Artur Owczarek, Bożena Karolewicz

Kwalifikacja i uwarunkowania prawne sporządzania leków w aptece ogólnodostępnej. Ocena dopuszczalności współpracy aptek w zakresie sporządzania leków recepturowych
2019-06-03

DOI: 10.32383/farmpol/116255

Qualification and legal conditions for the preparation of compounded medicines, in a generally accessible pharmacy. Assessment of the acceptability of cooperation of pharmacies in the field of drug preparation

Preparation of pharmaceutical formulations for an individual patient is based on the use of traditional technological processes (pharmaceutical compounding) to meet the special needs of the patient or group of patients. A pharmacist or pharmaceutical technician, within their professional competence, prepare a medicinal product to ensure its quality, safety and efficacy. Responsibility for quality assurance is based on provision of pharmaceutical legislation and the current pharmacopoeia. The Preparing Person a prescription medicine should have a fully equipped, designated place for preparation of a prescribed drug and have all qualifications/competences to ensure the quality and safety of the final product. The preparation of the drug in the pharmacy should be based on knowledge of the technology of preparation of prescription drugs and appropriate premises required by pharmaceutical law. Unlike manufactured drugs, which are subject to “procedure allows the marketing of a medicine” each time the batch is released and their quality is checked to fulfil the marketing admission requirements. The existence of these fundamental differences requires deepening the analysis of legal guidelines regulating the preparation conditions of prescription drugs, in order to retain all the expected attributes of the prescription drug without limiting the patient’s ability to purchase them in a community pharmacy.

Keywords: pharmacy compounding, pharmaceutical law, pharmaceutical service, extemporaneous dispensing.

© Farm Pol, 2019, 75 (5): 282–287