Rx Law Unit 1 Lec 1-3

Front 1

Define: legislative system

Back 1

passes bills into laws (statutes)

Front 2

Define: executive system

Back 2

enforces laws by creating regulations

Front 3

Define: judicial system

Back 3

interprets laws

Front 4

Define: constitutional law

Back 4

the interpretation and implementation of the United States Constitution

Front 5

Define: statutory law

Back 5

written law created by legislature

Front 6

Define: regulatory law

Back 6

law created by an executive branch agency under a delegation from a legislature

Front 7

Define: regulation

Back 7

A principle, rule, or law designed to control or govern conduct

Front 8

Define: judicial law

Back 8

laws resulting from judicial decisions

Front 9

Define: opinion

Back 9

a view or judgment formed about something

Front 10

Define: administrative law

Back 10

the body of law that governs the activities of administrative agencies of government

Front 11

Define: criminal law

Back 11

the body of law that relates to crime
- It regulates social conduct and proscribes threatening, harming, or otherwise endangering the health, safety, and moral welfare of people

Front 12

Define: civil law

Back 12

non-criminal law

Front 13

Define: misdemeanor

Back 13

Offense lower than felonies and generally those punishable by fine, penalty, Forfeiture, or imprisonment other than in a penitentiary

Front 14

Define: felony

Back 14

A serious crime, characterized under federal law and many state statutes as any offense punishable by death or imprisonment in excess of one year

Front 15

What are the Federal Register and Wisconsin Register?

Back 15

Daily publications of the status of pending pharmacy legislation

Front 16

What is the CFR?

What chapter relates to pharmacy?

Back 16

Code of Federal Regulations

pharmacy = Chapter 21

Front 17

What are the three conditions needed for legislature to have authority over pharmacy regulations?

Back 17

1. Scope of Authority

2. Statutory basis

3. Public Health, Safety, and Welfare

Front 18

What are the three types of legal action that can be taken against a pharmacist?

Back 18

1. Administrative

2. Criminal

3. Civil

Front 19

What is the FDCA's focus on purity?

Back 19

focuses on how things are made, processed, etc.

adulteration is the crime of not meeting purity standards

Front 20

Define: adulteration

Back 20

the crime of not meeting purity standards

Front 21

What is the FDCA's focus on labels?

Back 21

labels must specify:
- contents
- directions for use
- strength
- quantity

Front 22

Define: misbranding

Back 22

the crime of errors on a label

(i.e. the wrong label on a prescription)

Front 23

Give examples of how the FDCA promotes public health safety directly vs. indirectly

Back 23

directly = preventing harm by removing a product from the market

indirectly = requiring information on the label to give consumers the knowledge to prevent harm

Front 24

What is prohibited by the Pure Food and Drug Act of 1906?

Back 24

the adulteration and misbranding of foods and drugs in interstate commerce

Front 25

What is the significance of U.S. vs. Johnson in 1911

Back 25

led to the 1912 amendment to the Pure Food and Drug Act to prohibit false and fraudulent efficacy claims

Johnson falsely claimed on a label that a drug was effective against cancer

The court ruled that misbranding prevented false statements only on a drugs identity, not its efficacy

Front 26

What is the significance of the Elixir of Sulfanilamide Trajedy?

Back 26

led to passage of the FDCA (Food, Drug, and Cosmetic Act) of 1938

manufacturer used diethyl glycol as a solvent, leading to >100 deaths

Front 27

What was the main provisions of the FDCA of 1938?

Back 27

1) no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA

2) expanded definition of misbranding and adulteration, requiring that labels contain adequate directions for use and warnings

Front 28

What is the significance of U.S. vs. Sullivan

Back 28

determined that pharmacists who are not involved in interstate commerce are still subject to the federal regulations

- a GA pharmacist claimed he was exempt, but the courts disagreed (1948)

Front 29

What was established by the Durham-Humphrey Amendment of 1951?

Back 29

required all drugs to be labeled with "adequate directions for use"

- because many drugs were not safe for use except under medical supervision, two classes of drugs were established: legend & non-legend

Front 30

What prompted passage of the Kefauver-Harris Amendment of 1962?

What was its effects?

Back 30

experimental use of the sedative thalidomide caused birth defects in thousands of infants

aka the Drug Efficacy Amendment, it strengthened the new drug approval process by requiring that drugs be proven not only safe, but also effective

It also placed FDA in charge of drug advertising (instead of FCC)

the new law was made retroactive to all drugs marketed from 1938-1962

Front 31

Why was the Medical Device Amendment of 1976 necessary?

Back 31

previously, the FDA had no jurisdiction over medical devices unless it classified them as drugs

- numerous unsafe devices had been marketed and caused damage (Dalkon Shield)

Front 32

How did the Orphan Drug Act of 1983 incentivize manufacture of orphan drugs?

Back 32

provided tax and exclusive licensing incentives for manufacturers to develop and market these drugs or biologicals

Front 33

What is the Waxman-Hatch Amendment?

Back 33

the Drug Price Competition and Patent Term Restoration Act of 1984

- streamlined generic drug approval process while giving patent extensions to certain innovator drugs

Front 34

What is the Dietary Supplement Health and Education Act of 1994?

Back 34

permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA

- forced the FDA t regulate dietary supplements more as foods than as drugs

Front 35

How does the FDCA determine if a product is a drug?

Back 35

A. It is listed in the Official Compendia
B. It is used in the diagnosis, cure, mitigation, or treatment of disease
C. It is intended to affect the structure or any function of the body
D. any component of A, B, or C

Front 36

Define: biologics

Back 36

medical products derived form living organisms

i.e. viruses, toxins, antitoxins, vaccines

Front 37

How are medical devices divided into classes?

Give some examples of each class.

Back 37

Class is based on the degree of control necessary to assure the various types of devices are safe and effective

Class I: minimal potential for harm
(toothbrushes, elastic bandages)

Class II: most medical devices
(syringes, infusion pumps, tampons)

Class III: usually sustain or support life, are implanted, or present potential increased risk of illness or injury
(pacemakers, contact lenses)

Front 38

What are the conditions for a medical device to be exempt?

Back 38

must fall into an exempted category of Class I devices

- premarket notification application and FDA clearance are not required

Front 39

What is a label vs. labeling?

Back 39

A label is the actual piece of paper stuck on the bottle and the info on it. A label is a component of the labeling.

The ppi is labeling, but is not part of the label.

Front 40

What three publication make up the Official Compendia?

What is their purpose?

Back 40

1. US Pharmacopeia (USP)
2. National Formulary (NF)
3. Homeopathic Pharmacopeia of the US (HPUS)

They are important books for standards of quality and purity. The FDA does not have Q&P standards written into the regulations, rather it refers to specific standards in the compendia.