Regulatory Requirements for Conducting Research with Controlled Substances
Notes:
- Keep controlled substance records separate.
- Separate DEA license and separate records required for different locations.
- Dispensing records required for essential documents– electric or paper ok
- DEA Form 222: 21 CFR 1305
- Regulations: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_11.htm
- Reports (Theft or Loss of Controlled Substances– within 1 business day of discovery) 21 CFR 1301.74(c), 1301.76(b) — followed by DEA Form 106
- DEA Form 106 — 21 CFR 1301.76(b)
REGULATION: Title 21 Code of Federal Regulations. PART 1304 — RECORDS AND REPORTS OF REGISTRANTS INVENTORY REQUIREMENTS §1304.11 Inventory requirements
(a) General requirements. 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 at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.
(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.
(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
(6) Inventories of dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container that has been opened, the dispenser or researcher shall do as follows: (i) If the substance is listed in Schedules I or II, make an exact count or measure of the contents; or (ii) If the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
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