Exam 2 Lecture 11 Flashcards
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
DEA Recommended Questions
Within the past five years, have you been convicted of a felony?
Within the past two years, of any misdemeanor are you presently formally charged with committing a criminal offense?
In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates other than those prescribed to you by a physician?
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
The CSA requires all records and reports involving controlled substances to be kept for at least TWO YEARS from their origin date.
$10,000 fine for each unintentional violation, and more severe penalties/jail time for intentional violations.
Registrants must maintain “a complete an accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them.”
C-2 records must be kept separately from other records, while C3, C4, and C5 records may be kept separately or with other records, so long as they are readily retreivable –> big red ‘C”
3 file system prescription storage
Most common
File for C2
File for C3,C4,C5
File for non-controlled prescriptions
2 file system prescription storage
file for C2
File or C3, C4, C5, non-controlled substance prescriptions
readily retrievable
have a red “C” no less than 1 inch high, stamped in the lower right corner or prescription
must identify prescriptions by prescription number in a computer system and be able to search by:
- prescriber
- patient name
- drug dispensed
- date filled
central record keeping
the DEA allows central recordkeeping if the registrant notifies the DEA of its intent in writing 14 days in advance
If allowed, all records must be transferred to central location within 2 business days
central recordkeeping prohibitions
3 things cannot be stored centrally:
- executed (completed) order forms (DEA form 222)
- inventories
- prescriptions
Ordering C3, C4, and C5s
can utilized standard invoice for record of receipt so long as it contains:
- date
- must be able to easily identify control substances from non-controlled medications
Ordering C2s and C1s
All distributions of C2s must be completed using DEA form 222
- includes purchases, transfers, sales
- the only other way to deliver C2s is prescriptions
Single-sheet order form first introduced in 2019, only order form since Oct 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
POA agents should sign “Roberta Registrant by Agnes Agent, Attorney in Fact”
Ordering Order Forms
To order –> DEA Form 222A
must have name, address, registration number, and the books desired
must be signed by registrant or authorized agent
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 Part 3 and 4
Purchaser completes 5 upon receipt
Purchaser DEA 222 form important points
- must be filled via typewriter, computer printer, pen, or indelible pencil
- filled form is “executed” and blank is “unexecuted”
- NDCs may be filled in by the purchasers, if not orders can be delayed
- ordering 20+ products requires multiple forms
- Once completed, a copy of the form must be made bc original will be sent to supplier
- if error occurs, it must be voided by writing “VOID” across the front
Supplier DEA Form 222 Order Fulfillment
Supplier must add the following info
- DEA number
- NDC for products sent
- Number of bottles/containers sent
- Date sent
supplier keeps original DEA 22 and forwards a copy to DEA by the end of the month, or reports to Automation of Reports and Consolidated Orders System (ARCOS)
Partial filling an order
a supplier may partially fill and order, after which they have 60 days to supply the balance of the order
Endorsing an order
a supplier may send an order to another supplier within 60 days
second supplier fills the order (all or nothing)
defective order
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
order refusal
A supplier may refuse to accept an order.
They must send the form back to the purchaser with a note that the order was not accepted
Voiding part of an order
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 same modification completed by supplier
Purchaser Order Receipt
When the purchaser receives the order, the must record:
Date order was received
Number of containers of each item received
Executed DEA 222, typically lost in the mail.
Purchaser must execute a DEA form 222 identical to the first
Note with the new form stating original form number, date of lost form, and a note that the substances were not received
Unexecuted DEA 222 forms either lost or stolen
must report immediately to the DEA with form numbers if known, or dates
Unused DEA 222 due to termination of business
return order forms to DEA
Electronic DEA Form 222
Must apply for digital certificate from the DEA to authorize digital certificates as proof of identity
Digital certificate gives access to the Controlled Substance Order System (CSOS)
CSOS orders may include drugs from any schedule and non-controlled drugs
Electronic 222s cannot be endorsed from one supplier to another
Controlled Substance inventory
Every registrant must have a complete and accurate record of all controlled substances on hand on the date the inventory was taken
If the drug is in the registrant’s possession, it must be inventoried
initial inventory
must be conducted on the day the registrant first engages with controlled substances
official inventory
must be conducted at least once every two years.
some states have stricter requirements –> CSA states every two years
rescheduling inventory
must be conducted when a previously non-controlled substance medication becomes a controlled substance
only includes newly controlled drug
final inventory
conducted when registrant goes out of business
method of inventory
2 ways of taking inventory: you must note which method
- at the opening of business on the inventory date
- at the close of business on the inventory date
Inventory counting/estimating
C1 and C2s must be inventoried exact count
C3, C4, C5s may be estimated unless a bottle holds more than 1,000
You cannot use a perpetual inventory for your official inventory, you must handle the product
Each control substance should record:
- name, dosage form, strength, number of loose units, and full containers
