Federal Law Review

Question 1

Pure Food & Drug Act (1906)

Answer 1

prohibits interstate transportation or sale of adulterated and misbranded food/drugs

Question 2

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

Answer 2

ñcreated FDA ñall drug applications must be filed with the FDA ñclearly defines adulteration and misbranding of food/drugs

Question 3

DurhamñHumphrey Act (1951)

Answer 3

ñall products need directions for use, unless they have the label: caution federal law prohibits dispensing w/o a prescriptionñcan file prescriptions and order refills via telephone”ñcreates two categories of drugs (1) legend and (2) nonñlegend (OTC drugs)

Question 4

KefauverñHarris Amendment (1962)

Answer 4

requires all medications in the US to be pure, safe, and effective

Question 5

Comprehensive Drug Abuse Prevention and Control Act (1970)

Answer 5

ñcreated Drug Enforcement Agency (DEA) and 5 schedules of drugs

Question 6

Schedule I drugs

Answer 6

NO MEDICAL USEñhigh potential for abuse, e.g. crack” cocaine, meth, marijuana, rohypnol”

Question 7

Schedule II drugs

Answer 7

medical use, but high abuse potential w/severe psychological dependency e.g. cocaine, methadone, oxycodone

Question 8

Schedule III drugs

Answer 8

medical use, abuse potential less than schedule I & II

Question 9

Schedule IV drugs

Answer 9

medical use, abuse less than schedule III but may lead to limited psychological/physical dependencies

Question 10

Schedule V drugs

Answer 10

abuse potential less than schedule IV, includes exempt narcotics

Question 11

Poison Prevention Packaging Act of 1970

Answer 11

requires OTC & legend drugs to be in child resistant containers

Question 12

Occupational Safety and Health Act of 1970 (OSHA)

Answer 12

ensures safe and healthful workplace

Question 13

Drug Listing Act of 1972

Answer 13

all drugs have an 11 digit National Drug Code (NDC) number; digits 1ñ5 represent manufacturer, 6ñ9 represent the product, and 10ñ11 represent the size/package

Question 14

Orphan Drug Act of 1972

Answer 14

orphan drugs treat <200,000 cases per year, provides tax incentives for manufacturers

Question 15

Drug Price Competition & Patent Term Restoration Act of 1984

Answer 15

encourages creation of generic and new medications, extends patent licenses

Question 16

Prescription Drug Marketing Act of 1987

Answer 16

ñprohibits reimportation of a drug into the US by anyone except the manufacturer ñonly those licensed can sell/distribute ñlabel caution federal law restricts this drug to use by or on an order of a licensed veterinarian””

Question 17

Omnibus Budget Reconciliation Act of 1987

Answer 17

revises Medicare & Medicaid conditions participation regarding long term care facilities and pharmacy

Question 18

Anabolic Steroid Control Act of 1990

Answer 18

harsher penalties for abuse of anabolic steroids and their misuse by athletes

Question 19

Omnibus Budget Reconciliation Act of 1990 (OBRAñ1990)

Answer 19

ñmanufacturer gives lowest price to any customer/medicaid patient ñrequires offer to counsel ñgovernment spending on pharmacy project

Question 20

FDA Safe Medical Devices Act of 1990

Answer 20

ñall medical devices must be tracked ñrecords must be maintained for durable medical equipment

Question 21

Americans with Disabilities Act of 1990

Answer 21

ñprevents discrimination against potential employees who may have a disability

Question 22

Resource Conservation & Recovery Act

Answer 22

Environmental Protection Agency (EPA) provides guidelines to disposal of hazardous waste

Question 23

FDA Modernization Act

Answer 23

Federal drug legend represented by Rx

Question 24

Dietary Supplement Health & Education Act (DSHEA) of 1994

Answer 24

ñherbal supplement manufacturers may claim general health promotion but not disease claims ñmust have labeled ingredients/quantity ñmust identify plant ñmust be pure/quality

Question 25

Health Insurance Portability & Accountability Act (HIPAA) of 1996

Answer 25

ñimprove portability and continuity of health coverage ñprotects patient information ñinsurance reform ñadministrative simplification

Question 26

Isotretinoin Safety & Risk Management Act of 2004

Answer 26

Isotretinon (Accutane) causes severe birth defects ñmandatory registry of patients, pharmacy, & practitioners ñprovide regular education of risks associated w/the drug ñprescribe only for severe recalcitrant nodular acne ñ30 day prescription allotments ñpregnancy tests/blood tests required

Question 27

Anabolic Steroid Control Act of 2004

Answer 27

ñnew definition of steroid (no need to prove muscle growth) ñscheduled steroids as Schedule III ñ59 substances are anabolic steroids ñrequires registration, security, labeling, packaging, etc.

Question 28

Any Willing Provider Law

Answer 28

ñallows any pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the terms and conditions of the plan

Question 29

Freedom of Choice Law

Answer 29

ñallows a member of a prescription drug plan to select any pharmacy for their pharmacy benefit as long as the pharmacy agrees to the terms and conditions of the plan

Question 30

Freedom of Choice with Regard to LongñTerm Care Law

Answer 30

Long Term care residents may choose an outside pharmacy if their pharmacy services are not provided under contract. Long term care facilities may refuse if a system is already in place and may require outside pharmacies to agree to policies.

Question 31

Medicare Drug, Improvement, and Modernization Act (MPDIMA) of 2003

Answer 31

changes to medicare

Question 32

Combat Methamphetamine Epidemic Act of 2005

Answer 32

ephedrine, pseudoephedrine, and phenylpropanolamine are put in the controlled substance category of scheduled listed chemical products”, puts limits on grams per day sold and requires record keeping.”

Question 33

Medicaid TamperñResistant Prescription Act (2008)

Answer 33

ñprescriptions must have features to prevent unauthorized copying, modification, or counterfeiting

Question 34

USP

Answer 34

aims to cut down on infection transmitted to patients from pharmaceutical products by increasing sterility