The USPNF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version of USP NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.
The current version, USP 43NF 38, is become official on November 1, 2020.
The USP 43 NF 38 is the last edition that is available in print or on a USB flash drive. Starting with the First Supplement to USP 43 NF 38 that is published on February 1, 2020, only the online format will be available. Future supplements and editions including the First and Second Supplements to USP 43 NF 38 will not be printed or on flash drives. Only the online format will contain all current USPNF content.
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Features
More than 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USPNF monograph.
More than 350 general chapters providing clear, step-by-step guidance for assays, tests, and procedures
Helpful sections on reagents, indicators, and solutions, plus reference tables Includes new General Chapter <800> Hazardous Drugs Handling in Healthcare Settings
Benefits & Applications
The USPNF offers convenient, comprehensive information for all phases of producing quality prescription, nonprescription, and compounded medicines; excipients; biologics; medical devices; and dietary supplements. It is essential for quality control, quality assurance, regulatory/compendial affairs, research and development, method development/analytical services, and corporate management. USPNF monographs and methods can help to
- Ensure compliance with required U.S. quality standards
- Work to world-recognized standards of precision and accuracy
- Validate test results against proven benchmarks
- Establish and validate in-house standard operating procedures, and specifications
- Expedite new product development and approvals
A Valuable Reference for scientists, professionals, and students working in or with:
- Pharmaceuticals prescription and nonprescription drugs
- Biological and biotechnology products
- Blood and blood products
- Compounded preparations
- Cosmetics
- Dietary supplements
- Excipients/other drug ingredients
- Medical devices
- Medical gases
- Medical libraries
- Pharmacies
- Schools of medicine and pharmacy
- Veterinary drugs
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Pharmacopoeia
