Dac

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Definition
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German Drug Codex = generally accepted standard work, whose monographs are recognised by the Federal Institute for Drugs and Medical Devices and are used for the approval of finished drugs

General information
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  • Starting materials required for the manufacture of medicinal products must meet strict standards of quality. The requirements regarding identity, purity and content are mainly contained in the official pharmacopoeia. However, testing substances that are not described in the European Pharmacopoeia ( Ph. Eur.) or the German Pharmacopoeia ( DAB) poses problems in pharmacy practice. In order to close this gap, the Federal Association of German Associations of Pharmacists decided in 1967 to publish a supplementary book to the pharmacopoeia, the first edition of which was published in 1972 under the title "Deutscher Arzneimittel-Codex" (DAC). The monographs are compiled by the Commission of the German Drug Codex in close cooperation with its own testing laboratory. The prescribing body has recognised the function of the DAC as a supplementary book to the pharmacopoeia and prescribes the Codex in § 5 Pharmacy Operating Regulations as compulsory literature for every pharmacy.
  • The DAC currently contains more than 300 monographs for drugs, excipients, herbal drugs and preparations. The regulations are structured according to the specifications of the official pharmacopoeia. Care is taken to ensure that at least the proof of identity can be carried out in any normally equipped pharmacy laboratory. A collection of regulations for the prescription preparation of drugs in the pharmacy are summarized as part of the DAC in the "New Prescription Form" ( NRF), see below for recommended concentrations for dermatological drugs.

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Last updated on: 29.10.2020