Laws Affecting Prescription Processing

Question 1

The food, drug, and cosmetic act of 1938:

Answer 1

Requires manufacturers to prove a drugs purity, strength, and safety before it can be sold

Question 2

The health insurance portability act of 1996:

Answer 2

Governs patient privacy and the sharing of patient information

Question 3

Which federal agency is responsible for the regulation of labeling on prescription and OTC medications

Answer 3

FDA

Question 4

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

Answer 4

Medication guides

Question 5

The NDC for Nexium 40 is 0186-5040-31. The number “0186” identifies

Answer 5

Manufacturer

Question 6

The NDC for Benicar 40mg is 65597-104-30. The 30 identifies

Answer 6

Package size

Question 7

Each new drug is required to have an NDC number according to the:

Answer 7

Drug listing act of 1972

Question 8

According to the poison prevention packaging act of 1970, a Symbicort inhaler

Answer 8

Can be dispensed in a non-child resistant container

Question 9

According to the poison prevention act of 1970, which medication class can be dispensed in a non-child-resistant package in an outpatient setting

Answer 9

Oral contraceptives

Question 10

An OTC headache medication is falsely labeled. The medication is considered:

Answer 10

Misbranded

Question 11

To use and disclose the minimum necessary amount of protected information is a principle of which law?

Answer 11

HIPPA

Question 12

The NDC for Abilify 10mg is 59148-008-13. The 008 identifies

Answer 12

Medication name

Question 13

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

Answer 13

Durham-Humphrey Amendment of 1990

Question 14

The Poison Prevention Act of 1970 is responsible for requiring

Answer 14

Child resistant caps on prescriptions

Question 15

NDC numbers consist of

Answer 15

10 or 11 digits divided into 3 segments

Question 16

Federal law says that you can only refill an RX for a schedule III controlled substance 5 times in 6 months. Your state law says you can only refill and RX for a schedule III controlled substance 4 times in 6 months. What is the maximum number of refills you can dispense for a schedule III controlled substance RX?

Answer 16

4

Question 17

For a medication’s packaging to be considered child resistant, it:

Answer 17

Cannot be opened by 80% of children younger than 5 years of age, but can be opened by 90% of adults

Question 18

Which law requires manufacturer claims about vitamins and minerals to be true?

Answer 18

DSHEA (Dietary supplement health and education act of 1994)

Question 19

Which medication must have an imprint code?
Preparation H suppositories
Prempro 0.625 mg/2.5mg tablets
Pred-forte 1% ophthalmic suspension
Photonix 40 mg granules for suspension

Answer 19

Prempro tablets

Question 20

For meds that require medication guides you must give one

Answer 20

With all outpatient prescrptions

Question 21

Which medication must be accompanied by a patient package insert

Answer 21

Cenestin (contains estrogen)

Question 22

Which law allows manufacturers to submit ANDAs to market generic drugs

Answer 22

Hatch-Waxman Act of 1984

Question 23

Patient Package inserts contain information about the

Answer 23

Benefits and risks of using a medication

Question 24

Which law requires the pharmacist to consult about new prescriptions with patients

Answer 24

OBRA ‘90

Question 25

Which governmental agency publishes immunization requirements for children and adults each year

Answer 25

Cdc

Question 26

According to HIPPA, a patients lab results are considered

Answer 26

Protected Health Information (PHI)

Question 27

The Drug Price Competition and Patent Term Restoration Act of 1984 is also known as the

Answer 27

Hatch-Waxman Act