5 Written questions
5 Matching questions
- Federal Statuates
- State board of pharmacy.
- The Orange Book
- Food and Drug Administration
- Poison Prevention Act of 1970
- a Body established to ensure that the public is well served professionally by pharmacist.
- b FDA published the Approved Drug Products with Therapeutic Equivalence Evaluations
- c Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.
- d Promulgates rules and regulation and standards; inspects drug and food facilities to ensure public safety regarding drug products.
- e 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).
5 Multiple choice questions
- A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
- 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.
- Form required to order c-s I and II. Also need to transfer c-s I and II between pharmacies, and to returns to wholesaler or manufacturer. all DEA-222 come in triplicate.
- A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act(CSA). To combat controlled substance abuse.
- 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.
5 True/False questions
Food Drug and Cosmetic Act → 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.
HIPAA → The Health Insurance and Portability and Accountability Act, a federal law protecting the privacy of patient-specific health care information and providing the patient with control over how this information is used and distributed.
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.
Prospective Drug Review → 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.
Durham-Humphrey Amendment → established two classes of drugs, over the counter (OTC) and prescription. And mandated that labels of prescription, drugs include the legend. Caution Federal Law Prohibits dispensing without a prescription.