When a prescription isn't available from a manufacturer it is compounded in the pharmacy. Extemporaneous compounding, is the act of compounding for a specific prescription or patient whereas batch compounding is anticipatory compounding, for popular compounds dispensed from the pharmacy. The popularity of compounding is due to more physicians, medical institutions, etc. seeing the benefit of tailoring an individual's medications to meet their needs.
All compounding must be documented, according to state pharmacy law, for future reference and tracking should an issue ever arise with the compounded medication. Information that should be recorded includes:
- Date of production
- List of components used along with their manufacturer, lot # and expiration
- The compounding facility's lot #
- The compounding facility's expiration date
- Equipment used
- Weights and measures of the components used
- All in-process quality controls
- Statement of actual yield
- Samples of the labels created
- Description of the containers and closures for the drug
- Identification of individual(s) who did the compounding and verified the final product
Pharmacy equipment used for compounding must be maintained, cleaned, adjusted, and ready for use at all times. One type of non-sterile compounding equipment is a Class A, or Class III, prescription balance. It has 2 pans and is used for weighing substances from 10 mg to 120 grams. Weights for a Class A balance should be handled with plastic tip forceps, not the hands. During usage, the scale should be dry, level and not close to any air ducts, fans or other sources of air disruption. A digital balance has 1 pan and the drug is measured inside of its wind cover. It is more accurate than a Class A balance.
Other types of non-sterile compounding equipment include:
- Graduated cylinders – the substance to be measured should never constitute less than 5% of its capacity
- Ground glass compounding slabs
- Discardable ointment or parchment paper
- Weigh papers and weigh boats used to measure and transport powders and semisolid substances
- Stainless steel or hard rubber spatulas used for counting, transferring and mixing
- Mortars and pestles, made from glass, wedgewood, porcelain and ceramic – they are used for grinding, crushing, pulverizing and mixing pharmaceutical ingredients
Compounding requires aseptic technique, or methods to minimize the contamination of sterile products and includes thorough hand washing and wearing clean lint-free garments or barriers, wearing sterile gloves and avoiding touching one's face, hair or any other potentially contaminated objects in the area.