Mission and Preface

Printed on: Wed Feb 08 2023, 11:07:52 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-E09DC39F-1D28-4D90-8D76-0ED109FFB640_9_en-US
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Do Not Distribute DOI Ref: n2lry DOI: https://doi.org/10.31003/USPNF_M6923_09_01
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Mission and Preface

This section provides background information on the publishes the USP–NF on a set schedule, and each individual
United States Pharmacopeial Convention (USP), as well as document is associated with its indicated official date. Learn
general information about the United States Pharmacopeia and more about USP’s document-centric official dates on our
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the National Formulary (USP–NF). Whether a document is website (www.uspnf.com/new-uspnf-online-faqs/
official or not official is not linked to when a specific publication end-user#irg1).
becomes official, but is based on the individual document. USP
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MISSION STATEMENT
USP–NF is published in continuing pursuit of the mission of
USP: To improve global health through public standards and
ffirelated programs that help ensure the quality, safety, and benefit
of medicines and foods.
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HISTORY
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USP has a rich history, dating back to 1820, when 11 Learn more about USP’s history and major milestones on the
physicians met in the Senate Chamber of the U.S. Capitol USP website (https://www.usp.org/about/usp-timeline).
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building to establish a pharmacopeia for the United States.
CONTENT OF USP–NF
To
USP–NF contains official substance (ingredient) and frequently cited procedures, sometimes with acceptance
product monographs for official articles recognized in USP–NF criteria, in order to compile into one location repetitive
(see General Notices 2.20 Official Articles). USP–NF also includes information that is applicable to many monographs. See
monographs for compounded preparations. With few General Notices 3.10 Applicability of Standards for more
exceptions, such as articles covered by Global Health information about standards contained in USP–NF
monographs, the intent is that all articles for which monographs and general chapters.
monographs are provided in USP–NF are legally marketed in The USP Admissions List section of the USP–NF indicates
the United States or are contained in legally marketed articles. those new and revised monographs and general chapters as
Global Health monographs are provided for articles that are well as any omissions that published on a specific delivery date.
not approved or legally marketed in the United States, but that
have been approved by a stringent regulatory authority [as Revisions to USP–NF—
defined by the World Health Organization (WHO)] and are
used for essential purposes in other parts of the world (see USP–NF is continuously revised by an exceptional process
General Notices 3.10.40 Applicability of Global Health of public involvement and substantial interaction between
Monographs). USP and its stakeholders, both domestically and
A USP–NF monograph for an official substance, product, or internationally. Revisions are presented in the USP–NF three
preparation may consist of various components, including the times per year in November, February, and June. Accelerated
article’s name; definition; packaging, storage, and other Revisions [including Errata, Interim Revision Announcements
requirements; and a specification. General chapters provide (IRAs), and Revision Bulletins] are published periodically and
with greater frequency.
https://online.uspnf.com/uspnf/document/1_GUID-E09DC39F-1D28-4D90-8D76-0ED109FFB640_9_en-US 1/6
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Regular Revisions—USP′s regular revision process calls for Revision Type Revision Symbol and Text
publication of a proposed revision in the Pharmacopeial
Forum (PF) for a 90-day notice and comment period and, after ▲
▲ (USP 1-May-2023)
the revision is approved by the relevant USP Expert In Process Regular Revision ▲
▲ (NF 1-May-2023)
Committee, publication in the USP–NF.
Accelerated Revisions—The Accelerated Revision process is ▲
▲ (GH 1-May-2023)
used to make revisions to USP–NF official more quickly than Interim Revision Announcement ▲
▲(IRA 1-Jul-2023)
through USP’s Regular Revision process. Learn more about
accelerated revisions and the criteria for and implementation Revision Bulletin ▲
▲(RB 1-Jul-2023)
thereof on the USP website (http://www.uspnf.com/ ◆

Harmonization
official-text). ◆
▲
Errata ▲(ERR 1-Jul-2023)
Modification of Compendial References—
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▲
▲(CN 1-Jul-2023)
USP and its Expert Committees periodically deem it Chapter References
▲
necessary to modify general chapter titles or similar text that ▲(Official 1-Jul-2023)
may be referenced in other standards throughout the USP–NF. Pending ▲

▲(TBD)
When this occurs, USP staff undertake a rigorous process for
identifying and updating such references. These updates may
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occur through a regular revision, or, in cases in which an Commentary—
update appears to present no significant change in the For revisions that are published for public review and
affected standard, through a direct update of the reference in comment in PF, the proposal may advance to official status or
that standard without providing an opportunity for notice and be republished in PF for further notice and comment. If
comment. In all cases, USP will publish on its website a notice comments are received, they are considered and incorporated
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indicating the source change, any resulting references, and as appropriate by the Expert Committee(s). In cases where
whether those references will be updated through a regular proposals advance to official status without republication in
revision or a direct update. PF, a summary of comments received and the appropriate
Expert Committee’s responses are published in the
Updating Chemical Information— Commentary section of the USP website at the time the revision
is published (see Rules and Procedures of the 2020-2025
Updates to the Chemical Information section at the
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Council of Experts, Section 9.05 Publication in the
beginning of monographs occur on an ongoing basis. Pharmacopeial Forum).
Chemical names and molecular weights may also be reviewed The Commentary is not part of the official text and is not
and updated when a monograph undergoes revision to intended to be enforceable by regulatory authorities. Rather,
match the United States Adopted Names (USAN) or the original it explains the basis of the Expert Committee’s response to
source of chemical information. Chemical structures are public comments. If there is a difference between the contents
updated on a continuous basis.
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of the Commentary and the official text, the official text
Chemical names typically reflect the naming conventions at prevails. In case of a dispute or question of interpretation, the
the time of the monograph development or revision. If the language of the official text, alone and independent of the
nomenclature rules of CAS or IUPAC are significantly changed, Commentary, shall prevail.
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the chemical names can be revised or added to implement

those rules. Molecular weights are derived from the chemical
formula and are based on the table of atomic weights as USP-NF Presentations—
published by the IUPAC. When the IUPAC recommended See General Notices 2.10 Official Text for more information
values are changed to reflect the isotopic composition of about USP–NF product formats. The USP-NF is available online.
normal terrestrial material, it is understood that the changes USP43–NF38 (published November 1, 2019) was the last
in molecular weights will be made in due course. publication made available in print or on a flash drive.
To
Graphical representation of the chemical compound

structures is intended as a visual aid to help establish chemical USP–NF Translations—
identity and is understood to represent one of many possible
ways to depict the molecule. Addition of a graphical Translations of the USP–NF are available in Spanish, Russian,
representation or changes in such representation, that result and Chinese. The Spanish translation is current; other
in the same chemical information, e.g., a flipped chiral translations are based on previous revisions of the USP–NF.
molecule or adding a molecule structure, may be introduced
outside of the revision process. It is also understood that in the USP Reference Standards—
case of tautomerism, the molecule depicted may be one of the The use of USP Reference Standards promotes uniform
tautomers, but it is intended to represent all isomers in quality of drugs and supports reliability and consistency by
equilibrium. Stereogenic centers depicted with plain bonds those performing compliance testing and other users of USP–
imply mixtures of pertinent stereomers—enantiomer, NF, including manufacturers, buyers, and regulatory
diastereomers, epimers (anomers), etc. (see General Notices authorities. USP Reference Standards are referenced in specific
3.10 Applicability of Standards). procedures in both monographs and general chapters. USP
advances this material via careful characterization studies and
Shading and Symbols— collaborative testing, followed by review and approval of the
Shading is used to identify text that has been modified, compendial use of the reference material by Expert
added, or deleted since it was last published. Symbols identify Committees of the Council of Experts. This program benefits
the beginning and end of each revision or nonharmonized from the widespread voluntary contribution of suitable
text. The following table summarizes the types of symbols and materials and test data from pharmaceutical manufacturers.
the associated subscripts used in USP publications: The USP Catalog, which lists the collection of USP Reference
Standards, and more information about use and storage, can
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be accessed on USP′s website (https://www.usp.org/

reference-standards/reference-standards-catalog).
USP GOVERNING,
STANDARDS-SETTING, AND
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ADVISORY BODIES
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USP’s governing, standards-setting, and advisory bodies Working with the Food and Drug Administration—
include the USP Convention, the Board of Trustees, the USP works with the Secretary of the Department of Health
Council of Experts and its Expert Committees, Expert Panels,
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and Human Services, and the principal agency in the
Subcommittees, Joint Standard-Setting Subcommittees, and Department for this work is the Food and Drug Administration
staff. Additional volunteer bodies include Stakeholder Forums (FDA). USP works in many ways with the agency, but the
and Project Teams, which offer stakeholders the opportunity primary interaction is through the Government Liaison
to contribute, through advice and recommendations, to the Program. The Government Liaison Program allows
advancement of USP’s standards and processes. Learn about representatives of FDA and other government agencies to
the composition and work of the USP Convention, Board of
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Trustees, Expert Committees, and Expert Panels on the USP Subcommittee and related meetings, enabling interactions
website (https://www.usp.org/about/ between government staff and Expert volunteer bodies. Staff
convention-membership). Learn more about Stakeholder in the FDA Centers who are responsible for review of
Forums and Project Teams on the USP website (https:// compendial activities provide specific links and opportunities
www.usp.org/get-involved/provide-input/ for exchange of comments. The Office of Policy for
stakeholder-forums). A listing of all current Voting Delegates Pharmaceutical Quality in the Center for Drug Evaluation and
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of the USP Convention and members and Government Research provides a primary compendial point of contact
Liaisons to the Council of Experts and its Expert Committees between FDA and USP.
can be found on the USP website (https://www.usp.org/
about/convention-membership, https://www.usp.org/about/
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volunteer-experts/expert-committees).
RULES AND PROCEDURES

To
Governing Documents— www.usp.org/about/convention-membership/bylaws), and

USP–NF standards are recognized widely because they are the Rules and Procedures of the Council of Experts (https://
authoritative and science-based and are established by a www.usp.org/about/leadership/policies-rules). Collectively,
transparent and credible process. See the Articles of these documents serve USP volunteers and staff as the
Incorporation section in this publication; the Bylaws (https:// governing principles for USP’s standards-setting activities.
LEGAL RECOGNITION
Recognition of USP–NF— Drug, and Cosmetic Act (FD&C Act) defines the term “official
USP–NF is recognized by law and custom in many countries compendium” as the official USP, the official NF, the official
throughout the world. In the United States, the Federal Food, Homeopathic Pharmacopeia of the United States, or any
supplement to them. USP–NF standards play a role in the
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adulteration and misbranding provisions of the FD&C Act, compendial standards is mandatory, whether or not the
which apply as well to biologics, a subset of drugs, under the product claims to conform.
Public Health Service Act (see General Notices 2.30 Legal
Recognition). Compounding—
FDA requires that names for articles that are not official must
be clearly distinguished and differentiated from any name USP provides general chapters and monographs for
recognized in an official compendium. Drugs with a name compounded preparations, as well as monographs for bulk
recognized in USP–NF also will be considered misbranded substances used in compounding. USP standards are
unless they meet compendial standards for packaging and recognized in various provisions of the FD&C Act and such
labeling (see General Notices 3.10.10 Applicability of Standards provisions do not differentiate between manufactured and
to Drug Products, Drug Substances, and Excipients for more compounded medicines. Moreover, the FD&C Act and the
information). 2013 Drug Quality and Security Act specifically reference USP
standards for compounding. Learn more about compounding
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on the USP website (https://www.usp.org/compounding).
Drugs—
USP’s goal is to have substance and drug product Medical Devices—
monographs in USP–NF for FDA-approved drugs in the United
States, including chemical and biologic medicines, and their Section 201(h) of the FD&C Act defines a device as an
ingredients. USP also provides monographs in USP–NF for instrument, apparatus, similar article, or component thereof
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legally marketed therapeutic products not approved by FDA, recognized in USP–NF. Section 502(e) of the FD&C Act defines
e.g., pre-1938 drugs, over-the-counter (OTC) drugs marketed the established name of a device in the absence of an FDA
under FDA’s OTC Monograph system, dietary supplements, designation of the official name as the official title in an official
and compounded preparations. The Global Health section of compendium. Despite these statutory provisions, there is no
USP–NF contains monographs for articles that are not comparable recognition of USP’s role in establishing
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approved or legally marketed in the United States, but that compendial standards for medical devices as exists for drugs
have been approved by a stringent regulatory authority (as and biologics. Under authority granted by the Food and Drug
defined by WHO) and are used for essential purposes in other Administration Modernization Act of 1997, the Center for
parts of the world. Conformance with a USP–NF monograph, Devices and Radiological Health recognizes national and
if applicable, is required at all times in the life of an article from international standards, including some USP tests and assays,
production to expiration. for medical devices.
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Biologics— Nomenclature—
In the United States, biologics are considered to be a subset For information on the nomenclature development
of drugs, whether they were approved by FDA under the process, the Nomenclature and Labeling Expert Committee,
FD&C Act [and received a new drug application (NDA)] or and USP’s work with United States Adopted Names (USAN),
under the Public Health Service Act [PHS Act, where they see the USP website (https://www.usp.org/
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receive a biologics license application (BLA)]. As of March 23, expert-committees/
2020, applications for biological products approved under the nomenclature-and-labeling-expert-committee-work-plan).
FD&C Act are deemed to be licenses for the biological
Chemical Names and CAS Registry Numbers—
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products under the PHS Act. All PHS Act biologics are subject
to the applicable drug regulatory requirements of the FD&C Chemical subtitles given in the monographs are CA Index
Act, which means they are required to comply with the Names used by CAS, a division of the American Chemical
adulteration and misbranding provisions of the FD&C Act, Society. CAS Registry Number® and CAS RN® are registered
including USP–NF compendial requirements, to the extent trademarks of the American Chemical Society. They are
that such requirements apply to a particular biologic product. provided only in monographs in which the titles specify
This is equally so for biologics approved under the substances that are definable chemical entities. The first
To
long-standing PHS Act “351(a)” pathway, as well as the new subtitle is the inverted form of the systematic chemical name
“351(k)” pathway for biosimilars added by the 2010 developed by CAS for the purpose of the Collective Index (CI).
healthcare reform legislation (Biologics Price Competition and The second subtitle, given in uninverted form, is a preferred
Innovation Act, Title VII, Subtitle A of the Patient Protection IUPAC name (PIN) sanctioned and used by the International
and Affordable Care Act, Public Law 111-148). Union of Pure and Applied Chemistry (IUPAC). Preferred
IUPAC names also are used by the WHO. Occasionally a third
Dietary Supplements— subtitle is supplied for historical reasons or when the synonym
The Dietary Supplement Health and Education Act of 1994 uses an alternative, but equivalent, naming convention.
amendments to the FD&C Act provide that a dietary Monographs with chemical subtitles also generally carry CAS
supplement may be deemed a misbranded food if it is covered registry numbers. These numbers function independently of
by the specifications of an official compendium (e.g., USP–NF), nomenclature as invariant numerical designators of unique,
is represented as conforming to the specifications of an official unambiguous chemical substances in the CAS RegistrySM, and
compendium, and fails to so conform. This contrasts with thus are convenient and widely used.
pharmaceutical products, wherein conformance to applicable
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HARMONIZATION
ACTIVITIES
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USP participates in several collaborative activities with establishment of Good Pharmacopoeial Practices (GPhP) as a
global pharmacopeias in both bilateral and multilateral set of guiding principles for the appropriate establishment of
settings. Examples of USP’s current activities include the pharmacopeial standards. Following the completion of GPhP
following. in 2016, the IMWP has primarily served as a venue for
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information and knowledge exchange across global
Pharmacopeial Discussion Group— pharmacopeias and recently served as a forum for rapid
coordination of pharmacopeias to respond to public health
USP harmonizes pharmacopeial excipient monographs and emergencies, as was recently the case for the COVID-19
general chapters through the Pharmacopeial Discussion pandemic.
Group (PDG), which includes representatives from the
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European, Japanese, and United States pharmacopeias, and
WHO (as an observer). According to the PDG definition, “a Adopt Agreements—
pharmacopeial general chapter or other pharmacopeial USP grants the rights to copy USP standards for use in other
document is harmonized when a pharmaceutical substance or pharmacopeias through this formal mechanism.
preparation tested by the harmonized procedure yields the
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same results, and the same accept/reject decision is reached.” Bilateral Agreements—
Information regarding PDG, including history, purpose, the
PDG working procedure, and lists of monographs and general USP partners with pharmacopeias for the joint development
chapters that have completed stages 1–4 of the of pharmacopeial standards using this informal process.
pharmacopeial harmonization process, resulting in an
approved USP Stage 4 Harmonization text, is available on USP Exchange Programs—
USP’s website (https://www.usp.org/harmonized-standards). USP regularly welcomes the exchange of scientific
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personnel through this program, with the goal of sharing
International Meeting of the World Pharmacopeias— scientific knowledge among global organizations involved in
USP works with WHO and global pharmacopeial partners standards setting and the effective use of standards.
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in this WHO-led forum. Its initial focus was the strategy and
OTHER USP COMPENDIA

To
USP Compounding Compendium— manufacturers, regulatory agencies, and other stakeholders to

The USP Compounding Compendium is an online assess conformance of herbal medicinal ingredients with
compendium that includes all compounding-related general independent public standards and to control the quality of
chapters from the USP–NF as well as the supporting general articles moving in international commerce. The HMC is
chapters that are referenced in the compounding general available at https://hmc.usp.org.
chapters and in USP–NF General Notices. The purpose of the
USP Compounding Compendium is to provide compounding USP Dietary Supplements Compendium—
practitioners with convenient access to associated general The Dietary Supplements Compendium is an online
chapters. compendium that combines USP–NF standards for dietary
supplements, standards and information from the Food
USP Herbal Medicines Compendium— Chemicals Codex, regulatory and industry documents, and
The USP Herbal Medicines Compendium (HMC) is an online other tools and resources.
compendium that helps ensure the quality of the herbal
ingredients used in herbal medicines. HMC monographs Food Chemicals Codex—
provide quality specifications—tests, procedures, and The Food Chemicals Codex (FCC) is an online compendium
acceptance criteria—with validated analytical procedures and of internationally recognized monograph standards and tests
allied reference materials that aid in conformity assessment. for the purity and quality of food ingredients, e.g.,
HMC can help ingredient manufacturers, herbal product preservatives, flavorings, colorings, and nutrients. FCC is
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published every two years, with supplements every six can be accessed free of charge at http://
months. Proposed revisions to FCC are available for public www.foodchemicalscodex.org.
viewing and comment through the FCC Forum. The FCC Forum
OTHER USP RESOURCES
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Chromatographic Columns— USP Dictionary—
This comprehensive reference, previously titled The USP Dictionary of USAN and International Drug Names is
Chromatographic Reagents, provides detailed information an online resource containing the most up-to-date United
needed to conduct chromatographic procedures found in States Adopted Names of drugs; official USP–NF names;
USP–NF. Chromatographic Columns lists the brand names of nonproprietary, brand, and chemical names; graphic
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the column reagents cited in every proposal for new or revised formulas; molecular formulas and weights; CAS registry
gas- or liquid-chromatographic analytical procedures that numbers and code designations; drug manufacturers; and
have been published in PF since 1980. Chromatographic pharmacologic and therapeutic categories. The Dictionary
Columns also helps to track which column reagents were used helps to ensure the accuracy of the following: product
to validate analytical procedures that have become official. labeling; reports, articles, and correspondence; FDA regulatory
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The branded column reagents list is updated bimonthly and filings; and pharmaceutical package inserts. It is published
maintained on USP’s website. annually. For more information about the Dictionary see the
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Printed on: Wed Feb 08 2023, 11:07:52 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-E09DC39F-1D28-4D90-8D76-0ED109FFB640_9_en-US

Mission and Preface

building to establish a pharmacopeia for the United States.

thereof on the USP website (http://www.uspnf.com/ ◆

Modification of Compendial References—

may be referenced in other standards throughout the USP–NF. Pending ▲

the chemical names can be revised or added to implement

Graphical representation of the chemical compound

be accessed on USP′s website (https://www.usp.org/

RULES AND PROCEDURES

Governing Documents— www.usp.org/about/convention-membership/bylaws), and

OTHER USP COMPENDIA

USP Compounding Compendium— manufacturers, regulatory agencies, and other stakeholders to

OTHER USP RESOURCES

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