What version of USP is current?

What version of USP is current?

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 2022, Issue 1, will become official on May 1, 2022.

Is USP same as NF?

USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.

What are the USP guidelines?

USP is a scientific nonprofit organization that sets public standards for identity, strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states.

What is CP grade in chemicals?

CP (Chemically Pure) Grade—Products of purity suitable for use in general applications. FCC Grade—Products that meet the requirements of the current Food Chemical Codex.

What is USP grade material?

USP grade meets or exceeds requirements of the United States Pharmacopeia (USP). This grade is acceptable for food, drug, or medicinal use. It is also used for most laboratory purposes, but the USP being followed should always be reviewed prior to beginning to ensure the grade is appropriate for that methodology.

What is USP code?

The shortcut USP comes from United States Pharmacopeial convention. Every kind of material or phase has a USP code. It is a general grouping for materials and the differences between materials with similar modifications are excluded. For example all C18 phases have the same USP column code.

Is USP recognized by FDA?

USP has no role in enforcement of these or other provisions that recognize USP–NF standards, which is the responsibility of FDA and other government authorities in the United States and elsewhere.

Is USP credible?

USP is a globally recognized, nongovernmental, nonprofit organization that sets standards for identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. Some USP standards have been incorporated in FDA regulations.

What is CEP and cos?

‘CEP’ stands for ‘Certification of suitability to the monographs of the European Pharmacopoeia’. Although ‘COS’ (‘Certificate of Suitability’) has the same meaning, it is not the official acronym, .

Is USP a government agency?

While not a government entity, USP works closely with government agencies, ministries, and regulatory authorities around the world to help provide standards of identity, strength, quality, and purity that can help safeguard the global supply of medicines, dietary supplements, and food ingredients.

  • October 27, 2022