(21 U.S.C. 827; 21 CFR § 1304.33)
|Vice President, Research|
This law brings together a number of laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. All substances are placed in one of five schedules, based on medicinal value, harmfulness, and potential for abuse or addiction, with Schedule 1 reserved for the most dangerous drugs that have no recognized medical use.
Use of controlled substances for the purpose of research is, under federal law, subject to extensive licensing, registration, storage, security, use, and disposal requirements. Researchers are also subject to state registration and other regulatory requirements.
21 CFR § 1301.11 states the requirements for who must register under the law. The list includes every person who manufactures, distributes, dispenses, imports, or exports any controlled substances or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of a controlled substance. See 21 U.S.C. § 802 and 21 CFR § 1300.01 for definitions relating to controlled substances. The term "practitioner" includes scientific investigators.
See 21 CFR § 1301.13, for specific requirements setting forth the schedules of payment and registration. The registrant will be assigned to one of twelve groups (corresponding to months of the year). If the registrant is assigned to a group whose registration has an expiration date less than three months from the date of registration, then the registration for the new registrant will not expire until one year from that given date, in all other cases, the registration expires on the given expiration date. The form used for researchers is Form 225, and for renewal (annual) Form 225a. When applying for registration to use Schedule I drugs, three copies of the research protocol must be included along with the application form. See 21 CFR § 1301.18.
Storage and Security Controls
The security requirements are set forth in 21 CFR § 1301.72-76. Schedule I and II drugs must be stored separately from other drugs, in an approved safe. Specifications for the safe are set forth in the regulations, and the Drug Enforcement Administration Field Office may also be called upon to review proposed security systems. Schedule III-V must also be kept under lock and key, although the choices for what type safe or vault or cage must be used are broader than the rules for Schedule I and II drugs.
See 21 CFR 1304.01 et seq. for the sections on records and reports of registrants. Each registrant, unless specifically exempted by the code, must keep records to account for controlled substances used in any activity. The records must be kept for two years from the date of the inventory or records.
Inventories of dispensers and researchers (21 CFR 1304.11(e) (3)) An initial inventory of all controlled substances is required on the date the registrant first undertakes dispensing, manufacturing, or distributing the controlled substance. After the initial inventory, a new inventory must be taken at least every two years. The inventory must be a complete and accurate record of all controlled substances, and maintained in a written, typewritten, or printed form at the registered location. The following information must be included:
- The name of the substance;
- Each finished form of the substance (e.g. 10 milligram tablet);
- The number of units or volume of each finished form in each commercial container; and
- The number of commercial containers of each such finished form.
For damaged, defective, or impure substances awaiting disposal, or held for quality control or for extemporaneous compoundings, the inventory shall include:
- The name of the substance;
- The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and
- The reason for the substance being maintained by the registrant and whether the substance is capable of use in the manufacture of any controlled substance in finished form
If the substance is in a container which has been opened, and the substance is a Schedule I or II substance, the inventory should include an exact count or measure of the contents, or, if the substance is in Schedules III-V, an estimated count of the contents, unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required.
Continuing Records: 21 CFR § 1304.22 ( c) covers records for dispensers and researchers:
- The name of the substance;
- Each finished form and the number of units or volume of finished form in each commercial container;
- The number of units of finished forms and/or commercial containers acquired from other persons, including the date and number of units and/or commercial containers in each acquisition to inventory and the name, address and registration # of the person from whom the units were acquired;
- The number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed; and
- The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.
In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person (or research subject, e.g. mouse #1) to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.
21 CFR § 1304.23 lists in detail what records must by kept by chemical analysts.
See 21 CFR 1304.33 for specific reporting obligations. In general, reporting obligations in this part are limited to those registered to manufacture and distribute controlled substances. Import/export reporting obligations are in another part of the Code.
21 CFR § 1307.21 sets forth the procedure that is required under federal law for disposition of controlled substances. The registrant must list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area. The Special Agent will then give instructions on how to dispose of the substance. Controlled substances may only be used for duly authorized purposes, and unauthorized transfer of the substances is prohibited under the law.
Registrants may also transfer controlled substances to a DEA registered Reverse Distributor.
Employee responsibility to report drug diversion
It is the position of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. See 21 CFR §1301.91
While employee background checks on employees with access to controlled substances are recommended, they are not required. See 21 CFR §1301.90 et seq. for recommended screening procedures and specific questions to be asked. Note that when someone registers the same questions contained in the regulations that are suggested as part of the background check are asked on the registration application that is submitted to the DEA.
Last Revised: 6/17/10 12:09