Pharmacopeia (USP) is a pharmacopeia (compendium of
drug information) for the
United States published annually by the
United States Pharmacopeial Convention (usually also called the USP),
a nonprofit organization that owns the trademark and copyright. The
USP is published in a combined volume with the
National Formulary (a
formulary) 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
(prescription, over-the-counter, or otherwise), as well as animal
drugs. USP-NF standards also have a role in U.S. federal law; 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 dietary supplements,
and food ingredients (as part of the Food Chemicals Codex). USP has no
role in enforcing its standards; enforcement is the responsibility of
Drug Administration (FDA) and other government authorities in
the U.S. and elsewhere.
1 Product quality–standards and verification
2 Healthcare information
3 Promoting the Quality of Medicines program
4 International agreements and offices
5 See also
7 External links
Product quality–standards and verification
USP establishes written (documentary) and physical (reference)
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
Prescription and over-the-counter medicines available in the United
States must, by federal law, 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
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 Australia,
Canada and New Zealand,
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 Institute of
Medicine in 2006. The IOM had published the first five editions of the
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
At some indeterminate point 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 formularies, 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
United States Agency
for International Development (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:
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 advocacy
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.
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 Memoranda of
Understanding (MOU) with groups including the Chinese Pharmacopeia
Commission, nine countries belonging to the Association of Southeast
Asian Nations (ASEAN), 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 US Pharmacopeial Convention at IKP Knowledge Park at Hyderabad
The International Pharmacopoeia
Pill splitting, for a discussion of USP standards concerning
uniformity of dosage
^ U.S. Pharmacopeial Convention (2014-01-08), "Ron Piervincenzi,
Ph.D., Named Next CEO Of USP", PR Newswire
^ "National Formulary". MedicineNet. Retrieved 2015-12-11.
^ "Federal Register Food Additive Regulations; Incorporation by
Reference of the Food Chemicals Codex, 7th Edition".
www.federalregister.gov. Retrieved 2015-12-11.
^ "Are Dietary Supplements Dangerous? - Consumer Reports".
www.consumerreports.org. Retrieved 2015-12-11.
Pharmacopeia (USP). Medicare Prescription Drug
Benefit Model Guidelines Source Information". www.nlm.nih.gov.
^ webadmin. "Part D Model Guidelines Updated Far Too Infrequently".
Managed Care Magazine Online. Retrieved 2015-12-11.
^ "How to curb 'fake' food, drug products in Nigeria by PQM".
www.ngrguardiannews.com. Retrieved 2015-12-11.
^ "USAID extends USP's Promoting the Quality of Medicines (PQM)
programme - Express Pharma Online".
archivepharma.financialexpress.com. Retrieved 2015-12-11.
^ "Promoting the Quality of Medicines (PQM)". www.usp.org. Retrieved
^ "KENQOM Communications - Services Marketing, PR, Communications
& Content Marketing Agency: Chat with Jonathan Genn, EVP, Global
LifeSci Development Corp. Montgomery County". kenqom.blogspot.in.
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