Nonsterile Compounding>Beyond Use Date Practice Test

A pharmacist compounds an oral amoxicillin suspension for a pediatric patient who cannot swallow tablets. The preparation is made by triturating amoxicillin powder with Ora-Plus, then bringing to final volume with Ora-Sweet SF to yield 125 mg/5 mL, total volume 120 mL. The compounded product is a water-containing oral suspension, dispensed in an amber, tight, child-resistant bottle labeled "Shake well" and "Refrigerate." No stability-indicating assay is available in the pharmacy, and no specific stability data beyond USP <795> defaults are on file. The prescriber anticipates the child will complete therapy within two weeks, but asks the pharmacist to set an appropriate beyond-use date. The patient's caregiver is counseled to measure doses with an oral syringe and to keep the bottle refrigerated between uses.

A pharmacist compounds a 1 mg/mL amlodipine oral suspension for a 5-year-old who cannot swallow tablets. The suspension is prepared by triturating amlodipine tablets and levigating with Ora-Plus, then qs with Ora-Sweet to final volume. No stability-indicating data are available beyond standard references, and the product contains water and a preservative from the commercial vehicles. The suspension is dispensed in an amber, tight plastic bottle with instructions to shake well before use. The clinic requests a reasonable beyond-use date and storage recommendations for the family. The preparation is intended for oral administration and will be used at home. No special compendial testing has been performed on this batch, and the ingredients all have expiration dates well beyond the intended period of use.