5 Written questions
5 Matching questions
- Federal versus state drug control laws.
- Food, Drug, and Cosmetic Act of 1938.
- The patients Bill of Rights
- Medicare part D
- Food Drug and Cosmetic Act
- a A voluntary prescription drug benefit to medicare.
- b A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
- c The federal statute through which the FDA promulgates its rules and regulations. No new drug could be marketed unless it was proven safe for use.
- d Pharmacist are equally responsible for compliance with both Federal and State laws. If the federal law or regulation is more stringent then comparable state law, the more stringent law must be followed.
- e Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
5 Multiple choice questions
- Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
- Recognized standards that are similar to laws.
- FDA published the Approved Drug Products with Therapeutic Equivalence Evaluations
- 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).
- Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
5 True/False questions
HIPAA → Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
OSHA → Occupational Safety and Health Administration (1970). Was created to decrease hazards in the work place.
The Controlled Substances Act of 1970 → Law regulating the manufacture, distribution, and sale of certain drugs or substances that have potential for abuse or physical and psychological dependence
Medicare → National Drug Code Number is required on all o-t-c and prescription drug labels. 11 numbers. The first 5 id the manufacturer or distributor. The last 6 id the drug name package size and type of drug.
Durham-Humphrey Amendment → An amendment to the federal food and cosmetic act that required all new drugs marketed in the united states to be shown to not only safe, but effective.