General Notices Proposed Revisions: Questions and Answers
The first draft of the proposed revised General Notices attempted to clarify the distinction between "official" and "authorized" text, as described below. The second draft does not address these points, but additional revisions may be proposed at a later date.
Currently, all General Chapters are official by virtue of their inclusion in the USP-NF, which are recognized in law as official compendia of the United States. USP-NF distinguishes between enforceable and informational General Chapters by means of chapter numbers: USP intends chapters numbered below 1000 to be enforceable by FDA or other regulatory authorities while chapters numbered above 1000 are intended to be informational only.
USP is aware that this numerical distinction is not entirely adequate and may cause confusion within industry and regulatory authorities. Inclusion of General Information Chapters in the official compendium may at times cause them to be given a more regulatory status than USP intended. In addition, the distinction is imperfect: some chapters with numbers over 1000 may be referenced in a monograph, which makes them mandatory for those monographs.
The first draft of the General Notices revisions proposed to clarify the text that is official in a new way:
- USP, NF, FCC, and Non-U.S. Standards monographs all would be official.
- The General Notices would remain official.
- General Chapters and FCC General Tests and Assays that are included in the USP, NF, or FCC would be official whether the chapter number is above or below 1000. These would include every General Chapter that is referenced in an official USP, NF, FCC, or Non-U.S. Standards monograph. Other General Chapters also would be included, such as those that provide information that is necessary to performing compendial procedures or to assuring product quality, and those that are anticipated to be referenced in a monograph in the near future.
- Some information that currently is published in the USP-NF would be considered authorized text only, and would no longer be official. We anticipate that this text would move to a new volume (the "Companion Volume") that would not be called USP-NF, in order to clarify to regulatory authorities that these materials are not intended to be enforceable. Some of the USP General Chapters would move to the Companion Volume. These chapters would retain their chapter numbers. The Reference Tables section of the USP, including the Description and Solubility table, also would move to the Companion Volume as authorized text.
- Pending Standards would remain authorized text. Manufacturers are not permitted to claim conformance to a Pending Standards monograph.
- Other text, such as Information monographs, would remain authorized and would remain outside of the USP-NF and FCC.
Questions and Answers
Official vs. Authorized
Q: Why make Non-U.S. Standards standards official?
A: Non-U.S. Standards standards are similar to USP, NF, and FCC standards because manufacturers may label their products as conforming to the standard, allowing for second- or third-party testing. USP does not intend its other standards - all of which would be "authorized" under this proposal - to be used for second- or third-party testing.
Q: Why is USP considering publishing authorized text in a separate book?
A: The USP and the NF are recognized in law as "official compendia" of the U.S., which makes them enforceable. The proposed new book (the "Companion Volume") would not be called USP or NF, and we hope that this would help clarify that USP intends the text in the Companion Volume, including authorized General Chapters and other material, to be informational guidance only.
Q: What would the new book be called?
A: USP is still developing titles and welcomes suggestions. It would not be called USP-NF. We are using the descriptive name "Companion Volume" in the interim until we decide whether we will proceed with a separate book and a name is selected.
Q: Would I have to pay extra for the Companion Volume?
A: At this time, we anticipate that it would be included with the purchase of the USP-NF.
Q: Where would the Reagents, Indicators, and Solutions section of the USP-NF be published?
A: This section is provided as information useful to the completion of monograph tests but is not a requirement. Therefore, it would move to the Companion Volume.
Q: What about the Description and Solubility Reference Table? Would that be in the USP-NF or move to the Companion Volume?
A: We anticipate that the Description and Solubility Reference Table would move to the Companion Volume.
Q: Would the other tables in the Reference Table section, like the Solubilities, Atomic Weights, and Intrinsic Viscosity tables, move to the Companion Volume?
A: Yes, we anticipate that all of these Reference Tables would move to the Companion Volume.
Q: Where would the FCC Solutions and Indicators section be published? The introductory text to this section specifies that it is guidance only.
A: We welcome comments from industry regarding the placement of this text in the FCC, in the Companion Volume, or on the FCC Web site.
General Chapters
Q: What would USP do with General Chapters that have numbers below 1000?
A: All General Chapters that are referenced in a monograph would remain official and still would be published in the USP-NF. The placement of other General Chapters numbered below 1000 would be considered by the USP Expert Committees. Most probably would remain in the USP-NF and remain official. Some could be made "authorized" and move to the Companion Volume to the USP-NF. We welcome stakeholder input on these decisions.
Q: Do USP's Expert Committees have any guidelines/criteria about the chapters that should move to the Companion Volume and those that should stay in the USP-NF?
A: The Council of Experts had preliminary discussions on this topic, and the Expert Committees are discussing this in more detail. Examples of General Chapters that may remain official include chapters referenced in an official monograph or that are likely to be referenced in an official monograph, chapters that describe compendial requirements, and chapters that include other text that a USP Expert Committee considers necessary to perform compendial procedures or to ensure product quality.
Q: Would all of the General Chapters with numbers above 1000 move to the Companion Volume and become "authorized" instead of official?
A: Some would move to the Companion Volume. Some already are referenced in monographs, and therefore would remain official. We expect that the Expert Committees would want some others to remain official, as well, because of the importance of the topics covered and would decide to keep them in the USP-NF.
Q: Would any of the chapters numbered above 1000 be made enforceable?
A: The Expert Committees are considering the placement of each of the chapters, and we welcome your comments on the correct placement of each chapter. Some of the chapters that have numbers higher than 1000 may be kept in the USP-NF and made enforceable.
Q: If a General Chapter is included as official because it's referenced in one monograph, wouldn't that make it a requirement for all monographs?
A: No. Under the current General Notices, a substance or product is required to meet the applicable requirements set out in the General Notices, in the specific monograph, and in the General Chapters referenced by the monograph. This requirement would not change under the proposed General Notices. The fact that a General Chapter appears in the USP does not mean that the chapter applies to all USP monographs.
Q: What would USP do with chapters that include some text that is meant to be enforceable and some text that is just informational or guidance?
A: The Expert Committees responsible for the General Chapters will be considering these situations very carefully. In some cases, the chapters may be split into two, so that some text appears in the USP-NF and some appears in the new book as guidance. In other cases, the entire chapter could remain in the USP-NF.
Q: Would the General Chapter numbers be changed or eliminated?
A: No. Industry has commented previously that these numbers should not be changed or eliminated.
Q: What if my FDA filing refers to a General Chapter that moves to the new book?
A: The chapter number would not change, so your references would remain current. We will not propose to delete any chapters. Many of the chapters that your filings reference may remain in the USP-NF. Please submit comments about the chapters that should not move to the new book.
Q: Could Expert Committees write new General Chapters intended for the Companion Volume in the future? If so, would those chapters go through PF?
A: Yes, Expert Committees certainly could develop new General Chapters specifically for the Companion Volume. In fact, General Chapters for emerging technologies often have initiated as "informational" (above 1000) and moved to "enforceable" status only after broader adoption of the method or technology. We envision a similar situation for the informational chapters in the Companion Volume. Authorized text is not required to be published in PF, but we anticipate that the chapters would go through some type of public comment process.
Q: If an Expert Committee wants to make an authorized General Chapter into an official USP-NF General Chapter, would the chapter go through PF?
A: Yes.
Q: Will USP propose to reference USP-NF General Chapters in FCC monographs?
A: Not at this time, but the Food Ingredients Expert Committee may consider this in the future. We welcome your comments regarding the chapters that could be so referenced.
Q: Would the FCC General Tests and Assays be retitled "General Chapters"? Would they be given chapter numbers?
A: We welcome your comments regarding these questions. We are trying to understand the potential impact on industry if we rename the General Tests and Assays, "General Chapters." If we rename them "General Chapters," we also would consider assigning chapter numbers.
