Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 2

Question 1

Which agency is responsible for regulating the manufacture and distribution of controlled substances in the United States?

Accepted Answer

DEA (Drug Enforcement Administration)

Answer

FDA

Answer

FTC

Answer

CMS

Question 2

Under the Food, Drug, and Cosmetic Act, drugs that require a prescription must bear the legend:

Accepted Answer

'Caution: Federal law restricts this drug to sale by or on the order of a licensed practitioner'

Answer

'For Investigational Use Only'

Answer

'Approved by FDA for OTC sale'

Answer

'Schedule II Controlled Substance'

Question 3

Which ethical principle requires pharmacists to act in the patient's best interest?

Accepted Answer

Beneficence

Answer

Autonomy

Answer

Justice

Answer

Non-maleficence

Question 4

A pharmacist discovers a dispensing error after the patient has left. What is the first required action?

Accepted Answer

Immediately contact the patient and prescriber, and document the error

Answer

Wait to see if the patient reports adverse effects

Answer

Discard the original prescription to avoid liability

Answer

File a DEA report

Question 5

Under FDA regulations, which phase of clinical trials primarily evaluates drug safety in a small group of healthy volunteers?

Accepted Answer

Phase I

Answer

Phase II

Answer

Phase III

Answer

Phase IV

Question 6

Which law established the requirement for child-resistant packaging for most prescription and OTC drugs in the United States?

Accepted Answer

Poison Prevention Packaging Act (PPPA, 1970)

Answer

Drug Quality and Security Act (2013)

Answer

Hatch-Waxman Act (1984)

Answer

Orphan Drug Act (1983)