The pharmacopoeia specifies the quality standards that apply to substances and medicinal products. It describes how substances and certain medicinal products are defined, manufactured, and tested in order to be of the required "pharmacopoeial quality". It mostly describes the test procedures applied for controlling this quality in detail with regard to analytics. On the other hand, it is stipulated by law that substances and medicinal products listed in the pharmacopoeia that do not comply with the rules contained therein may not be manufactured or placed on the market. This ensures a high quality of medicinal products, among others due to fact that the quality of their starting materials meets the requirements of the pharmacopoeia.

Pharmacopoeias are an important instrument for the protection of patients. Especially the European Pharmacopoeia (Pharmacopoea Europae, abbreviated Ph. Eur.) is required for the licensing of medicinal products. When a pharmaceutical entrepreneur applies for such a marketing authorisation, he must prove the pharmaceutical quality of the product in addition to its efficacy and safety. In cases in which this is applicable, he can refer to the pharmacopoeias. Regulatory authorities recognise such referencing as a prerequisite for the pharmaceutical quality of the substances. This spares both manufacturers as well as the BfArM from having to demonstrate the pharmaceutical quality for each substance in detail.

Despite the European Pharmacopoeia's central role, national pharmacopoeias like the DAB have not lost their raison d'être. For substances not described in the European Pharmacopoeia, EU Member States may require compliance with the provisions of their own national pharmacopoeia, especially if the Ph.Eur. has no interest in elaborating a specific monograph or in cases where national healthcare interests necessitate such elaboration. Thus, despite the fact that the DAB has clearly lost in range, it continues to represent an important national addition to the European Pharmacopoeia.

Manufacturers of starting materials refer to both the German Pharmacopoeia and the European Pharmacopoeia for incoming goods inspections as well as for the production and release of medicinal products in order to confirm the pharmaceutical quality thereof.

Hospital pharmacies require this information mainly for the testing of starting materials for the production of their medicinal products, public pharmacies require it for testing substances used for formulations, and monitoring laboratories need the pharmacopoeia in order to test the medicinal products and starting materials after their manufacture or marketing authorisation.

Editing and further development of the German Pharmacopoeia is one of the statutory tasks of the BfArM. Suggestions as to modifications of or additions to the Pharmacopoeia are suggested by industry as well as by other authorities or users. If a new substance is to be included in the German Pharmacopoeia, the requirements and specifications are mainly elaborated in the BfArM’s laboratories.

Decisions as to what is included in the German Pharmacopoeia, where there is need for editing, but also whether something should be deleted from the pharmacopoeia are made by the German Pharmacopoeia Commission. The members of this commission are convened by the BfArM in agreement with the Paul-Ehrlich-Institute and the Federal Office of Consumer Protection and Food Safety.

However, in the case of comprehensive monographs applicable throughout Europe, the European Pharmacopoeia Commission must be consulted as to whether it intends to include the monograph in its work programme. The German Pharmacopoeia Commission (DAB-Commission) is made up of equal numbers of experts from medical and pharmaceutical science, healthcare professions, economic areas concerned, and regulatory authorities. This Commission currently consists of 24 full members and their deputies. In order to prepare its decisions and for tasks in connection with the Convention on the elaboration of a European Pharmacopoeia, the DAB-Commission can install expert committees for specific subjects. At present, more than 150 experts are appointed to the DAB Commission and its committees while 207 experts are delegated to the committees of the European Pharmacopoeia. This has resulted in a national network of pharmaceutical and in parts medical expertise that is unequalled in Germany which allows the BfArM to gather expertise on pharmaceutical quality quickly even beyond the pharmacopoeia when medicinal products appear to be of concern.

Yes. Significant examples for this are cannabis flowers and a standardised cannabis extract. Since 2017, physicians have been able to prescribe medical cannabis flowers or cannabis extract in pharmaceutical quality on special prescription forms. The definition of this pharmaceutical quality is specified in the corresponding monographs. This was first published in an announcement of 5 May 2017 and has been updated repeatedly since then. The BfArM played a crucial role in the development of this monograph, thus making an important standard available that is highly relevant for the care of certain patients.

In addition to this, the elaboration of a monograph "Cannabis Flos" for the European Pharmacopoeia was also mandated. This is done under the aegis of The Netherlands and Germany (represented among others by the BfArM).

In Europe, the history of pharmacy is intertwined with the development of religious orders and monasteries. The "Lorsch Pharmacopoeia" which was created around 795 in the Imperial Abbey of Lorsch in South Hesse, is considered to be the first German Pharmacopoeia and is now part of the UNESCO World Documentary Hertitage.

No. According to information from the World Health Organization (WHO), currently more than 50 countries in the world have national pharmacopoeias. Aside from the German Pharmacopoeia, for example, there are also the United States Pharmacopeia as well as the Japanese and Chinese pharmacopoeias. In addition, there is also a pharmacopoeia with worldwide validity which is published by the WHO (The International Pharmacopoeia).

In parallel to the national pharmacopoeias, the European Pharmacopoeia has been developed under the aegis of the Council of Europe since 1974.
The arrival of the European Pharmacopoeia also altered the tasks of the German Pharmacopoeia Commission and its committees. Existing monographs were increasingly incorporated into the European Pharmacopoeia and the elaboration of new monographs was now mainly done by the committees of the European Pharmacopoeia Commission. As a consequence, the committees of the German Pharmacopoeia Commission today mainly discuss the drafts for monographs of the European Pharmacopoeia. Many members of the national committees are also active in the working and expert groups of the European Pharmacopoeia Commission and can therefore report directly to DAB-Commission and committees.

150 years ago, the first pan-German pharmacopoeia was published in 1872 – one year after foundation of the German Reich. On the basis of the state pharmacopoeias of the 19th century, especially the 7th edition of the Prussian Pharmacopoeia (1862), the then General German Pharmacists' Association drew up the Pharmacopoea Germaniae (1865/1868) which was soon further developed to the first uniform German Pharmacopoeia, the Pharmacopoea Germanica (1872) and came into force on 1 November 1872. This pharmacopeia was written in Latin and is today referred to retrospectively as DAB 1.

Beginning with DAB 3 (1890), the German Pharmacopoeia was published in German for the first time and, as is customary to this day, with the Latin subtitle "Pharmacopoeia for the German Reich, Third Edition (Pharmacopoea Germanica, editio III)". From the fifth edition (of 1910) onwards, it was titled "German Pharmacopoeia" (DAB).
Of the historical pharmacopoeias that followed, DAB 6 has reached the greatest degree of recognition as it was valid for the extremely long period from 1927 until 1968 due to war and post-war circumstances. Later pharmacopoeia editions were revised and published more frequently due to the increasingly speedy developments in pharmaceutical science they had to adapt to.
The successor to DAB 10 was not termed "DAB 11" but "DAB 1996" instead. This naming convention ("DAB" + the year of the implementation) has been maintained ever since.

The current DAB 2022 contains 32 general texts and methods, 53 reagents as well as 1 buffer solution and 73 monographs on APIs or pharmaceutical preparations with 3 appendices. Even though more and more texts are disappearing from the German Pharmacopoeia because they have been included in the European Pharmacopoeia, new texts are continuously being elaborated and incorporated.

Thus, the 2022 edition contains a monograph "Light Liquid Synthetic Paraffin". Due to its manufacturing process, this substance exhibits a high purity in terms of aromatic hydrocarbons. To the extent possible, considering the pharmaceutical-technological properties of this substance, it will potentially serve as a substitute for "Light Liquid Paraffin" which is won by the reprocessing of petroleum and is contaminated with small amounts of aromatic hydrocarbons.

The 1872 pharmacopeia offers a glimpse into the history of pharmaceutical science yielding all sorts of amazing information. For example, that opium apparently used to be available in quite a decorative presentation: "Usually somewhat compressed or nearly globular cakes […] wrapped in poppy leaves and sprinkled with the fruit of any type of sorrel". Or, e.g., that navy pitch was used in the manufacture of medicinal products.

Some things we don't even want to know in too much detail. For example, that the lard included in the DAB until recently must be won by "melting out the fat clinging to the net and the kidneys", or that "sturgeons' swim bladders" dissolve almost completely in boiling water and were a component of the so-called "English plaster". On the other hand, for example, it is absolutely crucial to know that strychnine must be stored very carefully.

Many substances, which were surely less salubrious upon closer consideration, have since disappeared from the pharmacopoeia. One example for this is production of adhesive plasters using lead or mercury. Other substances continue to maintain their position to this day, e.g. liqueur wine, mistletoe or even gasoline.