1. United States Pharmacopeia Usp Monograph

Key peopleRonald T. Piervincenzi WebsiteThe United States Pharmacopeia ( USP) is a (compendium of information) for the published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the and also owns the on the pharmacopeia itself. The USP is published in a combined volume with the National Formulary (a ) as the USP-NF. If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation 'USP' or 'NF'. Drugs subject to USP standards include both human drugs (, or otherwise) and animal drugs. USP-NF standards also have a role in; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality or purity.

USP also sets standards for and food ingredients (as part of the ). USP has no role in enforcing its standards; enforcement is the responsibility of the U.S.

The monographs in this section are derived from monographs contained in the USP, including monographs found in the Dietary Supplements section of the USP. The presence of a monograph for an article in this compendium does not represent endorsement by USP that the article is in fact a dietary ingredient or a dietary supplement.

(FDA) and other government authorities in the United States and elsewhere. Contents.Product quality–standards and verification USP establishes written (documentary) and physical standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.Prescription and over-the-counter medicines available in the United States must, by, meet USP-NF public standards, where such standards exist.

Many other countries use the USP-NF instead of issuing their own pharmacopeia, or to supplement their government pharmacopeia.USP's standards for food ingredients can be found in its ( FCC). The FCC is a compendium of standards used internationally for the quality and purity of food ingredients like preservatives, flavorings, colorings and nutrients. While the FCC is recognized in law in countries like, and, it currently does not have statutory recognition in the United States, although FCC standards are incorporated by reference in over 200 FDA food regulations. USP obtained the FCC from the in 2006. The IOM had published the first five editions of the FCC.USP also conducts verification programs for dietary supplement products and ingredients. These are testing and audit programs.

Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letters 'USP' alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified products.Healthcare information In the past, Congress authorized the Secretary of HHS to request USP to develop a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their, and to revise such classification from time to time to reflect changes in therapeutic uses covered by Part D drugs and the addition of new covered Part D drugs. USP has developed six versions of the Model Guidelines, the last issued early in 2014 for the 2015–2017 benefit years.

Promoting the Quality of Medicines program Since 1992, USP has worked cooperatively with the (USAID) to help developing countries address critical issues related to poor quality medicines. This partnership operated as the Drug Quality and Information (DQI) program until 2009, when, to better meet growing global needs, USAID awarded USP a five-year, $35 million cooperative agreement to establish a new, expanded program:. In 2013 USAID extended the PQM program for five years (through September 2019), increased its funding to $110 million, and expanded the geographical reach of the program.PQM serves as a primary mechanism to help USAID-supported countries strengthen their quality assurance and quality control systems to better ensure the quality of medicines that reach patients.

PQM has four key objectives:. Strengthen quality assurance (QA) and quality control (QC) systems.

Increase the supply of quality assured medicines. Combat the availability of substandard and counterfeit medicines. Provide technical leadership and global advocacyUSP-USAID collaborative efforts have helped communities improve drug quality in more than 35 countries. Geoffrey bawa the complete works pdf free download.

PQM currently works in, and the.International agreements and offices USP works internationally, largely through agreements with other pharmacopeias, as well as regulatory bodies, manufacturer associations and others. In recent years, USP signed a series of with groups including the, nine countries belonging to the, and the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor). USP also operates an international office in Switzerland and offices and laboratories in Brazil, India, and China.

In November 2014, a delegation from Global LifeSci Development Corporation, as part of Montgomery County's business visit to India visited U.S. Pharmacopeial Convention at IKP Knowledge Park in Hyderabad in India. See also. Pharmacopeial Convention (2014-01-08), PR Newswire. Retrieved 2015-12-11. Retrieved 2015-12-11.

Retrieved 2015-12-11. Retrieved 2015-12-11. webadmin. Managed Care Magazine Online. Retrieved 2015-12-11. Retrieved 2015-12-11.

United States Pharmacopeia Usp Monograph

Retrieved 2015-12-11. Retrieved 2015-12-11. Retrieved 2015-12-11.External links.