Extemporaneous Preparation Record

For an extemporaneous preparation the responsible pharmacist decides whether the preparation is suitable for release. After release, the preparation records are stored systematically for a period determined by local guidelines or national law [1]. 

Of course these topics should be discussed in relation to the scale of the preparation and other items that affect the risk assessment. Commonly the product file for a non-standardised extemporaneous preparation, may consist of only a prescription assessment and a preparation record, possibly with a cover sheet for archiving the other sections may remain unfilled. If available, referral can be made to a general file for the appropriate dosage form. 

The extent of the final inspection and release policy depends on the type of preparation. Thus, for extemporaneous preparations an independent control of the preparation record and a few non-destructive inspections of the product will suffice. If no abnormalities are observed, an authorised pharmacist can perform the product release. In some countries a delegated person may release the extemporaneous product conditionally afterwards, within a defined time frame, the authorised pharmacist releases the product formally. 

For products that are prepared extemporaneously at a regular basis or even for a limited stock, a product specific documentation (product file) is needed. This will include specifications, instructions, and records but also a pharmaceutical assessment of safety data, toxicity, biopharmaceutical aspects, stability, and product design. The product file should also include a product review as soon as a product is used repeatedly or over longer periods. 

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