Chapter 1: Consumer Safety and Drug Regulation

Question 1

Controlled substances

Answer 1

Drugs controlled by additional prescription requirements because of the danger of addiction or abuse.

Question 2

Drug Enforcement Administration (DEA)

Answer 2

A bureau of the Department of Justice that enforces the Controlled Substances Act.

Question 3

Drug standards

Answer 3

Federally approved requirements for the specified strength, quality, and purity of drugs.

Question 4

Food and Drug Administration (FDA)

Answer 4

An agency within the Department of Health and Human Services that enforces the provisions of the Federal Food, Drug, and Cosmetic Act and amendments of 1951 and 1962.

Question 5

National Drug Code (NDC) Directory

Answer 5

Provides the FDA with a list of all drugs manufactured for commercial distribution.

Question 6

Orphan drugs

Answer 6

Drugs or biological products used for the diagnosis, treatment, or prevention of a rare disease or condition, that is, one affecting fewer than 200,000 persons in the United States, or greater than 200,000 persons where the cost of developing the drug is probably not recoverable in the United States.

Question 7

Over-the-counter (OTC) medication

Answer 7

Medication available without a prescription.

Question 8

True or False: Prescriptions cannot be written for OTC medications

Answer 8

False: Prescribers are able to write prescriptions for any FDA-approved medication and all OTC medications. Additionally, if a prescriber wishes for the patient to take an OTC medication differently from the instructions on the label (like taking more than the directed amount), a prescription can be written to help the patient with compliance.

Question 9

True or False: All herbal medicines and dietary supplements aren’t guaranteed to be safe to consume.

Answer 9

True: Herbal remedies and other dietary supplements are not approved or manufactured per production standards regulated by the Food and Drug Administration (FDA) and may have serious interactions with prescribed medications.

Question 10

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, who is responsible for ensuring that a dietary supplement is safe before it’s marketed?

Answer 10

The dietary supplement manufacturer