REGULATIONS

Question 1

What are some responsibilities of the Food and Drug Administration (FDA)?

Answer 1

Approve new drugs.
Regulate drug package inserts.
Regulate drug advertising.
Issue recalls on affected drugs and medical supplies.

Question 2

What is the purpose of the Drug Enforcement Administration (DEA) in relation to pharmacy?

Answer 2

Enforce the CSA pertaining to the manufacture, distribution, and dispensing of legally produced controlled substances.

Question 3

What is the Food and Drug Administration (FDA)?

Answer 3

Public Health agency that protects consumers by enforcing the Federal Food, Drug, and Cosmetic Act.

Question 4

Does the FDA have the authority to seize any food, cosmetic, or drug products that has been misbranded or adulterated?

Answer 4

Yes.

Question 5

What does CSA stand for, and what is it’s purpose?

Answer 5

Controlled Substances Act.

Place all federally regulated controlled substances into one of five “schedules”.

Question 6

What factors are used by the CSA to determine the schedule placement of a substance?

Answer 6

Medicinal value.
Harmfulness.
Abuse or addiction potential.

Question 7

True or False

Schedule V is reserved for the most dangerous drugs that have no recognized medical use.

Answer 7

False.

That is Schedule I. Schedule V is the used for the least dangerous drugs.

Question 8

Each state has a regulatory and licensing agency for policing the practice of pharmacy, referred to as what?

Answer 8

State Board of Pharmacy (BOP)

Question 9

True or False

The BOP sets forth the requirements for obtaining and maintaining licensure in pharmacy.

Answer 9

True.

Question 10

How often does an inspector visit a pharmacy to verify compliance with the Pharmacy Practice Act?

Answer 10

Once per year.

Question 11

Define the Pharmacy Practice Act.

Answer 11

Defines rules for practicing pharmacy. (Violations and how to avoid an infractions)

Question 12

Name of the document that lists the penalty associated with each violation of the Practice Act.

Answer 12

Administrative Code.

Question 13

Name the companion Act to the Federal Controlled Substances Act and explain it’s purpose.

Answer 13

The State Controlled Substances Act explains what drugs the State has determined to be their own controlled substances.

Question 14

True or False

The State is able to decrease the level of control over the federal laws, but they can never increase it.

Answer 14

False.

The State can increase the schedule, but not decrease control over federal laws.

Question 15

The DEA places drug products into “schedules” based on what?

a) the drug’s potential for abuse
b) the drug’s cost
c) the drug’s actions in the body
d) none of the above

Answer 15

a) the drug’s potential for abuse

Question 16

True or False

The Board of Pharmacy includes only professional pharmacy members.

Answer 16

False.

The BOP includes a well-rounded Board including consultants, practitioners (medical/nursing fields), and one lay-member.

Question 17

True or False

If there is ever a discrepancy between two laws, the more stringent law always prevails.

Answer 17

True.

Question 18

What is the CMS?

Answer 18

Centers for Medicare and Medicaid Services

Question 19

What does the CMS provide?

Answer 19

Increased healthcare quality available to it’s qualified members.

Question 20

What does NABP stand for?

Answer 20

National Association of Boards of Pharmacy

Question 21

What is the goal of NABP?

Answer 21

Research, develop, and help implement better ways of regulating pharmacy practices.