North Carolina MPJE

Pure Food and Drug Act of 1906 - answer-prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938 - answer-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 - answer-Established two classes of medications: Rx and OTC. Authorized oral prescriptions and refills of prescription drugs. Introduced label requirements for pharmacies Kefauver-Harris Amendment of 1962 - answer-Drugs must also be proven effective (in addition to safe). Transferred prescription drug advertising from Federal Trade Commission (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 - answer-AKA Controlled substances act. Medical Device Amendments of 1976 - answer-Established criteria for classifying devices into one of three classes Orphan Drug Act of 1983 - answer-Provides tax and licensing initiatives for manufacturers who develop drugs or biologicals for rare diseases or conditions Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984 - answer-Also known as the Waxman-Hatch Amendment. Streamlined the generic drug approval process while giving patent extensions for innovative drugs Prescription Drug Marketing Act (PDMA) of 1987 - answer-Bans sale, trade, or purchase of Rx drug samples. Established sales restrictions and recordkeeping requirements for Rx drug samples. Prohibits hospitals and other health care entities from reselling their Rx drugs to other businesses. Requires state licensing of wholesalers. Bans re-importation of Rx drugs except by manufacturer The Omnibus Budget Reconciliation Act of 1990 - answer-AKA OBRA-90. Included prospective drug use review, patient counseling, patient profiles Prescription Drug User Fee Act of 1992 - answer-Drug manufacturers required to pay fees when submitting a new drug application Dietary Supplement Health & Education Act (DSHEA) of 1994 - answer-Created a 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) - answer-Regulated the privacy and security of health information; improved efficiency and effectiveness of the health care system; improved the continuity of health insurance coverage and prohibits discrimination in health coverage Food & Drug Administration Modernization Act (FDAMA) of 1997 - answer-Streamlined regulatory procedures to expedite the availability of safe and effective drugs and devices; expands FDA authority over OTC drugs; establishes a data bank of information on clinical trials Drug Addiction Treatment Act (DATA) of 2000 - answer-Allows office-based opioid addiction treatment (i.e. Suboxone) Anabolic Steroids Act of 2004 - answer-All anabolic steroids are Schedule III Combat Methamphetamine Epidemic Act of 2005 & Methamphetamine Prevention Act of 2008 - answer-Pseudoephedrine laws The Patient Safety and Quality Improvement Act of 205 (PSQIA) - answer-Creates a voluntary program through which health care providers, including pharmacies, share information related to patient safety events with patient safety organizations Food & Drug Administration Amendments Act (FDAAA) of 2007 - answer-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 the Affordable Care Act of 2010) - answer-Allows a pathway for biosimilar approval