5 Written Questions
5 Matching Questions
- Food and drug Administration modernization Act of 1997. (FDAMA)
- Food Drug and Cosmetic Act
- Pure Food and Drug Act of 1906
- a a federal insurance program for persons over the age of 65 and qualified disabled or blind persons regardless of income
- b Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
- c Used to help manufacturers to quickly get their drugs to market. Encourage manufacturers to conduct research for new uses of drugs and to submit new drug applications. (NDAs). To encourage drug manufacturers to perform pediatric studies of drugs.
- d Omnibus Budget Reconciliation Act of 1990. Mandated three main provisions. Drug manufacturers provide the lowest price to medicaid patients. That drug review and patient counseling are now mandated.
- e This law was passed by congress because of the concern about the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs.
5 Multiple Choice Questions
- A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
- Recognized standards that are similar to laws.
- Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.
- A voluntary prescription drug benefit to medicare.
- Are used to treat relatively rare diseases. A rare disease is one that effects less then 200,000 persons or that the cost of developing it could not be made back from sales of the drug.
5 True/False Questions
State board of pharmacy. → Body established to ensure that the public is well served professionally by pharmacist.
PPI → Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
NDC → Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
Poison Prevention Act of 1970 → amendment to the Federal hazardous act. It regulates certain household products to be in special packaging that makes it hard for children to open but easy for most adults (child resistant containers).
Federal versus state drug control laws. → Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.