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LAW
Acts and Amendments
| Question | Answer |
|---|---|
| 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. |
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lolastudies
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