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Aufgaben und Kurzportrait DAC/NRF

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Scope of DAC/NRF

  • Core Task

DAC/NRF is published in semi-annual updates: Advised and supplied by an expert commission, revision in the laboratory and editorial implementation

  • Further Task Fields

Online Services: Formula Notes (Rezepturhinweise) for research and enquiries

Survey

The starting materials for the preparation of medicinal products must comply with strict standards in terms of quality. Requirements on identification, purity and content are included in the official pharmacopoeia. In pharmaceutical practice,problems occurred with the tests and assay of those substances which are neither described in the European Pharmacopoeia, the German Pharmacopoeia nor in the Homeopathic Pharmacopoeia. In 1967 the ABDA (Federal Union of German Associations of Pharmacists) decided to close this gap with a supplement to the Pharmacopoeia. The first edition was published in 1972 with the title "German Drug Codex” (Deutscher Arzneimittel-Codex = DAC). In compliance with its original intent, DAC-monographs are now being used as recognized standards by industrial manufacturers for the certificates of analysis of starting materials according to the Regulation on the Operation of Pharmacies (ApBetrO). The Federal Institute for Drugs and Medical Devices (BfArM) works with DAC-monographs in licensing procedures of finished products, including the standard marketing authorizations according to § 36 AMG (German Medicines Act). Since 1983, another publication plays an important role for the preparation of unlicensed medicines: the "New German Formulary" (Neues Rezeptur Formularium = NRF). It contains codified formulas and pharmacy-friendly preparation techniques. The contents of both publications were merged in 2013.

Editor of DAC/NRF is the ABDA – Federal Union of German Associations of Pharmacists. The ABDA assigns the independent expert commission of the German Drug Codex and the New German Formulary (DAC/NRF-Commission). Under their scientific advice, it is ensured that all monographs and texts reflect the acknowledged standard of pharmaceutical sciences. They also ensure that only medically safe and no dubious starting materials and medicines are monographed and obsolete formula are deleted. Monographs and texts are developed and editorially implemented in ABDA-owned laboratories in Eschborn.

Today, in addition to all the previous texts, the DAC/NRF contains common general regulations with the important glossary and electronic "DAC/NRF-Tools" to support risk assessment, compounding, testing and documentation. Apart from general methods and attachments, the DAC/NRF delivers 280 monographs for drugs, additives, herbal drugs and compoundings. These regulations are designed according to the requirements of the official pharmacopoeia and, where feasible, uses the analytical methods and reagents of the European Pharmacopoeia. It always is ensured that at least the identification can be performed in normally equipped laboratories in every pharmacy.

The DAC/NRF includes the general notes with important texts for preparation in the pharmacy as well as formula for concentrates and vehicles which are used in medicinal products. Since 2007, DAC/NRF has published alternative identification test methods of several hundred starting materials to simplify the incoming identification test of these goods by the pharmacy, without reducing the quality and safety.

In medical therapy, some medicines can only be prescribed with a formula because of lack of suitable finished drugs. These NRF-medicines are associated with the "compassionate use"- and "orphan drug"-problem. Corresponding niches of pharmacotherapy especially exist in Otolaryngology, Ophthalmology, Dentistry, in the local application in Dermatology and in special pediatric dosages. Only a few preparations have been taken from the largely obsolete Deutsche Rezeptformeln (German Dispensing Formulas). However, many regulations of the last official formulary of the GDR, the Standardisierte Rezepturen (codified formulas), have been assimilated in 1990.

Since 2008, in addition to the loose-leaf collection, the DAC/NRF is also available on DVD-ROM in a semi-annual update. Since 2013 subscribers can use all sections of DAC/NRF online (www.dac-nrf.de).

History

  • 2021

    New DAC monograph "Granules for Use in Traditional Chinese Medicine". Two stock preparations “Atropine sulfate stock solution 0.2% (NRF S.53.)” and "Cellulose silica filler (NRF S.54.)” and two new NRF formulas “Melatonin suspension 2 mg/mL (NRF 17.6.)” and “Hydrocortisone suspension 1 mg/mL / 10 mg/mL (NRF 34.2.)”. New bulk test instruction for "Propranolol solution 5 mg/mL (NRF 11.142.)”. 12th edition of "Tabellen für die Rezeptur".

  • 2020

    New test methods for alternative identification of numerous substances. New DAC monograph “Diluted base cream (DAC B-021-1)“. Additional concentration steps for "Oily Cannabidiol Solution (NRF 29.10.)" New NRF formulation "Miconazole solution 5 mg/mL", "Glucose solution 250 mg/mL for oGTT" and "Atropine sulfate eye drops 0.01%".

  • 2019

    Resume DAC monograph "Water-soluble aescin (DAC A-031)". New NRF formulation "Sildenafil citrate suspension 10 mg/mL", "Spironolactone suspension 5 mg/mL", and "Trichloroacetic acid solution 850 mg/mL / 1000 mg/mL". New calculation guide for suppositories and vaginal suppositories. 11th edition of "Tabellen für die Rezeptur".

  • 2018

    New DAC monographs "Refined notoginseng root dry extract (DAC N-185)", "Washable ointment base (DAC S-012)", and "Oral suspension base for intake (DAC G-105)". New NRF strain preparation Basis for Oral Suspensions and new NRF prescription Propranolol Hydrochloride Solution 1 mg/mL. Update of calculation aids for weighing correction, powder and capsules.

  • 2017

    Reference source guide for reagents, reference/comparative substances, and equipment (for preparation/testing). New DAC monograph: oxetacaine. New NRF prescriptions: cannabis flowers for inhalation and tea preparation, and captopril solution for pediatrics. Expanded calculation guide on powder-filled hard capsules with preparation calculation and in-process testing. 9th edition of Standardized Formulations with pictograms for dermatology basics and many overview tables. 10th edition of "Tabellen für die Rezeptur".

  • 2016

    New DAC monographs: "Cannabis flowers", "Discontinued, refined cannabis oleoresin", and "Octenidine dihydrochloride". New test methods for alternative identification: "Cannabis flowers", "Mannitol (for capsule production)", "Omperazole". Numerous new color illustrations. New NRF formulation: "Sotalolol hydrochloride solution" and "Thermogel." New edition of the tables for formulation. Convenient online calculator for weight correction factor. New calculation aids for powders and capsules.

  • 2015

    Four new NRF formulations: "Metoclopramide solution", "Benzdamine hydrochloride mouth rinse solution", "Lipophilic capsaicinoid cream" and "Oily cannabidiol solution". Four new test procedures for DAC/NRF bulk formulations: "Betamethasone valerate cream", "Trichloroacetic acid solution", "Amfetamine sulfate oral solution", and "Dexamfetamine sulfate drops". Ophthalmic ointment bases in the stock preparations section. New database structure for DAC/NRF formulation notes. Weekly DAC/NRF formulation tip (newsletter). 8th edition of Standardized Formulations with pictograms for dermatics.

  • 2014

    Inclusion of nine new test procedures for DAC/NRF bulk formulations. Restructuring of the General notes on dosage forms. Two new creams with prednicarbate. The newly crafted - more user-friendly - Excel file to calculate the weight-in correction factor.

  • 2013

    Interconnection of preparing and testing according to quality management systems and the Regulation on the Operation of Pharmacies by merging and restructuring of the DAC and NRF-sections. Joint general regulations relevant to the pharmacy definitions in the glossary. Inclusion of the chapters “durability“ and “approval tests” in the NRF formulation rules. Extension of the Tabellen der Rezeptur (List of Formula) – plausibility check at the pharmacy" with "prescripted pH ranges" of dermatic bases, lipid additions to ethyl alcohol for skin and pH correctors.

  • 2012

    NRF: Extension of the “Tabellen der Rezeptur (List of Formula) - plausibility check at the pharmacy" with the chapters "Receiving inspection of starting materials” and "Standard concentrations of dermatic ingredients in Pediatrics". Approval tests of NRF preparations for pharmacies according to the Regulation on the Operation of Pharmacies, chapter I.2.10.. Sixth edition of Standardisierte Rezepturen NRF/SR (codified formulas).

  • 2011

    DAC: Introduction of color images.
    NRF: Out of the specific perspective of the pharmacy further subgroups of drugs and precursors are differentiated with the durability classification in Chapter I.4.. Fifth edition of Standardisierte Rezepturen NRF/SR (codified formulas).

  • 2010

    NRF: Customizable sample letters to facilitate the communication between pharmacists and doctors, as well as forms for the documentation of the plausibility check.

  • 2009

    NRF: Constitution of the NRF-Commission. A concentrated Oseltamivir solution especially for children is monographed. Electronic work and documentation templates for all NRF formula. Revised and expanded Tabellen für die Rezeptur (Tables for Preparation) with two new outlines: "Tensides – emulsifiers and solubilizers" and "thickening agents". Regular information with the email newsletter of Pharmazeutische Zeitung (weekly published pharmaceutical journal of German pharmacists).

  • 2008

    In addition to the print version, a version of DAC/NRF on CD-ROM is introduced. Advantages are the simple keyword search, the specific selection of text passages, easy retrievability of NRF formulation rules for a particular dosage form or a drug. NRF® has existed for 25 years.

  • 2007

    NRF: CD-ROM with work and documentation templates regarding a structured and flexible preliminary work and the controlled preparation of unlicensed medicines in the pharmacy: for all NRF-concentrates and -vehicles, 44 NRF-formula rules and blank templates for dermatological individual prescriptions. A drug database is included for the weight-in correction factor in case of concentration-reduced substances (according to chapter I.2.1.1.). Fourth edition of Standardisierte Rezepturen NRF/SR (codified formulas).

  • 2006

    DAC: Introduction of alternative identification methods in an additional volume (Band 3). Monographs and texts adapted to Ph. Eur. 5.
    NRF: According to official influenza pandemic plans an Oseltamivir-solution is monographed (NRF 31.2.). Third edition of Standardisierte Rezepturen NRF/SR (codified formulas).

  • 2003

    DAC: Adjustment to the fourth edition of the European Pharmacopoeia in four stages.
    NRF: Preliminary last acquisition of SR-rules (codified formulas).

  • 2001

    NRF: First Statement on "Problematic drug formulation" by the Drug Commission of German Pharmacists. The NRF formula information point is established on behalf of the chamber of Pharmacists. A website with "NRF formula notes" is launched. Second edition of Standardisierte Rezepturen NRF/SR (codified formulas).

  • 2000

    DAC: Inclusion of new monographs on tea drugs and important starting materials for drug formulation.

  • 1999

    NRF: Creation of the first "NRF formula notes" regarding often requested issues of the pharmacy practice.

  • 1998

    NRF: First edition of Tabellen der Rezeptur (Tables for Preparation) as a supplement to NRF®.

  • 1997

    DAC: A complete overhaul of the DAC 1986 was required with the third edition of the European Pharmacopoeia and its separation from the German Pharmacopoeia 1997. It was performed in three stages from 1997 to 1999.
    NRF: Many rules of the Standardisierte Rezepturen (codified formulas, 1990), the last official formulary of the GDR, have been integrated into the NRF®. The first edition of the Standardisierte Rezepturen NRF/SR was published.

  • 1994

    NRF: After legalization of methadone for opiate substitution, the NRF 29.1. got standard in substitution treatment.

  • 1989

    NRF: Renunciation of superfluous formulas that are in competition with finished medicinal products (capsules) for the benefit of specific characteristics (alternatives of conservation). First formula-specific durability concept in chapter I.4.

  • 1988

    NRF: Redesign of the NRF®: General notes, cutting the previously DAC similar monographs on the specific medicinal product as a formula-rule with a preparation part and explanations. In a separate part: first formula for concentrates and vehicles.

  • 1987

    NRF: Adapting to change the formula operation to the new Regulation on the Operation of Pharmacies (ApBetrO 1987): starting material certificates, organization of formula and small industrial scale, expert meeting of the Central Testing Laboratory regarding "storability of drugs and preparations in the pharmacy."

  • 1986

    DAC: With the second edition of the European Pharmacopoeia and the German Pharmacopoeia ninth edition the DAC required a complete revision in 3 stages from 1986 to 1988. Additions until 1996

  • 1985

    DAC/NRF: With the second addition, the NRF® became a separate volume of DAC®. Monographs on ready-for-use formulations are transferred from DAC® to the NRF®. Simultaneously DAC® and German-Pharmacopoeia-ninth edition formulations are transferred into standard approvals (according to § 36 German Medicine Act).

  • 1983

    NRF: The Drug Commission of German Pharmacists publishes the first edition of the New German Formulary (NRF®) with 30 monographs as a supplement to the DAC®. This is followed by annual additions.

  • 1980

    Beginning of the preparatory work for the "New German Formulary (NRF)": In the course of overdue revision of the largely obsolete Deutsche Rezeptformeln (DRF/German Pharmaceutical formulas) the Drug Commission of German Pharmacists advises 84 DRF formulas and decides the acquisition of 40 monographs. The Central Laboratory of German Pharmacists is assigned with the revision.

  • 1979

    DAC: First revision required by the first edition of the European Pharmacopoeia, the German Pharmacopoeia eighth edition and the Homeopathic Pharmacopoeia first edition. Also basics and drugs for preparing in the pharmacy are monographed.

  • 1972

    DAC: In tradition of the German Pharmacists Association, the ABDA - Federal Union of German Associations of Pharmacists - developed/improved this work. Implementation of a full-Scientific Office and Central Laboratory of German Pharmacists. The loose-leaf collection, containing annual supplement deliveries, is made mandatory by terms of the Ordinance on the Operation of Pharmacies.