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This act prohibits the sale of adulterated or mislabeled food, drinks, and drugs

1906 Federal Food and Drug Act

1

This act limits the transport of opium. In order to purchase opium, a prescription is required

1914 Harrison Narcotic Act

2

This act made the Food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal

1938 Food Drug and Cosmetic Act

3

-requires drug companies to provide package inserts

1938 Food Drug and Cosmetic Act

4

-requires that a habit-forming drug to be labeled "may be habit forming"

1938 Food Drug and Cosmetic Act

5

-requires that a new drug has to be proven safe under FDA guidelines before marketing

1938 Food Drug and Cosmetic Act

6

This act distinguishes legend drugs(prescription) from over the counter drugs (otc)

1951 Durham Humphrey Amendment

7

Requires companies to label legend drugs "Caution: Federal law prohibits dispensing without a prescription"

1951 Durham Humphrey Amendment

8

Requires physician supervision for the purchase of legend drugs

1951 Durham Humphrey Amendment

9

over the counter drugs without medical supervision are required to have certain information on box

1951 Durham Humphrey Amendment

10

-product name
-name and address of manufacturer and/or distributor
-active ingredients
-quantities of all other ingredients whether active or not

1951 Durham Humphrey Agreement

11

All drugs made from 1938 forward have to be proven safe and effective

1962 Kefauver-Harris Amendment

12

Requires "good manufacturing practices" gmp

1962 Kefauver-Harris Amendment

13

Stricter requirements are now placed on drug manufacturers seeking drug approval; manufacturers have to prove their drug to be safe and effective before marketing it

1962 Kefauver-Harris Amendment

14

FTC(Federal Trade Commission), not the FDA, now handles drug advertisement

1962 Kefauver-Harris Amendment

15

Requires that a manufacturer must:
-Register annually
-Report any adverse reactions
-Be inspected every two years

1962 Kefauver-Harris Amendment

16

Drug Enforcement Agency(DEA) was formed which is a unit of the Justice Department. The controlled substances are now placed into schedules I-V which are based on abuse potential.

1970 Comprehensive Drug Abuse Prevention and Control Act(Controlled Substance Act)

17

This act requires childproof packaging on most drugs dispensed in a pharmacy

1970 Poison Prevention Packaging Act

18

This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases

1983 Orphan Drug Act

19

These drugs are made for such a small percentage of the population that the drug's demand does not make marketing and manufacturing in large quantities economically feasible

1983 Orphan Drug Act

20

This act streamlines the process for granting approval of generic drugs

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)

21

Gives manufacturers incentives to develop new drugs by giving patent extensions

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendement)

22

This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug after the expiration of the patent

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)

23

This act established the FDA as an agency of the Department of Health and Human Services

1988 Food and Drug Administration Act

24

Banned the sale, trade, or purchase of drug samples

1988 Prescription Drug Marketing Act

25

This act requires a pharmacist to attempt or offer to counsel patients on all new prescriptions

1990 Omnibus Budget Reconcilliation Act (OBRA)

26

This act requires pharmacists to provide information on any drug being dispensed such as: name and description of the medication, and how much of the medication should be taken, side effects, contraindications, interactions, adverse effects of the medication, storage, refill information and what to do if a dose is missed

1990 Omnibus Budget Reconcilliation Act (OBRA)

27

This act created rules and regulations regarding the privacy and security of patient health information

1996 Health Insurance Portablility and Accountability (HIPAA)

28

This act provides limitations stating who can access, distribute and receive patient health information

1996 Health Insurance Portability and Accountability Act (HIPAA)

29

This act makes health insurance portable for employees switching jobs.

1996 Health Insurance Portability and Accountability Act (HIPAA)