- <86> Bacterial Endotoxins Test Using Recombinant Reagents: Comments Received from Stakeholders, FAQs, and Additional Materials (posted 01-Nov-2024)
- <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products (posted 02-Dec-2024)
- <1245> Compaction Simulation Preview (posted 26-Apr-2024)
- Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)- 2nd Edition (posted 28-Apr-2023; input deadline 25-Jul-2023)
- Analytical Procedures for Quality of mRNA Vaccines and Therapeutics (Draft Guidelines: 3rd Edition) (posted 02-Aug-2024; input deadline 31-Oct-2024)
- Analytical Procedures for Viral Vectored Vaccine Quality (posted 29-Apr-2022)
- Bacterial Endotoxins Test Using Recombinant Reagents (posted 22-Aug-2023)
- Comment Period Extended for 〈823〉 Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses and 〈1823〉 Positron Emission Tomography Drugs—Information Appearing in Pharmacopeial Forum 49(5) (posted 17-Nov-2023)
- Deferred Proposal: General Notices and Requirements, 5.60.40 Impurities that are Unusually Toxic and/or Mutagenic (posted 30–Sep–2020)
- First Draft of Roadmap for Addressing Element-Specific Chapters and Tests in Excipient Monographs (posted 05–Aug–2020)
- Harmonization Stage 4 Publication of General Chapter <430> Particle Size Analysis by Dynamic Light Scattering (posted 28-Apr-2023)
- Modification to USP–NF 2021, Issue 2 Revisions, Deferrals, and Cancellations Lists (posted 29–Jan–2021)
- New Chapter <477> User-Determined Reporting Thresholds and its Implementation in USP-NF Monographs (posted 01-Nov-2023)
- New General Chapter <1220> Analytical Procedure Life Cycle (posted 24–Sep–2021)
- New Inhalation Product Monographs: Proposed Approach for Performance Tests using Non-standard Apparatus (posted 28–Aug–2020; comment deadline 30–Nov–2020; updated 25–Jun–2021)
- New Process and New Revision Markup for Chemical Information Updates in USP–NF (posted 25–Mar–2022)
- Official Date Change for Enoxaparin Sodium Monograph Revision (posted 30-Sep-2022)
- Omission of Containers for Dispensing Capsules and Tablets and Solubilities Reference Tables (posted 31-Mar-2023)
- Organic Impurities Procedures: Format Change for Presenting Relative Retention Times (posted 29–Oct–2021) | En español
- Pharmacopeial Forum 48(5) Stimuli Article: Selecting an Appropriate Volume for Subvisible Particles Per Container Calculation (posted 30-Sep-2022)
- Polyethylene Glycol (posted 29-Sep-2023)
- Polyethylene Glycol (posted 07-Oct-2024)
- Polyethylene Glycol (posted 27-Dec-2024)
- Polyethylene Glycol 12 Costearyl Ether (posted 31-Mar-2023)
- Revision Bulletin Notice Posting Update (posted 26–Mar–2021) | En español
- Talc, <901> Detection of Asbestos in Pharmaceutical Talc, <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc (posted 26-May-2023)
- Update: Guidance on the Use of Recombinant Reagents for Bacterial Endotoxin Test (posted 28–Aug–2020)
- Update: Reporting Thresholds in USP–NF Monographs (posted 12–Oct–2020)
- USP General Notices Biologics Nomenclature (posted 09-Jun-2022)
- USP Virtual Roundtable on Reporting Thresholds in Monographs (held on June 29, 2021) (posted 27–Aug–2021)
- USP is announcing a proposal to modify General Chapter <660> and the packaging and storage requirements in specified monographs (posted 27-Jan-2023)
Publication Announcements
- Changes to General Notices, Section 1 (posted 28-Feb-2024)
- Changes to USP's Description and Solubility Reference Table (posted 30-Sep-2022)
- Changes to USP's Description and Solubility Reference Table (posted 29-Sep-2023)
- Chemical Information Updates (posted 16-Dec-2022)
- Chemical Information Updates (posted 28-Apr-2023)
- Chemical Information Updates (posted 29-Sep-2023)
- Chemical Information Updates (posted 12-Feb-2024)
- Chemical Information Updates (posted 26-Apr-2024)
- Chemical Information Updates (posted 25-Oct-2024)
- Chemical Information Updates (posted 03-Feb-2025)
- Comment Deadline Extended: Pharmacopeial Forum 50(6) [Nov.-Dec. 2024] (posted 30-Jan-2025)
- Correction to Official Date of Posted IRA for Enoxaparin Sodium Monograph (posted 23-Nov-2022)
- Documentary Standard Updated for Equation Uniformity (posted 16-Dec-2022)
- Documentary Standards Updated for Equation Uniformity (posted 28-Apr-2023)
- Flecainide Acetate Tablets (posted 25-Oct-2024)
- General Chapters Affected by Omission to <1118> Monitoring Devices- Time, Temperature, and Humidity (posted 18-Apr-2023)
- General Chapters Affected by Revision to <1724> Semisolid Drug Products- Performance Tests (posted 28-Apr-2023)
- General Chapters Affected by Revisions to <1912> Measurement of Yield Stress of Semisolids (posted 28-Apr-2023)
- Mesalamine Extended-Release Capsules Updated Official Date (posted 22-Feb-2023)
- Monographs Affected by Revisions to <88> Biological Reactivity Tests, In Vivo (posted 26-Apr-2024)
- Monographs Affected by Revision to <126> Somatropin Bioidentity Tests (posted 30-Sep-2022)
- Monographs Affected by Revision to <211> Arsenic (posted 29-Apr-2022)
- Monographs Affected by Revision to <251> Lead (posted 29-Apr-2022)
- Monographs Affected by Revision to <261> Mercury (posted 29-Apr-2022)
- Monographs Affected by Revision to <206> Aluminum (posted 29-Apr-2022)
- Monographs Affected by Revision to <241> Iron (posted 29-Apr-2022)
- Monographs Affected by Revision to <291> Selenium (posted 29-Apr-2022)
- Monograph Affected by Revision to <541> Titrimetry (posted 12-Feb-2024)
- Monographs Affected by Revision to <616> Bulk Density of Powders (posted 28-Apr-2023)
- Monographs Affected by Revision to <789> Particulate Matter in Ophthalmic Solutions (posted 29-Sep-2023)
- Monographs Affected by Revision to <795> Pharmaceutical Compounding- Nonsterile Preparations (posted 01-Nov-2022)
- Monographs Affected by Revision to <797> Pharmaceutical Compounding- Sterile Preparations
- Monographs Affected by Revision to <941> Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction (XRPD) (posted 06–Apr–2021)
- Monographs Affected by Revisions
- Monographs Affected by a Style Update to the Uniformity of Dosage Units <905> Section (posted 16-Dec-2022)
- Monographs Affected by Revision to <1071> Rapid Microbiological Methods for the Detection of Contamination in Short-Life Products—A Risk-Based Approach (posted 03-Feb-2025)
- Monographs Affected by Revision to General Notices and Requirements (posted 03-Feb-2025)
- New USP-NF Publication Model: PF 50(5) and PF 50(6) Target Official Date Change (posted 01-Nov-2024)
- Pharmacopeial Forum 51(1) Stimuli Article: Characterization of Apex Vessel Geometries and Irregularities (posted 17-Jan-2025)
- Pre-Posting of General Chapter <1079.2. Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products (posted 02-Dec-2024)
- Revised General Chapter <795> Published in USP-NF (posted 01-Nov-2022)
- Revised General Chapter <797> Published in USP-NF (posted 01-Nov-2022)
- Upcoming Changes to USP's Description and Relative Solubility Reference Table (posted 24-Jun-2022)
- Update on the Extended Implementation Date for the Omission of Monographs for Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 (posted 01-Feb-2024)
- Update on Official Date for Xanthan Gum (posted 27-Sep-2024)
- USP-NF 2023, Issue 2: Metoprolol Succinate Extended-Release Tablets (posted 12-Apr-2024)
- USP-NF New Publication Model
- USP–NF Online: Official Dates for Monographs in Redesigned Format (posted 29-Apr-2022)
- USP-NF Online: Official Dates for Monographs in Redesigned Format (posted 28-Apr-2023)
- USP-NF Online: Official Dates for Monographs in Redesigned Format (posted 29-Sep-2023)
- USP-NF Online: Official Dates for Monographs in Redesigned Format (posted 26-Apr-2024)
- USP-NF Online: Official Dates for Monographs in Redesigned Format (posted 01-Nov-2024)
- USP-NF Online: Retirement of PDFs (posted 28-Jun-2024) En español