The United States Pharmacopeia ( USP ) is a pharmacopoeia (summary of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called USP), nonprofit organizations that own trademarks and copyrights. The USP is published in a combined volume with the National Formulary (formulary) as USP-NF . If the ingredients of a drug or drug product have applicable USP quality standards (in the form of a USP-NF monograph), it should be appropriate to use "USP" or "NF" designation. Drugs subject to USP standards include human medicines (prescription, over-the-counter, or otherwise), as well as veterinary medicines. The USP-NF standard also has a role in US federal law; drugs or medicinal substances with names recognized in the USP-NF are deemed to be contaminated if they do not meet compendium standards for strength, quality or purity. The USP also sets standards for food supplements, and groceries (as part of the Food Chemicals Codex). The USP has no role in upholding its standards; enforcement is the responsibility of the Food and Drug Administration (FDA) and other government authorities in the US and elsewhere.
Video United States Pharmacopeia
Product quality standards and verification
The USP establishes written (documentary) and physical standards (references) for medicines, foodstuffs, food supplement products, and ingredients. These standards are used by regulatory agencies and producers to help ensure that these products have an appropriate identity, as well as strength, quality, purity, and consistency.
Prescription drugs and over-the-counter medicines available in the United States must, according to federal law, meet USP-NF public standards, where such standards exist. Many other countries use the USP-NF instead of issuing their own pharmacopoeies, or to supplement their government pharmacopoeies.
The USP standard for groceries can be found at Food Chemicals Codex (FCC). The FCC is a summary of internationally used standards for the quality and purity of foodstuffs such as preservatives, flavorings, dyes and nutrients. Although the FCC is recognized under law in countries such as Australia, Canada and New Zealand, the FCC currently has no legal recognition in the United States, although the FCC standards are incorporated by reference in more than 200 FDA food regulations. The USP obtained the FCC from the Institute of Medicine in 2006. IOM has published the first five editions of the FCC.
The USP also conducts a verification program for dietary supplements and products. This is a test and audit program. Products that meet program requirements may display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letter "USP" itself on the food supplement label, which means the manufacturer claims to comply with USP standards. USP does not test such products with USP Verified products.
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Healthcare information
At some uncertain points in the past, Congress authorized the HHS Secretary to request the USP to develop a drug classification system that can be used by the Drug Benefit Medicare Prescription plan to develop their formulary, and to revise the classification from time to time to reflect changes in therapy. the use covered by Part D drugs and the addition of new Part D drugs are discussed. USP has developed six versions of the Model Guide, which was last published in early 2014 for the 2015-2017 benefit year.
Promoting the Drug Quality program
Since 1992, the USP has worked with the United States Agency for International Development (USAID) to help developing countries address important issues related to low-quality medicines. The partnership operated as a Drug Quality and Information (DQI) program until 2009, when, to meet increasing global demand, USAID awarded USP a five-year, $ 35 million cooperation agreement to build an expanded new program: Promoting Drug Quality (PQM ). In 2013 USAID expanded its PQM program for five years (through September 2019), raised its funding to $ 110 million, and expanded the geographic reach of the program.
PQM serves as a key mechanism to help USAID-supported countries strengthen their quality assurance and quality control systems to better ensure the quality of drugs reaching patients. PQM has four main goals:
- Strengthen quality assurance (QA) and quality control (QC) systems
- Increase the supply of quality-assured drugs
- Combat the availability of substandard and fake drugs
- Provide global technical and advocacy leadership
The collaborative effort of USP-USAID has helped people improve drug quality in more than 35 countries. PQM currently works in Africa, Asia, Europe/Eurasia, and Caribbean/Latin America.
International and office agreements
USP works internationally, mostly through agreements with other pharmacopeias, as well as regulatory agencies, producer associations and others. In recent years, the USP has signed a series of Memorandums of Understanding (MOUs) with groups including the Chinese Pharmacopeia Commission, nine countries incorporated in the Association of Southeast Asian Nations (ASEAN), and the Federal Service on Oversight of the Health and Social Development of the Federation Russia (Roszdravnadzor). The USP also operates international offices 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 the US Pharmacopeial Convention at IKP Knowledge Park in Hyderabad in India.
See also
- English Pharmacopoeia
- European Pharmacopoeia
- National Formulary
- International Pharmacopoeia
- Food and Drug Administration
- The Genome Valley
- Pharmacopoeia
- Pill splitting, for a discussion of USP standards on dosage uniformity
References
External links
- Official website
- Medicines Compendium
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