Unit 1: Chapter 3: Laws Affecting Prescription Dispensing

Question 1

According to HIPAA, when you use and disclose only the amount of protected patient info needed, it is called:

Answer 1

Minimum necessary rule

Question 2

The Haxman Watchman Act

Answer 2

Allowed manufacturers to submit ANDAs for generic meds

Question 3

FDA-approved handouts that inform patients about risks of drugs that pose the most significant and serious health concerns are called:

Answer 3

Medication guides (med guides)

Question 4

Which government agency helps enforce laws and regulations surrounding controlled substances?

Answer 4

DEA

Question 5

According to the poison prevention Act of 1970, which meds can be dispensed in a non-child-resistant package?

A. AntibioticsB
B. Heart failure meds
C. Inpatient meds
D. Oral corticosteriods

Answer 5

Inpatient meds

Question 6

THe Drug Price Competition and Patent Act of 1984 is also known as the :

Answer 6

Hatch-Waxman Act

Question 7

For meds that require a med guide, you must give one with all:

Answer 7

With all outpatient prescriptions

Question 8

The Food, Drug, and Cosmetic Act of 1938:

Answer 8

Requires manufactures to prove a drug’s purity, strength, and safety before it can be sold

Question 9

Which act requires putting a child-resistant cap on a prescription bottle?

Answer 9

Poison Prevention Packaging Act of 1970

Question 10

What did the Drug Listing Act of 1972 require?

Answer 10

Each new medication to have an NDC number.

Question 11

DSHEA requires that a:

Answer 11

Dietary supplement must make true claims.

Question 12

In an outpatient setting, this med can be dispensed in non-child-resistant packaging; ______.

Answer 12

Sublingual nitroglycerin tabs

Question 13

Which regulatory agency isresponsible for creating standards for packaging to protect children from accidental poisonings with meds?

Answer 13

Consumer Product Safety Commision

Question 14

The health Insurance Portability and Accounability Act of 1996:

Answer 14

Governs patient privacy and the sharing of patient info

Question 15

THe Omnibus Reconciliation Act of 1990 requires:

Answer 15

The pharmacist to consult about prescriptions with patients

Question 16

Which law created two classes of meds, prescription and nonprescription?

A. Pure food and drug act of 1906
B. Food drug and cosemtic act of 193
C. Durham-Humphrey Admendment of 1951
D. Omnibus Budget Reconciliation Act of 1990

Answer 16

Durham-Humphrey Admendment of 1951

Question 17

A patient package insert:

Answer 17

Is required to be dispensed for new-estrogen containing meds filled in an outpatient setting

Question 18

WHich federal agency is responsible for the regulation of labeling on prescription and OTC meds?

Answer 18

FDA