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USP Pending Standards Guideline

Background

The United States Pharmacopeia (USP) Pending Standards approach allows development and web publication of monographs for certain drug products, and the drug substances to be used in such drug products, that have been submitted or are intended to be submitted to the U. S. Food and Drug Administration (FDA) for approval to be legally marketed in the U.S., but have not yet received such approval. The policy is intended especially for generic manufacturers and drug master file (DMF) holders.

The Request for Revision process for the United States Pharmacopeia and the National Formulary (USP-NF) (see USP Guideline for Submitting Requests for Revision to USP-NF Version 3.0)  (536KB) is restricted to articles which have received final approval and are legally marketed in the U.S., and allows monographs to be published in the USP-NF following publication for notice and comment in Pharmacopeial Forum (PF). USP's approach for Standards for Articles Legally Marketed Outside the U.S. (SALMOUS) is intended to provide monographs on USP's Web site for articles legally marketed only outside of the U.S. if intended for neglected infectious diseases (see SALMOUS Guideline). In contrast, the Pending Standards approach is intended only for articles pending final approval in the U.S. Following evaluation of the Request for Revision, a Pending Standards monograph will be published on USP's Web site in draft form for notice and comment. Upon conclusion of the comment period, incorporation of comments as appropriate, and approval by the USP Council of Experts, the Pending Standards monograph will be considered authorized rather than official text, without the opportunity to use USP block letters on certificates of analysis or on container labeling. This is similar to the process used for SALMOUS monographs, which also are published only on USP's Web site and also are considered authorized rather than official text when approved by the Council of Experts because they are not part of the USP-NF. However, manufacturers may use the designation "S-USP" on certificates of analysis and/or on container labels to indicate compliance to SALMOUS standards.

• USP's historical objective of having a sound public monograph for all articles that fall within its purview-which now includes food ingredients, dietary supplements, drugs, and the ingredients thereof. This objective is congruent with the Federal Food, Drug, and Cosmetic Act, which recognizes that adequate public standards in USP and NF should exist for all drugs;
• Avoidance of a market access barrier that might arise if FDA approves a drug product and the USP-NF monograph does not correspond with the private regulatory standard;
• USP's interest in assuring FDA that potential over-the-counter (OTC) articles for which a Time and Extent Application or citizen petition will be or have been submitted can be backed by an official USP-NF monograph at the time that they are included in a final OTC drug monograph; and
• A general objective of having the public USP-NF standard and the private regulatory standard be as consistent with each other as possible-an objective that is facilitated by USP's 'flexible monograph' approach.

Since implementing the Pending Standards approach in early 2007, USP has received comments from several parties. USP has revised the approach and this Guideline to take into account these comments. The changes include: (i) clarification of what constitutes "intent to file" with the FDA; (ii) a requirement that the Sponsor promptly inform USP of any changes to methods or specifications resulting from the regulatory review and approval process, to ensure consistency between the monograph and the private specification approved by FDA; (iii) utilization of USP's Revision Bulletin process to move a Pending Standards monograph to official status upon product approval, to allow such monographs to become official more quickly than under the proposed Interim Revision Announcement process formerly utilized; and (iv) a requirement that the bulk material necessary to develop any accompanying USP Reference Standard be received by USP prior to posting a proposed Pending Monograph on the Web site, to help ensure that such USP Reference Standard will be available at the time the product is approved and the monograph becomes official.

Requirements

• Requests for Revision will be accepted only from sponsors (i) who have filed or intend to file with FDA an Abbreviated New Drug Application (ANDA) or Abbreviated New Animal Drug Application (ANADA); (ii) who have submitted a Drug Master File (DMF) for an article to FDA; or (iii) whose substance is or will be the subject of a Time and Extent Application (TEA) or citizen petition to amend an FDA OTC drug monograph.
• The sponsor of the Request for Revision should follow the USP Guideline for Submitting Requests for Revision to USP-NF and label the Request "Pending Standards."
• The sponsor will include with the Request for Revision documentation of its FDA filing or intent to file with FDA. Documentation of intent to file must include evidence satisfactory to USP that the sponsor intends to file its ANDA or ANADA, as applicable, within a period of six months. Documentation of a DMF at FDA occurs through provision of the DMF filing letter.
• If the proposed monograph includes the use of a new USP Reference Standard, unless otherwise determined by USP the proposed monograph shall not be published in draft on the USP Web site until a suitable reference standard bulk candidate has been received by USP.
• If the sponsor desires to maintain confidentiality of any information, the submission will include a request that some part or all of the proposed Request for Revision be viewed only by USP and/or FDA for a specified time period prior to publication in draft for public comment.
• The sponsor must agree to promptly inform USP of any changes or additions that should be made to a Pending Standard as a result of the regulatory review and approval process (including but not limited to providing USP with the dissolution test included in the approved product specifications) in order to ensure consistency between the Pending Standard and the private specification approved by FDA.

Process

• The Request for Revision will be reviewed in accordance with USP's usual process. If the determination is made to proceed, and the bulk material for the reference standard has been received by USP, the proposed monograph (excluding any information the sponsor has designated confidential as provided above) will be published as draft on USP's Web site. Following a 90-day comment period and review and approval by the USP Council of Experts (including incorporation of public comments as deemed appropriate and review and approval of the title by the USP Nomenclature Expert Committee), the monograph will be posted on USP's Web site, appropriately labeled as an "Authorized Pending Standard". The monograph will remain in draft on the Web site until the end of the 90-day comment period even if the sponsor obtains full FDA approval during the comment period.
• When approved by the USP Council of Experts, the monograph will be considered authorized rather than official text under USP's Constitution and Bylaws, because it has been prepared in accordance with the Rules and Procedures of the Council of Experts but is not yet part of an official compendium of the United States (USP-NF).
• If at any time USP is notified by the sponsor of the Pending Standard that changes are necessary as a result of any changes made to methods and/or acceptance criteria during the regulatory review and approval process, such changes shall be promptly made to the Pending Standard and clearly identified on USP's Web site. If such changes are made during the 90 day comment period described above, USP may, at its discretion, extend such comment period to allow additional time for notice and comment on such changes. If such changes are made after the Pending Standard has been approved by the USP Council of Experts, USP may, at its discretion, treat such changes as a Request for Revision and republish the Pending Standards as draft on USP's Web site for a 90 day notice and comment period.
• When FDA approves a drug product for which an authorized Pending Standards monograph exists, a substance contained in such drug product, or both, such monograph(s) will be moved from authorized to official status in the USP-NF via a Revision Bulletin pursuant to Section 9.02 (d) of the Rules and Procedures of the Council of Experts. The monograph will become officially immediately, unless otherwise specified in the Revision Bulletin, and will be included in the next available USP-NF or Supplement thereto.