What is included in USP 795?
- responsibility of compounder
- facility standards and equipment
- stability and beyond-use dates
- ingredient selection and quality
- checklist of considerations before compounding
- discussion of procedures for different dosage forms
- records and documentation
- quality control, verification and pt counseling
What is the USP 795 about?
- pharmaceutical non-sterile compounding
What should the compounding environment include?
Adequate space
- orderly placement and storage of equipment
Controlled temp/lighting
Clean
Sink with hot and cold running water
- essential for hand and equipment washing
Separate and distinct areas for sterile and non-sterile compounding
Compounding equipment must be:
- appropriate in design and size for intended purpose
- cleaned immediately after use
- properly maintained and calibrated
How do you determine beyond-use dates?
- aqueous or non-aqueous base
- expiration date of ingredients used
- storage temp
- references with stability data
When there is no data available, what does 795 say about solids and non-aqueous liquids prepared from commercially available dosage forms
Beyond-use date will be:
- 25% of the remaining expiration date of the commercial product
- 6 months
…whichever is earlier
What does 795 say about solids and non-aqueous liquids prepared from bulk ingredients?
beyond-use date = up to 6 months
What does 795 say about water-containing formulations (prepared from ingredients in solid form)?
- beyond-use date = up to 14 days in the fridge
What is the beyond-use date for all other formulations?
- up to 30 days
- as long as indicated treatment
- whichever is earlier
Compounded preparations should contain ___________% of the active ingredient
90-110%
What is the goal of the compounding process?
- to minimize error
- maximize prescriber’s intent
Why should only one compound be prepared at a time?
- to avoid errors
- to avoid cross-contamination
What is included in the final check of the preparation?
- weight variation
- proper mixing
- odor
- color
- consistency
- pH (is appropriate)
- pharmacist initials on Rx and label
What is a formulation record?
- recipe for compounding
- alphabetical order
Includes:
- ingredients
- equipment required
- instructions for preparation
Compounding should only be done if…
there is a therapeutic need and lack of product availability
