IRAT/GRAT 2

Question 1

What are list 1 chemicals under cmea

Answer 1

pseudophedrine
ephedrine
phenylpropanolamine-OFF MARKET

Question 2

Definition of regulated seller

Answer 2

a retail distributor

Question 3

What is the maximum amount of a list 1 chemical that may be sold to a purchaser in a single day

Answer 3

3.6 grams

Question 4

What is the max amount for a non liquid product thats in a blister pack

Answer 4

2 dosage units per blister

Question 5

What is the max amount you can purchase in a 30 day period?

Answer 5

9 grams

Question 6

If you were to have pseudoephedrine or ephedrine delivered via USPS what is the max amount?

Answer 6

7.5 grams

Question 7

What is requires by federal law for all regulated sellers under the cmea? How is this process completed?

Answer 7

Regulated sellers are required to complete a self-certification process that includes training their employees on new regulations and procedures. This is done online.

Question 8

t/f once a regulated seller self certifies they never have to do it again

Answer 8

FALSE it must be done annually

Question 9

What are the recordkeeping requirements for cmea products

Answer 9

name and address of purchaser
date and time of sale
name and amount of product sold

Question 10

Is keeping a record for slcp required

Answer 10

yes!

Question 11

When does the logbook requirement NOT apply under cmea

Answer 11

single sales package that DOES NOT contain more than 60 mg of psedophedrine (60mg tab or 2 30mg tabs)
this applies ONLY to pseudophedrine!!!

Question 12

What are purchasers required to do during the sale of one of these products
(CMEA)

Answer 12

Give a state or federally issued photo id and sign a written or electronic logbook

Question 13

The purchaser has presented id to the seller. What is the seller now required to do?
CMEA

Answer 13

-determine that the name in the logbook corresponds to the name on the ID and that the date and time are correct
-enter into the logbook the name of the product and quantity sold

Question 14

What statement must the logbook include?

Answer 14

it must include a notice to purchasers that entering a false statement or mirespresentation may subject them ti criminal penalties

Question 15

How long must logbook entries be maintained?

Answer 15

a minimum of two years

Question 16

If lost or theft of one of the slcp has occurred, how do you report it and what is the time frame?

Answer 16

-make and oral report to the DEA diversion field office ASAP
-file a written report within 15 days after the pharmacist becomes aware of the theft

Question 17

what form must you use to file the written report for loss and theft and what information should it include?

Answer 17

a DEA 107 form (report of loss or theft of listed chemicals) MUST be used
-report should include the DEA registration number, name, address, business address, telephone number, date and type of loss, and a description of the situation

Question 18

definition of Schedule Listed Chemical Product

Answer 18

includes any product that may be marketed or distributed lawfully in the United States
under the Federal Food, Drug, and Cosmetic Act as a non-prescription drug, and that contains ephedrine, pseudoephedrine, or phenylpropanolamine (PPA) (including salts, optical isomers, and
salts of optical isomers)

Question 19

T/F: SLCP applies to BOTH non rx and rx drugs

Answer 19

FALSE. It only applies to NON prescription drugs

Question 20

4 main requirements of the CMEA important

Answer 20

1. Requirement of regulated sellers to place the products BEHIND the counter or in locked
   cabinets.
2. Requirement of regulated sellers to check the identity of purchasers and maintain a log of EACH sale that includes the purchaser’s name and address, signature of the purchaser,
   product sold, quantity sold, date, and time.
3. Requirement of regulated sellers to maintain the logbook for at least TWO YEARS
4. Requirement of regulated sellers to train employees in the requirements of the law and certify to DEA that the training has occurred.

Question 21

what are some acceptable forms of identification under the CMEA

Answer 21

1. United States passport

2.Alien Registration Receipt Card or Permanent Resident Card, Form I-551;

3. A foreign passport that contains a temporary I-551 stamp, or temporary I–551 printed
   notation on a machine-readable immigrant visa;
4. An Employment Authorization Document which contains a photograph (Form I–766);

5.a foreign passport with an Arrival/Departure Record, Form I-94
(as defined in 8 CFR 1.4), or Form I-94A, bearing the same name as the passport and
containing an endorsement by DHS

6. A passport from the Federated States of Micronesia (FSM) or the Republic of the
   Marshall Islands (RMI) with Form I–94 or Form I–94A
7. a military identification card issued to such individual may be accepted
   only by the Armed Forces.

Question 22

T/F: all controlled substances are ordered with a DEA 222 form

Answer 22

FALSE only controlled 1 and 2
*DEA is required for each distribution or transfer of a schedule 1 or 2

Question 23

Lets say federally a drug has been moved from schedule 2 to 3, BUT in a certain state the drug is still considered a schedule 2 drug. Does a DEA form still have to be used?

Answer 23

Yes. some states may require a DEA 222 regardless of the federal classification

Question 24

who is entitled to obtain a DEA 222 form

Answer 24

any person with an active registration that is authorized to order schedule 1 and 2 controlled substances

Question 25

what information on a DEA 222 form CANNOT be altered by the DEA registrant?

Answer 25

-name, address, and registration number of the registrant.
-authorized activity
-schedules of the registrant

Question 26

if there is an error on the DEA 222 form how can it be fixed?

Answer 26

registrant must report any errors to DEA diversion field office or the Registration and Program Supoort Section of the Administration to modify

Question 27

I can fill out the DEA 222 form with a regular pencil

Answer 27

FALSE, a purchaser MUST complete a DEA 222 form by use of a compueter printer, pen, or indelible pencil

Question 28

between the purchaser and the supplier, who keeps the original and who gets the copy of the DEA 222

Answer 28

purchaser must make copy of the original and SEND the original to the supplier!!! the purchaser’s copy must be paper or electronic

Question 28

each DEA 222 form must be signed and dated by—

Answer 28

a person authorized to sign a registation application or a person granted power of attorney

Question 29

what must the purchaser do once items are received (section 4)

Answer 29

they MUST document on their DEA 222 copy the ACTUAL number of commercial or bulk containers received and the date it was received.

Question 30

even though the purchaser must retain a copy of each executed DEA 222 form, does this include copies of unaccepeted or defective forms?

Answer 30

YES

Question 31

how long should DEA 222 forms be kept available for inspection?

Answer 31

AT LEAST 2 years

Question 32

when should the supplier submit a copy of the DEA 222 to the DEA?

Answer 32

At the end of the month during which the order was filled

Question 33

For orders that are done through partial shipments, when should the supplier send a copy of the DEA 222 to the DEA?

Answer 33

Send the copy at the end of the month during which the FINAL shipment is made OR the 60 day validity period expires

Question 38

Red flags of pharmacy

Answer 38

doctor shopping
repeated dispensing of cocktail prescriptions
no individualization done by prescriber
filling MULTIPLE rx to strongest formulations
request for EARLY refills
doctor locates 100 miles away from pharmacy
large portion of rx were controlled substances written by ONE physician
pharmacist didn’t reach out to other pharmacists to see why they arent fillling a particular docotrs prescriptions
patient travels in groups to pharmacy
filling a LARGE % of cah=sh rx
verification of a prescription as legit was not simply satified because practicioer said so

Question 38

who enforces the controlled subdstance act

Answer 38

DEA-section under FBI

Question 39

definition of inventory

Answer 39

complete and accurate list of all stocks and form of con trolled substances in the possession of the registrant and shall be maintained in written, typewritten, or printed form at the registered location

Question 40

how is the inventory of schedule 2 determined

Answer 40

By a physical count

Question 41

how long should inventory records be maintained at the registered location

Answer 41

AT LEAST two years for copying and inspection

Question 42

in regard to inventory what should someone do when they are issued a DEA registration

Answer 42

take an initial inventory which is a physical count of ALL controlled substances in their possession

Question 43

information that should be included on an inventory record

Answer 43

date of inventory
whether the inventory was taken at opening or closing
the name of EACH inventoried controlled
the finished form of each of the substances
number of dosage units or volume in finished form
number of commercial containers of finished form
total count of the substance

Question 44

after initial inventory how often is it required to take a new inventory

Answer 44

AT LEAST every two years

Question 45

do you have to submit inventory info to the DEA?

Answer 45

no

Question 46

Drug x recently became a controlled substance this year. Does this drug have to be included in the inventory

Answer 46

yes

Question 47

what information do you need for damaged or defective controlled substances

Answer 47

name and total quantity of substance to nearest metric weight
reason for substance being maintained by registrant and wheher it is capable of use