5 Written questions
5 Matching questions
- Food, Drug, and Cosmetic Act of 1938.
- quasi-legal standards
- Food Drug and Cosmetic Act
- The Orange Book
- a 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.
- b FDA published the Approved Drug Products with Therapeutic Equivalence Evaluations
- c Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
- d Recognized standards that are similar to laws.
- e 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.
5 Multiple choice questions
- Promulgates rules and regulation and standards; inspects drug and food facilities to ensure public safety regarding drug products.
- A record maintained by the nursing staff containing information about the patients medication and it's frequency of administration.
- 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.
- A review of the patients medication profile by a pharmacist to screen for any drug problems prior to the drug being dispensed. (therapeutic duplications, drug-drug interactions, incorrect dosage, drug-allergy interactions, clinical abuse or misuse).
- Law regulating the manufacture, distribution, and sale of certain drugs or substances that have potential for abuse or physical and psychological dependence
5 True/False questions
The patients Bill of Rights → A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
Medicare part D → A voluntary prescription drug benefit to medicare.
Federal versus state drug control laws. → 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.
Orphan Drugs → 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.
OBRA → 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.