Non-Sterile Compounding

What is Extemporaneous compounding?

The on-demand preparation of a drug product according to a physician’s prescription, formula, or a recipe in the event that the product is not commercially available or if there is a drug shortage

What is required for compounding to determine the amount of ingredients needed

Compounding requires simple math calculations to determine the amount of ingredients needed

What is a practice of stock that the USP <795> provide?

Rotate stock to ensure that the oldest stock gets used first

What is a prevention practice of contamination that the USP <795> provide?

Prevent contamination when storing and handling ingredients and preparations

What is a practice of equipment location that the USP <795> provide?

Equipment must be located in a way that makes it easy to use, maintain, and clean

What is a practice of equipment cleaning that the USP <795> provide?

Equipment cleaning must be performed immediately after compounding to prevent cross-contamination of the next batch preparation

What is a Class A balance used for?

Should be used for all weighing required in prescription compounding

What is the minimum and maximum weight of a Class A balance?

• Minimum sensitivity: 6 milligrams (mg)

• Maximum capacity: 120 grams (g)

What type of scale is used in a Class A balance?

It may be an analog (torsion balance scale) or digital scale (preferred)

What is a beyond-use-date (BUD)?

The date after which a compounded medication should not be used

• Expiration date & BUD are not the same

How are expiration dates assigned?

Dates are assigned by manufacturers

How are beyond-use-dates (BUDs) assigned?

Dates are assigned to compounded and repackaged products based on the institution’s policy

What are the maximum beyond-use-date (BUD) for Non-aqueous (nowater) products?

6 months

What are the maximum beyond-use-date (BUD) for Topical/dermal preparations that contain water?

30 days

What are the maximum beyond-use-date (BUD) for Oral formulations that contain water?

14 days (refrigerated)

What are the non-sterile compounding techniques?

Spatulation, Trituration, Levigation

What is Spatulation?

Mixing powders and semi-solids (ointments, creams, etc…) on an ointment slab using a spatula

• Involves no particle size reduction, so the powders must already be fine and of a uniform size

What is Trituration?

Reducing the particle size of a substance by grinding using a mortar and pestle

What is Levigation?

Decreasing the surface tension between two ingredients by wetting with a small amount of insoluble liquid like glycerin for oil-soluble and mineral oil for water soluble bases, then spatulating or triturating