Board Certified Sterile Compounding Pharmacist (BCSCP) Practice Test

Access More Questions
Under USP 800, which drugs do not have to follow USP 800 if an AOR is performed?
Correct Answer:
Final dosage forms of compounded HD preps and conventionally manufactured HD products, including antineoplastic dosage forms that do not require any further manipulations other than counting or repackaging
Explanation:
The main idea here is that USP 800 allows a risk-based, alternative approach to handling hazardous drugs when a proper assessment demonstrates adequate containment. An AOR/alternative handling approach can justify not applying every USP 800 requirement to specific low-risk forms. The best answer identifies the drugs that may be exempt when such an AOR is performed: the final dosage forms of compounded hazardous-drug preps and conventionally manufactured hazardous-drug products that do not require any further manipulations beyond counting or repackaging. Since these forms aren’t being prepared or altered to create new dosage forms, their exposure potential is minimal, so with a documented AOR, they can be managed using containment and practices appropriate to that assessed risk rather than the full USP 800 suite. Other choices aren’t correct because USP 800 isn’t a blanket rule for all HDs regardless of AOR, and AOR is a sanctioned option you can use to tailor containment for certain forms. The notion that AOR is not allowed is incorrect, and while AOR can be used for other HDs, the statement about which drugs don’t have to follow USP 800 specifically points to those final dosage forms that require no further manipulation beyond counting or repackaging.

Access more questions from this quiz

Continue to Board Certified Sterile Compounding Pharmacist (BCSCP) Practice Test for more practice questions and the full quiz experience.

Access More Questions