Federal Regulations of Dispensing: Medications Objectives Exam 1

Question 1

Describe the organization of the Food and Drug Administration (FDA)

Answer 1

• component of the Department of Health and Human Services (DHHS)
• Commissioner of FDA appointed by president of DHHA w/ approval of Senate
• Four agencies oversee the core function of the agency
• Field divided into 5 geographic regions w/ district offices;

Question 2

What are the four agencies oversee the core function of the agency?

Answer 2

• Office of Foods and Veterinary Medicine
• Office of Global Regulatory Operations and Policy
• Office of Medical Products and Tobacco
• Office of Operations

Question 3

define food

Answer 3

• articles used for food or drink for man or other animals
• chewing gum
• articles used for components of any such article

Question 4

define drug

Answer 4

(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)

Question 5

define dietary supplement

Answer 5

: a product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: A vitamin, A mineral, An herb or other botanical, An amino acid, A dietary substance for use by humans to supplement the diet by increasing the total dietary intake, A concentrate, metabolite, constituent, extract, or combination of the previous

Question 6

define cosmetic

Answer 6

articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles

Question 7

define device

Answer 7

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory recognized by National Formulary or USP, used for diagnosis, cure, treatment, prevention of disease, intent to affect structure / function of the body

Question 8

define label

Answer 8

refers to information required on the container or wrapper

Question 9

define labeling

Answer 9

includes the label, it also applies to the information “accompanying” the drug, such as the package insert

Question 10

Differentiate FDCA requirements for prescription drugs from those for over-the-counter (OTC) drugs

Answer 10

a. OTC drugs must be labeled with “adequate directions for use” directed to the consumer. Prescription drugs must be labeled with “adequate information for use” directed to the healthcare professional. Some drugs can be both OTC and prescription depending upon the intended indications and whether those indications can be labeled with “adequate directions for use.”