Ch. 7: Controlled Substances, Part II Flashcards
FED DEA Form #___ registration form for retail pharmacies, hospitals, clinics, teaching institutions, practitioners, or mid-level practitioners
224
FED DEA Form #___ Registration form for drug manufacturers, distributors (suppliers/wholesalers) and researchers
225
FED DEA Form #___ Registration form for narcotic (opioid) treatment clinics
363
FED DEA Form #___ Registration form for bulk chemical manufacturers and distributors
510
FED DEA Form #___ Ordering form for schedule I and II drugs
222
FED DEA Form #___ Reporting form for theft or significant loss of controlled substances
106
FED DEA Form #___ Record of controlled substances destroyed
41
FED What is the requirement for a medical resident who will prescribe controlled substances in terms of registration with the DEA
A medical resident in a healthcare facility ho can prescribe controlled substances for pts within the institution by using the facilitys DEA number, without having to register with the DEA themselves
FED T/F Facilities involved with research of controlled substances must register w the DEA
True, full list pg 120
FED Healthcare providers practicing at what 4 types of facilities can prescribe, administer, or dispense controlled substances without registering with the DEA
1) Federal Bureau of Prisons
2) Indian Health Service
3) US Armed Forces (all branches, including Space Force)
4) US Public Health Service
* *BE AWARE: they can prescribe, administer, or dispense without registering with the DEA…. if they are to purchase or procure controls, they MUST STILL REGISTER
FED T/F A provider that purchases or procures controlled substances at the Fed Bureau of Prisons, Indian Health Service, US Armed Forces, or US Public Health service is exempt from registering with the DEA
FALSE. At these places, they can prescribe, administer, or dispense without registering with the DEA, but they MUST register with the DEA if they are to purchase or procure controlled substances
FED What are the two ways to procure Schedule III-V controlled substances through a supplier/wholesaler
1) using a purchase order (this is not a DEA form, the 222 is only for schedule I/II
2) use CSOS
FED T/F CSOS can be used to order schedule I-V drugs
True, CSOS does allow schedule I and II to be ordered
FED The receipts from either a purchase order or a CSOS order for ordering schedule III-V drugs should contain what 5 things
1) delivery date
2) name of each controlled substance in the order
3) drug formulation (oral solution)
4) number of dosage units in each container
5) number of packages ordered and delivered
FED Before ordering schedule I or II drugs in a retail pharmacy, who must register with the DEA using what form
PIC must register with DEA using form 224
FED In DEA Form 222, what schedules can be ordered, and how many items are there on the triplicate form vs the single-sheet form
DEA Form 222 to order only schedule I and II drugs
10 items = triplicate form
20 items = single-sheet form
FED T/F A physical/handwritten signature is required for both DEA form 222 and CSOS
False, CSOS uses a digital signature… I’m not sure if this is just for ordering or when its received, pg 121
FED T/F With both CSOS and DEA Form 222, the order can be endorsed to another supplier if there is an issue during fulfillment
False. Only DEA Form 222 can be endorsed to another supplier, CSOS cannot
FED When must the supplier report the transaction to the DEA when using DEA Form 222 and CSOS
DEA Form 222 = by the end of the month during which the order was filled
CSOS = within 2 business days of filling the order
FED Each pharmacy location should have how many designated registrants with the DEA
One…. but they can grant POA to other individuals, which allows those others to place orders in his/her absence
FED What is the federal limit of how many POAs can be granted to one single registrant?
There is no limit, the registrant can grant multiple POAs
FED T/F POA can be granted to licensed or unlicensed pharmacy perssonel
True, pg 122
FED Where should the POA be sent/filed?
POA should be filed at the pharmacy with the executed DEA Form 222 and must be readily retrievable–it is NOT submitted to the DEA, pg 122
FED Select all. Which of the following do not requirement documentation by use of CSOS or DEA Form 222 while moving a CII controlled substance?
A) Wholesaler to pharmacy
B) Pharmacy to wholesaler
C) Dispensed/administered to the patient
D) A central-fill pharmacy associated w/a retail chain filling CII drugs for one of the chains retail stores
E) Pharmacy to reverse distributor
F) Pharmacy to pharmacy
The only times when it is NOT required when transferring a CII, except:
C) Dispensed/administered to the patient
D) A central-fill pharmacy associated w/a retail chain filling CII drugs for one of the chains retail stores
FED The triplicate form of the DEA 222 Form will no longer be accepted after what date
October 31, 2021
FED What 4 things are pre-printed on Form 222
1) Serial number (consecutive number series)
2) Pharmacy name/address
3) Pharmacy DEA#
4) Drug schedules the pharmacy is permitted to order
FED What are the 3 colors of each copy of the DEA Form 222 and to whom does each color remain with
Copy 1 = brown = supplier
Copy 2 = green = DEA
Copy 3 = blue = purchaser
FED T/F If a mistake is made while filling out Form 222, the pharmacist/POA should make a single strike through over the error, write the correction, and initial it
False. If a mistake is made, write VOID on it, and start over with a new form
FED While using the triplicate version of Form 222, what should the purchaser do with the remaining two copies?
A) Send them to the supplier
B) Send the green one to the DEA, and the brown one to the supplier
C) Photocopy both, and send both to the supplier
A) Send them to the supplier. The first two copies must stay attached, the supplier cannot fill the order if they are separated
FED If the supplier is unable to provide the entire quantity and the purchaser is using form 222, they should provide a partial shipment and supply the balance within how many days
60 days
FED T/F While using Form 222, the supplier should deliver the scheduled drugs to the purchaser in a separate container from non-controlled drugs or OTC products
True
FED T/F When using either type of Form 222, when the order arrives at the pharmacy, it must be checked in by ____, who records what 2 things
Checked in by pharmacist
Records the number of packages and the date received
FED What color and number of 222 always goes to the DEA
Copy 2, Green
FED If using CSOS to purchase schedule I and II drugs, each person must obtain what
a personal digital certificate to sign orders
FED When using CSOS to place an order using a personal digital certificate, when can this certificate be shared
It cannot be shared, you need your own
FED When using CSOS, the supplier must report the transaction to the DEA how long after the date the order was filled
2 business days
FED If a completed 222 is lost or stolen, the purchaser must resubmit the order with a new 222 and provide a statement to the distributor with the new 222 containing what 3 bits of information
1) the serial # of the original form
2) the date of the initial order
3) a statement that the controlled substances were not received
FED If a completed 222 is lost or stolen and the pharmacy provides a statement to the supplier, what should be done with the pharmacys copy of the statement
The pharmacy must keep a copy of this statement with a copy of the initial order and the second order
FED If unused 222 forms are discovered to be lost or stole, the pharmacy must notify the local DEA office how soon
immediately
FED If unused 222 forms are discovered to be lost or stolen, the pharmacy must immediately notify what office and provide them with what information
The local DEA Diversion Field office and provide the serial number for each lost or stolen form, unless the numbers are unknown
FED If an electronic order is lost, the purchaser must provide a signed statement to the supplier with what 3 things
1) statement that the fulfilled order was not received
2) statement must have the unique tracking number
3) statement must have the date of the lost order
FED What is used to move schedule III-V drugs from one pharmacy to another
1) 222
2) CSOS
3) An invoice
4) 1 or 2
5) 2 or 3
6) Any of the above
an invoice or CSOS
FED T/F For a pharmacy going out of business and transferring controlled substances to another pharmacy, the inventory should be sent to the DEA
False, the inventory is not sent to the DEA
FED T/F When a pharmacy closes and moves controlled substances to another pharmacy, a complete inventory is taken and used as the transferring registrants final inventory, and as the initial inventory for the acquiring registrant
True, and each pharmacy needs to keep a copy of the inventory for at least 2 years
FED Select all. A pharmacy can sell controlled substances to other pharmacies or prescribers under what circumstances
1) The pharmacy selling is registered as distributor with the DEA
2) Both parties are registered with the DEA to dispense controlled substances
3) The total quantity sold does not exceed 5% of the total quantity dispensed each year by the selling pharmacy
2 & 3….. the pharmacy selling does NOT need to register with the DEA as a distributor, as long as 2 and 3 are in place
