Pharm Tech Law

Front 1

Pure Food and Drug Act of 1906

Back 1

prohibits interstate transportation or sale of adulterated and misbranded food or drugs

Front 2

Food, Drug, and Cosmetic Act of 1938 (FDCA 1938)

Back 2

1. requires all new drug applications be filed with the FDA.

2. defines adulteration and misbranding

Front 3

adulteration

Back 3

1. has filthy, putrid, decomposed (bad) substance

2. kept or made in unsanitary conditions

3. contain unsafe color additives

4. claims to be drugs in "official compedium" but is not, is different in either strength, quality or purity of the drug

Front 4

misbranding

Back 4

1. labels that are false or misleading

2. pckg doesn't have label with name and place of manufacturer, packer or distributor OR accurate quantity of contents OR is not labeled clearly and correctly

3. does not have habit-forming warning if it is habit-forming

4. is not labeled with est. name of drug, the quantities of the active ingredients, amount of alcohol, with the est. name of those substances

5. no "directions for use" or warnings for using under certain conditions

6. are dangerous to health when used in the manner as labeled

Front 5

Durham-Humphrey Act of 1951

Back 5

1. all products need adequate directions for us unless federal law says they need a prescription for it

2. makes 2 categories for drugs: legend and non legend

3. allow verbal prescriptions over the telephone

4. allow refills to be called in from physician's office

Front 6

legend drugs

Back 6

requires a prescription

Front 7

non-legend drugs

Back 7

does not require a prescription

Front 8

Kefauver-Harris Amendment of 1962

Back 8

all medication in the U.S. must be pure, safe, and effective

Front 9

Comprehensive Drug Abuse Prevention and Control Act of 1970

Back 9

controlled substances are put into the five schedules or categories based on their potential for abuse and accepted medical use in usa

Front 10

schedule I

Back 10

has no accepted medical use in USA

has high potential for abuse

ex/ crack

Front 11

schedule II

Back 11

has medical use BUT has high abuse potential with severe psych or phys dependency

ex/ adderall and morphine

Front 12

schedule III

Back 12

has accepted medical use
AND
has abuse potential but less than sched I and II

Front 13

schedule IV

Back 13

abuse potential less than sched III BUT may lead to limited phys or psych dependence

Front 14

schedule V

Back 14

less than sched IV

ex/ narcotics

Front 15

DEA

Back 15

Drug Enforcement Agency, supervised by Dept of Justice

Front 16

DEA form 224

Back 16

submitted by pharmacy to register with the DEA, must be renewed every 3 years