Usp chapter 797 beyond use dating

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Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures

usp chapter 797 beyond use dating
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To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources., However, administration and preparation per approved labeling are out of the scope of the chapter as described in 1.

































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Compounding has been a fundamental aspect of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills. Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.

The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion. We, myself included, historically have given day beyond use dating to our products without a second thought and no real scientific data to back up that claim. Seems the revised BUD guidance gives some credence to preservatives, sterilization methods, etc, but with a maximum BUD of 45 days. Email address:.

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