Federal Laws

Question 1

Pure Food and Drug Act 1906

Answer 1

Prohibited adulteration and misbranding of food and drug for interstate commerce

Question 2

Food, Drug, and Cosmetic Act of 1938

Answer 2

1) drug must be proven safe and approved by the FDA to be on the market
2) labels must contain appropriate warning

Question 3

Durham-Humphrey Amendment of 1951

Answer 3

1) OTC vs. RX

2) oral prescription and refill authorization

Question 4

Kefauver-Harris Amendment 1962

Answer 4

1) Drugs must be proven efficacious
2) Good Manufacturing Practices established
3) FTC to FDA (drug advertisement)
4) Established informed consent
5) Reporting of ADR

Question 5

Federal Drug Abuse Prevention Act 1970

Answer 5

aka Controlled Substance Act

Question 6

Medical Device Act 1976

Answer 6

Categorized medical devices into 1 of 3 classes
I: least regulated i.e. scissors
II: insulin syringe, insulin pump
III: pacemaker, contact lenses

Question 7

Orphan Drug Act 1983

Answer 7

created tax incentives for innovative drugs that treat rare diseases (affecting <200,000)

Question 8

Drug Price Competition and Patent Restoration Term Act 1984

Answer 8

AKA Waxman-Hatch Act

created an expedited version for generic approval (abbreviated NDA) and provided patent extension for innovative drugs

Question 9

Prescription Drug Marketing Act 1987

Answer 9

bans sales, trade, purchase of RX samples

Question 10

Omnibus Budget Reconciliation Act 1990

Answer 10

Objective was to save Medicaid money

Established prospective DUR (screen, counsel, patient profile)

Question 11

Prescription Drug User Fee Act 1992

Answer 11

Manufacturers have to pay to submit new drug application

Question 12

Dietary Supplement Health and Education Act 1994

Answer 12

Created term dietary supplement

Question 13

Health Insurance Portability and Accountability Act 1996

Answer 13

1) Privacy and Security
2) Efficiency and effectiveness of healthcare system
3) prohibited discrimination in healthcare

Question 14

Food Drug Administration Modernization Act 1997

Answer 14

Expedite process for new drug when it can be used for a serious or life-saving case

Question 15

Drug Addiction Treatment Act 2000

Answer 15

can treat opioid addiction in clinic setting (i.e. Suboxone)

Question 16

Anabolic Steroid Act 2004

Answer 16

All anabolic steroids schedule III

Question 17

Combat Methamphetamine Act 2005 and Methamphetamine Prevention Act 2008

Answer 17

Pseudoephedrine laws

Question 18

Patient Safety and Quality Innovation Act 2005

Answer 18

Voluntary program for healthcare providers to report adverse effects

Question 19

Food and Drug Administration Amendment Act 2007

Answer 19

FDA can mandate label change for safety concern

Question 20

Biologics Price Competition and Innovation Act

Answer 20

Pathway for biologic approval

Question 21

Federal Safety Innovation Act 2012

Answer 21

Reduce counterfeit drugs and drug shortages

Question 22

Drug Quality and Security Act 2013

Answer 22

regulated pharmacy compounding

Question 23

Comprehensive Addiction Recovery Act 2016

Answer 23

extends time frame in which CII’s can be partial filled

allows NP and PA’s to ask to fill buprenorphine for opioid addiction

Question 24

Substance Abuse Disorder Prevention that Promote Recovery and Treatment for Patient and Communities Act

Answer 24

controlled substances must be electronically transmitted for Medicare Advantage and Part D plans starting 1/1/2021