The role of a modern pharmacopoeia is to furnish quality specifications for drug substances and general requirements for dosage forms. The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of drugs.
How often is the United States Pharmacopeia–National Formulary revised?
The United States Pharmacopeia–National Formulary ( USP–NF) is continuously revised. Revisions are presented three times a year in the USP-NF as Issues 1, 2, and 3, and as monthly Accelerated Revisions on the USP website. USP uses its Accelerated Revision processes to expedite revisions to the USP–NF.
What is USP and why is it important?
What is USP? USP is the United States Pharmacopeial Convention – an independent, scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.
What is a USP NF formulary?
United States Pharmacopeia. 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".
What is the role of USP in food safety?
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 the U.S. Food and Drug Administration (FDA) and other government authorities in the United States.
What is the purpose of United States Pharmacopeia?
What is USP? The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public compendial quality standards for medicines and other articles (Bylaws, Articles II, and VII).
What is the importance and purpose of the United States pharmacopeia and the National Formulary?
It is the most comprehensive source for medicine quality standards in the world. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients.
What are the US Pharmacopeia standards?
Developing documentary standards and Reference Standards is the core of what we do at USP. These standards help to assess the quality, strength, identity, and purity of chemical medicines, biologics, food chemicals and ingredients, dietary supplements, among other items.
What is United States Pharmacopeia in pharmacy?
The U.S. Pharmacopeia is a reference of uniform preparations for the most commonly used drugs—with tests to ensure their quality, potency and purity. As the practice of pharmacy grew, medicines were increasingly made not only by pharmacists but by commercial providers.
What is the current United States Pharmacopeia?
The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
What is the most used pharmacopoeia?
Depending on the country, one or several pharmacopoeia(s) may be used. The most commonly used ones (and their current editions as of May 2018) are the: European Pharmacopoeia (Ph.
How many types of pharmacopoeia are there?
In addition to USP, there are three other large pharmacopeias in the world, the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP), all of which share the goal of publishing and producing quality standards for pharmaceuticals.
What is Pharmacopeia and National Formulary?
National Formulary: Full name: United States Pharmacopeia and National Formulary (USP-NF). An official publication, issued first by the American Pharmaceutical Association and now yearly by the United States Pharmacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs.
What is the difference between pharmacopoeia and formulary?
They are usually published under governmental jurisdiction. They differ from formularies in that they are far more complete; formularies simply list drugs or collections of formulas for the compounding of medicinal preparations. However, sometimes the terms "pharmacopoeia" and "formulary" are used interchangeably.
What is National Formulary of USA?
The United States Pharmacopeia-National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
What is National Formulary in pharmacy?
A national formulary generally concentrates on available and affordable medicines that are relevant to the treatment of diseases in a particular country. Formularies are also frequently created for different levels of health care, different sectors and for individual hospitals.
What is the USP?
The United States Pharmacopeial Convention ( USP) is a nonprofit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public compendial quality standards for medicines and other articles (Bylaws, Articles II, and VII). USP’s mission is “to improve global health through public standards and related programs ...
What are the standards for an article recognized in a USP compendium?
Standards for an article recognized in a USP compendium are expressed in the article's monograph, the General Notices, and applicable general chapters (such as General Chapter <1> Injections). USP’s primary compendia of standards are the United States Pharmacopeia and the National Formulary (USP–NF). USP standards may be adapted or adopted by any ...
When did the USP standards start?
Congress has consistently provided a role for USP standards in the adulteration and misbranding provisions of successive federal food and drug legislation, beginning with the Pure Food and Drugs act of 1906 and continuing to today with the Federal Food, Drug, and Cosmetic Act (FDCA).
How many countries use USP?
In addition, USP is utilized in over 140 countries worldwide and integrated into the laws of more than 40 countries. USP-NF includes three types of quality standards for prescription medicines: Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance.
What is the USP-NF?
The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients). It is the most comprehensive source for medicine quality standards in the world. The standards in USP-NF are used ...
Why are USP monographs public?
Because USP’s publicly available monographs articulate the regulatory expectations for quality, they accelerate product development and provide more regulatory predictability. As a result, monographs support competition, which generally reduces prices and expands patient access. Download as PDF. False.
Why are monographs important?
Monographs help secure the global drug supply chain. USP’s monographs are used by customs and border officials and public health and law enforcement authorities to confirm the quality of medicines and their ingredients from overseas sources.
What is USP expert committee?
USP Expert Committees are comprised of scientific experts from academia, industry, and the healthcare practitioner community. Expert committee members are not compensated. They volunteer their time and work. FDA experts participate in each of the standard-setting expert committees as government liaisons.
What is a general chapter?
They also describe the tests to validate that a medicine and its ingredients meet these criteria. General Chapters provide broadly applicable information to industry on accepted processes, tests and methods to support product development and manufacturing for innovative, generic and biosimilar medicines.
What is the meaning of purity in medicine?
Purity - Information on impurities that may be present in a medicine and the amounts of these that are permitted, along with testing methods to identify and measure them. An impurity is any component in the API or finished dosage form which is not the desired product or other formulation components. Levels that exceed may present patient safety concerns.
What is stage 4 of pharmacopeial harmonization?
Harmonization Stage 4 includes monographs or general chapters that have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USP–NF text. Stage 6 adopted text is published so that USP–NF users may become aware of its availability as a pharmacopeial standard and its targeted official date. View current Notices of Stage 4 Harmonization#N#(link is external)#N#.
How often is the USP-NF revised?
The United States Pharmacopeia–National Formulary ( USP–NF) is continuously revised. Revisions are presented three times a year in the USP-NF as Issues 1, 2, and 3, and as monthly Accelerated Revisions on the USP website. USP uses its Accelerated Revision processes to expedite revisions to the USP–NF. Accelerated Revisions include Revision ...
What is USP in medical terms?
USP is the United States Pharmacopeial Convention – an independent, scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.
What is USP NF?
USP–NF is a combination of two compendia, the United States Pharmacopeia ( USP) and the National Formulary ( NF ). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF. However, if an excipient is also used as a pharmaceutical active in an FDA-approved product released in the US, its monograph will appear in the USP section instead.
What is USP reference?
USP Reference Standards are highly-characterized physical specimens used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of medicines and ingredients. Materials based directly on official monographs in the USP–NF —whose standards and procedures are enforceable by the U.S. Food and Drug Administration—are recognized for use in official standards in the United States, and their use is effective in demonstrating compliance with statutory requirements.
Where are USP reference standards developed?
USP Reference Standards are developed in USP labs, often through direct collaboration with industry sponsors who donate materials and methodologies. Reference Standards may be selected and purchased through the USP Reference Standard Catalog section of our website.
What is a monograph?
A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests, and acceptance criteria. These tests and procedures require the use of official USP Reference Standards. Medicinal ingredients and products will have the stipulated strength, quality, and purity if they conform to the requirements of the monograph and relevant general chapters.
