COMPENDIAL UPDATES
The Pharmaceutical Microbiology Forum provides updates from the respective “forums” (similar to the U.S.P. Pharmacopeial Forum) for the British Pharmacopoeia, European Pharmacopoeia, Indian Pharmacopoeia, Japanese Pharmacopeia, USP Pharmacopeial Forum and the World Pharmacopoeia. Each monograph/general chapter cited will contain some material relevant to microbiology and a brief synopsis. Notifications of new content will be posted to the online forum. The principal goal of these updates is to collect proposed pharmacopeial revisions with microbiological relevance from several of the major pharmacopeias in one place. Remember that no guarantees are made relative to completeness of this update, and you should make reference to the respective pharmacopeial form if in doubt. If you find an item of interest, please refer to the specific proposal in the specific pharmacopeial forum. This page provides links to the individual sets of recall information by date added to the PMF website.
| Compendium | Proposal Type | Title | New[N] / Revised[R] | Synopsis [requirements or description] | Date of Update | BP [comment deadline March 31, 2026] |
monograph | Melatonin Oral Solution | R | Would require compliance with BP’s Oral Liquids and chapter 5.1.4 Microbiological Quality of Non-sterile Pharmaceutical Preparations | 3/12/2026 |
|---|---|---|---|---|---|
| BP [comment deadline March 31, 2026] |
monograph | Morphine Oral Solution | R | Would require compliance with BP’s Oral Liquids and chapter 5.1.4 Microbiological Quality of Non-sterile Pharmaceutical Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Morphine Granules for Oral Suspension | R | Would require compliance with BP’s Oral Liquids and chapter 5.1.4 Microbiological Quality of Non-sterile Pharmaceutical Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Ispaghula Husk Oral Powder | R | Would require compliance with BP’s Oral Liquids and chapter 5.1.4 Microbiological Quality of Non-sterile Pharmaceutical Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Morphine Sulfate Injection | R | Would require compliance with BP’s Parenteral Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Moxidectin Injection | R | Would require compliance with BP’s Parenteral Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Moxidectin Oral Solution | R | Would require compliance with BP’s Oral Liquids and chapter 5.1.4 Microbiological Quality of Non-sterile Pharmaceutical Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Moxidectin Oromucosal Gel | R | Would require compliance with BP’s Oromucosal Preparations | 3/12/2026 |
| BP [comment deadline March 31, 2026] |
monograph | Phenytoin Injection | R | Would require compliance with BP’s Parenteral Preparations | 3/12/2026 |
| EP [comment deadline March 31, 2026] |
monograph | Danaparoid Sodium | R | Bacterial endotoxins (2.6.14): less than 0.02 IU per unit of anti-factor Xa activity, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins. | 3/12/2026 |
| EP | monograph | Guar galactomannan | R | Microbial contamination TAMC: acceptance criterion 103 CFU/g (2.6.12). TYMC: acceptance criterion 102 CFU/g (2.6.12). Absence of Escherichia coli (2.6.13). Absence of Salmonella (2.6.13). |
3/12/2026 |
| IP [no new relevant items as of this report date] |
3/12/2026 | ||||
| JP [no new relevant items as of this report date] |
3/12/2026 | ||||
| USP PF [52(2)] | chapter | 〈1229〉 Sterilization of Compendial Articles. | R | From briefing: This proposal is based on the version of the chapter official as of December 1, 2025. The USP Microbiology Expert Committee proposes the following revisions: Change the chapter title to “Sterilization". Consolidate content by integrating relevant text from the following chapters: Steam Sterilization by Direct Contact 〈1229.1〉 (also appears in this issue of PF) Moist Heat Sterilization of Aqueous Liquids 〈1229.2〉 (also appears in this issue of PF) Biological Indicators for Sterilization 〈1229.5〉 (scheduled for omission) Physicochemical Integrators and Indicators for Sterilization 〈1229.9〉 (scheduled for omission) Sterilization Cycle Development 〈1229.14〉 (scheduled for omission) |
3/12/2026 |
| USP PF [52(2)] | chapter | 〈1229.1〉 Steam Sterilization by Direct Contact | R | From briefing: This proposal is based on the version of the chapter official as of August 1, 2013. The USP Microbiology Expert Committee proposes the following revisions: Change the chapter title to “Moist Heat Sterilization”. Consolidate content by integrating relevant text from the following chapters: Moist Heat Sterilization of Aqueous Liquids 〈1229.2〉 (also appears in this issue of PF) Sterilization-in-Place 〈1229.13〉 (scheduled for omission) |
3/12/2026 |
| USP PF [52(2)] | chapter | 〈1229.2〉 Moist Heat Sterilization of Aqueous Liquids | R | From briefing: This proposal is based on the version of the chapter official as of August 1, 2022. The USP Microbiology Expert Committee proposes the following revisions: Change the chapter title to “Sterilizing Filtration of Liquids”. Consolidate content by integrating relevant text from Sterilizing Filtration of Liquids 〈1229.4〉, which is being omitted. |
3/12/2026 |
| USP PF [52(2)] | chapter | 〈1229.4〉 Sterilizing Filtration of Liquids | R | From briefing: This proposal is based on the version of the chapter that was official as of May 1, 2018. The General Chapters—Microbiology Expert Committee proposes to omit this chapter, as the information will be included in a revision of 〈1229.2〉 Moist Heat Sterilization of Aqueous Liquids which also appears in this PF. |
3/12/2026 |
| USP PF [52(2)] | monograph | Ampicillin | R | Sterility Tests 〈71〉, Test for Sterility of the Product to Be Examined, Membrane Filtration Sample solution:Dissolve 6 g of Ampicillin in 800 mL of Fluid D containing sufficient sterile penicillinase to inactivate the ampicillin, and swirl the vessel until dissolution is complete before filtering. Acceptance criteria:Where the label states that Ampicillin is sterile, it meets the requirements. Bacterial Endotoxins Test 〈85〉:Where the label states that Ampicillin must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Ampicillin is used can be met. |
3/12/2026 |
| USP PF [52(2)] | monograph | Calcium Gluceptate Injection | R | Bacterial Endotoxins Test 〈85〉:NMT 0.32 USP Endotoxin Units/mg of calcium gluceptate. Other Requirements:It meets the requirements for Injections and Implanted Drug Products 〈1〉. |
3/12/2026 |
| USP PF [52(2)] | monograph | Cefazolin for Injection | R | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(2)] | monograph | Chlorophyllin Copper Complex Sodium | R | Tests for Specified Microorganisms 〈62〉:It meets the requirements of the tests for absence of Escherichia coli and Salmonella species. | 3/12/2026 |
| USP PF [52(2)] | monograph | Goserelin Implants | R | Bacterial Endotoxins Test 〈85〉:NMT 350 USP Endotoxin Units/Implant Sterility Tests 〈71〉, Test for Sterility of the Product to be Examined, Membrane Filtration:Meet the requirements |
3/12/2026 |
| USP PF [52(2)] | monograph | Hypromellose Ophthalmic Solution | R | Sterility Tests 〈71〉:Meets the requirements. | 3/12/2026 |
| USP PF [52(2)] | monograph | Indigotindisulfonate Sodium | R | Bacterial Endotoxins Test 〈85〉:Where the label states that Indigotindisulfonate Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Indigotindisulfonate Sodium is used can be met. Microbial Enumeration Tests 〈61〉:The total aerobic microbial count is NMT 102 cfu/g and the total combined yeasts and molds count is NMT 50 cfu/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the tests for absence of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella species. |
3/12/2026 |
| USP PF [52(2)] | monograph | Indigotindisulfonate Sodium Injection | R | Sterility Tests 〈71〉:Meets the requirements Bacterial Endotoxins Test 〈85〉:Meets the requirements |
3/12/2026 |
| USP PF [52(2)] | monograph | Nicardipine Hydrochloride in Dextrose Injection | N | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(2)] | monograph | Nicardipine Hydrochloride in Sodium Chloride Injection | N | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(2)] | monograph | Hydrogenated Soybean Phosphatidylcholine | N | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count does not exceed 102 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. Tests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. Bacterial Endotoxins Test 〈85〉:Where the label states that Hydrogenated Soybean Phosphatidylcholine must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Hydrogenated Soybean Phosphatidylcholine is used can be met. Where the label states that Hydrogenated Soybean Phosphatidylcholine must be subjected to future processing during the preparation of injectable dosage forms. |
3/12/2026 |
| USP PF [52(2)] | monograph | Hydrogenated Soybean Phospholipids | N | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. Tests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. |
3/12/2026 |
| USP PF [52(1)] | monograph | Acetaminophen Injection | N | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(1)] | monograph | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution | R | Sterility Tests 〈71〉:Meets the requirements | 3/12/2026 |
| USP PF [52(1)] | monograph | Croscarmellose Sodium | R | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count is NMT 103 cfu/g, and the total combined molds and yeasts count is NMT 102 cfu/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the test for absence of Escherichia coli. |
3/12/2026 |
| USP PF [52(1)] | monograph | Esomeprazole Sodium | N | Bacterial Endotoxins Test 〈85〉:Where the label states that Esomeprazole Sodium is sterile or must be subjected to further processing during the preparation of injectable dosage forms, the levels of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Esomeprazole Sodium is used can be met. Microbial Enumeration Tests 〈61〉:The total aerobic microbial count is NMT 102 cfu/g, and the total combined molds and yeasts count is NMT 102 cfu/g. |
3/12/2026 |
| USP PF [52(1)] | monograph | European Elder Berry Juice Concentrate. | R | Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 104 CFU/g, and the total combined molds and yeasts count does not exceed 103 CFU/g. Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:Meets the requirements |
3/12/2026 |
| USP PF [52(1)] | monograph | European Elder Berry Liquid Extract. | R | Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 104 CFU/g, and the total combined molds and yeasts count does not exceed 103 CFU/g. Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:Meets the requirements |
3/12/2026 |
| USP PF [52(1)] | monograph | Gadodiamide. | R | Bacterial Endotoxins Test 〈85〉:Meets the requirements if the label states that Gadodiamide must be subjected to further processing during the preparation of the injectable dosage form. Microbial Enumeration Tests 〈61〉:NMT 500 cfu/g of the total aerobic microbial count; NMT 50 cfu/g of the total combined molds and yeasts count |
3/12/2026 |
| USP PF [52(1)] | monograph | Gadodiamide Injection | R | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(1)] | monograph | Hexaminolevulinate Hydrochloride | N | Bacterial Endotoxins Test 〈85〉:Meets the requirements | 3/12/2026 |
| USP PF [52(1)] | monograph | Ketoconazole Cream | N | Microbial Enumeration Tests 〈61〉:The total aerobic bacterial count does not exceed 102 CFU/g, and the total combined molds and yeasts count does not exceed 101 CFU/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the tests for absence of Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa. |
3/12/2026 |
| USP PF [52(1)] | monograph | Levothyroxine Sodium for Injection | N | Bacterial Endotoxins Test 〈85〉:Meets the requirements Sterility Tests 〈71〉:Meets the requirements |
3/12/2026 |
| USP PF [52(1)] | monograph | Penciclovir | N | Microbial Enumeration Tests 〈61〉:The total aerobic bacterial count does not exceed 103 CFU/g, and the total combined molds and yeasts count does not exceed 102 CFU/g, and the bile-tolerant Gram-negative bacterial count does not exceed 103 cfu/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa. |
3/12/2026 |
| USP PF [52(1)] | monograph | Shatavari Root | N | Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 105 CFU/g, and the total combined molds and yeasts count does not exceed 103 CFU/g. Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli: Meets the requirements. |
3/12/2026 |
| USP PF [52(1)] | monograph | Shatavari Root Powder | N | Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 105 CFU/g, and the total combined molds and yeasts count does not exceed 103 CFU/g. Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli: Meets the requirements. |
3/12/2026 |
| USP PF [52(1)] | monograph | Sucroferric Oxyhydroxide | N | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count is NMT 103 cfu/g. The total combined yeasts and molds count is NMT 102 cfu/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the test for absence of Escherichia coli. |
3/12/2026 |
| USP PF [52(1)] | monograph | Sucroferric Oxyhydroxide Chewable Tablets | N | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count is NMT 103 cfu/g. The total combined yeasts and molds count is NMT 102 cfu/g. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the test for absence of Escherichia coli. |
3/12/2026 |
| USP PF [52(1)] | monograph | Water for Hemodialysis | R | Microbial Enumeration Tests 〈61〉:The total aerobic microbial count does not exceed 100 cfu/mL. Tests for Specified Microorganisms 〈62〉:It meets the requirements of the test for absence of Pseudomonas aeruginosa. Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:It contains less than 1 USP Endotoxin Unit/mL. |
3/12/2026 |
| USP PF [52(1)] | monograph | Water for Injection | R | Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:It contains less than 0.25 USP Endotoxin Units/mL. | 3/12/2026 |
| USP PF [52(1)] | monograph | Bacteriostatic Water for Injection | R | Sterility Tests 〈71〉:Meets the requirements. Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:Less than 0.5 USP Endotoxin Unit/mL. |
3/12/2026 |
| USP PF [52(1)] | monograph | Sterile Water for Inhalation | R | Sterility Tests 〈71〉:Meets the requirements. Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:It contains less than 0.5 USP Endotoxin Units/mL. |
3/12/2026 |
| USP PF [52(1)] | monograph | Sterile Water for Injection | R | Sterility Tests 〈71〉:Meets the requirements. Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:It contains less than 0.25 USP Endotoxin Units/mL. |
3/12/2026 |
| USP PF [52(1)] | monograph | Sterile Water for Irrigation | R | Sterility Tests 〈71〉:Meets the requirements. Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:It contains less than 0.25 USP Endotoxin Units/mL. |
3/12/2026 |
| USP PF [52(1)] | monograph | Pure Steam | R | Bacterial Endotoxins Test 〈85〉or Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉:The condensate contains less than 0.25 USP Endotoxin Units/mL when used in the production of parenterals. | 3/12/2026 |
| WHO [no new relevant items as of this report date] |
3/12/2026 | BP | monograph | Copper Sulfate Sterile Concentrate | N | The concentrate complies with the requirements for Concentrates for Injections or Infusions stated under Parenteral Preparations and with the following requirements. Where appropriate, the concentrate also complies with the requirements stated under Unlicensed Medicines. |
11/4/2025 |
| BP | monograph | Brimonidine Eye Drops | N | Brimonidine Eye Drops are a sterile solution of Brimonidine Tartrate. | 11/4/2025 |
| BP | monograph | Clarithromycin for Infusion | R | Clarithromycin for Infusion is a sterile material consisting of Clarithromycin with or without excipients. It is supplied in a sealed container. The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements. |
11/4/2025 |
| BP | monograph | Bleomycin Powder for Injection | R | Bleomycin Powder for Injection is a sterile material consisting of Bleomycin Sulfate with or without excipients. It is supplied in a sterile container. The contents of the sealed container comply with the requirements stated under Parenteral Preparations and with the following requirements. |
11/4/2025 |
| EP | monograph | Croscarmellose Sodium | R | Microbial contamination TAMC: acceptance criterion 103 CFU/g (2.6.12). TYMC: acceptance criterion 102 CFU/g (2.6.12). Absence of Escherichia coli (2.6.13). |
11/4/2025 |
| EP | monograph | Parenteral preparations | R | Sterility (2.6.1). Parenteral preparations comply with the test. Pyrogenicity. Parenteral preparations for human use, if applicable after reconstitution or dilution, comply with a suitable test for pyrogenicity. Guidance for the selection of a test is given in general chapter 5.1.13. The limit, when not indicated in the individual monograph, is determined in accordance with the recommendations of general chapter 5.1.10 when a test for bacterial endotoxins is selected or general chapter 2.6.30 when a monocyte-activation test is selected. The limit for intravitreal preparations for intraocular use is expressed per eye. Where the label states that the preparation is free from bacterial endotoxins, the preparation complies with the test for bacterial endotoxins (2.6.14 or 2.6.32). Where the label states that the preparation is apyrogenic, the preparation complies with the monocyte-activation test (2.6.30). Parenteral preparations for veterinary use comply with a suitable test for pyrogenicity when the volume to be injected in a single dose is 15 mL or more and is equivalent to a dose of 0.2 mL or more per kilogram of body mass. Guidance for the selection of a test is given in general chapter 5.1.13. |
11/4/2025 |
| EP | monograph | Sorbitol, Liquid, Partially Dehydrated | R | Microbial contamination TAMC: acceptance criterion 103 CFU/g (2.6.12). TYMC: acceptance criterion 102<;sup> CFU/g (2.6.12). Absence of Escherichia coli (2.6.13). Absence of Salmonella (2.6.13). |
11/4/2025 |
| IP [no new relevant items as of this report date] |
11/4/2025 | ||||
| > | |||||
| JP [no new relevant items as of this report date] |
11/4/2025 | ||||
| USP PF [51(6)] | chapter | 〈771〉 Ophthalmic Products—Quality Tests | R | STERILITY Ophthalmic dosage forms▲All ophthalmic drug products▲ (USP 1-Feb-2027)must meet the requirements of Sterility Tests 〈71〉. ▲Sterility is considered a critical quality attribute for ophthalmic drug products.▲ (USP 1-Feb-2027)If the specific ingredients used in the formulation do not lend themselves to routine sterilization techniques, ingredients that meet the sterility requirements described in 〈71〉, along with aseptic manufacture, may be used. The immediate container▲primary container–closure system▲ (USP 1-Feb-2027)for ophthalmic ▲drug▲ (USP 1-Feb-2027)products shall be sterile at the time of filling and ▲container▲ (USP 1-Feb-2027)closing. antimicrobial preservatives ▲Multidose drug products shall contain a suitable antimicrobial preservative, and the effectiveness of the preservative during the use period of the drug product must be verified. The efficacy of the preservative must also be maintained for the shelf life of the product. Alternatively, preservative-free multidose drug products require a packaging system that has been demonstrated to maintain sterility during the use period of the drug product. The efficacy of the preservative-free packaging system must also be maintained for the shelf life of the drug product.▲ (USP 1-Feb-2027) Antimicrobial agents must be added to products that are packaged in containers that allow for the withdrawal or administration of multiple doses, unless one of the following conditions prevails: 1) there are different directions in the individual monograph; 2) the radiopharmaceutical drug product contains a radionuclide with a physical half-life of <24 h; 3) the drug product, without additional agents, is sufficiently microbicidal to meet the requirements of Antimicrobial Effectiveness Testing 〈51〉; or 4) the container–closure system is capable of maintaining sterility of the product throughout its shelf life until opened or accessed. Once opened or accessed, it must maintain antimicrobial effectiveness during the intended use period. Antimicrobial agents must meet the requirements of 〈51〉 and Antimicrobial Agents—Content 〈341〉. Acceptance criteria for antimicrobial preservative content in multidose products should be established. bacterial endotoxins All injected ophthalmic drug products shall be prepared in a manner designed to minimize bacterial endotoxins as defined in Bacterial Endotoxins Test 〈85〉. The limits are not more than 0.5 EU/mL for ophthalmic irrigation products and not more than 2.0 EU/dose/eye for injected or implanted drug products. Typically, this test is not required for topically applied ophthalmic ▲drug▲ (USP 1-Feb-2027)products. This chapter does not address the endotoxin limits for devices that are injected or implanted. |
11/4/2025 |
| USP PF [51(6)] | chapter | 〈825〉 Radiopharm-aceuticals—Preparation, Compounding, Dispensing, and Repackaging. | R | [from Briefing] Clarify in 1.2 Sterile Radiopharmaceuticals that 70% isopropyl alcohol (IPA) must be allowed to dry, prior to initial needle puncture, when wiping vial septa. Revise 3. Immediate Use of Sterile Radiopharmaceuticals as follows: Add the requirement that intrathecally administered radiopharmaceuticals not be dispensed according to the immediate use standards. Revise 3. Immediate Use of Sterile Radiopharmaceuticals as follows: Add the requirement that intrathecally administered radiopharmaceuticals not be dispensed according to the immediate use standards. Add requirements that nondirect infusion generators may not be eluted according to the immediate use standards and that nondirect infusion generators are required to be stored and eluted in a segregated radiopharmaceutical processing area (SRPA) in ISO 8 total airborne particles or better. Garbing and aseptic qualifications for the environment must be performed. Clarify requirements in 4.1 Aseptic Qualifications under Gloved Fingertip and Thumb Sampling. In 4.2 Reevaluation, Retraining, and Requalification: Clarify the requirement that gloved fingertip and thumb sampling is not required but may be allowed to be in conjunction with media-fill testing. Clarify the requirement for reevaluation and requalification after a pause in sterile radiopharmaceutical processing. Clarify the requirements for ancillary individuals with regard to whether or not they handle sterile radiopharmaceuticals directly. Clarify the expectation for all personnel entering ISO classified areas to meet the requirements for the specific classified area that they access. In 6. Microbiological Air and Surface Monitoring, delete requirements for incubation of samples in separate incubators. Make the following changes to 7. Cleaning and Disinfecting: Update the frequency requirement for cleaning and disinfecting surfaces. Update Table 5 to include a requirement for cleaning and disinfecting the surfaces of handwashing sink(s) used as part of aseptic garbing. Update 7.2 Cleaning Supplies to add a requirement for cleaning, disinfecting, and sporicidal agents used within the PEC to be sterile with the exception of tool handles and holders. In 7.6 Cleaning and Disinfecting Items from Patient Care Area, update to include syringe-carrying containers. |
11/4/2025 |
| USP PF [51(6)] | chapter | 〈1155〉 Injectable Iron Colloidal Products—Characterization Methods | N | Sterility Tests 〈71〉 Bacterial endotoxins (Bacterial Endotoxins Test 〈85〉 and Guidelines for Bacterial Endotoxins Testing 〈1085〉) |
11/4/2025 |
| USP PF [51(6)] | chapter | 〈1156〉 LG Polymer Microparticle Drug Products—Characterization Methods | N | Bacterial endotoxins (Bacterial Endotoxins Test 〈85〉 and Guidelines For Bacterial Endotoxins Testing 〈1085〉) Sterility Tests 〈71〉 Sterility Sterility should be determined both within and on the surface of the LG polymer microparticles. Thus, during method development, studies should be conducted to detect any organisms inside the test sample. |
11/4/2025 |
| USP PF [51(6)] | chapter | 〈1225〉 Validation of Compendial Procedures | R | This chapter is always of general importance. | 11/4/2025 |
| USP PF [51(6)] | chapter | 〈1771〉 Ophthalmic Products—Performance Tests | R | Sterilization Ophthalmic drug products must be sterile, and the sterilization methods used for the manufacturing process should be appropriately justified. (For example, see Ref. 1.) During the sterilization step of the manufacturing process, degradation and morphological changes can occur in the drug product. These changes depend on the formulation, container–closure system, and sterilization process. Such changes should be minimized to ensure product integrity and efficacy. Autoclaving: The high temperatures required for this moist heat sterilization method can cause irreversible damage to certain dosage forms, especially those containing heat-sensitive components. Filtration: While sterile filtration through a 0.2-µm filter is effective, it is only applicable to formulations that can be successfully filtered without impacting their quality or performance. It may not be suitable for suspensions or viscous solutions. Dry heat sterilization: This method requires prolonged exposure to high temperatures, which can also degrade heat-sensitive materials and is generally unsuitable for ophthalmic preparations. Ethylene oxide (EtO): Although useful for terminal sterilization, EtO may leave harmful residuals if not carefully removed, posing safety concerns. Gamma irradiation: Exposure to radiation can lead to chemical changes in the formulation and container materials, potentially affecting the product's safety and stability. An alternative approach is to manufacture the drug product using sterile ingredients in an aseptic environment. This method avoids exposing the formulation to conditions that may lead to degradation, but it requires meticulous control and compliance with stringent aseptic techniques to prevent contamination. |
11/4/2025 |
| USP PF [51(6)] | monograph | Aronia melanocarpa Fruit Aqueous Dry Extract | N | •Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does not exceed 103 cfu/g. •Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Arsenic Trioxide | N | •Bacterial Endotoxins Test 〈85〉:Where the label states that Arsenic Trioxide must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Arsenic Trioxide is used can be met. •Microbial Enumeration Tests 〈61〉:The total aerobic microbial count does not exceed 102 cfu/g. The total molds and yeasts count does not exceed 501 cfu/g. |
11/4/2025 |
| USP PF [51(6)] | monograph | Arsenic Trioxide Injection | N | •Bacterial Endotoxins Test 〈85〉:Meets the requirements •Sterility Tests 〈71〉:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Cordyceps sinensis Fruiting Body | N | •Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. •Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Cordyceps sinensis Fruiting Body Powder | N | •Microbial Enumeration Tests 〈2021〉:The total aerobic bacterial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. •Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella SpeciesandTest for Absence of Escherichia coli:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Latanoprost Ophthalmic Solution | N | •Sterility Tests 〈71〉:Meets the requirements | 11/4/2025 |
| USP PF [51(6)] | monograph | Palonosetron Injection | N | •Bacterial Endotoxins Test 〈85〉:Meets the requirements •Sterility Tests 〈71〉:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Phosphatidylserine | N | •Microbial Enumeration Tests 〈2021〉:The total bacterial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. •Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:Meets the requirements |
11/4/2025 |
| USP PF [51(6)] | monograph | Scaffold Bovine Dermis | R | •Sterility Tests 〈71〉:It meets the requirements. •Bacterial Endotoxins Test 〈85〉:It meets the requirements as directed in Medical Devices—Bacterial Endotoxin and Pyrogen Tests 〈161〉. |
11/4/2025 |
| WHO [no new relevant items as of this report date] |
11/4/2025 |
Sponsor's Corner
The sponsors of the PMF are absolutely essential to the existence of the PMF. Each sponsor is listed below in order of the sponsorship level (ranges from $5000.00/year to $100.00/year), and then alphabetically. Please click on the sponsor logo to be taken to a page specific to that sponsor.
< PMF is a not-for-profit scientific and educational organization.