Drug regulations

pure food and drug act

accurate labeling

Food, drug, cosmetic act

need pre-market approval of all new drugs

Kefauver-harris amendment

• requires proof of effective and safety for drug

dependence, addiction, withdrawl

D: cns adaption to repeated use

A: compulsive use despite consequences

W: discomfort from cessation os use

sch 1

highest abuse potential

• heroin, LSD

sch 2

high abuse potential, severe dependence

• Opioids, cocaine

sch 3

moderate/low dependence

sch 4

low risk

sch 5

lowest risk

MassPAT

tracks controlled substance prescribing to reduce misuse.

black box warnings

drug approval process

1. preclinical investigations

2. clinical investigations

3. new drug application

4. post-marketiig surveillance

teratogenic risk categories: A

safest - no fetal risk in human studies

teratogenic risk categories: B

no fetal risk in animal studies

teratogenic risk categories: C

animal studies show risk

teratogenic risk categories: D

evidence of fetal risk

teratogenic risk categories: X

highest risk - proven fetal harm