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411:(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 called Promoting the Quality of Medicines (PQM). 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.
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The U.S. Pharmacopeia (USP) was formed in 1820 when 11 physicians came together to take action to protect patients from being harmed by the inconsistent and poor-quality medical preparations at that time. The first standards were "recipes" that guided the preparation of medicines, which were often
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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"
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relying heavily on crude botanical drugs having therapeutic activities. When the modern pharmaceutical industry emerged, USP standards changed from those "recipes" to a set of quality specifications for medicines along with analytical tests to be performed to assess their purity, quality, and
399:, 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.
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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.
448:, 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.
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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:
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USP-USAID collaborative efforts have helped communities improve drug quality in more than 35 countries. PQM currently works in Africa, Asia, Europe/Eurasia, and the
Caribbean/Latin America.
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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
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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
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is a compendium of standards used internationally for the quality and purity of food ingredients like preservatives, flavorings, colorings, and nutrients. While the
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with groups including the
Pharmacopeia of the People's Republic of China Chinese Pharmacopeia Commission, nine countries belonging to the
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is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity. USP also sets standards for
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616:"Federal Register | Food Additive Regulations; Incorporation by Reference of the Food Chemicals Codex, 7th Edition"
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alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards.
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monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to
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standards are incorporated by reference in over 200 FDA food regulations. USP obtained the
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instead of issuing their own pharmacopeia, or to supplement their government pharmacopeia.
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Prescription and over-the-counter medicines available in the United States must, by
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866:"PQM's Work in Latin America and the Caribbean | U.S. Pharmacopeial Convention"
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information) for the United States published annually by the over 200-year old
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This article is about a compendium of drug information. For other uses, see
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public standards, where such standards exist. Many other countries use the
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is an example of a publication created by the United States
Pharmacopeia.
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208:(usually also called the USP), a nonprofit organization that owns the
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does not test such products as it does with USP Verified products.
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Strengthen quality assurance (QA) and quality control (QC) systems
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Combat the availability of substandard and counterfeit medicines
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in 2006. The IOM had published the first five editions of the
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727:"How to curb 'fake' food, drug products in Nigeria by PQM"
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USP's standards for food ingredients can be found in its
235:. If a drug ingredient or drug product has an applicable
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844:"PQM in Europe-Eurasia | U.S. Pharmacopeial Convention"
640:"Are Dietary Supplements Dangerous? - Consumer Reports"
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689:"Part D Model Guidelines Updated Far Too Infrequently"
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263:; a drug or drug ingredient with a name recognized in
887:Федеральная служба по надзору в сфере здравоохранения
62:, and by adding encyclopedic content written from a
409:United States Agency for International Development
407:Since 1992, USP has worked cooperatively with the
591:"U.S. Pharmacopeia: Building trust for 200 years"
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547:"Ron Piervincenzi, Ph.D., Named Next CEO Of USP"
428:Provide technical leadership and global advocacy
422:Increase the supply of quality assured medicines
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486:Pharmacopoeia of the People's Republic of China
446:Association of Southeast Asian Nations (ASEAN)
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545:U.S. Pharmacopeial Convention (2014-01-08),
223:is published in a combined volume with the
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776:"Promoting the Quality of Medicines (PQM)"
713:"Promoting the Quality of Medicines (PQM)"
403:Promoting the Quality of Medicines program
299:Product quality–standards and verification
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82:Learn how and when to remove this message
351:is recognized in law in countries like
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306:establishes documentary (written) and
206:United States Pharmacopeial Convention
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472:European Pharmacopoeia
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16:Annual drug compendium
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568:MedicineNet
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72:August 2022
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