Block 1 Flashcards
Where does policy come from?
Non-public source
Define Law
Body of principles that govern conduct and the observance of which can be enforced by the government, or that which must be obeyed and followed by citizens or be subject to legal sanctions or consequences.
Define Ethics
Standards of behavior enforced by professional organizations
Define Mores
Standards of behavior made by society and enforced by peer pressure
What are the two things John Locke made?
State of Nature and Social Contract
Define Police Power
Authority of government to make laws related to public health, safety, and welfare
What level of government does Police Power exist?
State
How can the Federal government obtain Police Power?
Commerce Clause
What branch of government makes laws, allocates money, and confirms presidential appointments?
Legislative Branch
What branch of government interprets the laws?
Judicial Branch
What branch of government enforces the laws?
Executive Branch
Define Employment at Will.
Employment at Will is when there is no contract between you and the employer.
What are the 4 types of law?
Constitution, Treaty, Statute, and Regulation
Out of the 4 types of law, which is the highest form and which is the lowest?
Constitution is the highest and Regulation is the lowest.
What convention did the US sign a treaty to make marijuana an illegal substance?
Single National Convention on Drugs in 1961
What is a law called that is enacted by the legislature (federal or state)?
Statute
What are 3 sources of Law?
Common Law, Judicial or Case Law, and Stare Decisis
Describe Common Law.
Body of legal principles that came over from England. It formed the bases of our legal system
Describe Judicial or Case Law.
Law that comes from judges deciding cases. This source of Law comes for the US.
Describe Stare Decisis.
Means the decision stands. Rule of Precedent. This is when a decision from a similar case will be the ruling of the new case.
How does Stare Decisis help lawyers?
It helps them give legal advice based off the prior case.
When did Equity start?
Equity started in England in the Middle Ages and was brought to the US.
Define Equity.
Equity is a court where you can get something other than money if you were wronged.
Injunction
Court order for someone to stop doing something
UCC
Uniform Commercial Code
Model Statute taht deals with commercial issues
Model Pharmacy Act
Model Statute
Only 3 states accepted it, but the wording from it is used by many states in their own versions of the statute
Import Drug Act
1848
Prohibited importation of adulterated drugs
Wiley-Heyburn Act
Federal Pure Food and Drug Act of 1906
Major advancement in prohibiting adulterated and misbranded drugs and foods
Sulfanilamide Tragedy
1937
ethylene glycol was being used as a base for an elixir
Lead to the Federal Food, Drug, and Cosmetic Act of 1938
Federal Food, Drug, and Cosmetic Act of 1938
Gave FDA primary enforcement authority
Prohibited interstate commerce from being adulterated or misbranded
Made it where only a pharmacist could dispense a drug with a written prescription and there were no refills allowed
Durham-Humphrey Amendment
1952
Amendment to the Federal Food, Drug, and Cosmetic Act
Separated OTC from Rx drugs.
Allowed oral prescriptions and allowed refills if they were allowed on the original prescription, orally given to the pharmacist, or dispensed by the practitioner.
Also allowed the states to decide who can prescribe
Thalidomide Tragedy
1961
Caused birth defects in infants
Lead to the Kefauver-Harris Amendment in 1963
Kefauver-Harris Amendment
1963
Required the manufacturer to prove safety and efficacy of drugs to the FDA. This was for all drugs made after 1962 and for drugs between 1938 and 1962 for which NDAs had been approved.
It required the FDA to approve the drug instead of disapproving it.
Grandfather Clause exempted drugs made before 1938.
Drug Price Competition and Patent Term Restoration Act of 1984
FDCA Amendment
Waxman-Hatch Act
Struck a balance between generic and brand name manufacturers
Made it where generic needed to prove bioequivalence
Prescription Drug Marketing Act of 1987
FDCA Amendment
Reduced the public risk of having prescription drugs be advertised on commercial channels
Food and Drug Administration Modernization Act of 1997
Major overhaul of FDCA
Clarified that compounding pharmaceuticals was regulated by states
Allowed some pharmacies to compound medication before they received that prescription for a specific patient
Banned advertising compounding services and soliciting prescriptions for compounding
Required that before dispensing the label of a prescription product contain “Rx only” (eliminated the Federal Legend”
Drug Quality and Security Act of 2013
FDCA Amendment
Eliminated bans on solicitation and advertising from FDAMA of ‘97
Established “Outsourcing Facilities”
Established “Track and Trace”
Poison Prevention Packaging Act of 1970
Allowed Consumer Product Safety Commission to establish standards for child-resistant caps
Comprehensive Drug Abuse Prevention and Control Act of 1970
Principal law regulating drugs that are subject to or have potential for abuse or physical or psychological dependence
Enforced by the Drug Enforcement Administration
Title 21-Food and Drugs, Chapter 1
Says FDA sets regulations for Food, Drug, and Cosmetic Act
Title 21-Food and Drugs, Chapter 2
Says DEA sets regulations for Federal Controlled Substances Act
OBRA ‘90
Omnibus Reconciliation Act of 1990
Stated, “In order to participated in Medicaid, states must have in place drug use review (DUR) programs, require pharmacists to offer counseling to Medicaid recipients, and require pharmacists to make reasonable efforts to obtain, record, and maintain patient medication records
HIPAA
Health Insurance Portability and Accountability Act of 1996
Title 2-Administrative Simplification
Protects privacy and security
Creates a National Provider Identifiers
Required pharmacy to have backup system for records
Electronic Signatures in Global and National Commerce Act
Allowed the use of electronic prescriptions
Affordable care Act of 2010
Allowed pharmacists to provide MTM
Kentucky Revised Statute (KRS 315) Chapter 315
1960
Established the Kentucky Board of Pharmacy
KRS 218A
Controlled Substances (1972) Kentucky's "Controlled Substances Act"
KRS 217
Foods, Drugs, and Poisons (1960)
Kentucky’s Food, Drug, and Cosmetic Act
Kentucky Administrative Regulation Title 902 Chapter 55
Controlled Substances
KAR 201.2
Board of Pharmacy
USC
United States Code
Statutes made by Federal Government
CFR
Code of Federal Regulations
KRS
Kentucky Revised Statute
KAR
Kentucky Administrative Regulations
