Quiz 23

Question 1

Law

Answer 1

is a rule passed and enforced by the legislative branch of government.

Question 2

Regulation

Answer 2

is a written rule and procedure that exists to carry out a law of the state or federal government.

Question 3

Standards

Answer 3

is a set of criteria to measure product quality of professional performance against a norm.

Question 4

Pure Food and Drug Act of 1906

Answer 4

To prohibit the interstate transportation or sale of adulterated and misbranded food and drugs.

Question 5

Food, Drug, and Cosmetic Act of 1938

Answer 5

Pharmacy manufacturers are required to file a New Drug Application to prove the product is safe for human use.

Question 6

Durham-Humphrey Amendment of 1951

Answer 6

Responsible for “Caution: Federal Law Prohibits Dispensing without an Prescription” label.

Question 7

Kefauver-Harris Amendment of 1962

Answer 7

added to the Food, Drug and Cosmetic Act of 1938, to ensure the drug is not only safe from humans but effective as well.

Question 8

Comprehensive Drug Abuse Prevention and Control Act of 1970

Answer 8

Created to combat control drug abuse and to supersede previous federal drug abuse. Controlled Substances are now classified by potential abuse in 5 categories (see HO page from pharm tech I)

Question 9

Poison Prevention Packing Act of 1970

Answer 9

Child-resistant container that cannot be opened by 80% of children under 5 but can be opened by 90% of adults.

Question 10

Orphan Drug Act of 1983

Answer 10

Encourages the development of Orphan Drugs by providing tax incentive and allowing manufacturers to be granted a time exclusive licenses to market the drugs.

Question 11

Orphan Drug

Answer 11

is a drug that is intended for use in a few patients with a rare disease or condition.

Question 12

OBRA-90

Answer 12

Pharmacist are now require to do counseling and DUR

Question 13

HIPPA

Answer 13

Health Insurance Portability Act and Accountability Act. Patient confidentiality
(may share info with Provider, ins.co, Law enforcement and parents of minor) with out signed release.

Question 14

3 main reasons a Pharm Tech gets fired

Answer 14

1) Patient confidentiality 2) Control Substance 3) Exceeding Authority

Question 15

Medicare Prescription Drug, Improvement and Modernization Act of 2003

Answer 15

Provides some drug coverage, especially for those with economic hardships or high price medications.

Question 16

Combat Methamphetamine Epidemic Act of 2005

Answer 16

the act reclassifies all products containing the chemicals pseudoephedrine, phenylpropanolamine, and ephedrine and restricts the amount that can be purchased in any 30 day period.

Question 17

Statutory Law

Answer 17

Statutes are laws passed by a legislative body, ex: Congress,

Question 18

Regulatory Law

Answer 18

Rules and regulations made by government agencies ex: FDA, DEA and Pharmacy Board.

Question 19

Common Law

Answer 19

The system of precedents established by decisions in cases throughout legal history. Ex: contracts, property law

Question 20

Tort Law

Answer 20

The legal term for personal injuries that citizen commits against another in a lawsuit. Ex: Malpractice, Negligence

Question 21

OTC

Answer 21

A medication that the FDA has approved for sale without a prescription.

Question 22

Legend Drug

Answer 22

A drug that requires an Rx from a licensed provider for a valid medical purpose.

Question 23

5 Parts of a Prescription

Answer 23

1) Provider Info 2) Patient name and DOB 3) Drug 4) Sig 5) refills

Question 24

5 parts of a Prescription Label

Answer 24

1) Pharmacy Label 2) Patient info 3) Provider info 4) Drug Name 5) SIg

Question 25

CI

Answer 25

Not accepted medical use in the US

Question 26

CII

Answer 26

Extremely high abuse potential No refills Must be filed separately from other schedules Rx record must be kept for 5 years

Question 27

CIII and CIV

Answer 27

Less abuse potential Refillable 5 times or six months Rx must be filled 6 months from it's original issue date CIII-CV are filed together and kept for 5 years

Question 28

CV

Answer 28

Less abuse potential than above schedules Refillable 11 times or 12 months Rx must be filled 12 months from it's original issue date CIII-V are filed together and kept for 5 years.