CSP Fulfillment and Dispensing 2

Question 1

A refrigerated biologic must be stored at which temperature range per USP labeling conventions?

Accepted Answer

2-8°C (36-46°F)

Answer

USP defines 'refrigerator' storage as 2-8°C (36-46°F).

Question 2

A patient reports that a cold-chain package arrived with an indicator showing a temperature excursion. What should the pharmacy do first?

Accepted Answer

Instruct the patient not to use it, quarantine it, and check stability data with the manufacturer

Answer

Excursions require quarantine and a stability check with the manufacturer before anyone decides whether the product can be used.

Question 3

Under the Drug Supply Chain Security Act (DSCSA), what must dispensers be able to do with prescription drug packages?

Accepted Answer

Verify product identifiers and exchange transaction data electronically

Answer

DSCSA requires interoperable electronic tracing and verification of product identifiers across the supply chain.

Question 4

Why do manufacturers often use limited distribution networks for specialty drugs?

Accepted Answer

To control handling and data reporting, and to support REMS or complex patient support

Answer

Limited distribution lets manufacturers make sure handling, patient support, and data reporting are done properly.

Question 5

What is the main purpose of a refill reminder call ahead of a specialty shipment?

Accepted Answer

Confirming the patient still needs therapy and checking adherence, side effects, and delivery details

Answer

Refill calls check ongoing need, adherence, side effects, and delivery details before the pharmacy ships.

CSP - Certified Specialty Pharmacist Practice Test