What is monograph medicine used for?
Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
Is USP FDA approved?
Under the FDCA, USP standards are binding for dietary supplement manufacturers that label their products as compliant with USP specifications. FDA has issued more than 200 regulations for food substances that incorporate USP’s Food Chemicals Codex specifications by reference.
What type of drug is monograph?
Nonprescription drug products marketed under the OTC Drug Review are referred to as OTC monograph drugs.
Why is a drug monograph given to patients?
All monographs include a description section that gives a high level overview of the drug product, key development issues, place in therapy, and related regulatory information.
What is NF in pharmacy?
Share. The United States Pharmacopeia (USP) and National Formulary (NF) are the official standards for all prescription and over-the-counter medicines, dietary supplements, excipients and other healthcare products manufactured and sold in the United States.
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.
What does USP standard mean?
A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.
What is the purpose of a USP monograph?
USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. These monographs appear in the USP–NF.
What is the latest edition of the USP-NF?
These monographs appear in the USP–NF. The 2016 edition— USP 40–NF 35 —became official on May 1, 2017. Index Review and search the combined USP and NF index.
What is the new USP 40-nf 35?
General Chapter <531> was proposed for comment in Pharmacopeial Forum 41 (6) [Nov.–Dec. 2015] and will appear in USP 40–NF 35 with an official date of May 1, 2017. The revision of <531> will affect one monograph, Thiamine Hydrochloride Tablets.
What is the new USP glycerin monograph?
Glycerin Monograph. Because of the serious hazards associated with the use of diethylene glycol-contaminated glycerin, and in response to recommendations set forth in the FDA Guidance for Industry, “Testing of Glycerin for Diethylene Glycol” published in May 2007, USP has revised the USP Glycerin monograph.