Flashcards in Federal Laws Deck (17)
-First law to regulate the development, compounding, distribution, storage and dispensing of drugs.
-No false or misleading information on label about drug strength or purity.
-No interstate transport or sale
Pure Food and Drug Act of 1906
-Clearly defined adulteration and misbranding.
-Created the federal agency called the Food and Drug Administration.
-Required that products be safe for human use.
Food, Drug, and Cosmetic Act (FDCA) of 1938
-Distinguished between prescription (legend) and nonprescription drugs.
-Required that all drug products have adequate usage directions or bear the legend "Caution: Federal Law Prohibits without Prescription."
-Allowed verbal prescription and refill requests by telephone.
Durham-Humphrey Amendments to FDCA of 1951
-Required that drugs be not only safe but effective as well.
-Required that pharmaceutical manufacturers file and Investigation New Drug Application before starting clinical trials on humans.
Kefauver-Harris Amendment to FDCA of 1962
-Established the federal agency called the Drug Enforcement Agency (DEA).
-Classified drugs that have the potential for abuse and/or addiction into five classes.
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act) of 1970
-Required National Drug Code numbers to be assigned to every marketed drug
Drug Listing Act of 1972
-Provided tax incentives for developing and marketing drugs used to treat rare conditions (Orphan drugs).
-Established lifelong exclusive license to manufacturer that developed and orphan drug.
Orphan Drug Act of 1983
-Streamlined the FDA approval process for marketing generic drugs.
-Extended the term of patents for companies that develop new drugs.
Drug Price Competition and Patent Term Restoration Act of 1984
-Prohibited the re-importation of drugs to the United States, except by the manufacturer.
Prescription Drug Marketing Act of 1987
-Redefined anabolic steroids as Schedule III controlled substances.
Anabolic Steroid Control Act of 1990
-Required pharmacist to engage in drug utilization reviews (DUR).
-Required pharmacists to offer counseling to patients about their prescriptions without charge.
Omnibus Budget Reconciliation Act (OBRA) of 1990
-Treated herbal supplements as food products, rather than drugs.
-Prohibited manufacturers of herbs and dietary supplements from making claims that their products treat or cure any specific diseases or illness.
Dietary Supplement Health and Education Act (DSHEA) of 1994
-Addressed patient privacy concerns.
-Allowed for employees to more easily move their health insurance from one job to another.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
-Provided a voluntary prescription drug plan for Medicare patients for additional cost.
-Created a type of health insurance called health savings accounts
Medicare Modernization Act of 2003
-Changed federal legend to "Rx Only"
FDA Modernization Act of 2004
-Restricted sales of OTC drugs used in the manufacture of methamphetamines, such as pseudoephedrine, ephedrine, and phenylpropanolamine.
Combat Methamphetamine Epidemic Act of 2005