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A pharmacy compounds an oral suspension from crushed tablets in a water-containing vehicle. No specific stability data are available. Under NAPRA's non-sterile compounding guidance, what is the default maximum beyond-use date if stored in the refrigerator?
In the absence of product-specific stability data, NAPRA's guidance (based on USP <795>) sets default beyond-use dates of no later than 14 days for water-containing oral formulations stored in the refrigerator, 30 days for water-containing topical or mucosal formulations, and up to 6 months for non-aqueous formulations (or the earliest ingredient expiry). Published stability studies can support longer dates. Source: NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018) and Guidance Document (2018), beyond-use date table; USP <795> (2014 edition referenced by NAPRA).
Using the non-aqueous or topical default for an aqueous oral preparation.
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