Lecture 2 - 6/30/2022

Question 1

Factors Determining CS Schedule

Answer 1

(1) Its actual or relative potential for abuse;
(2) Scientific evidence of its pharmacological effect, if known;
(3) The state of current scientific knowledge regarding the drug or other substance;
(4) Its history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) What, if any, risk there is to the public health;
(7) Its psychic or physiological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

Question 2

Schedule I info

Answer 2

1. high abuse potential
2. no current acceptable medical treatment in US
3. no acceptable info regarding safety…even under medical supervision

Question 3

Schedule II info

Answer 3

1. high abuse potential
2. accepted medical use ( may have severe restrictions)
3. Abuse may lead to sever physical & Psychological dependence

Question 4

Schedule III info

Answer 4

1. Less abuse potential than CI & CII
2. currently acceptable medical treatment in US
3. Abuse may lead to moderate or low physical dependence or high psychological dependence

Question 5

Schedule IV info

Answer 5

1. low potential of abuse relative to CIII
2. current acceptable medical treatment in US
3. Abuse may lead to limited physical dependence or high psychological dependence relative to CIII

Question 6

Schedule V info

Answer 6

1. Low abuse potential
2. Current acceptable medical treatment in US
   Abuse may lead to limited physical dependence or high psychological dependence relative to CIV

Question 7

A Schedule V drug cannot contain more than…..

Answer 7

1. 200 mg of codeine per 100mL or 100 g
2. 100mg of dihydrocodeine, ethylmorphine, or opium per 100mL or 100g
3. 2.5mg of diphenoxylate and not less than 25mcg of atropine per dosage unit
4. 0.5mg of difenoxin and not less than 25mch of atropine sulfate per dosage unit

Question 8

Controlled substance Registration

Answer 8

21 USC 822

1. Closed system of Distribution = only registrants may engage in manufacturing, distribution and dispensing

Question 9

how often do manufactures & Distributors need to renew registration

Answer 9

annual

Question 10

How often do dispensers need to renew registration

Answer 10

every 3 years

Question 11

Exceptions to controlled substance registration

Answer 11

1. agent or employee of a registered manufacturer, distributor, dispenser acting in the normal course of business or employment
2. common carrier contact carrier or warehouseman acting in normal course of business or employment
3. ultimate user who possess the CS for lawful purpose

Question 12

Activates that require DEA CS registration

Answer 12

Manufacturing
Distributing
Reverse Distributing
Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)
Research (CI) and Research (CII-V) 
Narcotic Treatment Program (including compounder)
Importing
Exporting
Chemical Analysis

Question 13

DEA Form 224 is….

Answer 13

Application for registration for Dispenser

Question 14

DEA Form 225 is…

Answer 14

Application for registration for Manufacturers, Distributors, Narcotic Treatment Programs

Question 15

How to validate DEA number

Answer 15

Step 1: add the first, third, and fifth digits of the DEA number

Step 2: add the second, fourth, and sixth digits of the DEA number and multiply by 2

Step 3: add the result of Step 1 to the result of Step 2- the last digit must be the same as the last digit of the DEA number.

Example: DEA number AB7258367
Step 1: 7 + 5 + 3 = 15
Step 2: 2 + 8 + 6 = 16 x 2 = 32
Step 3: 15 + 32 = 47

Question 16

1st letter DEA =

Answer 16

code identifying type of registrant

Question 17

2nd letter of DEA =

Answer 17

1st letter of registrants last name or business name

Question 18

A =

Answer 18

Deprecated (used by older entities)

Question 19

B =

Answer 19

Hospital / Clinic

Question 20

C =

Answer 20

Practitioner

Question 21

D =

Answer 21

Teaching Insitution

Question 22

E =

Answer 22

Manufacturer

Question 23

F =

Answer 23

Distributor

Question 24

G =

Answer 24

Researcher

Question 25

H =

Answer 25

Analytical Lab

Question 26

J =

Answer 26

Importer

Question 27

K =

Answer 27

Exporter

Question 28

L =

Answer 28

Reverse Distributor

Question 29

M =

Answer 29

Mid level practitioner

Question 30

N =

Answer 30

Military practitioner

Question 31

P, T, R, S, U =

Answer 31

Narcotic Treatment Program

Question 32

X =

Answer 32

Suboxone/Subutex Prescribing Program

Question 33

DEA 223 form is…

Answer 33

issued as the CS registration ( CII-CV) if application approved by DEA

Question 34

DEA 222 form is….

Answer 34

used to order drugs CI-CII

Question 35

CS: Security Requirements

Answer 35

21 CFR 1301.71(a)

Registrants must provide effective controls and procedures to guard against theft and diversion of controlled substances

Some factors used in evaluating effective security controls and procedures:

The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging,

• labeling, cooperative buying, etc.);
• the type and form of controlled substances handled;
• the quantity of controlled substance handled;
• location of the premises
• type of building (and general characteristics)
• the type of closures on vaults, safes, and secure enclosures
• Adequacy of lock control system
• Adequacy of alarms

Question 36

MA controlled Substance Security:

Answer 36

247 CMR 6.02 (6)

1. All Controlled substances (C2-C5) must be stored in pharmacy area
2. Controlled substances in C6 maybe stored in pharmacy area or in a clean room adjacent to pharmacy area
3. C2-C5 shall be locked in substantially constructed cabinet or dispersed throughout C6 stock in a manner designed to reduce risk of diversion