Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
Nystatin Topical Powder in Talc   100,000 units/gram
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    nystatin bulk powder, USP    PWD  See notes section 
    talc, sterile 4 g    PWD  See notes section 
Recipe Total Quantity:
Final Quantity Desired: g

Directions: The strength (potency) of each bottle of bulk nystatin USP is different, therefore a new calculation for dilution is required with each batch prepared. Add amount required to make 100,000 units/gram concentration.

1. Weigh out nystatin powder and talc powder required.
2. Blend powders together in mortar and pestle.
3. Dispense in plastic squeeze bottle.

Notes The BUD should be EITHER 180 days OR the time remaining until the earliest expiry date of any ingredient, whichever is shorter.

180 day room temperature stability is for Galenova brand nystatin ONLY.

Use either Sterile Talc 2 g, 3 g or 4 g sizes, available from Future Use Special Access Program. (FSAP).
Talc used in dusting powders must be sterile.
See recipe for Nystatin Topical Powder in Magnesium Carbonate for alternate recipe.

THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use, or physician/pharmacy experience.

Packaging:  Plastic Bottle

Auxiliary Labels: For External Use Only
  Store at Room Temperature

Storage/Expiry:Room Temperature: 180 days

Last Date Revised: 2-Sep-21

References:Boies, Philippe (Galenova Inc.). RE: Nystatin Powder Stability [Email]. Message to: Kristina Haagsma (Alberta Health Services, Edmonton, AB). 2021 Sept 2. cited 2021 Sept 2.
For stability data.

Martin A. Erickson. Pharmacy Times (August, 2004). Compounding Online Question Database. Available from http://www.pharmacytimes.com/publications/issue/2004/2004-08/2004-08-8147

Faxed Communication from Rexall Pharmacy On Call to Alberta Children's Hospital Pharmacy. Sept 15, 2005.

Telephone Communication with Rexall Pharmacy On Call on April 19, 2013 to confirm refrigerated storage information.

Purified Talc. In: Martindale: The Complete Drug Reference [database on the Internet]. Hudson (OH): Lexicomp Inc.: 2016 [updated 7 July 2010; cited 6 July 2016]. Available from: http://online.lexi.com. Subscription required to view.
 
National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations. Ottawa, ON: National Association of Pharmacy Regulatory Authorities (NAPRA); 2018.
Available at: https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_Preparations_Guidance_June2018_FINAL.pdf

Completed Compound Check
Lot NoDate Prepared Expiry DateTechnicianPharmacist
   29-Nov-2021         


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