Beyond use dating for compounded pharmaceuticals

The factors that influence the stability of compounded preparations are generally the same as those for manufactured drug products (see ).

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These beyond-use date limits may be exceeded when there is supporting valid scientific stability information that is directly applicable to the specific preparation (i.e., the same drug concentration range, p H, excipients, vehicle, water content, etc.).

See also the beyond-use dating information in the Federal law requires that manufactured drug products be labeled with an expiration date. The label on the container or package of an official compounded preparation must bear a beyond-use date.

See the table The compounder must avoid formulation ingredients and processing conditions that would result in a potentially toxic or ineffective preparation.

The compounder’s knowledge of the chemical reactions by which drugs degrade provides a means for establishing conditions under which the rate of degradation is minimized.

At all steps in the compounding, dispensing, and storage process, the compounder is to observe the compounded drug preparation for signs of instability.

For more specific details of some of the common physical signs of deterioration, see The beyond-use date is not later than the intended duration of therapy or 30 days, whichever is earlier.Good compounding practice dictates beyond-use labeling for all compounded a drug dosage form, a dietary supplement, or a finished device.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 ).Beyond-use dates are to be assigned conservatively.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.

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