Pharmacy Pharmacy Law 3

Question 1

Which schedule includes drugs with no accepted medical use in the US and a high potential for abuse?

Accepted Answer

Schedule I

Answer

Schedule II

Answer

Schedule III

Answer

Schedule IV

Question 2

A pharmacy technician who is authorized to call in a new prescription to another pharmacy for a Schedule III controlled substance must:

Accepted Answer

Only do so if allowed by the prescribing practitioner

Answer

Obtain DEA registration first

Answer

Never do so — only pharmacists may call in Schedule III prescriptions

Answer

Use DEA Form 222 for the transfer

Question 3

Under federal law, what is the maximum number of refills allowed for a Schedule IV controlled substance?

Accepted Answer

Up to 5 refills within 6 months

Answer

No refills allowed

Answer

Up to 3 refills within 6 months

Answer

Up to 12 refills within one year

Question 4

The Poison Prevention Packaging Act (PPPA) requires child-resistant containers for most prescription drugs. Which patient can request a non-child-resistant container?

Accepted Answer

The patient or their caregiver

Answer

The prescribing physician

Answer

The pharmacy manager only

Answer

No one — child-resistant containers are always required

Question 5

Which amendment to the FD&C Act required drug manufacturers to prove both safety AND efficacy prior to approval?

Accepted Answer

Kefauver-Harris Amendment (1962)

Answer

Pure Food and Drug Act (1906)

Answer

Food, Drug, and Cosmetic Act (1938)

Answer

Drug Price Competition and Patent Term Restoration Act (1984)

Question 6

Which law created the framework for generic drug approval by establishing the Abbreviated New Drug Application (ANDA)?

Accepted Answer

Hatch-Waxman Act (1984)

Answer

OBRA '90

Answer

DQSA (2013)

Answer

FDAAA (2007)