Usp 797 beyond use dating guidelines
Compounding is an integral part of pharmacy practice and is essential to the provision of health care.
The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounders ability in the compounding facility to extemporaneously compound preparations that are of acceptable strength, quality, and purity.).
The compounder may also refer to applicable publications to obtain stability, compatibility, and degradation information on ingredients.
Assurance of sterility in a compounded sterile preparation is mandatory.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.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.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.