Shared Flashcard Set

Details

PTCB Study 2017
Pharmacy Law
26
Pharmacology
Not Applicable
04/14/2017

Additional Pharmacology Flashcards

 


 

Cards

Term

 

 

 

Pure Food and Drug Act of 1906

Definition

 

 

 

Prohibits the interstate transportation of sale of adulterated and misbranded food and drugs. 

Term

 

 

 

Food, Drug, and Cosmetic act of 1938 (FDCA 1938) 

Definition
  • FDA Created 

 

  • All new drug applications to be filed with FDA 

 

  • Defined what is adulteration and misbranding of drugs and food products
Term

 

 

 

Durham-Humphrey act of 1951

Definition



  • Requiring all products to have directions for use
  • Separated meds into legends and otc  
  • Allowed scripts to be given over the phone 
  • Allowed refills to be phoned in 
Term

 

 

 

 

Kefauver-Harris Amendment of 1962 

 

 

Definition



  • Requires all meds to be pure, safe and effective
  • Established procedures for drug applications and investigational drugs
  • Drug manufacturers are required to be responsible for Good Manufacturing Process 
Term

 

 

 

Comprehensive Drug Abuse Prevention and Control Act of 1970 

Definition

 

 

  • Created drug schedule
  • Created DEA 

 

Term

 

 

 

Poison Prevention Packaging Act of 1970 

Definition
  • Requires child-resistant packaging 
  • Exceptions 
    • Single-time dispensing as ordered by prescriber 
    • Signed agreement from patient 
    • One otc size for elderly or disabled that states "This Package for Households Without Young Children" or "Package Not Child Resistant" 
Term

 

 

 

Occupational Safety and Health Act of 1970

Definition
  • Created OSHA 
  • Requires the use of Safety Data Sheets (SDSs) which are to be provided by the seller of a paticular product to the purchaser 
  • Requires safe and healthful workplace 
  • Requires reportin system for job-related injuries and illness 
  • Addresses air quality, flammable liquid, eye and skin protection, and hazard communication standards 
Term

 

 

 

 

Drug Listing Act of 1972 

Definition



  • Created NDC Number 
    • First 5 digits are manufacturer 
    • Next 4 digits are drug product 
    • Next 2 digits are packaging and size 
Term

 

 

 

 

Federal Privacy Act of 1974

Definition
  • Regulates what personal information the federal government can collect and how the information can be used. 
  • People have the right to:
    • See government's information about them 
    • Change or delete incorrect, irrelevant, untimely, or incomplete information 
    • Sue the government for violations including allowing others unauthorized access 
Term

 

 

 

 

Orphan Drug Act of 1983 

Definition

 

  • Orphan Drugs are medications for treaments of diseases or conditions in which there are fewer than 200,000 cases in the world. 
  • Provides tax incentives and exclusion licensing of products for manufacturers to develop and market orphan medications 
Term

 

 

 

 

Hatch-Waxman Act of 1984 

Definition



  • Encourages generic and new medications by streamlining the process for generic drug approval and by extending patent licenses 
Term

 

 

 

 

Prescription Drug Marketing Act of 1987 

Definition



  • Prohibits reimportation of a drug into the United States by anyone except the manufacturer 
  • Forbits the sale or distribution of samples to anyone other than those licensed to prescribe them 
  • Required special label statement for medications to be administered to animals 
Term

 

 

 

 

Omnibus Budget Reconciliation Act of 1987

Definition
  • Established extensive revisions to Medicare and Medicaid Conditions of Participation regarding long-term care facilities and pharmacy.
Term

 

 

 

 

Anabolic Steroid Control Act of 1990

Definition
  • Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes 
Term

 

 

 

 

Omnibus Budget Reconciliation Act of 1990 

Definition
  • Establish drug use review programs consisting of three essential components: 
    1. Prospective drug use review
    2. Retrospective drug use review
    3. Educational programs 
Term

 

 

 

 

Food and Drug Administration Safe Medical Devices Act of 1990

Definition
  • All medical devices are to be tracked and records maintained for durable medical equipment.
Term

 

 

 

 

Resource Conservation and Recovery Act (RCRA) 

Definition
  • Law that provides the general guidelines for the waste management program envisioned by Congress.
Term

 

 

 

 

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Definition
  • Indicates requirements that must be met for herbal products 
Term

 

 

 

 

Health Insurance Portability and Accountability Act of 1996 (HIPPA) 

Definition
 
  • Title I: Insurance reform. Protects health insurance coverage for workers and families when they change or lose their jobs 
  • Title II: Administrative simplification. Establishes electronic transaction and Code Set Standards; requires health information privacy
Term

 

 

 

 

Medicare Prescription Drug Improvement and Modernization Act of 2003 

Definition
  • Implemented changes that improved Medicare benefits 
Term

 

 

Isotretinoin Safety and Risk Management Act of 2004 

Definition
  • Legilation that enacted registry, education for physicians, patients and pharmacies and prescribing requirements as well as monitoring requirements 
Term

 

 

 

 

Anabolic Steroid Control Act of 2004 

Definition
  • Redefined anabolic steroid by removing the requirement to prove muscle growth 
  • Provided handling requirements 
Term

 

 

 

 

Combat Methamphetamine Epidemic Act of 2005

Definition
 
  • Products containing ephedrine, pseudoephedrine, and phenylpropanolamine are subject to sales restrictions, storage requirements, and record-keeping requirements.
  • The Act specifies a 3.6 g/day base product sales limit, a 9 g/30-day base product purchase limit, a blister package requirement, and mail order restrictions.
Term

 

 

 

 

Medicaid Tamper-Resistant Prescription Act 

Definition
  • Applies to handwritten prescriptions for Medicaid patients 
  • Requires a tamper-resistant prescription pad
Term

 

 

 

 

United States Pharmacopia 795

Definition
  • Provides guidance on applying good compounding practices in preparation of nonsterile compounded formulations 
Term

 

 

 

 

United States Pharmacopeia 797 

Definition
  • Contains many procedural training and quality assurance requirements for preparing sterile products
  • Disigned to cut down on infections 
Supporting users have an ad free experience!