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Acts and Amendments

1906 Federal Food and Drug Act *Enacted: to stop the sale of inaccuratly labeled drugs
1914 Harrison Narcotics Act *Enacted: to curve the recreational use of opium *Requires stricter policies for practitioner and patient regarding narcotic drugs.
1938 Food, Drug, and Cosmetic Act * Enacted: because 1906 FFDA not worded stricktly enough and did not include cosmetics. *Describes the exact labeling for products and defined adulteration & misbrandening as illegal. *requires co.'s to place package inserts and directions 4 safe use
Misbranding Making false or exaggerated claims to promote a product that mislead the consumer.
Adulteration Deals with the mishandling of a medication during preperation and/or storage which can lead to injury or death to the consumer.
Two new topics in the 1938 FDCA? Misbrandening and Adulteration
1951 Durham-Humphry Amendment *Added more instructions for drug co.'s. *This amendment made the initial distinction between Rx's (legend drugs) and O-T-C's
The Label "Caution: Federal law prohibits dispensing without a prescription," is required by which Act/Amendment? The 1951 Durham-Humphry Amendemt
1962 KeFauver-Harris Amendments *To ensure safty of all new drugs on the U.S. market. *Helped establish rules of clinical drug investigations and the informed consent of study subjects.
1970 Comprehensive Drug Abuse Prevention And Control Act *DEA (Drug Enforcement Administration) formed to enforce laws concerning controlled substances and their distribution.
1970 Poison Prevention Packaging Act *required manufacturers and pharmacies to place all medications in containers with child proof caps or packaging.
1983 Orphan Drug Act Encouraged Drug co.'s to develop drugs for rare diseases by providing research assistance, grants, and other monitary aid to manufacturers. *It covered diseases affecting >200,000 ppl if it could be proven that $ out < $ in.
Which Act/Amendment encouraged manufacturers to develop drugs for rare diseased by providing marketing exclusivity for orphan drugs for 7 yrs. after FDA approval? The 1983 Orphan Drug Act
1987 Perscription Drug Marketing Act *Addressed issues about distribution and wholesale ansestry of human prescription drugs. *Intent: to solidify the legal supply channel of perscription drugs from manufacturers to authorized distributers, helping end counterfeit drugs and ingredients
1990 Omnibus Budget Reconciliation Act (OBRA '90) *Affected responsibilities of phamacists and health care personnel in general. *Outlines specifics for PH.'s to participate in Medicaid. *The DUE (Drug Utilization Evaluation) was created unter '90 OBRA to ensure all Rx's were reviewed for appropriatness
Which Act/Amendment states that a Ph. must counsil (at the time of purchase) all patients who receive new perscriptions? 1990 OBRA
3 Important provisions of the OBRA '90 are: 1-Ealuation of therapy 2-Review of therapy 3- DUE board review
Which Act/Amendment is specific to Medicaid coverage? 1990 OBRA
1996 Health Insurance Portability and Accountability Act Meant to protect certain health info.
The '96 HIPPA is also known as... Protected Health information/ PHI
2000 Drug Addiction Treatment Act (DATA Permits Physicians to perscribe controlled substances (approved by the DEA) to ppl suffering from opium addiction for the purpose of maintenance or detoxification treatments.
2003 Medicare Modernization Act (MMA) Under the Medicare Advantage Program, this Act provided a drug discount card to ppl with for low incomes who need help obtaining medication.
2005 Combat Methamphetamine Epidemic Act *Enacted to combat the abuse of Pseudophedrine as an additive to make methamphetamine. *Addresses manufacturing, law enforcment, and sales of this drug.
1972 Drug Listing Act; National Drug Code (NDC) *Implimented unter the FDA *A unique 10-digit # divided into 3 segments *#'s identify: 1-labeler(manufacturer) 2- product, 3- and trade package size.
Created by: lolastudies



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