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Non-Sterile Preparations ( USP 795)

Non-Sterile Preparations ( USP 795). Beyond-Use Date (BUD). Stability information can be found on: Drug Information Handbook Primary literature Pubmed International Journal of Pharmaceutical Compounding (IJPC) – membership required Tertiary sources

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Non-Sterile Preparations ( USP 795)

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  1. Non-Sterile Preparations(USP 795)

  2. Beyond-Use Date (BUD) • Stability information can be found on: • Drug Information Handbook • Primary literature • Pubmed • International Journal of Pharmaceutical Compounding (IJPC) – membership required • Tertiary sources • http://www.nationwidechildrens.org/outpatient-pharmacy-services • http://paddocklabs.com • In absence of stability info, use USP 795

  3. Non-Sterile Preparations (USP 795) • USP – United States Pharmacopeia • NF – National Formulary • Definitions for terms • Suitable compounding environment • Appropriate equipment usage • Other chapters (1160, 1163, 1176) • Calculations, quality assurance, acceptable balances

  4. Beyond-Use Dating (USP 795) • Non-aqueous liquids and solid formulations • Manufactured product = active ingredient • Not later than 6 month / 25% rule • USP or NF product = active ingredient • Not later than 6 months • Combination • BUD = chose the earlier BUD

  5. 6 months/25% rule example • Compound using 2 active ingredients: • Drug ABC expires 7/16 • Drug XYZ expires 4/15 • Drug XYZ expires sooner • Calculate how many days until 4/30/2015 • http://www.timeanddate.com/date/dateadd.html • Example: Calculate from 2/14/2014 = 440 days • 440 days (0.25) = 110 days + 2/1414 = 6/04/14 • 6 months from 2/14/14 = 8/14/14 • 6/04/14 is sooner, used as exp date

  6. Beyond-Use Dating (USP 795) • Water-containing formulations (made from solid products) • Not later than 14 days for liquid preparations when refrigerated • All other formulations • Not later than intended duration of therapy or 30 days (whichever is earlier)

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