Pharmacy Law

Question 0

Legislative law drawn from?

Answer 0

Legislative branch of government (US congress and state legislatures)

Question 1

Constitutional law drawn from where?

Answer 1

Constitution and bill of rights

Question 2

Administrative law derived from where?

Answer 2

Executive branch of government (president or state governor and their cabinets)

Question 3

Common law aka case law drawn from where?

Answer 3

Judicial branch of government (court system)

Question 4

Criminal law enforced by whom?

Answer 4

Enforced by state rep against persons or companies

Question 5

Civil law, what happens?

Answer 5

Plaintiff brings suit against alleged defendent

Question 6

Contract law

Answer 6

Agreement between two or more parties and is typically enforced on civil court

Question 7

Ethics, what is it?

Answer 7

system of moral values given to a vocation or profession to follow

Question 8

Pure Food and Drug Act

Answer 8

enacted in 1906, prohibited sale and distribution of adulterated or misbranded food or drugs

Question 9

Food. Drug, and Cosmetic Act

Answer 9

enacted in 1938, required all drug manufacturers to file a NDA with the FDA before any drug could be approved or disapproved for the market, also had to ensure the purity, safety, packaging, and strength of a medication

Question 10

Durham-Humphrey Amendment

Answer 10

1951 amendment, each prescription has legend saying “Caution: Federal law prohibits dispensing this medication without a prescription

Question 11

Kefauver-Harris Amendment

Answer 11

enacted in 1963, required that all medications, both prescription and nonprescription, be pure, effective, and safe to use on humans

Question 12

Controlled Substance Act

Answer 12

enacted in 1970, required the pharmaceutical industry to keep records and maintain security measures for certain medications, divided controlled substances into five classes

Question 13

DEA Form 222

Answer 13

form used to order schedule II drugs

Question 14

Poison Prevention Packaging Act

Answer 14

enacted in 1970, created standards for child-resistant packaging

Question 15

Drugs that do not need to be in child-resistant packaging

Answer 15

sublingual nitroglycerin tablets
birth control pills
certain corticosteroid tablets
bulky meds, like some of the Potassium effervescent tablets

Question 16

Occupational Safety and Health Act

Answer 16

enacted in 1970, established to prevent workplace disease and injuries

Question 17

Drug Listing Act

Answer 17

enacted in 1972, assigns a unique and permanent drug code to each medication, known as the National Drug Code (NDC)

Question 18

Federal Hazardous Substance Act

Answer 18

enacted in 1960, involves different aspects, including the use and disposal of hazardous material in the pharmacy setting

Question 19

Orphan Drug Act

Answer 19

enacted in 1983, offers financial incentives to organizations that develop and market medications that were not previously available in the US. medications that treat a small part of the population or a rare disease

Question 20

Omnibus Budget Reconciliation Act (OBRA)

Answer 20

enacted in 1990, requires pharmacies that fill prescription orders for Medicaid patients to obtain, record, and maintain basic patient information

Question 21

Anabolic Steroids Control Act

Answer 21

enacted in 1990, allows the CSA to regulate anabolic steroids

Question 22

Health Insurance Portability and Accountability Act (HIPPA)

Answer 22

enacted in 1996, implemented to improve continuity and portability of health insurance for patients

Question 23

FDA Modernization Act

Answer 23

enacted in 1997, designed to reform the regulation of cosmetics, food, and medical products, main focus is safe pharmacy compounding and regulation of medical devices

Question 24

Combat Methamphetamine Epidemic Act

Answer 24

enacted in 2005, intended to stop the use of the illegal drug methamphetamine, regulates drug trafficking and under this act, any person found in violation will have their property seized

Question 25

DEA enforces what?

Answer 25

federal regulatory body that is responsible for enforcing controlled substance legislation

Question 26

FDA enforces what?

Answer 26

FDA established to enforce the safety and effectiveness of foods medications, biological products, cosmetics, and radioactive substances

Question 27

Joint Commission on Accreditation of Healthcare Organization (JCAHO)

Answer 27

body that accredits and certifies healthcare organizations in the US

Question 28

National Association of the Boards of Pharmacy

Answer 28

assists the boards of pharmacy in each state to protect public heath by developing uniform standards