The USP–NF 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–NF 2021, Issue 1, will become official on May 1, 2021.
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- More than 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP–NF 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
The USP–NF Online is the only source for all official USP–NF content. This online platform provides access to all updates posted within the 12 months after your subscription start date. This includes Accelerated Revisions (e.g., Revision Bulletins and Errata) that are posted at the end of each month. Online features include enhanced search capabilities, ability to set alerts and bookmark pages, and a history tab to quickly access all available versions of a document. Content is updated monthly making USP–NF Online a one-stop shop for all content. A 12-month subscription to the USP–NF Online can be purchased based on the number of end-users at your organization. (View online technical support.)
To see a list of benefits of the USP–NF Online, see Frequently Asked Questions (FAQs).
The Spanish USP–NF Online is also available to purchase at the USP Store. Click here for more information on the benefits of the Spanish USP–NF Online.
USP–NF print publications are no longer being produced starting with First Supplement to USP43–NF38. Some print copies are still available for purchase at the USP Store. The last print publication available in English is the USP43–NF 38 main edition (5-volume set) which does not include the Supplements (First Supplement and Second Supplement to USP43–NF38). The content for both the First Supplement and Second Supplement to USP43–NF38 is only available in the USP–NF Online.
USB Flash Drive
USP no longer provides USP–NF content on a USB flash drive starting with First Supplement to USP43–NF38 in English and USP43–NF38 in Spanish. The only publication available in the USB flash drive format is USP42–NF37 and its Supplements. The USB flash drive format provides a searchable PDF with a secure PDF viewer.
USP42–NF 37 Second Supplement was the last Spanish language Flash Drive produced. Access to USP–NF content in Spanish is only available in the Spanish USP–NF Online.
USP is aware of minor technical issues with the USP–NF English and Spanish USB flash drive products. These issues are rare and appear to be limited to systems running on Windows 10. If you experience an “Access violation” error message while using the search function, please close the Lock Lizard application and restart. If you experience any other issues, please contact us here.
Flash Drive Technical Requirements
One free USB 2.0 slot.
Benefits & Applications
The USP–NF 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. USP–NF 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
- Dietary supplements
- Excipients/other drug ingredients
- Medical devices
- Medical gases
- Medical libraries
- Schools of medicine and pharmacy
- Veterinary drugs