Exam 2 - Lecture 11 (Controlled Substance Ordering and Inventory)

Question 1

DEA requires what 4 things of registrants for safety measures?

Answer 1

1. activities conducted
2. type and form of controlled substances handled
3. quantity of controlled substances handled
4. storage system of controlled substances

Question 2

employees not allowed to handle controlled substances

Answer 2

registrants shall not employ any person who has been convicted of a felony offense relating to controlled substances OR had DEA registration denied, revoked or surrendered a DEA registration for cause

Question 3

T/F: if someone has a felony, they cannot work in a pharmacy

Answer 3

F, but must be taken into consideration when hiring someone though

Question 4

how long must all records and reports involving controlled substances be kept?

Answer 4

2 years

Question 5

what is the fine from the DEA for an unintentional violation related to record keeping?

Answer 5

$10,000

Question 6

what is the fine from the DEA for a serious (intentional) error related to record keeping?

Answer 6

jail time and hefty fines

Question 7

DEA registrants must maintain “a complete and accurate record of each substance…

Answer 7

…manufactured, imported received, sold, delivered, exported, or otherwise disposed of by them”

Question 8

prescriptions way be stored in what two ways? describe those 2.

Answer 8

1. 3 file system (most common)
   -file for CII prescriptions
   -file for CIII, CIV, and CV prescriptions
   -file for non controlled prescriptions
2. 2 file systems
   -file for CII prescriptions
   -file for CIII, CIV, CV and on controlled substance prescriptions
   -CIII, CIV, and CV must be readily retrievable, so its easier to keep them separate rather than label each of them

Question 9

what is readily retreivable?

Answer 9

1. have a red C no less than 1 inch high, stamped in the lower right corner of the prescriptions face
2. must identify prescriptions by prescription number in a computer system and be able to search by
   -prescriber name
   -patient name
   -drug dispensed, and
   -date filled

Question 10

DEA allows central record keeping when?

Answer 10

if the registrant notifies the DEA of its intent in writing 14 days in advance

Question 11

three things. that cannot be stored centrally

Answer 11

1. executed order forms (DEA form 222)
2. inventories
3. prescriptions

Question 12

Can utilize standard invoice for record of receipt so long as it contains what 2 things?

Answer 12

1. date
2. must be able to easily identify controlled substances from non-controlled medications

Question 13

all distributions of CIIs must be completed utilizing what form?

Answer 13

DEA form 222

Question 14

DEA form 222 includes:

Answer 14

purchases, transfers and sales

Question 15

power of attorney

Answer 15

used for DEA registrants to have agents execute DEA form 222s in their place
-separate one for each agent
-may be revoked at any time and must be available for inspections

Question 16

how to sign POA form

Answer 16

“(registrant name) by (agent of registrant name), Attorney in Fact”

Question 17

Current requirements for DEA form 222 (8)

Answer 17

1. supplier info
2. purchaser name
3. purchaser signature
4. date
5. # of packages
6. package size
7. drug name
8. last line completed

*supplier completes 3 and 4, purchaser completes 5 upon receipt