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Frequently Asked Questions about USP–NF
English Edition—Formats and Subscriptions
Q. What formats is USP–NF available in? How are they different? A. USP–NF is available in print, online, and CD formats. The same official information is featured in all formats. The print format is published in a 3–volume set, with each volume housing a complete table of contents and index. The print format features a thick, durable paper stock that is practical for everyday laboratory and manufacturing use. The English edition is shipped in a convenient slipcase for easy access and storage. In the print version, each new edition or Supplement includes changes made since the previous edition. The CD format consists of a single CD published at each update. Both the CD and online formats contain a single complete table of contents; provide a variety of search, cut and paste, and bookmarking capabilities unique to the electronic versions. The CD and online format of USP 30–NF 25 will also include viewable chemical structures for more than 300 impurities that the print format does not. The online and CD formats are cumulative–the content of each new edition or Supplement integrates changes since the previous edition. The online format provides cumulative content that integrates changes since the previous edition or Supplement at each update. Like the CD, the online format features a single complete table of contents; provides a variety of search, cut and paste, and bookmarking capabilities; and includes viewable chemical structures for more than 700 impurities. The online format also includes "My USP–NF," a feature that allows users to save frequent searches, create a personal table of contents, and bookmark important sections. Q. Why is the print edition in three volumes? How is content divided? A. Beginning in 2007, USP expanded the print format to enhance readability, usability, and comprehension as well as allow room for future expansion. Each year, new content is added to reflect revisions, and USP–NF was close to exceeding print industry page and binding limits. In efforts to accommodate future growth as well as keep the volumes equal in page size, a 3–volume format was selected. The 3–volume print format applies to both English and Spanish editions. When dividing content, USP took into consideration how subscribers use the USP–NF and tailored the volumes to maintain ease of use, i.e. keeping API monographs next to dosage form monographs in alphabetical order. To help users find specific information, all volumes contain a full table of contents and index. Here is a breakdown of volume contents:
Q. If I get the USP–NF online or CD versions, do I still need to have a print copy? A. Yes, USP recommends having the current edition in print. The USP–NF print tracks all revisions by Supplement and provides archival records that augment the electronic information. The print also provides backup in the event of an electronic failure. Q. What is the difference between the online and CD formats? A. The USP–NF Online does not need to be installed on your hard drive or server. It is maintained at USP and new editions or Supplements are posted online by USP. Online access is regulated through individual or corporate passwords/IDs. The USP–NF CD is a single–user version for use on your hard drive. Every time a new edition or Supplement is released during your subscription period, you will replace your old CD with a new one. Q. When is USP–NF published? When does it become official? A. The USP–NF is published annually in one main edition and two Supplements. The 2008 main edition is available November 1, 2007, and becomes official on May 1, 2008. The First Supplement is available in February 2008 and becomes official on August 1, 2008. The Second Supplement is available in June 2008 and becomes official on December 1, 2008. (Please note that beginning in 2007, official dates were changed to allow for longer implementation periods.) Q. Have the official dates changed? A. Beginning in 2007, USP extended the official dates to provide users additional time to adopt revisions made to the compendia. The new implementation periods give users six months from publication date to implement new official texts as opposed to the previous 60–day period. Q. When do USP–NF subscriptions begin and end? A. Print subscriptions are available for 1 year from January to December and include the main edition and two Supplements. CD subscriptions are available for 1 year from January to December and include the main edition and two Supplements. Each new edition or Supplement integrates content from all previous editions to date. Subscriptions to the USP–NF online are available for one or more users on a 12–month rolling basis. This means you can choose to start your subscription at any time during the year and continue it for 12 consecutive months. USP–NF online includes all updates posted online during the 12 months after the subscription start date. Each new update that is posted integrates content from all previous editions to date. Spanish Edition—Formats and Subscriptions
Q. Is the USP 31–NF 26 Spanish Edition official? A. Yes, all content in the Spanish USP 31–NF 26 is an exact translation from the latest English edition and therefore shares the same official status. Both the English and Spanish main editions of USP 31–NF 26 become official on May 1, 2008. Q. What translation process is used and how is quality ensured? A. USP uses the most rigorous development and quality control processes to ensure an accurate, high–quality translation from the official English edition. A special advisory group of volunteer scientific experts from many Spanish–speaking countries guide the translation process and help to establish a special glossary of pharmaceutical terminology acceptable across regions that use multiple dialects of Spanish. USP staff scientists thoroughly check all translated content for accuracy. Q. What formats is the USP–NF Spanish Edition available in? A. The USP–NF Spanish edition is available only in a print format at this time. The print format is published in a 3–volume set, with each volume housing its own complete table of contents and index. The print format features an thick, durable paper stock that is practical for everyday laboratory and manufacturing use. Also in the print version, each new edition or Supplement includes changes made since the previous edition. Q. Why is the USP–NF Spanish Edition in three volumes? How is content divided? A. Beginning in 2007, USP expanded the print format to enhance readability, usability, and comprehension as well as allow room for future expansion. Each year, new content is added to reflect revisions, and USP–NF was close to exceeding print industry page and binding limits. In efforts to accommodate future growth as well as keep the volumes equal in page size, a 3–volume format was selected. The 3–volume print format applies to both English and Spanish editions. When dividing content, USP took into consideration how subscribers use the USP–NF and tailored the volumes to maintain ease of use, i.e. keeping API monographs next to dosage form monographs in alphabetical order. To help users find specific information, all volumes contain a full table of contents and index. Here is a breakdown of volume contents:
Q. When is the USP–NF Spanish Edition published? When does it become official? A. The USP–NF Spanish Edition is published annually in one three–volume main edition and two Supplements. The 2008 main edition is available in January 2008, and becomes official on May 1, 2008. The First Supplement is available in April 2008 and becomes official on August 1, 2008. The Second Supplement is available in August 2008 and becomes official on December 1, 2008. (Please note that beginning in 2007, official dates were changed to allow for longer implementation periods.) Q. Why have the official dates changed? A. Beginning in 2007, USP extended the official dates to provide users additional time to adopt revisions made to the compendia. The new implementation periods give USP 31–NF 26 Spanish Edition users four months from publication date to implement new official texts as opposed to the previous 60–days. Each annual subscription to the Spanish USP–NF includes the main edition and two Supplements as well as access to USP scientific, technical, and customer service support. Q. When does a subscription to the USP–NF Spanish Edition begin and end? What does a subscription include? A. Subscriptions to the USP–NF Spanish edition are for one year on a January–December basis. This means that a 2007 subscription includes the 2007 main edition and two Supplements, no matter when in the year you start subscribing. Q. How can I purchase a subscription to the USP–NF Spanish Edition? A. You can order a subscription through your local USP Authorized Distributor or directly from USP. Q. Do I need to purchase the USP–NF Spanish Edition on a yearly basis? A. USP recommends purchasing the USP–NF Spanish Edition each year to ensure that you are always using the most current edition. USP publishes the USP–NF Spanish Edition as a yearly edition with two Supplements. The current edition is the only official edition and is necessary to establish compliance with current regulatory standards and procedures. Previous editions are not adequate for compliance. Legal Status and Content
Q. What is the legal status of the USP–NF? A. References to the USP and the NF occur in U.S. federal and state statutes regulating articles (substances and preparations) used in medical practice. The 1938 Food, Drug, and Cosmetic (FDC) Act recognizes USP–NF standards as enforceable by the Food and Drug Administration for drugs manufactured and marketed in the U.S. Such drugs must meet USP–NF standards to avoid possible charges of adulteration and misbranding. The USP–NF is also recognized in the 1994 Dietary Supplement Health and Education Act (DSHEA) as an official compendium for dietary supplement standards. DSHEA specifically provides that a dietary supplement represented as conforming to the specifications of an official compendium shall be deemed misbranded if it fails to do so. Many statutes and regulations governing the practice of pharmacy at the state level reference USP–NF requirements for compounding, packaging and storage of drugs. Q. How is the USP–NF used? A. USP–NF information helps to characterize drug substances and products, excipients, and other articles. USP–NF can also be used to set up and conduct in–process, batch release, or other quality control tests; to prepare for regulatory inspections; and to establish and validate Standard Operating Procedures (SOPs). USP–NF saves you the effort and expense of developing and validating your own standards and procedures. The detailed chemical, physical, biological, and microbiological tests and procedures in USP–NF provide valuable information for a multitude of applications in a pharmaceutical laboratory. USP–NF can be used as the starting point for product innovation and analytical method development. Comprehensive guidelines help in developing and testing pharmaceuticals and devising formulations. Q. Why is it important to have the latest edition of the USP–NF? A. USP–NF is published annually, with one main edition and two Supplements each year. The current edition of USP–NF is the only official edition. For the purpose of law within the United States, it is important to establish compliance with standards and procedures in the current official edition. Older editions are not acceptable for official compliance. USP–NF information is continuously evolving and changing. Therefore, having the current edition is the only way to get the latest official information. Q. How exactly do USP–NF changes impact me and how can I keep track of them? A. Because of the official status of USP–NF for regulatory compliance, it is extremely important to establish compliance with any changes that impact official articles that you characterize or test. Changes typically occur in all sections of USP–NF. Therefore, you must review and establish compliance not only with changes in the monographs relevant to you but also with changes in related general chapters; you must also review any new general chapters to ensure if the content impacts you. In addition, changes to the general notices may change the way you define or interpret text in the USP–NF. You must review all changes to ensure that your product is in compliance with current official standards. Advance notice of all proposed and upcoming changes to USP–NF are available for your review, evaluation, and comments in the Pharmacopeial Forum before they become official in the USP–NF. (See Related Resources.) Q. Does the USP–NF include monographs for dosage forms? A. Yes, the USP–NF includes monographs specific to common dosage forms (including combinations) like tablets, injections, creams/ointments, oral solutions/suspensions, capsules, and inhalation products. For instance, the USP–NF provides monographs for Acetaminophen, Acetaminophen Capsules, Acetaminophen Oral Solution, Acetaminophen Suppositories, Acetaminophen Tablets, and Acetaminophen and Aspirin Tablets. USP 31–NF 26 features more than 4,200 dosage form monographs for drug substances, dietary supplements, biologic products, devices, dietary ingredients, GCs, mucosals, oral liquids, topicals, excipients, injectables, and oral solids combined. USP–NF now also includes guidance and testing methods for residual solvents that conform to guidelines from the International Committee on Harmonization (ICH). Q. What is the difference between monographs, general chapters, and general notices? A. Monographs are specific to an official article, product or ingredient and include the official title, descriptive information, definitions, packaging and storage requirements, identification tests, purity and limit tests and assays. General chapters describe tests and procedures common to multiple monographs. While all monographs are official and enforceable, only general chapters <1> to <999> are intended to be enforceable. Other general chapters are informational or interpretive and not referenced in individual monographs. General notices are informational and contain basic guidelines for the interpretation and application of the standards, tests, assays, and other specifications in the USP–NF. Q. Why do I need to subscribe to USP–NF if I am interested only in one monograph? A. Every monograph references, on average, 10 general chapters that may affect your product. USP–NF content is introduced and/or revised throughout the year. There could be changes in the monograph you're interested in, in the related general chapters, or in the general notices anytime during the year. These changes are published and official in the main edition and two Supplements of USP–NF included in a year's subscription. Related Resources
Q. What will I need to carry out the various tests and procedures described in the USP–NF? A. Official tests and assays in the USP–NF call for the use of USP Reference Standards, highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. You can order the official Reference Standards for the tests and assays you need to conduct from USP's inventory of more than 2,000 standards. Q. Where can I find out about USP–NF changes that occur between Supplements? A. Proposed and upcoming changes to USP–NF are first published in USP's bimonthly journal Pharmacopeial Forum (PF). PF features Interim Revision Announcements (IRAs)–revisions to USP–NF monographs and chapters that become official before the next edition or Supplement is published. PF also publishes in–process revisions under consideration, scientific rationale for changes or additions, and harmonization information. PF is available in print and online subscriptions. Q. How can I get involved in the USP–NF standards–setting process and offer comments on existing standards? A. The best way to get involved in USP's public standards–setting process and to offer your comments and feedback is also through Pharmacopeial Forum (PF). All changes and additions to the USP–NF are first proposed in the PF to invite public comment. PF provides guidance on how to submit comments and input. A summary of the comments received and USP's responses are also featured in the PF. Q. How can I learn more about how to use the USP–NF? A. USP offers an international Pharmacopeial Education program, with multiple–language courses at locations worldwide. The courses teach practical skills in applying USP–NF standards and tests. Q. What is Chromatographic Reagents? A. Chromatographic Reagents is a USP publication that lists the brand names and manufacturers of column reagents used to validate USP–NF chromatographic procedures. |
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Copyright © 2008 The United States Pharmacopeial Convention
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