CSP Regulatory Compliance 2

Question 1

Under the DSCSA, which data elements make up the product identifier on a prescription drug package?

Accepted Answer

NDC, serial number, lot number, and expiration date

Answer

The DSCSA product identifier includes the NDC, a unique serial number, lot number, and expiration date, encoded in a 2D data matrix barcode.

Question 2

A specialty pharmacy determines that a product it received is illegitimate under the DSCSA. Within what time frame must it notify FDA and affected trading partners?

Accepted Answer

Within 24 hours

Answer

Once a product is determined illegitimate, FDA and trading partners must be notified within 24 hours, typically using FDA Form 3911.

Question 3

How long must a dispenser keep DSCSA transaction information, history, and statements?

Accepted Answer

6 years

Answer

The DSCSA requires trading partners to retain transaction documentation for at least 6 years from the date of the transaction.

Question 4

Which component of a REMS program may require pharmacies to be specially certified before dispensing a drug?

Accepted Answer

Elements to Assure Safe Use (ETASU)

Answer

ETASU can require prescriber and pharmacy certification, documentation of safe-use conditions, and patient monitoring or enrollment.

Question 5

Under the 2023 revision of USP <797>, what is the maximum beyond-use date for a Category 1 compounded sterile preparation stored in a refrigerator?

Accepted Answer

24 hours

Answer

Category 1 CSPs have a BUD of no more than 12 hours at controlled room temperature or 24 hours refrigerated.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP Regulatory Compliance 2