Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
34 Cards in this Set
- Front
- Back
Pure Food & Drug Act (1906)
|
prohibits interstate transportation or sale of adulterated and misbranded food/drugs
|
|
Food, Drug & Cosmetic Act of 1938 (FDCA 1938)
|
-created FDA
-all drug applications must be filed with the FDA -clearly defines adulteration and misbranding of food/drugs |
|
Durham-Humphrey Act (1951)
|
-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 |
|
Kefauver-Harris Amendment (1962)
|
requires all medications in the US to be pure, safe, and effective
|
|
Comprehensive Drug Abuse Prevention and Control Act (1970)
|
-created Drug Enforcement Agency (DEA) and 5 schedules of drugs
|
|
Schedule I drugs
|
NO MEDICAL USE-high 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 1-5 represent manufacturer, 6-9 represent the product, and 10-11 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
|
-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" |
|
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 (OBRA-1990)
|
-manufacturer gives lowest price to any customer/medicaid patient
-requires offer to counsel -government spending on pharmacy project |
|
FDA Safe Medical Devices Act of 1990
|
-all medical devices must be tracked
-records must be maintained for durable medical equipment |
|
Americans with Disabilities Act of 1990
|
-prevents 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
|
-herbal supplement manufacturers may claim general health promotion but not disease claims
-must have labeled ingredients/quantity -must identify plant -must be pure/quality |
|
Health Insurance Portability & Accountability Act (HIPAA) of 1996
|
-improve portability and continuity of health coverage
-protects patient information -insurance reform -administrative simplification |
|
Isotretinoin Safety & Risk Management Act of 2004
|
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 |
|
Anabolic Steroid Control Act of 2004
|
-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. |
|
Any Willing Provider Law
|
-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
|
|
Freedom of Choice Law
|
-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
|
|
Freedom of Choice with Regard to Long-Term 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 Tamper-Resistant Prescription Act (2008)
|
-prescriptions must have features to prevent unauthorized copying, modification, or counterfeiting
|
|
USP <797>
|
aims to cut down on infection transmitted to patients from pharmaceutical products by increasing sterility
|