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Pharmacy Laws
| Law | Year | Details |
|---|---|---|
| Pure Food and Drug Act | 1906 | Prohibited the sale of misbranded or adulterated food and drugs in interstate commerce |
| Harrison Narcotics Tax Act | 1914 | Regulate and tax the distributions importation, and production of opiates |
| Food, Drug, and Cosmetic Act | 1938 | Authorizes the FDA to Mandate drug manufacturers to submit evidence of new drugs' safety and effectiveness before marketing and distribution to the general public. Issue and enforce quality standards for food, drugs, medical devices, and cosmetics. |
| Durham-Humphrey Amendment | 1951 | Defined two specific categories for medications, legend (Rx) and over-the-counter (OTC). contains a specific requirement relating to the labeling of drugs that move in interstate commerce |
| Kefauver-Harris Amendment "Drug Efficacy Amendment" | 1963 | Required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects. Informed concent was need for new drug testing. |
| Comprehensive Drug Abuse Prevention and Control Act "The Controlled Substances Act" (CSA) | 1970 | Five schedules (i.e., I – V) Possession of many substances was made illegal. The manufacturing and distribution of illegal drugs were given harsh penalties. The act also established standards to deal with drug abuse. |
| Poison Prevention Packaging Act (PPPA) | 1970 | Prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous products must utilize child-resistant packaging. |
| Occupational Safety and Health Act (OSHA) | 1970 | |
| Drug Listing Act | 1972 | National Drug Code (NDC) |
| Medical Device Admentment | 1976 | Devices were classified and subjected to different levels of control. Class 1, 2, 3 |
| Resource Conservation and Recovery Act "Solid Waste Disposal Act" | 1976 | Regulates the disposal of hazardous |
| Drug Regulation Reform | 1978 | Intended to reduce the costs involved in the development of new drugs so that manufacturers would be able to develop more drug products at lower cost. |
| Orphan Drug Act | 1983 | Orphan disease is a rare disease or condition that affects fewer than 200,000 people. Tax credits for qualified clinical trials. Exemption from user fees. Potential seven years of market exclusivity after approval |
| "Drug Price Competition and Patent Term Restoration Act "Waxman-Hatch Act"" | 1984 | Increased generic drug availability, competition, and reduced costs. |
| Prescription Drug Marketing Act (PDMA) | 1987 | Encouraged the distribution of authentic, properly labeled, and effective drugs. Required that wholesalers of drugs be state licensed. Regulated blood centers that provided healthcare services and their ability to distribute blood-derived products. |
| Omnibus Budget Reconciliation Act (OBRA-90) | 1990 | |
| FDA Safe Medical Devices Act | 1990 | |
| Anabolic Steroid Control Act | 1990 | Amends the Controlled Substances Act, establish penalties for physical trainers or advisers who endeavor to persuade or induce individuals to possess or use anabolic steroids, adds anabolic steroids as a schedule III |
| Americans with Disabilities Act (ADA) | 1990 | Prohibits discrimination against the disabled, regardless of whether their impairment is physical or mental. |
| Dietary Supplement Health and Education Act | 1994 | Clearly defined the term dietary supplement. It imposed sanctions against any manufacturer of a dietary supplement that claimed that the supplement actually treated or cured a specific condition. |
| Health Insurance Portability and Accountability Act (HIPAA) | 1996 | Required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge |
| Food and Drug Administration Modernization Act (FDAMA) | 1997 | Increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. |
| DATA | 2000 | Allows practitioners to treat opioid addiction |
| Medicare Prescription Drug, Improvement, and Modernization Act (MMA) | 2003 | Provided prescription drug coverage for the elderly and gave private health plans (a.k.a., "Medicare Advantage" plans) a much larger role in the Medicare program |
| Combat Methamphetamine Epidemic Act | 2005 | Requires record-keeping and identification of all sales and reports to law enforcement of any 'suspicious' transactions. Purchasers are limited to '3.6 grams of pseudoephedrine base' per day and 9 grams per month. |
| Isotretinoin (Accutane®) Safety and Risk Management Act (Proposal Only) | 2005 | Registry of all those involved in Accutane distribution or use, public education about the drug. |
| Patient Protection and Affordable Care Act (PPACA) "Affordable Care Act" | 2010 | Preexisting medical conditions can’t be used to deny coverage. Basic benefits for Medicare enrollees, providing preventive services. Adult children up until age 26, who could remain covered under their parents' health plans. Enforced by a tax penalty. |
| Drug Quality and SecurityAct | 2013 | Improve safety and security of supply chain |
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