USP

Question 0

What is included in USP 795?

Answer 0

• 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

Question 1

What is the USP 795 about?

Answer 1

• pharmaceutical non-sterile compounding

Question 2

What should the compounding environment include?

Answer 2

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

Question 3

Compounding equipment must be:

Answer 3

• appropriate in design and size for intended purpose
• cleaned immediately after use
• properly maintained and calibrated

Question 4

How do you determine beyond-use dates?

Answer 4

• aqueous or non-aqueous base
• expiration date of ingredients used
• storage temp
• references with stability data

Question 5

When there is no data available, what does 795 say about solids and non-aqueous liquids prepared from commercially available dosage forms

Answer 5

Beyond-use date will be:

• 25% of the remaining expiration date of the commercial product
• 6 months

…whichever is earlier

Question 6

What does 795 say about solids and non-aqueous liquids prepared from bulk ingredients?

Answer 6

beyond-use date = up to 6 months

Question 7

What does 795 say about water-containing formulations (prepared from ingredients in solid form)?

Answer 7

• beyond-use date = up to 14 days in the fridge

Question 8

What is the beyond-use date for all other formulations?

Answer 8

• up to 30 days
• as long as indicated treatment
• whichever is earlier

Question 9

Compounded preparations should contain ___________% of the active ingredient

Answer 9

90-110%

Question 10

What is the goal of the compounding process?

Answer 10

• to minimize error

- maximize prescriber’s intent

Question 11

Why should only one compound be prepared at a time?

Answer 11

• to avoid errors

- to avoid cross-contamination

Question 12

What is included in the final check of the preparation?

Answer 12

• weight variation
• proper mixing
• odor
• color
• consistency
• pH (is appropriate)
• pharmacist initials on Rx and label

Question 13

What is a formulation record?

Answer 13

• recipe for compounding
• alphabetical order

Includes:

• ingredients
• equipment required
• instructions for preparation

Question 14

Compounding should only be done if…

Answer 14

there is a therapeutic need and lack of product availability