USP standards are used in more than 140 countries around the world. Some international regulatory authorities and governments have incorporated our standards into their laws and regulatory provisions to help protect the quality of products and ingredients produced in or exported to their countries. See below for recognition details related to specific categories of USP standards.
Manufacturers and suppliers wishing to export medicines to the U.S. should abide by U.S. law and U.S. FDA regulations, which specify USP–NF standards. (Visit “USP in U.S. Law” for information on U.S. legal status and FDA information.) In addition, USP works with the Pharmacopeial Discussion Group to harmonize to standards and also offers standards for international use through non–U.S. monographs and the USP Medicines Compendium.
Food ingredient standards that USP publishes in the Food Chemicals Codex (FCC) compendium are recognized accordingly:
- In Canada, food additives must comply with relevant specifications in regulations issued by Health Canada. If no such regulations exist, food additives must meet the specifications of the FCC 4th Edition "as amended from time to time." See: Canadian Food and Drug Regulations under Section B.01.045(b).
- For Australia and New Zealand, the Food Standards Australia and New Zealand recognizes the Sixth Edition of the FCC as a primary source of identity and purity specifications for substances added to food in Standard 1.3.4 Identity and Purity of its Food Standards Code.
- In Brazil, FCC standards are recommended, along with other standards.
- The Joint FAO/WHO Expert Committee on Food Additives (JECFA), an international scientific body that evaluates and assesses the safety of food additives for the Codex Alimentarius Commission, has used certain FCC specifications to develop its standards.
- In Israel, the Public Health Regulations state that those who produce, import, market or store a food additive must comply with the requirements established in the latest edition of FCC or in the latest edition of the Compendium of Food Additive Specifications (JECFA).