PTCB CPhT PTCE Question # 35 Topic 4 Discussion

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.