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Laws and Amendments

Laws and Amendments- Chapter 3

TermDefinition
Pure Food and Drug Act of 1906 Prohibited the sale of adulterated or misbranded food and drugs.
Harrison Narcotics Tax Act of 1914 Regulated and taxed the production, importation, distribution and use of opiates.
Food, Drug, and Cosmetic Act of 1938 Amended the Pure Food and Drug Act of 1906 to include increased safety/toxicity and labeling standards, criminalization of false therapeutic claims, extended control to cosmetics and therapeutic devices, and authorized inspections of factories.
Durham-Humphrey Act of 1951 Divided drugs into two classes - legend (prescription) and non-legend (OTC). Granted the FDA the authority to categorize prescription drugs. Allowed verbal prescriptions over the phone and allowed refills to be called in from a physician's office.
Kefauver-Harris Amendment of 1962 Provided the framework and procedures for the drug approval process. Required all medications in the U.S. to be effective.
Poison Prevention Packaging Act of 1970 Required most OTC and prescription drugs to be packaged in child-resistant containers to protect children from injury or illness.
Occupational Safety and Health Act of 1970 Enforced workplace safety standards, required a reporting system for job-related injuries, attempted to reduce hazards in the workplace and conducts audits to ensure compliance. Requires the use of Safety Data Sheets (SDSs). Created OSHA and NIOSH.
Comprehensive Drug Abuse Prevention and Control Act of 1970 Created the Drug Enforcement Administration (DEA) and regulated drug classification, procurement, distribution, prescription, and registration.
Drug Listing Act of 1972 Required registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identified and reported using a NDC.
Medical Device Amendments of 1976 Divided devices into three classes with varying amounts of control required for safety and effectiveness.
Federal Anti Tampering Act of 1983 Makes it a crime to tamper with packaged consumer products.
Orphan Drug Act of 1983 Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan drugs.
Prescription Drug Marketing Act of 1987 Prohibits the reimportation of a drug into the U.S. by anyone except for the manufacturer. Forbids the sale or distribution of samples to anyone other than those licensed to prescribe them.
Omnibus Budget Reconciliation Act (OBRA) of 1990 Imposed pharmacist counseling obligations, prospective drug utilization review requirements, and record- keeping mandates.
Anabolic Steroid Control Act of 1990 Aimed to minimize the misuse and abuse of anabolic steroids for non-medical purposes and enacted harsher penalties.
Food and Drug Administration Safe Medical Devices Act of 1990 Improved postmarket surveillance of devices by requiring facilities and manufacturers to report adverse events.
Dietary Supplement Health and Education Act of 1994 Defined and regulated dietary supplements under the FDA for Good Manufacturing Practices as foods and not drugs.
Health Insurance Portability and Accountability Act of 1996 Created national standards to protect sensitive patient health information. The HIPAA Privacy Rule and Security Rule provide covered entities with the standards for permitted uses and disclosures.
Drug Addiction Treatment Act (DATA) Act of 2000 Permitted physicians who met certain qualifications to treat opioid dependency with narcotic medications including buprenorphine in treatment settings other than opioid treatment programs.
Medicare Modernization Act of 2003 Added a prescription drug benefit to Medicare health benefits for senior citizens and disabled individuals. Established Medicare Part D, a voluntary prescription drug benefit.
Combat Methamphetamine Epidemic Act of 2005 Restricted the sale of ephedrine, pseudoephedrine, and phenylpropanolamine containing products and required merchants to keep a logbook or records of sales.
Accutane ipledge program of 2006 Designed to mandate distribution in the US for isotretinoin (Accutane). Special website must be used by doctors and pharmacists to order and receive this medication.
Ryan Haight Act of 2008 Added various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet.
Patient Protection and Affordable Care Act of 2010 Expanded Medicaid eligibility and radically overhauled individual insurance markets.
Drug Quality and Security Act of 2013 Granted the FDA more authority to regulate and monitor the manufacturing of compounded drugs.
Comprehensive Addiction and Recovery Act of 2016 Established a comprehensive, coordinated, balanced strategy through enhanced grant programs that would expand prevention and education efforts while also promoting treatment and recovery to address the opioid epidemic.
Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Provided emergency assistance and health care response to those affected by the coronavirus pandemic including addressing supply chain shortages and funding the development of vaccines and drugs used for COVID-19.
Synthetic Drug Abuse Prevention Act of 2012 Banned synthetic compounds in synthetic marijuana products and synthetic stimulants. Place under Schedule 1 of the CSA. Part of the FDA administration safety and Innovation act of 2012.
The Drug Price Competition and Patent- Term Restoration Act of 1984 Designed to lower drug prices by providing a way to increase competition in drug industry. Provides a faster procedure for New Drug Applications for approving generic drugs whose safeguard protection is about to expire.
Created by: ssouza271
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