UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
What is required before any controlled substances can be dispensed, administered, possessed,
or stored? - CORRECT ANSWER Every pharmacy that dispenses a controlled
substance must be registered with the DEA. First, a state license must be obtained.
What does the DEA require of every potential registrant before issuing a DEA registration? -
CORRECT ANSWER To register as a new pharmacy, the DEA Form 224 must be
completed.
How often must a DEA registration be renewed? - CORRECT ANSWER A pharmacy
registration must be renewed every three years utilizing DEA Form 224a, Renewal
Application for DEA Registration.
If the pharmacy changes location, does the pharmacy need a new DEA Registration? -
CORRECT ANSWER Yes, a pharmacy that moves to a new physical location must
request a modification of registration. If the change of address involves a change in state, the
proper state issued license
and, if applicable, controlled substances registration must be obtained prior to the approval of
modification of the federal registration. If the modification is approved, DEA will issue a new
certificate of registration and, if requested, new schedule II order forms (DEA Form 222).
The registrant should maintain the new certificate with the old certificate until expiration.
If the modification is approved, does the DEA issue a new certificate of registration and new
DEA Form 222's? - CORRECT ANSWER If the modification is approved, DEA will
issue a new certificate of registration and, if requested, new schedule II order forms (DEA
Form 222).
What should the registrant do with the old active DEA Registration? - CORRECT
ANSWER The registrant should maintain the new certificate with the old certificate
until expiration.
,If a pharmacy closes or ceases dispensing controlled substances, what must be done with the
DEA Registration and the unused 222 forms? - CORRECT ANSWER A pharmacy that
discontinues business activities either completely or only regarding controlled substances
must return its DEA registration certificate and unused official order forms (DEA Form 222)
to the local DEA Registration Specialist.
If a pharmacy transfers its business operations (sale) to another pharmacy, who does the
pharmacy notify and when? - CORRECT ANSWER A pharmacy registrant that
transfers its business operations to another pharmacy registrant must submit in person or by
registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her
area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent
in Charge waives this time limitation in individual instances).
Does the transferring pharmacy need to take a controlled substance inventory and if so,
when? - CORRECT ANSWER On the day the controlled substances are transferred, a
complete inventory must be taken and a copy of the inventory must be included in the records
of both the person transferring the business and the person acquiring the business.
Does a copy of the inventory need to be sent to the DEA? - CORRECT ANSWER It is
not necessary to send a copy of the inventory to the DEA unless requested by the Special
Agent in Charge.
How does the transferring pharmacy transfer CII controlled substances to the receiving
pharmacy? - CORRECT ANSWER To transfer schedule II controlled substances, the
receiving registrant must issue an official order form (DEA Form 222) or an electronic
equivalent to the registrant transferring the drugs.
What should the transferring pharmacy do with its controlled substance records? -
CORRECT ANSWER On the day the controlled substances are transferred, a complete
inventory must be taken which documents the drug name, dosage form, strength, quantity,
and date transferred. In addition, DEA Form 222 or the electronic equivalent must be
prepared to document the transfer of schedule II controlled substances. This inventory will
serve as the final inventory for the registrant going out of business and transferring the
controlled substances. It will also serve as the initial inventory for the registrant acquiring the
controlled substances. A copy of the inventory must be included in the records of each
pharmacy. It is not necessary to send a copy of the inventory to the DEA.
, To whom can a pharmacy transfer expired or unwanted controlled substances for destruction?
- CORRECT ANSWER A pharmacy may transfer controlled substances to a DEA
registered reverse distributor who handles the disposal of controlled substances.
What is required to dispose of CII controlled substances? - CORRECT
ANSWER When a pharmacy transfers schedule II controlled substances to a reverse
distributor for destruction, the reverse distributor must issue an official order form (DEA
Form 222) or the electronic equivalent to the pharmacy.
How does a reverse distributor notify the DEA when controlled substances are destroyed? -
CORRECT ANSWER DEA registered reverse distributor who will destroy the
controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of
Drugs Surrendered) to the DEA when the controlled substances have been destroyed.
How and when should a pharmacy notify the DEA of controlled substance theft or significant
loss? - CORRECT ANSWER A pharmacy must notify in writing the local DEA
Diversion Field Office within one business day of discovery of a theft or significant loss of a
controlled substance. Although not specifically required by federal law or regulations, the
registrant should also notify local law enforcement and state regulatory agencies. A pharmacy
must also complete a DEA Form 106 (Report of Theft or Loss of Controlled Substances).
Must a pharmacy also notify law enforcement or state regulatory agencies (i.e. Board of
Pharmacy)? - CORRECT ANSWER Although not specifically required by federal law
or regulations, the registrant should also notify local law enforcement and state regulatory
agencies.
Can the pharmacy have its corporate parent notify the DEA of the theft or loss? - CORRECT
ANSWER The notice must be signed by an authorized individual of the registrant.
What else must the pharmacy do with regard to report the theft or loss? - CORRECT
ANSWER A pharmacy must also complete a DEA Form 106 (Report of Theft or Loss
of Controlled Substances).
When must the pharmacy file the Form 106 with the DEA? - CORRECT
ANSWER Within 24 hours