KNOW ABOUT

UNITED STATE PHARMACOPOEIA (USP)

By
Dr.T.V.VidyaSagar
Neuheit Pharma Technologies Private Limited

CONTENTS

Important definitions
Importance of Pharmacopiea
Introduction
History
Sections
Revisions
Other relevant information available related to USP.
Question and Clarifications

PHARMACOPOEIA, PHARMACOPEIA (or ) PHARMACOPOEA

(Drug-making):
A book containing an official list of medicinal drugs together with articles on their
preparation and use, published by the authority of a government or a medical or
pharmaceutical society.
A collection or stock of drugs.
MONOGRAPH:
A monograph is a work of research or literature written about a single, specific subject.
It is primarily written by experts in a particular field of study for others in that same
field of study. (Ex:Scientists about discoveries etc.,)

Importance of Pharmacopoeia :
Pharmacopoeial

standards are objective, public standards of quality for medicines and

formulated preparations.

The

Pharmacopoeia is an important statutory element of the overall system for the

control of medicines which complements and assists the licensing and inspection
processes.

All

three statutory components complement and support the quality assurance system
operated by the manufacturer.

Pharmacopoeial

standards are compliance requirements, that is, they provide the

means for an independent judgment as to the overall quality of an article.

They

apply throughout the shelf-life of a product and are used by a wide variety of
organisations including suppliers, purchasers, inspectors, medicines regulators and
official and independent control laboratories.

Introduction about USP

The United States Pharmacopeial Convention (USP) is a scientific non-profit organization
that sets standards for the identity, strength, quality, and purity of medicines, food
ingredients, and dietary supplements manufactured, distributed and consumed worldwide.
USPNF is a book of Public Pharmacopeial Standards
Combination of Compendia: United States Pharmacopeia (USP) & National Formulary (NF)
USP: Monographs for drug substances, dosage forms, dietary supplements
NF: Excipient monographs

USPs standards enforceable in US by FDA- developed & relied upon in >140 countries

USP History
1820
January: Founded by physicians; Only 217 drugs
December 15: First edition was published
1830: First Revision Published; Revisions continue at 10-year intervals
1942: USP revision cycle changed: every 5 years
1975: USP acquired NF and came as USP-NF
2002: USPNF published annually
2006: First international laboratory facility in Hyderabad, India
Certification: ISO 9001:2008: Quality Management Systems standard
ISO 17025:2005 General Requirements for the Competence of Testing & Calibration
Laboratories

FDA Practices Recognize USP Standards

USP SECTIONS
All the 3 volumes and 2 supplements become official after 6 months from the release date
Online updation is done with each supplement or annual revision
Volume 1 General notices, chapters, Dietary supplements, Reagents & NF Monographs
Volume 2 USP Monographs A H
Volume 3 USP Monographs I Z
NF contains Excipients monographs. If the excipient is also a drug substance, then it appears
in USP with suitable cross-referencing.

Section

Release Date

Official Date

3 volumes

Nov 1st

May 1st of next year

Supplement 1

Feb 1st

Aug 1st

Supplement 2

June 1st

Dec 1st

USP-NF Revisions
Annually-standard revisions in USP-NF and twice yearly supplements
Standard revisions:
Published in PF

90 day comment period

Approved by USP committee

Publication in next USP-NF or Supplement as applicable

Accelerated Revision: In PF & on USP Web site (Errata, IRAs)

Revision Bulletin : Posted on 1st of every month in USP website
Recall: USP 33NF 28, released on November 1, 2009-- recalled on January 8, 2010
Reason for Recall: Errors occurred when monographs were redesigned into a new format

USP-NF Revisions:
Annually-standard revisions in USP-NF and twice yearly supplements.
Accelerated revisions in PF & on USP Web site (Errata, IRAs & RBs)
Standard revisions: Published in PF

90 day comment period

Approved by USP committee
Publication in next USP-NF or
Supplement as applicable.

Accelerated Revision: To make revisions more quickly than through standard

revision process. It includes Errata, IRAs, RBs.

ERRATA :
Text erraneously published in USP-NF or Supplement.
Not subjected to notice or comment.
Published on USP Web site and immediately official.
Incorporated into next USP-NF or Supplement.
INTERIM REVISION ANNOUNCEMENTS:
Given in PF as proposed IRA with 90 day comment period.
If no comments- immediately official on USP Website under Official Text
section.
Incorporated into next available USP-NF or Supplement.
REVISION BULLETIN :
If rapid publication is required.
Posted on 1st of every month in USP website.
Incorporated in next available USP-NF or Supplement.

PHARMACOPEIAL FORUM:
It includes proposed changes and additions to USP-NF.
Also includes stage 4 harmonization and stimuli articles
public comments (90 days)

for

Published in the next available USP-NF/Supplement.

Bi-monthly publication and comes 6 times a year.
Totally online from Jan 3, 2011
Current version is 42 (1).
Admissions to USP-NF:
Articles covered in the supplements for previous version will be given under this
section.
Annotated List :
New articles and changes appearing in Current version will be given under this
section.

USP PENDING MONOGRAPHS:

Pending for FDA approval.
Not Official.
Published on USP website prior to FDA approval.
Development of monograph in a shorter time frame.
Intended for Generic manufacturers and Drug Master file (DMF) holders and will
enable the monograph development begin prior to FDA approval of their Generic
products.
USP Reference Standards:
List is given in USP catalogue that can be accessed on USP Website.