Federal Drug Law Flashcards
Pure Food and Drug Act of 1906
prohibited adulteration and misbranding of foods and drugs in interstate commerce
Food, Drug, and Cosmetic Act (FDCA) of 1938
Core of today’s drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties
Durham-Humphrey Amendment of 1951
Established 2 classes of meds: RX and OTC. Authorized oral prescriptions and refills of prescription drugs. Introduced label requirements for pharmacies
Kefauver-Harris Amendment of 1962
Drugs must also be proven effective (in addition to safe). Transferred rx drug advertising from Federal Trade Commision (FTC) to FDA. Established Good Manufacturing Practices. Required informed consent of research participants and reporting of ADRs
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
AKA controlled substances Act
Medical Device Amendments of 1976
Established criteria for classifying devices into one of three classes
Orphan Drug Act of 1983
Provides tax and licensing incentives for manufacturers who develop drugs or biologicals for rare diseases or conditions
Drug Prices Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Also known as Waxman-Hatch Amendment. Streamlined generic drug approval process while giving patent extensions for innovative drugs
Waxman-Hatch Amendment
Also known as Drug Prices Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984. Streamlined generic drug approval process while giving patent extensions for innovative drugs
Prescription Drug Marketing Act (PDMA) of 1987
Bans sale, trade, or purchase of rx drug samples. Established sales restrictions and recordkeeping requirements for Rx drug samples. Prohibits hospitals and other heath care entities from reselling their Rx drugs to other businesses. Requires state licensing of wholesalers. Bans re-importation of Rx drugs except by manufacturer
Omnibus Budget Reconciliation Act of 1990
Aka OBRA-90. Included prospective drug use review, patient counseling, patient profiles
Prescription Drug User Fee Act of 1992
Drug manufacturers required to pay fees when submitting a new drug application
Dietary Supplement Health and Education Act (DSHEA) of 1994
Created new category of food called “dietary supplements”. Permits manufacturers to make claims that would have otherwise been illegal under FDCA. Forced FDA to regulate dietary supplements more as foods than drugs
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
regulated privacy and security of health information; improved efficiency and effectiveness of health care system; improved continuity of health insurance coverage and prohibits discrimination in health care coverage
Food and Drug Administration Modernization Act (FDAMA) of 1997
Streamlined regulatory procedures to expedite availability of safe and effective drugs and devices; Expands FDA authority over OTC drugs; Establishes data bank of information on clinical trials
Drug Addiction Treatment Act (DATA) of 2000
allows office-based opioid addiction treatment (ie Suboxone)
Anabolic Steroids Act of 2004
All anabolic steroids are schedule III
Combat Methamphetamine Epidemic Act of 2005 & Methamphetamine Prevention Act of 2008
Pseudoephedrine laws
Patient Safety and Quality Improvement Act of 2005 (PSQIA)
Creates a voluntary program through which health care providers, including pharmacies, share information related to patient safety events with patient safety organizations
Food and Drug Administration Amendments Act (FDAAA) of 2007
FDA may mandate labeling changes related to safety; Require clinical trial data reporting and registries; Require post-market clinical studies to assess risk (Phase 4 studies)
Biologics Price Competition and Innovation Act
Included in Affordable Care Act of 2010 - allows a pathway for biosimilar approval
FDA Safety and Innovation Act of 2012
Contains provisions directed at reducing drug counterfeiting, blocking import of adulterated products, detecting and reducing drug shortages
Drug Quality and Security Act of 2013
regulated pharmacy compounding and tracking of medications throughout the distribution system
Comprehensive Addiction and Recovery Act of 2016
extends time frame in whcih C-IIs can be partially filled. allows NPs and PAs to apply for waiver to prescribe buprenorphine for opioid addiction
Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act
controlled substance prescriptions for Medicare Advantage and Part D required to be transmitted electronically beginning Jan 1, 2021
Poison Prevention Packaging Act (1970)
Many OTC products and most Rx products must be dispensed in child-resistant container. containers may only be used once unless container is a glass vial or threaded-plastic container, in whcih only a new cap is needed to be dispensed. Patient can request rx dispensed in non-child resistant container and may make blanket request. physician may state that drug should be dispensed in non-child-resistant container but may NOT issue blanket order
Rx exempt: sublingual nitro, oral contraceptives
Health Information Technology for Economic and Clinical Health Act (HITECH)
HITECH Act amendments to HIPAA require that in the event of an unauthorized disclosure of PHI, the covered entity must have notification process for alerting patients.
Adulterated
FD&C of 1938 prohibits this. Adulteration is defined as filthy, putrid, decomposed substances. If something in product not supposed to be there, it’s adulterated. Examples: drug made in unsanitary conditions OR held in conditions where it may impact quality/health
Misbranded
FD&C of 1938 prohibits this. Misbranding deals with labeling or labels. Federal law requires certain information to be on product’s label/labeling. Federal law prohibits certain statements from appearing on product’s label/labeling. misbranded if label DOESNT say something required or DOES say something it shouldn’t. No “false of misleading” info should be advertised and inactive ingredients must be listed on labeling as well
FDA Class I Recall
reasonable probability that use of, or exposure to, violative product will cause serious adverse health consequences or death
FDA Class II Recall
use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where probability of serious adverse health consequences is remote
FDA Class III Recall
situation in which use of, or exposure to, violative product not likely to cause adverse health consequences
Red Book
Drug Pricing
Orange Book
Therapeutic Equivalence
Yellow Book
International Travel Vaccines
Green Book
Animal Drug Products
Pink Book
Vaccine- preventable diseases
Purple Book
Biological Products
USP 795
Nonsterile compounding
USP 797
Sterile Compounding
USP 800
Hazardous Drug Handling
