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Pharmacy preparations and compounding

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  • Collaborators Delegates of the 50th EAHP General Assembly.

  • Contributors The position paper was approved and adopted by the delegates of the 50th EAHP General Assembly in October 2020.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.

  • The term ‘pharmacy preparation’ is not uniformly used throughout continental Europe when referring to medicines prepared or manufactured by a pharmacist. For this position paper, the term ‘pharmacy preparation’ shall encompass all wordings referring to pharmacy-made preparations, including but not limited to hospital preparations, individual preparations and large batch preparations, (small) stock preparations, magistral preparation, officinal preparation, extemporaneous preparations, preparations from raw materials and preparations to modify already marketed medicines.

  • Compounding’ is defined as the process of combining, mixing, or modifying ingredients to create a medication tailored to the needs of an individual patient [US Food and Drug Administration, Compounding and the FDA: Questions and Answers. Available at: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers%23what].

  • Literature divides pharmacy preparations into ‘preparation by adapting an existing product’ (“reformulating a licensed product into a different dosage form suitable for the intended use”) and ‘preparation from raw materials’ (“formulating active substances and excipients into a dosage form suitable for the intended use”) 9 (p4). European law covers compounding/pharmacy preparations and distinguishes between two types, namely the ‘magistral formula’ (“any medicinal product prepared in a pharmacy following a prescription for an individual patient”) and the ‘officinal formula’ (“any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia that is intended to be supplied directly to the patients served by the pharmacy”) [Article 3 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use].

  • ‘Reconstitution’ is defined as the “manipulation to enable the use or administration of a medicinal product for products with a marketing authorisation issued by any competent medicines regulatory authority, the reconstitution is carried out in accordance with the instructions given in the summary of product characteristics (SmPC) or the package leaflet.” [Council of Europe. Resolution CM/Res(2016)2 on good reconstitution practices in healthcare establishments for medicinal products for parenteral use], including also pharmacy preparations and investigational medicinal products (IMPs).

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