Regulation

Question 1

The act the prohibited interstate commerce in adulterated or misbranded food, drinks and drugs

Answer 1

1906 Food and Drug Act

Question 2

FDA previously named

Answer 2

Food, drug, and insecticide act

Question 3

Harrison Narcotic Act

Answer 3

1914

Manufactures, importers and physicians to be licensed and taxed

Question 4

Required new drugs to be safe before marketing (due to fatal poisoning from liquid sulfanilamide)

Answer 4

1938 Food, Drug, and Cosmetic Act

Question 5

1965 - medicare

Answer 5

Social Security Act

Question 6

Childproof packaging for all prescription medication

Answer 6

Poison Prevention Packaging Act 1970

Question 7

Quicker introduction to drugs and extension of drug patent

Answer 7

Hatch Watchman Act 1984

Question 8

HIPAA (Health Insurance Portability and Accountability Act)

Answer 8

1996 - Personal Health Information (PHI)

Question 9

OBRA (Omnibus Budget Reconciliation Act)

Answer 9

1990 - requires patient counseling

Question 10

The limits of exempt narcotics can be sold – hours

Answer 10

48 hours

Question 11

Limits for pseudophed sales

Answer 11

3.6 grams per day

9 grams total per month

Question 12

Phase I drug test

Answer 12

20-100 patients, several months

Mainly safety purpose

Question 13

Phase II drug test

Answer 13

up to several hundreds patients
months - 2 years
Safety, MAINLY effectiveness

Question 14

Phase III drug test

Answer 14

hundreds-thousands
1-4 years
safety, effectiveness, DOSAGE

Question 15

Controlled Substance Act year

Answer 15

1970

Question 16

Sched II record must be kept for – years and others are kept for – years

Answer 16

7 years for CII

2 years for others