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The United States Pharmacopeia (USP) publishes an official compendium in a combined volume with the
as the USP-NF. The United States Pharmacopoeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. 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), as well as animal drugs. USP-NF standards also have a role in U.S. a drug or drug ingredient with a name recognized in USP-NF is deemed 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 Food Chemicals Codex). USP has no role in enf enforcement is the responsibility of FDA and other government authorities in the U.S. and elsewhere.
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 Food Chemicals Codex (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.
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
benefit years.
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: 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.
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:
Increase the supply of quality assured medicines
Combat the availability of substandard and counterfeit medicines
Provide technical leadership and global advocacy
USP-USAID collaborative efforts have helped communities improve drug quality in more than 35 countries. PQM currently works in , , , and the .
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 . 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 US Pharmacopeial Convention at IKP Knowledge Park at Hyderabad in India.
, for a discussion of USP standards concerning uniformity of dosage
[, About US Pharmacopeial Convention,
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World Services Ltd.药典的海词问答与网友补充：
药典的相关资料：
药典&:&pharmacopé ...
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药典&:&фармакопéя ...
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【近义词】
相关词典网站：pharmacopeia
[fɑ:m?k??'pe??]
[fɑ:m?ko?'pe??]
处方汇编，药典
大家都在背：
1. Postexposure prophylaxis is an integral part of the pharmacopeia in preventing severe disease after acute infections.
在预防急性传染后的严重疾病方面,暴露后预防是药典的一个主要部分.
来自互联网
2. Methods: The methods of bacterial endotoxins test and pyrogen test in Chinese pharmacopeia 2000 were used.
方法参照中国药典2000年版细菌内毒素检查法及热原检查法.
来自互联网
3. Methods: The test was used according to the pharmacopeia of china 2005 verification test item.
方法采用中国药典2005年版二部附录微生物限度检查方法项下方法的验证.
来自互联网
1. (pharmacology) a book containing a compilation of pharmaceutical products with their formulas and methods of preparation
1.药典：药典是国家的药品标准。我国的《唐新本草》(659年)是世界上最早的药典。欧洲最早的药典是意大利的“Nuoro Receptario Composita”(1498年)。近代我国曾出版过《中华药典》(1930年)。新中国成立1953年颁布了《中国人民共和国药典》(简称《中国药典》)，现已出至1995年版。其他重要药典如《美国药典》(USP，1820年)，《英国药典》(B.Ph，1864年)
2.《苏联药典》(1866年)
3.《日本药典》(J.P.，1886年)。1945年后联合国出版过《国际药典》(ph.I)，但对各国药典无约束性，只供各国编撰药典时参考
医学英语 ... pharmaceutical factory: 药厂 pharmacopeia: 药典 prescription: 药方.
- 基于668个网页
2. 药典公司
创办人李革在获得哥伦比亚大学有机化学博士学位后，曾创办了药典公司(Pharmacopeia)，药明康德是他的第二次创业。但这家成立9 …
- 基于17个网页
1. 药典委员会
药材生产||production of medicinal materials药厂||drug factory药典||pharmacopeia药典委员会||committee of pharmacopeia药动团||kinetophore药动学||pharmacoki.
- 基于2个网页
the relative average deviation is less than 0 . 2 % compared with pharmacopeia method .与药典法相比，相对平均偏差小于0．2%。
- 基于1个网页
as the nutrition Aspartic acid can be found in pharmacopeia and food additives reference books .天门冬氨酸作为营养品，在药典及食品添加剂的工具书中都有明确记载。
- 基于2个网页
1. 中国药典
methods : the chemical physics and immunological characters of the STF were examined and identified in with Chinese pharmacopeia and using MTT-Leukocyte adherence inhibition assay ( MTT-LAI ) .方法：按中国药典及白细胞粘附抑制试验（MTT法)对STF的理化性质和免疫学性质进行了检测和鉴定。
- 基于4个网页
0){var rand = parseInt(Math.random() * (000)+100000);top.location.href='/'+encodeURIComponent(document.getElementById('s').value.trim().replace( / /g, '_'))+'?renovate='+}else{top.location.href='/'+encodeURIComponent(document.getElementById('s').value.trim().replace( / /g, '_'));};}" action="/">
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