Federal Law Review Flashcards
Pure Food & Drug Act (1906)
prohibits interstate transportation or sale of adulterated and misbranded food/drugs
Food, Drug & Cosmetic Act of 1938 (FDCA 1938)
ñcreated FDA ñall drug applications must be filed with the FDA ñclearly defines adulteration and misbranding of food/drugs
DurhamñHumphrey Act (1951)
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)
KefauverñHarris Amendment (1962)
requires all medications in the US to be pure, safe, and effective
Comprehensive Drug Abuse Prevention and Control Act (1970)
ñcreated Drug Enforcement Agency (DEA) and 5 schedules of drugs
Schedule I drugs
NO MEDICAL USEñhigh potential for abuse, e.g. crack” cocaine, meth, marijuana, rohypnol”
Schedule II drugs
medical use, but high abuse potential w/severe psychological dependency e.g. cocaine, methadone, oxycodone
Schedule III drugs
medical use, abuse potential less than schedule I & II
Schedule IV drugs
medical use, abuse less than schedule III but may lead to limited psychological/physical dependencies
Schedule V drugs
abuse potential less than schedule IV, includes exempt narcotics
Poison Prevention Packaging Act of 1970
requires OTC & legend drugs to be in child resistant containers
Occupational Safety and Health Act of 1970 (OSHA)
ensures safe and healthful workplace
Drug Listing Act of 1972
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
Orphan Drug Act of 1972
orphan drugs treat <200,000 cases per year, provides tax incentives for manufacturers
Drug Price Competition & Patent Term Restoration Act of 1984
encourages creation of generic and new medications, extends patent licenses
Prescription Drug Marketing Act of 1987
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””
Omnibus Budget Reconciliation Act of 1987
revises Medicare & Medicaid conditions participation regarding long term care facilities and pharmacy
Anabolic Steroid Control Act of 1990
harsher penalties for abuse of anabolic steroids and their misuse by athletes
Omnibus Budget Reconciliation Act of 1990 (OBRAñ1990)
ñmanufacturer gives lowest price to any customer/medicaid patient ñrequires offer to counsel ñgovernment spending on pharmacy project
FDA Safe Medical Devices Act of 1990
ñall medical devices must be tracked ñrecords must be maintained for durable medical equipment
Americans with Disabilities Act of 1990
ñprevents discrimination against potential employees who may have a disability
Resource Conservation & Recovery Act
Environmental Protection Agency (EPA) provides guidelines to disposal of hazardous waste
FDA Modernization Act
Federal drug legend represented by Rx
Dietary Supplement Health & Education Act (DSHEA) of 1994
ñherbal supplement manufacturers may claim general health promotion but not disease claims ñmust have labeled ingredients/quantity ñmust identify plant ñmust be pure/quality
Health Insurance Portability & Accountability Act (HIPAA) of 1996
ñimprove portability and continuity of health coverage ñprotects patient information ñinsurance reform ñadministrative simplification
Isotretinoin Safety & Risk Management Act of 2004
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
Anabolic Steroid Control Act of 2004
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.
Any Willing Provider Law
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
Freedom of Choice Law
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
Freedom of Choice with Regard to LongñTerm Care Law
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.
Medicare Drug, Improvement, and Modernization Act (MPDIMA) of 2003
changes to medicare
Combat Methamphetamine Epidemic Act of 2005
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.”
Medicaid TamperñResistant Prescription Act (2008)
ñprescriptions must have features to prevent unauthorized copying, modification, or counterfeiting
USP
aims to cut down on infection transmitted to patients from pharmaceutical products by increasing sterility
