21 CFR Section 1305 Flashcards
What is DEA Form 222 required for?
Distribution of Schedule I or II substances.
What information does DEA Form 222 include?
Order form number, name, address, and registration number of the registrant, the authorized activity, and schedules of the registrant.
DEA forms for what substances can only contain these drugs?
Carfentanil, etorphine hydrochloride, and diprenorphine
How many suppliers can be listed on any one DEA 222 form?
Only one supplier of any form. Must include name and address of supplier and supplier’s DEA registration number.
Can unexecuted DEA Forms 222 be kept and executed at a location other than the registered location printed on the form?
Yes, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection.
Who retains the DEA Form 222, purchaser or supplier?
Purchaser makes a copy of the original, then submits the original to the supplier.
For how long a filled DEA Forms 222 valid?
No more than 60 days after execution by the purchaser. If an order cannot be filled in its entirety, the balance may be filled in part and supplied by additional shipments within 60 days of the date of the DEA Form 222.
Where must items ordered on DEA Forms 222 be shipped?
Only to the purchaser and the location printed by the Administration on DEA Form 222.
How are DEA Forms 222 filed by the supplier?
If not required to report acquisition/disposition via Automation of Reports and Consolidated Orders System (ARCOS), then email or mailed to Registration Section. Must be forwarded at the close of the month during which the order was filled. If filled by partial shipments, must be forwarded at the close of the month during which the final shipment is made of the 60-day validity period expires.
Describe endorsed DEA Forms 222.
If the first supplier cannot fill all or part of the order in the time limitation, form may be endorsed to another supplier for filling. Must only be made by the supplier to whom the DEA Form 222 was first made. First supplier may not fill any part of an order on an endorsed form.
Can defective DEA Forms 222 be corrected?
No, must be replaced by a new form. Purchaser, after receiving an unaccepted order, must file the form and the supplier’s statement of non acceptance in the files of the purchaser.
What occurs if an unfilled DEA Form 222 has been lost in transmission?
Purchased executes another and attaches a statement containing order form number and date or lost form, stating that goods covered by the lost form were not received. Copy of this statement must be attached to a copy of the second DEA Form 222 sent to the supplier. If the first form shows up at the supplier, the supplier marks the face “Not accepted” and returns to the purchaser.
What occurs if used or unused DEA Forms 222 are stolen or lost, other than in the course of transmission?
Purchaser immediately reports to Special Agent in Charge of the DEA in the Divisional Office responsible for the area. Includes the serial number of each form lost.
If the loss includes original forms and the supplier is unable to state the serial numbers, the supplier must report the date or approx date of receipt and the names and addresses of the purchasers. If the purchaser cannot state the order form numbers, purchaser reports the date or approx date of issuance.
Who is reported if lost, unused DEA Forms 222 are recovered?
Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office.
What forms must the purchaser retain?
Each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.
What forms must the supplier retain?
The original of each DEA Form 222 that it has filled.
How must DEA Forms 222 be maintained?
Separately from all other records of the registrant at the registered location printed on the form. Electronic storage okay, if forms can be retrieved at registered location.
DEA Forms 222 for what drugs must be kept separate from all other DEA Forms 222?
Carfentil, etorphine hydrochloride, and diprenorphine.
How can electronic copies of DEA Forms 22 be kept separate?
If copies are readily retrievable separately from all other records.
How are orders cancelled on DEA Forms 222?
In writing by purchaser. Supplier indicates cancellation by drawing a line through the canceled item and printing canceled in the space provided for the number of items shipped. Also appropriate if a supplier voids part or all of an order.
What format do DEA Forms 222 no longer come in?
Triplicate, as of October 2021
