Law

Question 1

Federal Food and Drug Act of 1906

Answer 1

(Wiley)
Purity and misbranding

✪ old meat in 1906

Question 2

Narcotic Tax Act of 1914

Answer 2

(Harrison)
Tax on opiates

• replaced by CSA 1970

✪ Narcotic 1914

Question 3

Federal Food, Drug and Cosmetic Act of 1938

Answer 3

(FDCA 1938)

• Prove claims
• Cosmetic and therapeutic devices now regulated
• FDA

✪ FDCA 1938

Question 4

Drug Abuse Prevention / Controlled Substances Act of 1970

Answer 4

(CSA)
- DEA number and registratio

• replaced Harrison 1914

✪ Prevention 1970

Question 5

The Durham-Humphrey Amendment of 1951

Answer 5

• OTC distinction

- Prescription restriction

Question 6

The Bureau of Narcotics and Dangerous Drugs (BNDD)

Answer 6

Drug Enforcement Administration

Question 7

Medical Law Device (1976)

Answer 7

Pre-market approval of devices

Question 8

Combat Methamphetamine Epidemic Act (2005)

Answer 8

Regulation of ephedrine,etc.

• identify and address for 2 years
• daily limit = 3.6g
• 30 day mail limit = 7.5g
• 30 day limit = 9.0g

✪ Methamphetamine 2005

Question 9

Omnibus Budge Reconcilliation Act (1990)

Answer 9

(OBRA)
Patient counseling

✪ Like COBRA venom, 1990

Question 10

Dietary Supplementary Health And Education Act (1994)

Answer 10

• Only 3 claims on its label
• Supplemental panel

✪ Education 1994

Question 11

Kefauver-Harris Amendment (1962)

Answer 11

(Drug Efficacy Amendment)

• Prove effectiveness/safety
• Disclose side effects
• GMP (no garage)

✪ Couple (two names) has to prove themselves

Question 12

Poison Prevention Packaging Act (1970)

Answer 12

Child resistant packaging

Question 13

Federal Anti-Tampering Act (1983)

Answer 13

Tamper-resistant barriers on OTCs