Beyond use dating for compounded pharmaceuticals


19-May-2020 05:27

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Compounding pharmacists have to take special care to consider the long-term potential effects on stability of combining active ingredients with established expiration dates with other substances, making sure that sub-potent preparations aren’t the result of compounding.Sub-potent medications lead to inferior care for patients, and additional difficulties with ongoing treatment regimes.Stability of a drug or compounded medication is defined as the quality of remaining potent within an established range and exhibiting the same characteristics and properties as it did at the time of its manufacture.All drugs deteriorate over time in terms of potency and stability.Once time moves beyond their expiration date, drugs can become volatile, unstable, lose potency, and lose efficacy in general.Because of this fact, it is always a bad idea to medicate any patient, animal or human, with drugs that have already expired.A licensed accredited compounding pharmacist or outsourcing facility, following best practices, applicable state regulations and FDA guidelines, will determine the effective expiration date for any compounded medications that they produce.

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All medications, including compounded drugs, have a period during which they are most effective.Accordingly, the BUD, or “Use By” date on pharmacy labels, is the shortest date of either of the sterility or stability parameters, which is illustrated with the following two examples. As noted in the preceding section, the BUD or “USE BY” is the date and time by which either the CSP MUST BEGIN to be administered to the patient or be discarded.Once CSP administration begins, the STERILTY storage time BUD becomes invalid and HANG TIME begins.Both the expiration date of the product used as the active ingredient, as well as the life of all of the ingredients used in compounding, must be taken into account when determining an appropriate expiration date for the compounded drug.

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Why Compounded Medications Expire Ideally, any drug will remain stabile throughout its use by patients.

CSPs are rarely subjected to the extensive scientific testing required for determination of expiration dates for commercially manufactures drug products. chemically stable longer than the default sterility storage limit, 2.



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