{
  "abstract": "Background and Importance Compounding (magistral and officinal pharmacy preparation) is exempt from EU pharmaceutical legislation (Directive 2001/83/EC, Art. 3), allowing each member state to implement its own rules. Such regulatory diversity may impede patient access to tailor-made medications, which are increasingly important as industry cannot always fulfil the individual patient’s needs (eg, in the case of shortages). Yet, a comparative overview of compounding legislation across the EU is lacking – information that is essential for policymakers seeking to address challenges like shortages and to ensure equitable patient access.Aim and Objectives Therefore, the aim of this study is to examine national legislation to identify and compare requirements EU member states implement for compounding.Material and Methods National legislation of 12 countries was compared: Denmark, Latvia, Finland, France, Germany, the Netherlands, Poland, Czech Republic, Slovakia, Italy, Spain and Portugal. For each country, an overview was created describing how and where compounding is defined in its national legislation, and who the responsible regulatory authorities are. In addition, seven compounding requirements were identified and compared between countries.Results All 12 countries provide a definition for magistral formula, while nine countries provide one for officinal formulae. One country offers a third definition: hospital preparation. Four countries require an additional permit or authorisation for a pharmacy to compound, while two countries include permission in the pharmacy licence. Three countries suggest the possibility of compounding if a suitable, licensed alternative is available. The conditions for this requirement differed per country. Three countries have additional rules in place for active ingredients (eg, excluding highly potent, narcotic or psychotropic substances from compounding). All countries permit pharmacy-to-pharmacy delivery under the condition that a written contract exists between parties, or authorisation is granted to the preparing or dispensing pharmacy. Four countries provide a description about the scale of compounding, with two countries setting explicit restrictions preventing large-scale use. Only two countries specify allowance of compounding in special circumstances such as war conditions.Conclusion and Relevance Legislative frameworks for compounding are heterogenous across EU member states, leading to questions about equitable patient access and uncertainties for policy makers. The findings of this study call for more harmonisation.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Utrecht University, Department of Pharmaceutical Sciences, Utrecht, The Netherlands"
      ],
      "name": "J Hoek"
    },
    {
      "affiliations": [
        "Utrecht University, Department of Pharmaceutical Sciences, Utrecht, The Netherlands"
      ],
      "name": "D Neza"
    },
    {
      "affiliations": [
        "Utrecht University, Department of Pharmaceutical Sciences, Utrecht, The Netherlands"
      ],
      "name": "ML De Bruin"
    }
  ],
  "title": "3PC-013 What are the requirements for compounding in Europe? A comparative analysis of national legislation across 12 member states",
  "uid": "68abd638-e30c-5ab8-bf08-ed18ab8932f3"
}