Pharmacy Law Flashcards
Laws are categorized by
Criminal, civil, administrative
Statutes are laws that are….
Passed by congress and signed by the president
Laws are categorized by…
Criminal, civil, administrative
Criminal laws are…
Homicide, illegal drugs, thefts, and antisocial behavior.
Civil law-
Personal injury, business disputes, land details, libel and slander, commercial interests and non criminal matter
Plaintiff
The one taking to court
Defendant
The one being accused
Tort law
Often civil but can overlap into criminal
Medical malpractice falls under which law?
Tort law, most often named civil lawsuit brought on by plaintiff
What is the main purpose of the CDC
Protect public health and safety
NIOSH - national institute of occupational safety and health works under who?
CDC
CMS- formerly known as the health care financing administration regulates what programs
Medicare, Medicaid, state children’s health insurance program, health insurance probability and accountability act (hippa) clinical laboratory improvements
DEA regulates legal trade of..
Narcotic and dangerous drugs
DEA works directly with….
FBI
FDA does what?
Protect public health ensuring safety, efficiency and security of drugs
FDA reviews and approves what?
New drug application, new generic equivalents, new therapeutic indications for existing meds.
Pure Food and Drug act of 1906
Law that made it possible for federal inspection of meat products and forbade sale, manufacture and transport of altered food products and poisonous medicines
Shirley Amendment of 1912
It prohibited the use of fraudulent therapeutic claims by drug companies.
Food, Drug, and Cosmetic Act of 1938 (FDCA)
It required manufacturers to provide package inserts and to follow FDA guidelines to present evidence of safety for new drugs before marketing. This law also gives the FDA authority to issue food standards and inspect facilities
Durham-Humphrey Amendment of 1951
Created a distinction between “OTC” and “Legend Drugs”.
Durham-Humphrey Amendment of 1951 also known as
Prescription Drug Amendmet
Federal Hazardous Substances Act 1960
FDA began labeling harmful substances including corrosive, toxic, flammable, pressure generating
Kefauver-Harris Amendment of 1962
Also known as the “Drug Efficacy Amendment”.
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
Comprehensive Drug Abuse Prevention and Control Act of 1970 also known as
Controlled substance act 1970
Comprehensive Drug Abuse Prevention and Control Act of 1970
Created a closed system for controlled substances monitored by DEA and started the scheduling system
Poison Prevention Packaging Act of 1970
(PPPA) all legend and controlled drugs, with some exceptions, must be dispensed in a childproof container.
Occupational Safety and Health Administration (OSHA) 1970
Regulates workplace environment; makes sure that businesses provide workers with safe and healthful working conditions
Drug Listing Act of 1972
Requiring manufacturers, repackages, distributors to register the product and list all commercial drug products with FDA
Medical Device Amendment of 1976
Requires life-sustaining and life-supporting devices to have premarket approval from the FDA
Orphan Drug Act of 1983
Provided incentives for the development of orphan drugs for treatment of rare diseases
Drug Price Competition and Patent Term Restoration Act of 1984
simplified the process for generic drugs to be approved
Drug Price Competition and Patent Term Restoration Act of 1984 also known as
Hatch-Waxman act
Anabolic Steroid Control Act of 1990
Made anabolic steroids a schedule 3
Prescription Drug Marketing Act of 1987
Addressed the “gray” area of marketing miss labeled, subpotent, adulterer, expired or counterfeit medications
Omnibus Budget Reconciliation Act of 1990also known as
OBRA
Omnibus Budget Reconciliation Act of 1990
Mandated drug utilization reviews similar to MTM and counseling
Dietary Supplement Health and Education Act of 1994
This act changed the definition and regulations for dietary supplements
Health Insurance Portability and Accountability Act 1996
Ensures confidentiality of patients medical records set guidelines for maintaining the privacy of health
Health Insurance Portability and Accountability act 1996 also known as
HIPAA
FDA Modernization Act of 1997
Simplified the rules and made it easier and quicker for FDA to approve new drugs or grant access into investigated medications
Drug addiction treatment act of 2000
DEA registered and approved physicians allowed to proscribe controls as a means to detox or maintain individuals with opioid addiction
Medicare Modernization Act of 2003
Offered voluntary benefits of Medicare advantage or Medicare part D for prescription coverage
USP Chapter 797 - 2004
Enforced standards for sterile compounding
Combat Methamphetamine Epidemic Act of 2005
Enacted to regulate the OTC sales of pseudoephedrine.
The Medicaid Tamper-Resistant Prescription Pad Law of 2008
required that all written prescriptions for covered outpatient drugs are required to be written on a tamper-resistant prescription pad.
Affordable Care Act of 2010
Made an open market for people to shop for incurace
