Pharmacopoeia

What does the Pharmacopoeia contain?

§ 55(1) of the Medicinal Products Act describes the pharmacopoeia as the published collection of recognised pharmaceutical standards for the quality, testing, storage, and supply of medicinal products, as well as for containers and packaging. In practice, it consists of monographs for individual substances and preparations, as well as general methods and limit values. The European Pharmacopoeia is developed at the Council of Europe through the EDQM and applies in all contracting states. In addition, there is the German Pharmacopoeia and the Homeopathic Pharmacopoeia. The German Pharmacopoeia Commission is based at the Federal Institute for Drugs and Medical Devices; publication takes place under § 55(7) AMG in the Federal Gazette.

Which version is currently in force?

The European Pharmacopoeia is published in editions with ongoing supplements. Version 12.1 entered into force on 1 January 2026, and version 12.2 on 1 April 2026. Anyone working in compounding pharmacy must therefore follow the supplements continuously, as testing requirements and limit values may change. For some years now, the European Pharmacopoeia has only been available electronically, which means ongoing licence costs for pharmacies. For students, many university libraries provide access, though this may be tied to the university network. After graduating, this access is lost.

Why is the Pharmacopoeia relevant for graduates from EU countries abroad?

The European Pharmacopoeia also applies in Bulgaria, Romania, Hungary, Croatia, Malta, and the Baltic states, as these countries are contracting parties to the underlying Council of Europe convention. The professional foundations are therefore the same, and monographs do not need to be learnt from scratch. Differences arise in the national section and in German-language terminology. This is precisely the level tested in the knowledge test and in the Third Section of the Pharmaceutical Examination, for example when testing starting materials under the Pharmacy Operating Ordinance.

Common misconceptions

The pharmacopoeia is not a textbook but a binding standard. The German Drug Codex with the New Prescription Formulary (DAC/NRF), by contrast, does not form part of the official pharmacopoeia, but is used just as frequently in practice. It is only binding to the extent that individual regulations refer to it.