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1906 Pure Food and Drug Act
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prohibited the sale of misbranded or adulterated food and drugs in interstate commerce
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1914 Harrison Narcotic Act
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This act requires a prescription to purchase opium and limits the transport of it.
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1938 Food, Drug, and Cosmetic Act
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This act required drug companies to provide package inserts. Also, this act required that habit-forming drugs be labeled as such and new drugs have to be proven safe under the FDA guidelines before they are marketed.
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1951 Durham-Humphrey Amendment
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This law defines what drugs require a prescription by a licensed practitioner and require the legend on its label
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1962 Kefauver-Harris Amendment
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Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug.
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1970 Comprehensive Drug Abuse Prevention and Control Act
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requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs.
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1970 Poison Prevention Packaging Act
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requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies
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1970 Occupational Safety and Health Act
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gave the Federal Government the authority to set and enforce safety and health standards for most of the country's workers.
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1972 Drug Listing Act
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Requires every drug to have a unique 10-digit number divided into three segments; numbers identify the labeler, product, and trade package size
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1983 Orphan Drug Act
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This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
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1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)
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established the approval pathway for generic drug products
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1987 Prescription Drug Marketing Act
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This act prohibited the re-importation of drugs to the United States with the exception of the manufacturer.
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1990 Anabolic Steroid Control Act
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This act redefined anabolic steroids as a Schedule 3 controlled substances and to provide criminal penalties for illicit use to coaches and others who endeavor to persuade or induce athletes to take anabolic steroids.
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1990 Omnibus Budget Reconciliation Act
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requires pharmacists to offer counseling to Medicaid patients regarding medications
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1994 Dietary Supplement Health and Education Act
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expanded the definition of dietary supplements and restricted the FDA's regulatory authority over them.
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1996 Health Insurance Portability and Accountability Act
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requires the creation of national standards to protect sensitive patient health information from being disclosed.
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2000 Drug Addiction Treatment Act
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Permits physicians to prescribe controlled substances (preapproved by the DEA) in schedules C-III, C-IV, or C-V to persons suffering from opioid addiction, for the purpose of maintenance or detoxification treatments
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2003 Medicare Prescription Drug Improvement and Modernization Act
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established prescription drug coverage and the modern Medicare Advantage program
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2005 Combat Methamphetamine Epidemic Act
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Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine.
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2009 Biologics Price Competition and Innovation Act
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This statute created an abbreviated pathway to approve biosimilar products.
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2010 Affordable Care Act
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Changed the income cutoff required for Medicaid eligibility (raised it higher) allowing MANY more people to be eligible
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2013 Drug Quality and Security Act
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Gives greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process
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