Food and Drug Administration — what it published

Dates this agency has set that have not yet arrived

What is in this list

Comment deadlines and effective dates from anything this agency published in the archive, still ahead of 11 September 2026.

Dates set before this archive began are not here, and their absence is not evidence that none exist.

as_of 2026-09-11

2026-09-11 today Takes effect Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software Health and Human Services Department · Food and Drug Administration
2026-09-16 +5d Takes effect Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product Health and Human Services Department · Food and Drug Administration
2026-09-16 +5d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Health and Human Services Department · Food and Drug Administration
2026-09-18 +7d Comments close International Association of Color Manufacturers; Filing of Color Additive Petition Health and Human Services Department · Food and Drug Administration
2026-09-18 +7d Comments close Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate Health and Human Services Department · Food and Drug Administration
2026-09-28 +17d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs Health and Human Services Department · Food and Drug Administration
2026-09-28 +17d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees Health and Human Services Department · Food and Drug Administration
2026-09-30 +19d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form Health and Human Services Department · Food and Drug Administration
2026-10-01 +20d Takes effect Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 Health and Human Services Department · Food and Drug Administration
2026-10-09 +28d Comments close Radiology Devices; Reclassification of Digital Breast Tomosynthesis System Health and Human Services Department · Food and Drug Administration
2026-10-13 +32d Comments close Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
2026-10-13 +32d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed Health and Human Services Department · Food and Drug Administration
2026-10-16 +35d Comments close Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Health and Human Services Department · Food and Drug Administration
2026-10-16 +35d Comments close Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Health and Human Services Department · Food and Drug Administration
2026-10-16 +35d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food Health and Human Services Department · Food and Drug Administration
2026-10-16 +35d Comments close Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Health and Human Services Department · Food and Drug Administration
2026-10-16 +35d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries Health and Human Services Department · Food and Drug Administration
2026-10-17 +36d Comments close Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Health and Human Services Department · Food and Drug Administration
2026-10-19 +38d Comments close Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
2026-10-23 +42d Comments close Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Health and Human Services Department · Food and Drug Administration
2026-10-26 +45d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Health and Human Services Department · Food and Drug Administration
2026-10-27 +46d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Health and Human Services Department · Food and Drug Administration
2026-10-27 +46d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Health and Human Services Department · Food and Drug Administration
2026-10-27 +46d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Health and Human Services Department · Food and Drug Administration
2026-10-30 +49d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Health and Human Services Department · Food and Drug Administration
2026-10-30 +49d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Health and Human Services Department · Food and Drug Administration
2026-11-03 +53d Comments close Advancing Development of Botanical Drug Products; Request for Information Health and Human Services Department · Food and Drug Administration
2026-11-09 +59d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Health and Human Services Department · Food and Drug Administration
2026-11-09 +59d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications Health and Human Services Department · Food and Drug Administration
2026-11-10 +60d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Health and Human Services Department · Food and Drug Administration

9 more beyond these.

11 September 2026 4 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA classified cardiovascular machine learning-based notification software as class II medical devices and amended sunscreen monograph requirements.

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RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software

The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 11 September 2026 today

91 FR 57785FR Doc. 2026-18612official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate

The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate." This final order amends "Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" (Over- the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE).

91 FR 57892FR Doc. 2026-18551official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.

Comments close 10 November 2026 in 60 days

91 FR 57893FR Doc. 2026-18529official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed

The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Comments close 13 October 2026 in 32 days

91 FR 57895FR Doc. 2026-18528official PDF federalregister.gov

10 September 2026 10 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA published ten documents including one proposed rule withdrawing a food additive petition, one notice establishing a fiscal year 2027 priority review voucher fee rate, and eight rules classifying medical devices.

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Proposed RuleHealth and Human Services Department Food and Drug Administration

Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis or 10 kilograms per metric ton of food.

91 FR 57531FR Doc. 2026-18469official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2027 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a tropical disease, rare pediatric disease, or material threat MCM priority review voucher and outlines the payment procedures for such fees.

Takes effect 1 October 2026 in 20 days

91 FR 57617FR Doc. 2026-18464official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures

The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mechanical deviation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57495FR Doc. 2026-18433official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures

The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57500FR Doc. 2026-18432official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access

The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57498FR Doc. 2026-18431official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease

The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57493FR Doc. 2026-18430official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery

The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57502FR Doc. 2026-18429official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device

The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57504FR Doc. 2026-18428official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System

The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the vaginal hydrogel packing system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57509FR Doc. 2026-18427official PDF federalregister.gov

RuleHealth and Human Services Department Food and Drug Administration

Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device

The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Takes effect 10 September 2026 1 days ago

91 FR 57507FR Doc. 2026-18426official PDF federalregister.gov

9 September 2026 7 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published seven notices on September 9, 2026, including guidance on neonatal parenteral nutrition compounding and patent extension determinations.

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NoticeHealth and Human Services Department Food and Drug Administration

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.

91 FR 57358FR Doc. 2026-18368official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

91 FR 57359FR Doc. 2026-18349official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Comments close 9 November 2026 in 59 days

91 FR 57347FR Doc. 2026-18333official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

Comments close 8 March 2027 in 178 days

91 FR 57356FR Doc. 2026-18300official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications."

Comments close 9 November 2026 in 59 days

91 FR 57352FR Doc. 2026-18299official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Comments close 8 March 2027 in 178 days

91 FR 57355FR Doc. 2026-18298official PDF federalregister.gov

NoticeHealth and Human Services Department Food and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

Comments close 8 March 2027 in 178 days

91 FR 57350FR Doc. 2026-18297official PDF federalregister.gov

4 September 2026 1 document

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA published a notice requesting information on advancing botanical drug product development, with comments due November 3, 2026.

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NoticeHealth and Human Services Department Food and Drug Administration

Advancing Development of Botanical Drug Products; Request for Information

The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders' perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Comments close 3 November 2026 in 53 days

91 FR 56887FR Doc. 2026-18133official PDF federalregister.gov

3 September 2026 1 document

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA determined that Phenaphen with Codeine No. 3 and No. 4 oral capsules were not withdrawn for safety or effectiveness reasons.

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NoticeHealth and Human Services Department Food and Drug Administration

Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met.

91 FR 56654FR Doc. 2026-18023official PDF federalregister.gov

Earlier

17 further days of this agency's activity are in the long-form archive, oldest to newest, on one page.

Everything Food and Drug Administration has published, 2026-08-10 to 2026-09-11 →

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