E2 Lecture 11 Flashcards
DEA considerations
Activities conducted
Type and from of controlled substance handled
Quantity of controlled substance handled
Storage system of control substances
Employee screening
“The registrant shall not employ any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause.”
This means someone arrested but not yet convicted of a felony can be employed
Also if someone is convicted of a felony not related to CS they can be employed
Employment waivers
If a registrant wants to employ an individual who does not qualify for employment, they may apply for a waiver
The DEA will not consider a waiver unless diversion is unlikely to occur
Records and reports
All records and reports involving controlled substances must be kept for 2 years from their origin date
$10,000 fine for unintentional violation, jail time for intentional violation
C-II records must be kept separately from other records, C-III, IV, and V may be kept separately or with other records, so long as they are readily retrievable
Three-file system
Most common
File for C-II prescriptions
File for C-III, IV, V prescriptions
File for non-controlled prescriptions
Two file system
File for C-II prescriptions
File for C-III, IV, V, and non-controlled substance prescriptions
*C-III, IV, V prescriptions must be readily retrievable
Readily retrievable requirements
- Must have a red “C” no less than 1 inch high, stamped in the lower right corner of the prescription face
- Must identify by prescription number and search by
- Patient name
- Prescriber name
- Drug dispensed
- Date filled
Central Record keeping
The DEA allows central record keeping if the registrant notifies the DEA of its intent in writing 14 days in advance
Must include:
- The records to be kept centrally
- Exact location of records
- Name, address, DEA number, type of DEA registration of the registrant storing records centrally
- Whether central records will be maintained manually or computer
If allowed, all records must be transferred to central location within 2 business days
Central Record Keeping prohibitions
- Executed order forms (DEA form 222)
- Inventories
- Prescriptions
Ordering C-III, C IV, and C-V’s
Can utilize standard invoice for record of receipt as long as it contains:
- Date
- Must be able to easily identify controlled substances from non-controlled substances
Ordering C-II’s (and C-Is)
READ section
All distributions of C-IIs must be completed using a DEA form 222
- Includes purchases, transfers, and sales
- The only other way to deliver C-IIs is via prescription
Single-sheet order form is the only available form since October 2021
Power of attorney
A separate POA must be filled out for each person individually
POAs may be revoked at any time, and must be available for inspections alongside other records (keep at registered locations)
POA agents should sign “Roberta Registrant by Agnes Agent, Attorney in Fact”
Ordering Order Forms
To order DEA Form 222s, the registrant must submit a DEA Form 222a
Requisitions must have the name, address, and registration number of the registrant, and the number of books desired
Must be signed by the registrant or an authorized agent
DEA Form 222s
Sent with order numbers and contain the name, address, registration number, authorized activities, and schedules the registrant can handle
THESE CANNOT BE ALTERED
Current DEA Form 222
- Supplier information
- Purchaser name
- Purchaser signature
- Date
- # of packages
- Package size
- Drug name
- Last line completed
Supplier completes parts 3 and 4
Purchaser completes part 5 upon receipt
Purchaser DEA 222 Form Important Points
Forms must be completed via typewriter, computer printer, pen, or indelible
pencil
A filled-out form is an executed DEA 222, a blank form is an unexecuted
DEA 222
NDCs may be filled in by purchasers, but if the NDC is not available the order
may be delayed.
If you are ordering more than 20 products, you must complete multiple forms
Once completed, a copy of the form must be made because the original
will be sent to the supplier
If an error occurs when filling out a DEA 222, it must be voided by writing
“VOID” across the front and filed with all other executed forms
Supplier DEA Form 222 Oder Fulfillment
Supplier DEA number
NDC number for product(s) sent
Number of bottles or containers sent
Date sent
The supplier keeps the original DEA 222 and forwards a copy of the
form to the DEA by the end of the month, or reports information on the
Automation of Reports and Consolidated Orders System (ARCOS)
Partial filling an order
Unique supplier DEA Form 222 situations
A supplier may partially fill an order, after which time they
have 60 days to supply the balance of the order
Endorsing an order
Unique supplier DEA Form 222 situations
A supplier may send an order to another supplier within 60
days. Second supplier fills full order (all or nothing)
Defective order
Unique supplier DEA Form 222 situations
If a supplier finds an issue with a DEA 222, they must send the form back to the purchaser with a statement explaining the refusal to fill.
Oder refusal
Unique supplier DEA Form 222 situations
A supplier may refuse to accept an order. They must send the form back to the purchaser with a not that the order was not accepted.
Voiding part of an order
Unique supplier DEA Form 222 situations
If a supplier cannot fill a full order, they may draw a line
through the voided items and print “canceled” on the number of items shipped.
Purchasers can cancel drugs as well, with the same modification completed by the supplier.
Purchaser order receipt
When the purchaser receives the oder, they must record
- Date the order was received
- # of containers of each item received
On their copy of DEA Form 222. If maintained electronically, a scan of the the completed DEA form 222 should be linked to the receipt
Executed DEA Form 222–> typically lost in the mail
If this occurs the purchaser must execute a new DEA 222 identical to the first
Note saying this is the original form number, date of lost form, and note that substances were not received
