Exam 2

Question 1

Controls Federal CS Act

Answer 1

DEA

Question 2

Enforces Texas CS Act

Answer 2

DPS/TBSP

Question 3

Pure Food and Drug Act

Answer 3

Can’t be misbranded or adulterated

Question 4

FDCA

Answer 4

SAFE (but not effective)

Question 5

Kefauver-Harris

Answer 5

Safe AND effective

Response to thallidomide tragedy

Established GMP facilities

Established DESI

Question 6

DESI established by?

Answer 6

Kefauver-Harris

Question 7

Established GMP facilities?

Answer 7

Kefauver-Harris

Question 8

Response to thallidomide tragedy?

Answer 8

Kefauver-Harris

Question 9

Codeine concentration limits in C5

Answer 9

200 mg/100 ml (C5)

If more, then C3 (not C4)

Question 10

Codeine concentration limits in C3

Answer 10

1800/100ml

Question 11

Opioid concentration limits in C5

Answer 11

100/100ml (c5 federal)

50/100ml (texas)

Question 12

Opioid concentration limits in C3

Answer 12

500/100ml (Federal and Texas)

Question 13

Texas requires an Rx for codeine- containing product

Answer 13

True

Question 14

Precursor to Federal CS Act?

Answer 14

Drug Abuse Control Amendments

Question 15

Drug Price Competetion and Patent Term Restoration Act

Answer 15

Reduce HC costs

Patent 5 years

ANDA

Question 16

Reduced HC costs?

Answer 16

Drug Price Competetion and Patent Term Restoration Act

Question 17

Extended patent 5 years?

Answer 17

Drug Price Competetion and Patent Term Restoration Act

Question 18

ANDA?

Answer 18

Drug Price Competetion and Patent Term Restoration Act

Question 19

DEA 224

Answer 19

Needed for a pharmacy to dispense controlled substances

Question 20

DEA 222

Answer 20

Ordering and transferring CIIs

Send 1 and 2 to Supplier
Supplier sends copy 2 to DEA
Pharmacy keeps copy 3

Anyone can fill, but only person with POA can sign it

Question 21

DEA 106

Answer 21

Theft or significant loss; report in writing to DEA within one business day

Fill and send (within 2 months) to:

• DEA
• TSBP
• Police recommended

If unable to send out in 2 months, you can update TSBP and DEA.

Question 22

DEA 41

Answer 22

On site destruction of a CS

• Record method of destruction
• 2 signatures of employees who witness
• Must leave irretrievable

Preferred method: delivery to a reverse distributor (treated as a transfer, if C2 use DEA 222, if C3-5, invoice)

Question 23

Banned reimportation of Rx drugs made in US?

Answer 23

Prescription Drug Marketing Act

Question 24

FDA Modernization Act

Answer 24

“Rx only”

Question 25

Established REMS?

Answer 25

FDAAA

Question 26

Required side effects statement?

Answer 26

FDAAA

Question 27

Purple book

Answer 27

Therapeutic equivalence; interchangeable, bio-similars, pricing

Ex: Changing to a different BZD

Question 28

Notify DEA about theft or significant loss in how much time?

Answer 28

1 business day

Question 29

NDC

Answer 29

Manufacturer 4-5
Drug 4
Packaging Code 2

Question 30

Orange Book

Answer 30

Generic equivalence

A- safe and effective
B- Do not use

Can do AA and AB

Question 31

DEA can’t ask about what without consent?

Answer 31

Financial, sales, and pricing data (anything money related)

Question 32

Practioners

Answer 32

MD
DO
DDS
Podiatrist
Vet

Question 33

Mid-level practitioners

Answer 33

RN
PA

C3-5 only, C2 in some settings

Question 34

Can’t change on a C2

Answer 34

Name of Pt
Name of Drug
Name of Prescriber
Date of Rx

Question 35

Requires child- resistant container for Rx and certain OTC drugs?

Answer 35

Poison-Prevention and Packaging Act