A product is extemporaneously prepared only when there is no product with a marketing authorization available and where you are able to prepare the product in compliance with accepted standards.
Staff involved are competent to undertake the tasks to be performed.
The requisite facilities and equipment are available. Equipment must be maintained in good order to ensure that performance is unimpaired, and must be fit for the intended purpose.
The professional associate (Pharmacist) is satisfied as to the safety and appropriateness of the formula of the product.
Ingredients are sourced from recognized pharmaceutical manufacturers and are of a quality accepted for use in the preparation and manufacture of pharmaceutical products. Where appropriate, relevant legislation must be complied with.
Particular attention and care are paid to substances which may be hazardous and require special handling techniques.
The product is labelled with the necessary particulars, including an expiry date and any special requirements for the safe handling or storage of the product.
If you are undertaking large-scale preparation of medicinal products, all relevant standards and guidance are adhered to.
Records are kept for a minimum of 2 years. The records must include: the formula; the ingredients; the quantities used; their source; the batch number; the expiry date; where the preparation is dispensed in response to a prescription, the patient’s and prescription details and the date of dispensing; the personnel involved, including the identity of the pharmacist taking overall responsibility.
