Federal Drug Law

Question 1

Pure Food and Drug Act of 1906

Answer 1

prohibited adulteration and misbranding of foods and drugs in interstate commerce

Question 2

Food, Drug, and Cosmetic Act (FDCA) of 1938

Answer 2

Core of today’s drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties

Question 3

Durham-Humphrey Amendment of 1951

Answer 3

Established 2 classes of meds: RX and OTC. Authorized oral prescriptions and refills of prescription drugs. Introduced label requirements for pharmacies

Question 4

Kefauver-Harris Amendment of 1962

Answer 4

Drugs must also be proven effective (in addition to safe). Transferred rx drug advertising from Federal Trade Commision (FTC) to FDA. Established Good Manufacturing Practices. Required informed consent of research participants and reporting of ADRs

Question 5

Federal Comprehensive Drug Abuse Prevention and Control Act of 1970

Answer 5

AKA controlled substances Act

Question 6

Medical Device Amendments of 1976

Answer 6

Established criteria for classifying devices into one of three classes

Question 7

Orphan Drug Act of 1983

Answer 7

Provides tax and licensing incentives for manufacturers who develop drugs or biologicals for rare diseases or conditions

Question 8

Drug Prices Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984

Answer 8

Also known as Waxman-Hatch Amendment. Streamlined generic drug approval process while giving patent extensions for innovative drugs

Question 9

Waxman-Hatch Amendment

Answer 9

Also known as Drug Prices Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984. Streamlined generic drug approval process while giving patent extensions for innovative drugs

Question 10

Prescription Drug Marketing Act (PDMA) of 1987

Answer 10

Bans sale, trade, or purchase of rx drug samples. Established sales restrictions and recordkeeping requirements for Rx drug samples. Prohibits hospitals and other heath care entities from reselling their Rx drugs to other businesses. Requires state licensing of wholesalers. Bans re-importation of Rx drugs except by manufacturer

Question 11

Omnibus Budget Reconciliation Act of 1990

Answer 11

Aka OBRA-90. Included prospective drug use review, patient counseling, patient profiles

Question 12

Prescription Drug User Fee Act of 1992

Answer 12

Drug manufacturers required to pay fees when submitting a new drug application

Question 13

Dietary Supplement Health and Education Act (DSHEA) of 1994

Answer 13

Created new category of food called “dietary supplements”. Permits manufacturers to make claims that would have otherwise been illegal under FDCA. Forced FDA to regulate dietary supplements more as foods than drugs

Question 14

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Answer 14

regulated privacy and security of health information; improved efficiency and effectiveness of health care system; improved continuity of health insurance coverage and prohibits discrimination in health care coverage

Question 15

Food and Drug Administration Modernization Act (FDAMA) of 1997

Answer 15

Streamlined regulatory procedures to expedite availability of safe and effective drugs and devices; Expands FDA authority over OTC drugs; Establishes data bank of information on clinical trials

Question 16

Drug Addiction Treatment Act (DATA) of 2000

Answer 16

allows office-based opioid addiction treatment (ie Suboxone)

Question 17

Anabolic Steroids Act of 2004

Answer 17

All anabolic steroids are schedule III

Question 18

Combat Methamphetamine Epidemic Act of 2005 & Methamphetamine Prevention Act of 2008

Answer 18

Pseudoephedrine laws

Question 19

Patient Safety and Quality Improvement Act of 2005 (PSQIA)

Answer 19

Creates a voluntary program through which health care providers, including pharmacies, share information related to patient safety events with patient safety organizations

Question 20

Food and Drug Administration Amendments Act (FDAAA) of 2007

Answer 20

FDA may mandate labeling changes related to safety; Require clinical trial data reporting and registries; Require post-market clinical studies to assess risk (Phase 4 studies)

Question 21

Biologics Price Competition and Innovation Act

Answer 21

Included in Affordable Care Act of 2010 - allows a pathway for biosimilar approval

Question 22

FDA Safety and Innovation Act of 2012

Answer 22

Contains provisions directed at reducing drug counterfeiting, blocking import of adulterated products, detecting and reducing drug shortages

Question 23

Drug Quality and Security Act of 2013

Answer 23

regulated pharmacy compounding and tracking of medications throughout the distribution system

Question 24

Comprehensive Addiction and Recovery Act of 2016

Answer 24

extends time frame in whcih C-IIs can be partially filled. allows NPs and PAs to apply for waiver to prescribe buprenorphine for opioid addiction

Question 25

Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

Answer 25

controlled substance prescriptions for Medicare Advantage and Part D required to be transmitted electronically beginning Jan 1, 2021

Question 26

Poison Prevention Packaging Act (1970)

Answer 26

Many OTC products and most Rx products must be dispensed in child-resistant container. containers may only be used once unless container is a glass vial or threaded-plastic container, in whcih only a new cap is needed to be dispensed. Patient can request rx dispensed in non-child resistant container and may make blanket request. physician may state that drug should be dispensed in non-child-resistant container but may NOT issue blanket order
Rx exempt: sublingual nitro, oral contraceptives

Question 27

Health Information Technology for Economic and Clinical Health Act (HITECH)

Answer 27

HITECH Act amendments to HIPAA require that in the event of an unauthorized disclosure of PHI, the covered entity must have notification process for alerting patients.

Question 28

Adulterated

Answer 28

FD&C of 1938 prohibits this. Adulteration is defined as filthy, putrid, decomposed substances. If something in product not supposed to be there, it’s adulterated. Examples: drug made in unsanitary conditions OR held in conditions where it may impact quality/health

Question 29

Misbranded

Answer 29

FD&C of 1938 prohibits this. Misbranding deals with labeling or labels. Federal law requires certain information to be on product’s label/labeling. Federal law prohibits certain statements from appearing on product’s label/labeling. misbranded if label DOESNT say something required or DOES say something it shouldn’t. No “false of misleading” info should be advertised and inactive ingredients must be listed on labeling as well

Question 30

FDA Class I Recall

Answer 30

reasonable probability that use of, or exposure to, violative product will cause serious adverse health consequences or death

Question 31

FDA Class II Recall

Answer 31

use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where probability of serious adverse health consequences is remote

Question 32

FDA Class III Recall

Answer 32

situation in which use of, or exposure to, violative product not likely to cause adverse health consequences

Question 33

Red Book

Answer 33

Drug Pricing

Question 34

Orange Book

Answer 34

Therapeutic Equivalence

Question 35

Yellow Book

Answer 35

International Travel Vaccines

Question 36

Green Book

Answer 36

Animal Drug Products

Question 37

Pink Book

Answer 37

Vaccine- preventable diseases

Question 38

Purple Book

Answer 38

Biological Products

Question 39

USP 795

Answer 39

Nonsterile compounding

Question 40

USP 797

Answer 40

Sterile Compounding

Question 41

USP 800

Answer 41

Hazardous Drug Handling