New recipe form

The New Formulation Form (NRF) is a compilation published by the ABDA - Federal Association of German Pharmacists' Associations , in which formulas, standardizations and pharmacy-appropriate manufacturing techniques for drugs are recorded. It is used for quality assurance of prescription drugs (magistral formulations) , especially for those drugs that are not available as finished drugs ( orphan drugs , compassionate use ).

The NRF is affiliated with the German Medicines Codex (DAC) and has been published since 1983. It replaced the German recipe formulas (DRF), numerous regulations have been adopted from the standard recipes 1990 (SR), the last official formula collection in the GDR. The contents of the NRF are developed by the Pharmaceutical Laboratory of the NRF working group in Eschborn .

When using magistral prescriptions, doctors and pharmacists assume liability risks and disclosure obligations that are normally subject to pharmaceutical companies. Therefore, formulations should not be used without hesitation and only after the patient has been informed in detail in writing about the effects and all possible side effects of the prescription drug. The production of prescriptions in pharmacies is based on an exception regulated in the German Medicines Act (AMG) to the pharmaceutical approval obligation applicable to pharmaceutical manufacturers. It is intended to give doctors the opportunity to optimally treat patients for whom there are no suitable finished medicinal products. The German courts therefore narrowly interpret the possibility of using this exception to the authorization requirement for medicinal products. Manufacture in the pharmacy must follow recognized pharmaceutical rules even if this exception is invoked. A resolution of the Council of Ministers of the European Union of January 19, 2011 makes it clear that the use of formulations is only indicated if there is a clear additional benefit for the patient or if no finished medicinal product is available. If an approved finished medicinal product is available and there is no clinical or scientific justification for the use of a magistral formulation, the finished medicinal product must be used. Since this resolution was drawn up by the "European Committee on Pharmaceuticals and Pharmaceutical Care", it corresponds to a pharmaceutical rule and is therefore to be used as a prerequisite for the production of magistral formulations. This also corresponds to various German higher regional courts, which prohibit the reproduction of finished medicinal products with reference to the exemption in the AMG.

literature

• Standardized recipes (NRF / SR) . 5th edition. Govi, Eschborn 2011, ISBN 978-3-7741-1139-4 , pp. 171 .

Web links

• pharmaceutical-newspaper

Individual evidence

1. ↑ Pharmaceutical rule within the meaning of AMG Section 8, Paragraph 1, No. 1: It is forbidden to manufacture or market drugs or active ingredients that are not insignificantly reduced in quality by deviating from the recognized pharmaceutical rules.
2. ↑ Resolution CM / ResAP (2011) 1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients , Council of Ministers of the European Union, January 19, 2011.
3. ↑ Guideline for the prescription of drugs in dermatological therapy contracted by a doctor, publisher: Deutsche Dermatologische Gesellschaft (DDG) President: Thomas Luger Professional Association of German Dermatologists (BVDD) President: Michael Reusch; 2010.