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Overview and Laws

Overview and LawsDefintion
1906 Federal and Drug Act (Pure Food and Drug) Enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs.
1938 FOOD, DRUG, AND COSMETIC ACT (FDCA) Replaced 1906. Clarification of misbranding and adulteration defintions. Adequate testing of new drugs for safety. New Drug Application with the FDA.
1951 Durham-Humphrey Amendment Distinction between OTC and LEGEND AND NONLEGEND (OTC) drugs (RX). Required to carry "Caution: Federal law prohibits dispensing without prescription".
1962 The Kefauver- Harris Amendment (Drug Efficacy Amendment) Manufacturers to provide proof of the effectiveness and safety before approval and regulated information about side effects
1970 Poison Prevention Packaging Act (PPPA) Child resistant container
1914 Narcotic Tax Act (Harrison Narcotic Act) Collect tax for Opiates. Any entity which produce, distribute, dispense or sold be registered
1987 Omnibus Budget Reconciliation Act Required that all long-term care facilities receive consultant pharmacist services
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances) Controlled substances. Required DEA numbers
1972 Drug Listing Act NDC
1974 Federal Privacy Act Regulate personal information. The government allowed to collect on private individuals.
1984 Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984) Generic drug regulation
1987 Prescription Drug Marketing Caution prescription for pets
OBRA '90 Mandated drug utilization evaluation (DUE), formerly known as drug utilization review (DUR), be perfomed on each prescription or medication order.
1994 Dietary Supplement Health and Education Required manufacturers of herbal supplements to identify all of its ingredients by name on the label
2003 Medicare Prescription Drug Improvement and Modernization Provided Medicare beneficiaries with preventive medical benefits and Medication therapy Management. Require the sale of methamphetamines to be logged, or require manufacturers of herbal supplements to identify all of its ingredients by name on its label
2005 Combat Methamphetamine Epidemic Act Regulated OTC sales of Pseudoephedrine. Daily sales not to exceed 3.6 grams. Monthly not exceed 9 grams. Via mail not exceed 7.5 grams for 30 days.
Notice of Privacy Practices Under HIPAA Privacy Rule, a document that informs individuals about how their protected health information (PHI).
1996 HIPAA (Health Insurance Portability and Accountability Act) Establishes federal standards protecting sensitive health information from disclosure without patient's consent.
1983 Orphan Drug Act Drug development for rare diseases by offering incentives like tax credits, reduced user fees, and potential 7 years of market exclusivity after approval.
1973 DEA (Drug Enforcement Administration) Which is a federal law enforcement agency in the United States responsible for enforcing controlled substances laws and combating drug trafficking
FDA (Food and Drug Administration) a U.S. federal agency responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, cosmetics, and other regulated products
1904 NABP (National Association of Boards of Pharmacy) nonprofit organization that assists state boards of pharmacy in protecting public health. maintains the CPE Monitor for completed continuing education for both pharmacists and pharmacy technicians
1872 APHA (American Public Health Association) an organization dedicated to advancing public health and advocating for health policies based on scientific evidence
1951 TJC (also known JCAHO) The Joint Commission provides accreditation, certification, and resources to improve healthcare quality and patient safety.
Created by: isantose11
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