The DEA Flashcards
What form does a pharmacy need to fill out in order to dispense controlled substances?
DEA 224
Who needs to apply to dispense controlled substances?
Any dispenser of a controlled substance
Do pharmacies get a DEA number?
Yes, each individual pharmacy gets a DEA number
Registration fee for DEA 224
$731
How to validate a DEA number
- Add up the odd digits in the DEA number
- Add up the even digits in the DEA number, then multiply by 2
- Add the numbers from the first 2 steps together
- Look at the last digit of the sum- that should be the last number in the DEA number
First letter in a DEA number- what is it?
The registrant type (M for midlevel, etc.)
Second letter in a DEA number- what is it?
The first initial of the person’s last name (9 if it’s a business)
How often do you have to renew DEA registration for a pharmacy?
Every 3 years (like licensure!)
What form do you fill out with a license update?
DEA 224a
How long do you have to retain DEA invoices/copes of DEA forms for? What is the exception?
2 years- federal AND NYS law
Exception is the 224 form- that has to be kept with the pharmacy’s registration records
What form needs to be filled out for ordering CIs and CIIs?
DEA 222
Are DEA 222 triplicate forms still used?
No
Electronic form of DEA 222?
CSOS, it’s the electronic version of it and it allows a more streamlined and paperless ordering process
Limit on how many items you can put on a single 222 form (the physical copy)
20 items, one for each line.
If you’re trying to order more- attach another form and keep going!
Limit on how many controlled substances you can order in one CSOS transaction
Unlimited
What DEA form should you use to report theft or significant loss of controlled substances?
DEA 106
Who do you have to report the loss/theft of controlled substances to?
The DEA and the BNE
When do pharmacies have to fill out DEA 106 after a theft/loss?
Within 1 business day of discovery
What details have to be included in the DEA 106 form?
Drug name, strength, dosage form, quantity lost/stolen
What DEA form do you fill out when destroying controlled substances?
DEA Form 41
When to use DEA form 41
When you need to destroy or dispose of controlled substances that are expired, damaged, or otherwise unusable
What needs to be on DEA Form 41?
Name of the drug, dosage form, strength, and quantity of the substance, and name of the person authorized to witness the destruction
What DEA form does a pharmacy or facility need to fill out in order to operate as an opioid treatment program?
DEA Form 363
What does the DEA Form 363 do?
Grants authorization to dispense Schedule II-V controlled substances for maintenance or detox treatment
What form does a pharmacy fill out if they handle or distribute bulk chemicals that are precursors to controlled substances?
DEA Form 510
What entities aren’t required to register with the DEA?
Federal Bureau of Prisons
VA locations
Indian Health Service
US Armed Forces
Basically: any federal entity
How can you order CIII-CVs?
Can be obtained by using a purchase order or through CSOS
What is used to record the delivery date and to confirm the correct CIIIs-CVs arrived?
Invoice or a packing slip
What should receipts from getting CIIIs-CVs have on them?
Name of each control in the order
Drug formulation
Number of dosage units in each container
Number of packages ordered and delivered
Can a controlled substance order be endorsed to another supplier?
Yes
What kind of signature is needed of a 222 form?
Handwritten signature in pen or indelible pencil
What kind of signature is needed on a CSOS form?
Electronic
When must the supplier report a 222 transaction to the DEA?
By the end of the month during which the order was filled
When must the supplier report a CSOS transaction to the DEA?
Within 2 business days of filling the order
POA for ordering controlled substances: explain what usually happens
Each pharmacy location has one designated registrant that’s allowed to order CIIs UNLESS the registrant grants a POA to another individual and authorizes them to act in the registrant’s place
Provisions for the use of a POA
Can be granted to licensed or unlicensed personnel
Can grant multiple POAs
Registrant must terminate a POA at any time by executing a notice of revocation
A new POA is only needed if a different person signs the renewal application
POA should be filled at the pharmacy with the executed 222 form and must be readily available
What tracks the movement of a CII?
222 form or the electronic alternative (CSOS)
Documentation for CII movement is NOT required in what situations?
Drug is dispensed or administered to a patient
When a central-fill pharmacy associated with a retail chain is filling CIIs for one of the chain’s retail stores
Does CSOS need to be used to order CIIIs-CVs?
No, but it can be used
Each person authorized to place orders for CIs and CIIs need what?
A personal digital certificate to sign orders
How does CSOS work? (4 steps)
Purchaser creates an electronic order using DEA-approved software
Purchaser signs it with their digital certificate and electronically transmits it to the supplier
Supplier receives the order, verifies the certificate, and fills the order
Supplier reports the transaction to the DEA within 2 business days from the date the order was filled
Advantages of CSOS
Less ordering errors
Less paperwork
Decreased administrative costs
Faster drug delivery
Easy to use, so you can order more
Lost/stolen 222 forms or electronic orders: what does the purchaser have to do?
Resubmit the order with a new 222 form and submit it to the supplier
Provide a statement to the distributer with the new 222 form containing: serial number of the original form, date of initial order, statement that the controlled substances weren’t received
Keep a copy of the statement with a copy of the initial and second orders
Lost or stolen DEA forms: what to do when unused forms are discovered to be lost/stolen
Immediately notify the local DEA Diversion Field Office and provide them with the serial number for each lost/stolen form unless an entire or multiple books were stolen and the serial numbers are unknown
(if the serial numbers are unknown, the pharmacy can provider the approximate date the DEA issued the forms)
Lost/stolen DEA forms: what to do if an electronic order was lost
Purchase must provide a signed statement to the supplier stating the fulfilled order wasn’t received; must contain the unique tracking number and date of the lost order
Distribution of controlled substances between DEA registrants: where can a pharmacy transfer controlled substances to?
Another pharmacy, original supplier, or the manufacturer
What needs to be filled out to transfer CIIs?
222 or CSOS
An 222 form or CSOS is used to do what?
Transfer CIIs
An invoice oe CSOS is used to do what?
Transfer CIII-CV drugs
Records of controlled substance transfers must be kept for how long?
5 years
DEA Inventory requirements: what should the record include?
Date of inventory, if it was taken at the beginning or close of business
Names of drugs, dosage form and strength
Quantity or volume in each container
Number of commercial containers
Do you need to submit a copy of your inventory to the DEA?
No
When is an exact count in controlled substance inventory needed?
All CIIs
CIIIs-CVs holding >1000 dosage units
When is an estimated count in controlled substance inventory needed?
CIII-CV containers holding ≤1000 dosage units
