VERIFIED CORRECT ANSWERS
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Orphan Drug Act of 1983 - CORRECT ANSWER-Passed for drugs that treat diseases that affect
very few people to help with tax relief and other incentives for manufactures to develp and
market such drugs.
Drug Price Competition and Patent Term Restoration Act of 1984 - CORRECT ANSWER-
Encourages the manufacturing process of generic drugs by companies and formed the modern
system of generic drug regulation. The act outlines the process for drug companies to file an
abbreviated new drug (ANDA) to receive approval of a generic drug by the FDA.
Prescription Drug Marketing Act of 1987 - CORRECT ANSWER-Solidified legal supply channel of
rx drugs from manufacturer to authorized distributors, prevent the selling of counterfeit drugs.
Omnibus Budget Reconciliation Act (OBRA) of 1990 - CORRECT ANSWER-requires pharmacists to
offer counseling to Medicaid patients regarding medications which includes DUR
FDA Safe Medical Devices Act of 1990 (SMDA) - CORRECT ANSWER-Implemented medical device
reporting of serious incidents that occur from the use of medical devices.
Anabolic Steroids Control Act of 1990 - CORRECT ANSWER-Placed anabolic steroids under the
umbrella of the Controlled Substances Act of 1970. Labeled as a CIII.
, Americans with Disabilities Act of 1990 (ADA) - CORRECT ANSWER-Legislation in the United
States that extends civil rights protection of persons with disabilities to private-sector
employment, all public services, public accommodations, transportation, and
telecommunication including physical accessibility and the removal of barriers to hotels,
restaurants, grocery stores, and parks if that can be accomplished without great difficulty or
expense.
Dietary Supplement Health and Education Act of 1994 - CORRECT ANSWER-Defines and
regulates dietary supplements under the FDA's Good Manufacturing Practices.
Health Insurance Portability and Accountability Act (HIPAA) of 1996 - CORRECT ANSWER-Privacy
of protected health information including the use and disclosure of a patient's PHI.
FDA Modernization Act of 1997 (FDAMA) - CORRECT ANSWER-A law that made sweeping
changes to the Federal Food, Drug and Cosmetic Act of 1938. This was designed to streamline
clinical research and make it easier to test and market new drugs. Among other things, it
established a fast-track process for high-priority drugs to treat life-threatening conditions,
expanded patient access to investigational drugs, and instituted an extra exclusivity period for
products tested in periatric populations
Medicare Prescription Drug Improvement and Modernization Act of 2003 - CORRECT ANSWER-
Gave low-income patients who need assistance with increasing drug costs the option of a
prescription drug discount card.
Dietary Supplement and Nonprescription Drug Act of 2006 - CORRECT ANSWER-Amends the
Food, Drug and Cosmetic Act by requiring reporting of adverse events by dietary supplements
and non prescription drugs. Reporting includes abuse, , withdrawls and overdose of the drug.
Patient Protection and Affordable Care Act of 2010 - CORRECT ANSWER-• Requires individuals
not covered by employer or government health insurance to purchase insurance or pay a
penalty.