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 43–NF 38, will become official on November 1, 2020.
The USP 43–NF 38 is the last edition that will be available in print or on a USB flash drive. Starting with the First Supplement to USP 43–NF 38 that will be 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 USP–NF content.
Click here for Frequently Asked Questions (FAQs) related to the transition from print/USB flash drive formats to the online format.
What's Inside USP 43–NF 38
- Annotated List. Learn what monographs, general chapters, reagents, and tables are new and revised.
- Ordering Information
- Technical Services and Account Managers
- Currency Change Request
- Credit Application
- Authorized Distributors
- 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
Includes a five-volume print main edition and two separate print supplements. Each volume contains a complete table of contents and index.
Please note that the USP 43–NF 38 will be the last five-volume printed edition. Future supplements and editions – including the First and Second Supplements to USP 43–NF 38 – will not be printed. Starting with the First Supplement to USP 43–NF 38 that will be published on February 1, 2020, the print format will not be available. Only the online format will contain all current USP–NF content.
Provides access to all updates posted online during the 12 months after subscription start date. Online features include enhanced search capabilities, ability to set alerts and bookmark pages, and a new history tab to quickly access all available versions of a document. Content is updated monthly with Accelerated Revisions, including Revision Bulletins and Errata, making USP–NF Online a one stop shop for all content. The USP–NF Online subscription is based on 12 months and can be purchased for 1 or more licenses. (View online technical support.)
Benefits of the new USP–NF Online platform include:
- New individual accounts, enabling each user to customize what they see on the product dashboard, making more efficient use of your time.
- Completely new comprehensive search tool that operates like search tools on many popular websites, helping you to find exactly what you need.
- Simplified navigation of all content with annotations to explain the content of different sections, thereby simplifying access for new or infrequent users.
- The ability to save personalized bookmarks and easily return to any page through the “Viewing Activity” function, so you can efficiently go back to previous pages.
- The ability to receive notifications of upcoming changes to specific documents, so you always know when key documents and tests are updated.
- The ability to search across multiple editions of the USP–NF Online instead of having to log out and then change editions.
USB Flash Drive
The USB flash drive format provides a searchable PDF of the same quality content found in print that is viewed with a secure PDF viewer. Functions include a search tool, clearly bookmarked contents for quick navigation, and printing. Each main edition and supplement integrates content from all previous editions. Subscribers will receive updates that occur during their subscription period on a new cumulative USB flash drive.
Please note that the USP 43–NF 38 is the last edition that will be available in on a USB flash drive. Future supplements and editions – including the First and Second Supplements to USP 43–NF 38 – will not be on a flash drive. Starting with the First Supplement to USP 43–NF 38 that will be published on February 1, 2020, USB flash drive formats will not be available. Only the online format will contain all current USP–NF content.
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