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USP–NF 2021, Issue 1 Commentary

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USP–NF 2021, Issue 1 Commentary Commentary USP–NF 2021 Issue 1 November 2, 2020 In accordance with USP’s Rules and Procedures of the Council of Experts (“Rules”), and except as provided in Section 9.02 Accelerated Revision Processes, USP publishes proposed revisions to the United States Pharmacopeia and the National Formulary (USP–NF) for public review and comment in the Pharmacopeial Forum (PF), USP’s free bimonthly journal for public notice and comment. After comments are considered and incorporated as the Expert Committee deems appropriate, the proposal may advance to official status or be re-published in PF for further notice and comment, in accordance with the Rules. In cases when proposals advance to official status, a summary of comments received and the appropriate Expert Committee's responses, as well as Expert Committee-initiated changes, are published in the Proposal Status/Commentary section of USPNF.com at the time the official revision is published. The Commentary is not part of the official text and is not intended to be enforceable by regulatory authorities. Rather, it explains the basis of Expert Committees’ responses to public comments on proposed revisions. If there is a difference or conflict between the contents of the Commentary and the official text, the official text prevails. For further information, contact: USP Executive Secretariat United States Pharmacopeia 12601 Twinbrook Parkway Rockville, MD 20852-1790 USA Commentary for USP–NF 2021, Issue 1 Comments were received for the following when they were proposed in Pharmacopeial Forum: General Notices to USP-NF General Chapters <191> Identification Tests—General <210> Monosaccharide Analysis <476> Control of Organic Impurities < 601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <631> Color and Achromicity <643> Total Organic Carbon <915> Measurement of Structural Strength of Semisolids by Penetrometry <922> Water Activity <1051> Cleaning Glass Apparatus <1086> Impurities in Drug Substances and Drug Products <1088> In Vitro and In Vivo Evaluation of Dosage Forms <1102> Immunological Test Methods <1151> Pharmaceutical Dosage Forms < 1153> Drug Products Containing Nanomaterials <1195> Significant Change for Bulk Pharmaceutical Excipients <1235> Vaccines for Human Use—General Considerations <1238> Vaccines for Human Use—Bacterial Vaccines <1239> Vaccines for Human Use—Viral Vaccines <1711> Oral Dosage Forms—Performance Tests <1788> Methods for the Determination of Subvisible Particulate Matter <1788.1> Light Obscuration Method for the Determination of Subvisible Particulate Matter <1788.2> Membrane Microscope Method for the Determination of Subvisible Particulate Matter <1788.3> Flow Imaging Method for the Determination of Subvisible Particulate Matter <1912> Measurement of Hardness of Semisolids Monographs Abacacvir Lamivudine and Zidovudine Tablets Albuterol Inhalation Solution Amlodipine Besylate Tablets Atomoxetine Hydrochloride Azithromycin for Oral Suspension Baclofen Injection Benazepril Hydrochloride and Hydrochlorothiazide Tablets Benztropine Mesylate Bifidobacterium Bifidum Bifidobacterium Longum Subsp. Longum Calcipotriene Calcium Magnesium Citrate Commentary for USP–NF 2021, Issue 1 Carbidopa and Levodopa Tablets Carbomer Copolymer Carbomer Homopolymer Carbomer Interpolymer Cefepime for Injection Cetirizine Hydrochloride Cilostazol Tablets Clarithromycin Extended-Release Tablets Clobetasol Propionate Ointment Clonazepam Tablets Clonidine Hydrochloride Extended-Released Tablets Clozapine Clozapine Tablets Codeine Phosphate Dacarbazine Dacarbazine for Injection Dimenhydrinate Doxepin Hydrochloride Capsules Edetate Disodium Compounded Ophthalmic Solution Epinephrine Bitartrate Escitalopram Oral Solution Esomeprazole Magnesium Exemestane Tablets Felodipine Fentanyl Citrate Ferumoxides Injection Fluconazole Tablets Gadoterate Meglumine Injection Galantamine Tablets Granisetron Hydrochloride Injection Granisetron Hydrochloride Tablets Haloperidol Haloperidol Tablets Hydroxychloroquine Sulfate Tablets Ipratropium Bromide Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Ipratropium Bromide Inhalation Solution Lacosamide Lacosamide Injection Lacosamide Oral Solution Lacosamide Tablets Lactobacillus Reuteri Lactobacillus Rhamnosus Lamotrigine Orally Disintegrating Tablets Commentary for USP–NF 2021, Issue 1 Levofloxacin Tablets Liothyronine Sodium Loratadine Capsules Maltitol Maltitol Solution Methylphenidate Hydrochloride Minoxidil Tablets Modafinil Modafinil Tablets Nefazodone Hydrochloride Noncrystallizing Sorbitol Solution Oil-and Water-Soluble Vitamins with Minerals Chewable Gels Omeprazole Magnesium Oxcarbazepine Tablets Oxycodone Hydrochloride Oral Solution Pindolol Prazosil Hydrochloride Pyrazinamide Quinapril Tablets Quinine Sulfate Capsules Regorafenib Rifabutin Rifabutin Capsules Risperidone Oral Solution Sodium Phenylbutyrate Oral Powder Sodium Phenylbutyrate Tablets Sorafenib Tablets Sorafenib Tosylate Sorbitol Sorbitol Solution Sorbitol Sorbitan Solution Spironolactone Compounded Oral Suspension Sterile Purified Water Sterile Water for Inhalation Sterile Water for Injection Sterile Water for Irrigation Telmisartan Tetraxetan Tranexamic Acid Urea C13 Vecuronium Bromide Water-Soluble Vitamins Preparation No comments were received for the following proposals: Commentary for USP–NF 2021, Issue 1 Monographs Acebutolol Hydrochloride Betaxolol Hydrochloride Bethanechol Chloride Injection Butylated Hydroxytoluene Carbachol Carbachol Ophthalmic Solution Cefonicid for Injection Cefonicid Sodium Cetylpyridinium Chloride Ciprofloxacin Ophthalmic Ointment Citicoline Clotrimazole Cyclopropane Diazoxide Dibucaine Hydrochloride Dimenhydrinate Tablets Doxepin Hydrochloride Doxycycline Extended-Release Capsules Epinephryl Borate Ophthalmic Solution Ergotamine Tartrate Injection Ethynodiol Diacetate and Mestranol Tablets Flavoxate Hydrochloride Flumethasone Pivalate Flumethasone Pivalate Cream Gallamine Triethiodide Gallamine Triethiodide Injection Gemifloxacin Mesylate Guanethidine Monosulfate Tablets Half-Strength Lactated Ringer's and Dextrose Injection Haloperidol Decanoate Hyoscyamine Tablets Isoetharine Hydrochloride Isoetharine Inhalation Solution Isoetharine Mesylate Isoxsuprine Hydrochloride Injection Lactated Ringer's Injection Lactated Ringer's and Dextrose Injection L-alpha-Glycerylphosphorylcholine Maprotiline Hydrochloride Modified Lactated Ringer's and Dextrose Injection Nandolol and Bendroflumethiazide Tablets Naratriptan Hydrochloride Nortriptyline Hydrochloride Nortriptyline Hydrochloride Capsules Nortriptyline Hydrochloride Oral Solution Oxcarbazepine Oral Suspension Oxymetholone Oxymetholone Tablets Paclitaxel Injection Commentary for USP–NF 2021, Issue 1 Penbutolol Sulfate Penbutolol Sulfate Tablets Penicillin V Benzathine Penicillin V Benzathine Oral Suspension Penicillin V for Oral Suspension Penicillin V Tablets Pilocarpine Ocular System Potassium Chloride in Lactated Ringer's and Dextrose Injection Proparacaine HCl Quinapril Hydrochloride Ropinirole Extended-Release Tablets Ropinirole Hydrochloride Rufinamide Tablets Sertraline Hydrochloride Sodium Chloride Tablets Sodium Chloride Tablets for Solution Tetracycline Hydrochloride Compounded Oral Suspension Thioridazine Hydrochloride Ticarcillin and Clavulanic Acid Injection Tizanidine Hydrochloride Tomato Extract Containing Lycopene Triflupromazine Oral Suspension Trioxsalen Trioxsalen Tablets Zalcitabine Zalcitabine Tablets Zinc Carbonate General Notices Monograph/Sections: General Notices and Requirements/Multiple Sections Expert Committee: Council of Experts No. of Commenters: 3 Section 1. Title and Revision Comment Summary #1: The commenter supported USP’s continuing efforts to transition the USP and NF compendia to a fully electronic format, with the latest revisions to the General Notices completing this timely effort. Response: Comment incorporated. The Council of Experts (CoE) acknowledged the supportive comment. Comment Summary #2: The commenter suggested adding the months in which the compendia become official to the example titles: “USP–NF 2021 Issue 1: Published November 1, 2020; Official May 1, 2021.” Response: Comment not incorporated. The six-month implementation period does not apply to all standards that are published in each issue (e.g., delayed implementation or accelerated revisions), thus including it in the title would not be accurate. Section 3.10 Applicability of Standards Commentary for USP–NF 2021, Issue 1 Comment Summary #3: The commenter disagreed that chemical information should be provided in monographs solely for informational purposes. The commenter proposed any changes to chemical structures be published in Pharmacopeial Forum for public comment and proposed adding information to the General Notices from the Mission and Preface, noting the graphical representation of the chemical compound structure in the monograph is understood to represent one of many possible ways to depict the molecule. Response: Comment not incorporated. The revision specifically aligns USP policy with the intention of providing chemical information and structures for informational purposes. In cases where any specifications represented by chemical information are critical to establishing identity, purity, potency, or another quality attribute of an official article, the monograph will include such specifications in the text that states requirements. The CoE agreed that chemical and structural information in a monograph must be subject to stringent
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