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Pharmacy Laws & Regulations - Chapter 2 Test

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5 Written Questions

5 Matching Questions

  1. Kefauver-Harris Amendment
  2. Food Drug and Cosmetic Act
  3. The Joint Commission
  4. Orphan Drugs
  5. PPI
  1. a "A private, voluntary, not-for-profit organization that evaluates and accredits hospitals and other healthcare organizations on the basis of predefined performance standards; formerly known as The Joint Commission on Accreditation of Healthcare Organizations or JCAHO "
  2. b Patient Package Inserts FDA requires to distribute PPI's to educate the pt about proper care and dangers of prescription drugs.
  3. c 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.
  4. d 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.
  5. e Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)

5 Multiple Choice Questions

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. Promulgates rules and regulation and standards; inspects drug and food facilities to ensure public safety regarding drug products.

5 True/False Questions

  1. Prospective Drug ReviewA 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).


  2. State board of pharmacy.A voluntary prescription drug benefit to medicare.


  3. The Controlled Substances Act of 1970Law regulating the manufacture, distribution, and sale of certain drugs or substances that have potential for abuse or physical and psychological dependence


  4. Medicare part DA voluntary prescription drug benefit to medicare.


  5. Pure Food and Drug Act of 1906This 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.


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