bulk repackage/nonsterile cmpd

1. bulk repackaging---transfer meds from commercial container to your container elixir ---base solution is a mixture of OH and h20 emulsion---use a stabilizing agent for mixing liquids that normally do not mix excipient-- --inert substance added to a drug(inactive) hydophillic- --mixes easily with water nonsterile compounding---no clean room/hood needed oleaginous base---(oily) ingredient that does not dissolve in water reconstitution---added water to a powder solute---’important’ ingredient in the solution solvent---takes in solute suspension---not fully dissolved/shake it up unit dose----single dose of drug blister card---’foil pill popout’ sealed by heat mostly bulk repackage/nonsterile cmpd

2. good manufacturing practice(GMP) labels---checked by dpharm equipment ---clean Expiration/BUD ---one year after doing repackage or date on Container…sooner date rules package---right size/dark/clear preparation ----one drug type at a time record---all items logged for reference repackaging is not sterile but likely use---- lab coat, hair back, wash hands, face mask, gloves Unit dose=one dose package documentation in log sheet in case of recall, ect--- date, drug, dosage form, manufacturer, man lot #, man exp date, phamacy lot #, pharm exp date, cpht initials, Show----unit dose log record

4. expiration normal expiration determined by FDA and manufacturer beyond use dates (BUD)established by USP 795/pharmacy When you open a bulk commercial bottle, expiration is invalid. nonsterile compounding in most pharmacies why do compounding? med not made by company pt allergic to original med need special dose combine meds need different form add flavoring follow USP 795 and state BOP Clean your equip—show pic

6. compounding expiration compounding has 3 thing to consider active ingredient, inactive ingredient, diluent exp date of components reconstituted c water-----14 days in frig semisolid/topical--30 days nonliquid---6 months after compound or sooner show example formula for compounding show punch method video-https://youtu.be/r18bLkbyMgM Show formula record pic-- how much IBU powder to get 240ml of 2% IBU gel? 2%=2g/100ml 2g/100ml=x/240ml x=480/100 x=4.8g of IBU powderhttp://www.pharmacytimes.com/publications/issue/2013/April2013/What-Does-USP-795-Mean-to-You

9. scales • Class III=class A balance=torsion balance=uses weights, arrest knob to lock scale in place • Weighs anything over 120mgdigital scale/class II=.0001g to 100g • Digital scale/class III=60g-120g