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Chapter 15: Drug Shortages and Counterfeit Drugs

The trend in drug shortages for 2016 is one of:

a. Decreasing new shortages and increasing active shortages

b. Increasing new shortages but decreasing active shortages

c. Slight increase in new shortages and decreasing active shortages

d. Decreasing new shortages and a gradual decrease in active shortages

d. Decreasing new shortages and a gradual decrease in active shortages

Most shortages have occurred due to:

a. Raw material shortages

b. Natural disasters

c. Manufacturing or quality problems

d. Corporate decisions

c. Manufacturing or quality problems

Package inserts must include which of the following items:

a. Name of the company that manufactured the drug

b. Location of the factory

c. Country of origin for the active pharmaceutical ingredient (API)

d. None of the above

d. None of the above

FDA can help prevent drug shortages by:

a. Prioritizing approvals of new products

b. Forcing companies to increase production

c. Forcing companies to continue to produce a drug

d. Decreasing drug prices

a. Prioritizing approvals of new products

FDA can help alleviate an ongoing drug shortage by:

a. Requiring companies to manufacture additional product

b. Fine companies that don’t provide advanced notice of a shortage

c. Allowing companies to import products that meet FDA criteria

d. Override patents and approve new formulations

c. Allowing companies to import products that meet FDA criteria

The FDASIA bill was signed in July 2012 and gave FDA what new authority with regard to drug shortages?

a. Allows FDA to make their own products to prevent shortages

b. Allows FDA to require manufacturers to notify them in advance ...

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