compounding
- Guideline or reference source
- PIC/SPI007 Recommendation on the validation of asceptic processes
- WHO Glossary
- Definition
- 1) A process wherein bulk drug substance is combined with another bulk drug substance and/or one or more excipients to produce a drug product. 2) WHO: The preparation and supply of a single unit of a product intended for immediate use by a specific consumer. Compounding may provide a solution to the individual's needs, when a medicine is not available, or is unavailable in a form suitable for a particular patient. The reasons why compounding might be needed comprise: different dosage form required, for example liquid form required but only tablets available, ointment required instead of cream; sensitivity/allergy to excipients and preservatives; discontinued or unavailable medicine; different dose or concentration required; different route of administration required; compliance problems, for example palatability. Compounding is also known as extemporaneous dispensing.
- Related Term
- bulk product
- extemporaneous dispensing
- magistral formula
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