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MPJE - USP Chapter 795 – Pharmacy Compounding – Nonsterile Preparations

Responsibilities of a “Compounder" Compounder should be capable and qualified to conduct the activities Ingredients are verified identity, quality and purity Prepared in accordance with good compounding practices, official standards and relevant scientific evidence
Responsibilities of a “Compounder" Critical process steps are validated to ensure consistency and reproducible quality in finished products Environment is appropriate to the activities
Responsibilities of a “Compounder" Beyond-use dating (BUD) and stability determinations are made in accordance with scientific data and published literature; and that finished compounded products are appropriately labeled with BUD information
Responsibilities of a “Compounder" Process steps are appropriately detailed to prevent errors Adequate procedures are undertaken and documented to allow investigation and correction of errors in process, quality control, or finished products.
Compounding Environment Area or facility where compounding activities will occur has appropriate design and adequate space for the activity. Design minimizes the possibility of cross-contamination between products
Compounding Environment Storage areas must be appropriate for the compounding activities. Water supply needs to be available. Must be well-lighted and have appropriate temperature regulation.
Compounding Environment Regular cleaning and maintenance program. Maintained in clean and sanitary condition. Adequate facilities for compounding personnel to wash and prepare for USP 795 activities
Compounding Environment Compounding equipment must be appropriate to the activity. Equipment could include glassware, heating and mixing devices, measuring and balance equipment, tableting and encapsulating equipment, as well as other electrical and mechanical devices
Compounding Environment Devices that require calibration and other validations must have timely reviews.
Stability of Compounded Preparations BUD - For non-aqueous formulations BUD is NOT later than the time remaining until the earliest expiration date of any API, or 6 months, whichever is earlier
Stability of Compounded Preparations BUD - For water-containing oral formulations BUD is NOT later than 14 days when stored at controlled cold temperatures
Stability of Compounded Preparations BUD - For water-containing topical/dermal and mucosal liquid and semisolid formulations BUD is NOT later than 30 days
Compounding Records and Documents 4 types records Formulation record Compounding record Material data safety sheet (MSDS) Certificate of analysis (CoA)
Created by: LilTren