Pure Food and Drug Act of 1906

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

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

• FDA Created 

• All new drug applications to be filed with FDA 

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

Durham-Humphrey act of 1951

• 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 

Kefauver-Harris Amendment of 1962 

• 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 

Comprehensive Drug Abuse Prevention and Control Act of 1970 

• Created drug schedule
• Created DEA 

Poison Prevention Packaging Act of 1970 

• 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" 

Occupational Safety and Health Act of 1970

• 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 

Drug Listing Act of 1972 

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

Federal Privacy Act of 1974

• 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 

Orphan Drug Act of 1983 

• 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 

Hatch-Waxman Act of 1984 

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

Prescription Drug Marketing Act of 1987 

• 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 

Omnibus Budget Reconciliation Act of 1987

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

Anabolic Steroid Control Act of 1990

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

Omnibus Budget Reconciliation Act of 1990 

• Establish drug use review programs consisting of three essential components: 

1. Prospective drug use review
2. Retrospective drug use review
3. Educational programs 

Food and Drug Administration Safe Medical Devices Act of 1990

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

Resource Conservation and Recovery Act (RCRA) 

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

Dietary Supplement Health and Education Act of 1994 (DSHEA)

• Indicates requirements that must be met for herbal products 

Health Insurance Portability and Accountability Act of 1996 (HIPPA) 

• 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

Medicare Prescription Drug Improvement and Modernization Act of 2003 

• Implemented changes that improved Medicare benefits 

Isotretinoin Safety and Risk Management Act of 2004 

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

Anabolic Steroid Control Act of 2004 

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

Combat Methamphetamine Epidemic Act of 2005

• 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.

Medicaid Tamper-Resistant Prescription Act 

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

United States Pharmacopia 795

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

United States Pharmacopeia 797 

• Contains many procedural training and quality assurance requirements for preparing sterile products
• Disigned to cut down on infections