Book Pharmacy Laws and Acts Flashcards
What act states that government pre-approval of drugs is required?
Food and Drug Act of 1906
What act states that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and are required to pay a tax?
1914 Harrison Narcotics Tax Act
What Act states that before any new drug can be marketed, it must be proven safe when used according to directions on its label?
1938 Food, Drug, and Cosmetic (FDC) Act
What amendment established Legend Drugs and Over the Counter Drugs?
1951 Durham-Humphrey Amendment
What Amendment required that all new drugs marketed in the United States must first be shown to be safe and effective?
1962 Kefauver-Harris Amendment
What Amendment regulates prescription drug advertising under the authority of the FDA and required “informed consent” by research subjects in clinical investigations?
1962 Kefauver-Harris Amendment
What Amendment Established Food Manufacturing Practices (GMP) requirements for pharmaceutical manufacturing?
1962 Kefauver-Harris Amendment
What Act established the Medicare program?
1965 Social Security Act
What Act requires all consumer products in interstate commerce be honestly and informatively labeled?
1966 Fair Packaging and Labeling Act
What Act requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacists?
1970 Poison Prevention Packaging Act
What act classifies five levels of controlled substances that have potential for abuse and therefore restricts their distribution?
1970 Controlled Substances Act (CSA)
What act establishes that Drug Enforcement Administration (DEA) as a division of the Justice Department?
1970 Controlled Substances Act (CSA)
What Amendment requires pre-market approval for safety and effectiveness of life-sustaining medical devices?
1976 Medical Device Amendment
What act provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases?
1983 Orphan Drug Act
What act allows for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs?
1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
What act restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states?
1987 Prescription Drug Marketing Act
What act requires pharmacists to offer counseling to Medicaid patients regarding medications?
1990 Omnibus Budget Reconciliation Act (OBRA)
What act was passed to address the abuse of steroids by athletes and especially youngsters and teenagers?
1990 Anabolic Steroid Control Act
What act encourages providers to use electronic transactions and allows a minimum amount of patient health information to be transferred among providers, without patient consent, for purposes of treatment, payment, or administrative operations?
1996 Health Insurance Portability and Accountability Act
What act makes health-care providers responsible for maintaining the privacy and security of patient information?
1996 Health Insurance Portability and Accountability Act
What act makes health-care providers responsible for informing the patient of their privacy policies and procedures; and allowing the patient to review and correct records?
1996 Health Insurance Portability and Accountability Act
What act establishes optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management (MTM)?
2003 Medicare Modernization Act
What Act establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine?
2005 Combat Methamphetamine Epidemic Act
What act establishes Rick evaluation and Mitigation Strategy (REMS) requirements for manufacturers of drugs and biologicals?
2007 FDA Amendments Act
What act promotes expanded health information technology and improves privacy and security provisions of HIPAA?
2009 Health Information Technology for Economic and Clinical Health (HITECH) Act
What act had the overall goal to improve patient care, quality, and outcomes while also reducing costs?
2010 Patient Protection and Affordable Care Act
What act established user fees to enhance access to medications and medical devices and made provisions for addressing drug product shortages in the United States?
2012 FDA Safety and Innovation Act
What Act Expands the authority of the Food and Drug Administration for compounded drugs?
2013 Drug Quality and Security
