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DOI: 10.3390/ijms19071987

In place of stability testing, 503A compounding pharmacies often rely on the following to establish the beyond-use date: Manufacturer recommendations Published clinical literature Limits set by the USP However, variances in formulation, container/closure system, and storage conditions between the medication the compounding pharmacy is altering and the reference drug that has undergone stability testing can result in an inaccurate beyond use date

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