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.
USP 42 - NF 37 will come into force on 1st May 2019. It will be enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.
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
The new edition with 2019 standards — USP 42–NF 37 — published in November 2018, and becomes official May 1, 2019. It is available as a one-year subscription in print, online, and USB flash drive formats.
Includes a five-volume print main edition and two separate print supplements. Each volume contains a complete table of contents and index.