PTCB PTCE Question Answer
Abeyond-use date (BUD)indicates the period of time that a:
Compounded preparation is expected to retain its purity and potency.
Manufactured preparation is expected to retain its purity and potency.
Manufactured preparation is expected to stay on the shelf.
Compounded preparation is expected to take to prepare.
Beyond-use dates (BUDs) apply specifically to compounded medicationsand indicate thetime frame in which the medication remains stable and safe to use.
BUDs are different from expiration dates, which are determined by manufacturers through long-term stability testing.
USP <795> BUD Guidelines for Nonsterile Compounds:
Non-aqueous formulations(e.g., capsules, powders) →6 months
Water-containing oral formulations(e.g., suspensions) →14 days (refrigerated)
Water-containing topical formulations(e.g., creams, lotions) →30 days
Why Other Options Are Incorrect:
B. Manufactured preparation expiration dates?❌Expiration dates apply tocommercially manufactured drugs, NOT compounded ones.
C. Shelf-life of manufactured drugs?❌This is determined by themanufacturer’s expiration date.
D. Time to prepare a compound?❌BUDsdo not refer to preparation time.
????Reference:USP <795> & USP <797> Guidelines, PTCE Compounding Study Materials.
TESTED 20 Dec 2025
Copyright © 2014-2025 ACE4Sure. All Rights Reserved