EXAM 2 Federal Controlled Substance Law Pt1

Question 1

Which number initiated the registration process and was replaced by the DEA number?

Answer 1

BNDD number

Question 2

KNOW the DEFINITIONS
on the Handout

Question 3

What are the factors that get a drug scheduled?

Answer 3

-Actual or relative potential for abuse
-Scientific evidence of pharmacologic effect (fe it works on opioid receptors)
-Current scientific knowledge of substance

-History and current pattern of abuse
-Scope, duration, and significance of abuse
-Risk to public health
-Psychic and physiological dependence liability
-Immediate precursor of a substance already abused

Question 4

Where is the original list of scheduled drugs?

Answer 4

in the US Code (21 USC 812) - but not maintained

-the updated list is in the Code of Federal Regulations: 21 CFR 1308

Question 5

Where do we see C-I scheduled drugs?

Answer 5

Research setting -> researcher needs to be registered with the DEA and a DEA number

Examples:
-Heroin
-Marijuana
-Bath salts
-Psilocybin
-fentanyl-related substances (not the fentanyl that is approved for pain)

Question 6

C-II drugs

Answer 6

-high potential abuse
-may cause severe psychological or physical dependence

-Cocaine !!!
-Codeine !
-Morphine !
-Hydrocodone
-Hydromorphone
-Meperidine
-Methylphenidate
-Methamphetamine
-Methadone
-Secobarbital

Question 7

Psychological vs. physical dependence

Answer 7

Physical: body needs it to function properly,
-> withdrawal if you stop the drug
->Vomiting, sweating, pain

Psychological: Addiction
-> need regardless of consequences

Question 8

What is the abuse potential for C-III drugs

Answer 8

Abuse potential
-moderate to low physical dependence
-high psychological dependence

Question 9

Examples for C-III

Answer 9

-Dronabinol
-codeine combos
-anabolic steroids
-C-II drugs in suppository form (fe secobarbital moves to C-III if in suppository)
-buprenorphine
-Narcotics (dose-dependent)

Question 10

How much of narcotics are allowed to not be considered C-II? (but considered C-III)

Answer 10

not more than

1.8 g codeine/100ml

90 mg per dose unit (fe tablet)

50 mg morphine/100ml or per 100g

Question 11

Example of a C-III narcotic product

Answer 11

30mg codeine with acetaminophen

if it had 91 mg it would be a C-II

Question 12

What is the abuse potential for C-IV drugs

Answer 12

-Low potential for abuse
-Limited physical or psychological dependence liability (compared to C-III)

-Benzos (alprazolam, lorazepam)
-diet pills (phentermine)
-hypnotics (zolpidem, zaloplon)
-carisoprodol
-butorphanol
-tramadol

Question 13

What is the abuse potential for C-V drugs?

Answer 13

-Low abuse potential compared to C-IV
-Abuse leads only to limited physical or psychological dependency

Question 14

Examples of C-V

Answer 14

-Low level codeine combos (Cheratussin AC)
-diphenoxylate/atropine (Lomotil)
-Lyrica (Pregabalin)

OTC:
200 mg
Cheratussin AC (codeine with Robitussin)

Question 15

Max dose of codeine in OTC products Cheratussin and Lomotil

Answer 15

-200 mg codeine/100ml or 100g
Cheratussin AC (codeine with Robitussin):
10mg codeine per 5ml

2.5 mg diphenoxylate/atropine and not less than 25mcg atropine

Question 16

How much codeine can be in Guanfacin to still be considered C-V?

Answer 16

10 mg codeine per 5 ml (2mg per 1 ml)
-> considered C-V

Question 17

How much diphenoxylate can be in Lomotil to still be considered C-V?

Answer 17

2.5 mg of diphenoxylate
and not less than 25mcg atropine