt on the bottle or package of vials).
The record of use of each drug needs to contain: number of units (e.g., mg or ml) removed, purpose, date of removal, and the “written or typewritten name or initials” of the person who “dispensed” the drug. If the drug is used to make up a stock solution, keep a record of amounts dispensed from that stock and include the same pieces of information in that record.
Records must be maintained at the "registered location," that is, the address on the license. They must be kept readily retrievable, but there is no specific requirement on exactly where they must be kept.
1. Approved by the Animal Care and Use Committee: September 19, 2002 Revised April 20, 2006.
2. The functions are reviewed by our private accrediting agency Association for Asessment and Accreditation of Laboratory Animal Care International during their triennial site visit which is the rationale for this review during semi-annual inspections.