Usp 797 beyond use dating


22-Aug-2017 18:40

FDA-Registered 503B Outsourcing Facility that specializes in a wide array of sterile and non-sterile compounded medications.Edge provides high quality, safe medications with longer Beyond Use Dating and batch testing for every lot manufactured.

When using manufactured solid dosage forms to prepare a solution or aqueous suspension, the compounder is also to consider factors such as hydrolysis and the freeze-thaw property of the final preparation before assigning a beyond-use date.Assurance of sterility in a compounded sterile preparation is mandatory.Compounding and packaging of sterile drugs, such as ophthalmic solutions, will require strict adherence to guidelines presented in the general test chapter The beyond-use date is the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded.Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.

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Compounders are to consult and apply drug-specific and general stability documentation and literature when available, and are to consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy when assigning a beyond-use date (see ).In assigning a beyond-use date for a compounded drug preparation, in addition to using all available stability information, the compounder is also to use his or her pharmaceutical education and experience.