Pharmacy Technician Federal Laws

Front 1

Pure Food & Drug Act (1906)

Back 1

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

Front 2

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

Back 2

-created FDA
-all drug applications must be filed with the FDA
-clearly defines adulteration and misbranding of food/drugs

Front 3

Durham-Humphrey Act (1951)

Back 3

-all products need directions for use, unless they have the label: "caution federal law prohibits dispensing w/o a prescription
-creates two categories of drugs (1) legend and (2) non-legend (OTC drugs)
-can file prescriptions and order refills via telephone

Front 4

Kefauver-Harris Amendment (1962)

Back 4

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

Front 5

Comprehensive Drug Abuse Prevention and Control Act (1970)

Back 5

-created Drug Enforcement Agency (DEA) and 5 schedules of drugs

Front 6

Schedule I drugs

Back 6

NO MEDICAL USE-high potential for abuse, e.g. "crack" cocaine, meth, marijuana, rohypnol

Front 7

Schedule II drugs

Back 7

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

Front 8

Schedule III drugs

Back 8

medical use, abuse potential less than schedule I & II

Front 9

Schedule IV drugs

Back 9

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

Front 10

Schedule V drugs

Back 10

abuse potential less than schedule IV, includes exempt narcotics

Front 11

Poison Prevention Packaging Act of 1970

Back 11

requires OTC & legend drugs to be in child resistant containers

Front 12

Occupational Safety and Health Act of 1970 (OSHA)

Back 12

ensures safe and healthful workplace

Front 13

Drug Listing Act of 1972

Back 13

all drugs have an 11 digit National Drug Code (NDC) number; digits 1-5 represent manufacturer, 6-9 represent the product, and 10-11 represent the size/package

Front 14

Orphan Drug Act of 1972

Back 14

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

Front 15

Drug Price Competition & Patent Term Restoration Act of 1984

Back 15

encourages creation of generic and new medications, extends patent licenses

Front 16

Prescription Drug Marketing Act of 1987

Back 16

-prohibits reimportation of a drug into the US by anyone except the manufacturer
-only those licensed can sell/distribute
-label "caution federal law restricts this drug to use by or on an order of a licensed veterinarian"

Front 17

Omnibus Budget Reconciliation Act of 1987

Back 17

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

Front 18

Anabolic Steroid Control Act of 1990

Back 18

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

Front 19

Omnibus Budget Reconciliation Act of 1990 (OBRA-1990)

Back 19

-manufacturer gives lowest price to any customer/medicaid patient
-requires offer to counsel
-government spending on pharmacy project

Front 20

FDA Safe Medical Devices Act of 1990

Back 20

-all medical devices must be tracked
-records must be maintained for durable medical equipment

Front 21

Americans with Disabilities Act of 1990

Back 21

-prevents discrimination against potential employees who may have a disability

Front 22

Resource Conservation & Recovery Act

Back 22

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

Front 23

FDA Modernization Act

Back 23

Federal drug legend represented by Rx

Front 24

Dietary Supplement Health & Education Act (DSHEA) of 1994

Back 24

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

Front 25

Health Insurance Portability & Accountability Act (HIPAA) of 1996

Back 25

-improve portability and continuity of health coverage
-protects patient information
-insurance reform
-administrative simplification

Front 26

Isotretinoin Safety & Risk Management Act of 2004

Back 26

Isotretinon (Accutane) causes severe birth defects
-mandatory registry of patients, pharmacy, & practitioners
-provide regular education of risks associated w/the drug
-prescribe only for severe recalcitrant nodular acne
-30 day prescription allotments
-pregnancy tests/blood tests required

Front 27

Anabolic Steroid Control Act of 2004

Back 27

-new definition of steroid (no need to prove muscle growth)
-scheduled steroids as Schedule III
-59 substances are anabolic steroids
-requires registration, security, labeling, packaging, etc.

Front 28

Any Willing Provider Law

Back 28

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

Front 29

Freedom of Choice Law

Back 29

-allows 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

Front 30

Freedom of Choice with Regard to Long-Term Care Law

Back 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.

Front 31

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

Back 31

changes to medicare

Front 32

Combat Methamphetamine Epidemic Act of 2005

Back 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.

Front 33

Medicaid Tamper-Resistant Prescription Act (2008)

Back 33

-prescriptions must have features to prevent unauthorized copying, modification, or counterfeiting

Front 34

USP <797>

Back 34

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