Notices Requesting Feedback

<312> Molecular Weight Determination for Alginates General Chapter Prospectus (posted 29–Oct–2021; input deadline 28–Nov–2021)
<313> Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers General Chapter Prospectus (posted 29–Jan–2021; input deadline 28–Feb–2021)
<314> Molecular Weight Determination for Copolymers Containing Alkyl Methacrylate or Alkyl Acrylate General Chapter Prospectus (posted 29–Jan–2021; input deadline 28–Feb–2021)
<315> NMR Number-average Molecular Weight Determination for LG Polymers (posted 29-Dec-2023; input deadline 28-Jan-2024)
<316> GPC Molecular Weight and Polydispersity Determination for LG Polymers Using Universal Calibration (posted 29-Dec-2023; input deadline 28-Jan-2024)
<317> ICP OES Testing for Sodium Hydroxide and Potassium Hydroxide (posted 17-Nov-2023; input deadline 16-Dec-2023)
<320> NMR Spectroscopy for Determination of Degree of Hydrolysis for Polyvinyl Alcohol and Vinyl Alcohol Homopolymer, and Monomer Ratio for Vinyl Alcohol and Vinyl Acetate Copolymer (posted 30-Aug-2024; input deadline 29-Sep-2024)
<470> Determination of Diethylene Glycol and Ethylene Glycol in Polyethylene Glycol (posted 26-Jan-2024; input deadline 29-Feb-2024)<1xxx> Supplier Qualifications General Chapter Prospectus (posted 26–Mar–2021; input deadline 25–Apr–2021)
<477> User-Defined Reporting Thresholds General Chapter Prospectus (posted 30–Dec–2021; input deadline 29–Jan–2022)
<567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs) General Chapter Prospectus (posted 25–Sep–2020; input deadline 30–Oct–2020)
<795> Pharmaceutical Compounding—Nonsterile Preparations (posted 01–Sep–2021)
<797> Pharmaceutical Compounding— Sterile Preparations (posted 01–Sep–2021)
<901> Detection of Asbestos in Pharmaceutical Talc General Chapter Prospectus (posted 30–Apr–2021; updated 09–Aug–2021)
<1xxx> Solid-state NMR Spectroscopy–Theory and Practice General Chapter Prospectus (posted 26–Feb–2021; input deadline 28–Mar–2021)
<1002> Filters and Membranes General Chapter Propectus (posted 26–Mar–2021; input deadline 25–Apr–2021)
<1003> Resuspendability- Quantitative Assessment (posted 27-Jan-2023; input deadline 26-Feb-2023)
<1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products (posted 27-Jan-2023)
<1114> Ensuring Microbiological Quality of Articles of Botanical Origin General Chapter Prospectus (posted 29 Apr-2022)
<1154> Liposome Drug Products (posted 24-Jun-2022; input deadline 24-Jul-2022)
<1155> Iron Colloidal Formulations- Characterization Methods (posted 26-Apr-2024, input deadline 26-May-2024)
<1156> Product Quality and Performance Tests for the Microsphere Drug Products (posted 26-Apr-2024, input deadline 26-May-2024)
<1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products
<1331> Calibration and Verification of Volumetric Apparatus General Chapter Prospectus (posted 26–Feb–2021; input deadline 28–Mar–2021)
<1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research (updated 30-Jun-2022; input deadline 31-Jul-2022)
<1785> Osmolality/Osmolarity- Practical Consideration General Chapter Prospectus (posted 23-Feb-2024; input deadline 24-Mar-2024)
<1901>Theory and Practice of Asbestos Detection in Pharmaceutical Talc General Chapter Prospectus (posted 30–Apr–2021; updated 09–Aug–2021)
<2760> Impurities in Dietary Ingredients and Dietary Supplements General Chapter Prospectus (posted 24–Sep–2021; input deadline 24–Oct–2021)
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; input deadline 31-Jun-2022)
Azeotropic Isopropyl Alcohol Notice of Intent to Revise (posted 30–Apr–2021)
Bacterial Endotoxins Test (BET): USP Requests Additional Data for the Comparability of Recombinant Reagents to Compendial Reagents (posted 11–Jun–2021)
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)
Isopropyl Alcohol Notice of Intent to Revise (posted 30–Apr–2021)
Magnesium Family of Monographs (posted 27–Aug–2021)
Modification to USP–NF 2021, Issue 2 Revisions, Deferrals, and Cancellations Lists (posted 29–Jan–2021)
New Inhalation Product Monographs: Proposed Approach for Performance Tests using Non-standard Apparatus (posted 28–Aug–2020; comment deadline 30–Nov–2020)
Polyethylene Glycol Castor Oil Notice of Intent to Revise (posted 13-Jun-2024, input deadline 15-Jul-2024)
Process Analytical Technology- Definition, Attributes, Enablers, and Use Cases (posted 29-Mar-2024, input deadline 28-Apr-2024)
Proposed Compendial Approach for the Implementation of <60> Microbiological Examination of Nonsterile Products ̶ Tests for Burkholderia Cepacia Complex (BCC) (posted 29-Mar-2024, input deadline 27-Jun-2024)
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)