E2 Lecture 3 Flashcards
What does DEA consider when evaluating a registrant’s safety measures?
activities conducted
type and form of controlled substances handled
quantity of controlled substances handled
storage system of controlled substances
Who shall a registrant not employ?
CONVICTED of felony relating to controlled substances
application for registration with DEA denied
DEA registration revoked
surrendered DEA registration for cause
Screening Questions
Within the past 5 years, have you been convicted of a felony?
Within the past 2 years, have you had a misdemeanor or are you presently formally charged with committing a criminal offense
Within the past 3 years, have you ever knowingly used any narcotics, amphetamines, or barbiturates other than those prescribed to you?
ANSWERS DO NOT DISQUALIFY APPLICANTS
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
What does the DEA look at when assessing an employer’s waiver?
description of previous violations
status of individuals state licensure
individuals access to controlled substances
physical & professional safeguards imposed by registrant
proposed handling of controlled substances
any other pertinent information
How long does CSA require records & reports be kept for?
at least 2 years from their origin date
How serious is the DEA about recordkeeping?
10,000$ fine for each unintentional violation
severe penalties/jail time for intentional violations
Storage of Records
C-II records must be kept separately from other records
C-III, C-IV, C-V records may be kept separately or with non-controlled records, SO LONG AS THEY ARE READILY RETRIEVABLE
3-File System
File for C-II
File for C-III, C-IV, C-V
File for non-controlled
2-File System
File for C-II
File for C-III, C-IV, C-V, non-controlled
What 1 or two criteria must a prescription meet to be termed “readily retrievable”?
- have a red “C” no less than 1 inch high stamped in the lower right corner of prescription face
or
- Identify prescriptions by prescription # in a computer system by:
- prescriber name
- patient name
- drug dispensed
- date filled
Central Recordkeeping
Registrant must notify the DEA of its intent in writing 14 days in advance including:
- exact records to be kept centrally
- exact location of records
- name, address, DEA, and type of DEA registration of registrant
- if central records will be stored manually or by computer
all records should be transferred to central location within 2 business days
What 3 things cannot be stored centrally?
Executed DEA Form 222
Inventories
Prescriptions
Ordering C-III, C-IV, C-V
ordered the same way as non-controlled
utilizes standard invoice for record of receipt containing:
- date
- easily identify controlled from non-controlled medications
** labeled controlled or separate section for controlled
Ordering C-I and C-II
must be completed using a DEA Form 222
- includes purchases, transfers, and sales
- only other way is through a prescription
Power of Attorney
?????
Ordering a DEA Form 222
registrant must submit a DEA Form 222a
must have:
- name, address, and registrant number
- number of books desired
- signed by registrant or authorized agent
What are DEA Form 222’s sent with to the registrant?
order form numbers
name, address, and registrant number
authorized activities
schedules that can be handled
THESE CANNOT BE ALTERED OR CHANGED
What happens if there is an error in the DEA Form 222 sent to the registrant?
registrants must send the forms back to the DEA
Current DEA Form 222
supplier information
purchaser name
purchaser signature
date
of packages
package size
drug name
last line completed
What parts are completed by the supplier?
Part 3 and Part 4
What parts are completed by the purchaser?
Part 5 after receiving medications
- date order was received
- number of containers of each item received
Purchaser DEA Form 222 Important Points
- forms must be completed via typewriter, computer printer, pen, or indelible pencil
- NDC may be filled in by purchasers, but if the NDC is not available the order can be delayed
- If you order more than 20 products, you must complete multiple forms
- ONCE COMPLETED, A COPY OF THE FORM MUST BE MADE AS THE ORIGINAL WILL BE SENT TO THE SUPPLIER
- if an error occurs, it must be voided by writing “VOID” across the front and filed with all other executed forms
Supplier DEA Form 222 Order Fulfillment
supplier DEA number
NDC number for products sent
number of bottles or containers sent
date sent
SUPPLIER KEEPS THE ORIGINAL DEA 222 FORM AND FORWARDS A COPY OF THE FORM TO THE DEA BY THE END OF THE MONTH OR REPORTS TO ARCOS
Unique Supplier DEA Form 222 Situations
- Partial Filling: may partially fill but they have 60 days to supply the balance
- Endorsing: may send an order to another supplier within 60 days but the second supplier must fill full order (cannot have some here and some there)
- Defective Order: if there is an issue with form, must send the form back to purchaser with statement of why they refused
- Order Refusal: may refuse to accept an order, must send the form back to purchaser with statement of why they refused
- Voiding Part of an Order: if they cannot fill a full order, they may draw a line through the voided items and print “canceled” on the number of items shipped
Executed DEA Form 222 Lost in Mail
purchaser must execute a new DEA Form 222 identical to the first with:
- original form number
- date of lost form
- not that substances were not received
Unexecuted DEA Form 222 Lost or Stolen
report immediately to the DEA with:
- form numbers
- dates ordered
if found, report to DEA immediately
Unused DEA Form 222
return orders to DEA
