PTCE Compounding 5

Question 1

A Category 1 CSP (compounded sterile preparation) is one that is:

Accepted Answer

Prepared without a sterility test and assigned a short BUD

Answer

Prepared with full sterility testing and assigned up to 45 days BUD

Answer

Prepared in ISO Class 8 only

Answer

Prepared from commercially available sterile products only

Question 2

Which type of balance is required by USP for weighing ingredients less than 120 mg in a compounding pharmacy?

Accepted Answer

Class III prescription balance or analytical balance

Answer

Class II balance

Answer

Top-loading balance

Answer

Triple-beam balance

Question 3

Cocoa butter (theobroma oil) is commonly used in suppository compounding primarily because it:

Accepted Answer

Melts at body temperature (34–36°C) and solidifies at room temperature

Answer

Dissolves in rectal fluid

Answer

Is water-soluble

Answer

Has antimicrobial properties

Question 4

Which practice is required before compounding a batch of sterile preparations to prevent cross-contamination?

Accepted Answer

Decontaminating and disinfecting the ISO Class 5 PEC with 70% IPA

Answer

Running HEPA filters at reduced speed

Answer

Wearing only gloves without a gown

Answer

Opening the BSC's sash completely for airflow

Question 5

What is the role of a wetting agent in suspensions?

Accepted Answer

To reduce the contact angle between the powder and liquid, promoting uniform dispersion

Answer

To increase the viscosity of the suspension

Answer

To serve as the active pharmaceutical ingredient

Answer

To prevent oxidation of the drug

Question 6

A prescription calls for 'PCAB-accredited' compounding. What does PCAB accreditation indicate?

Accepted Answer

The pharmacy has met voluntary quality and safety standards for compounding set by an accreditation body

Answer

The pharmacy is federally licensed to manufacture drugs

Answer

The pharmacy is exempt from state board inspections

Answer

The pharmacy only compounds controlled substances

Question 7

Which compounding scenario would require compliance with USP <800> hazardous drug handling guidelines?

Accepted Answer

Preparing a methotrexate oral solution for a pediatric patient

Answer

Mixing a normal saline IV bag

Answer

Compounding a vitamin C topical cream

Answer

Preparing an antacid suspension from OTC ingredients