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Data / Federal rules / Drugs

Federal rules on drugs: 69 since January 2024

48 final rules and 21 proposed rules since January 23, 2024, 14 of them marked significant. 2 are open for comment now. Most come from the Food and Drug Administration (39), Centers for Medicare & Medicaid Services (18), Nuclear Regulatory Commission (3), Health and Human Services Department (3).

SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.

Open for comment

DocumentAgencyTypeComments due
Nonclinical Testing Terminology
2026-19350
Food and Drug AdministrationFinal ruleDec 7
Nonclinical Testing Terminology
2026-19349
Food and Drug AdministrationProposed ruleDec 7

Every document, newest first

DocumentAgencyTypePublished
Nonclinical Testing Terminology
2026-19350
Food and Drug AdministrationFinal ruleSep 22
Nonclinical Testing Terminology
2026-19349
Food and Drug AdministrationProposed ruleSep 22
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-15652
Centers for Medicare & Medicaid ServicesFinal ruleAug 3
Reducing Barriers to Medical Use Licensing
2026-15080
Nuclear Regulatory CommissionProposed ruleJul 27
Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2026-14910
Food and Drug AdministrationFinal ruleJul 23
Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
2026-14909
Food and Drug AdministrationProposed ruleJul 23
Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2026-14327
Centers for Medicare & Medicaid ServicesProposed ruleJul 16
Reforming and Modernizing the NRC's Radiation Protection Framework
2026-14208
Nuclear Regulatory CommissionProposed ruleJul 15
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
2026-14073 · significant
Food and Drug AdministrationProposed ruleJul 13
Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies
2026-13602
Centers for Medicare & Medicaid ServicesProposed ruleJul 6
Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments
2026-10292 · significant
Centers for Medicare & Medicaid ServicesProposed ruleMay 22
Modification of Certain Terminology in Title 21
2026-08826
Food and Drug AdministrationProposed ruleMay 6
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-06642
Centers for Medicare & Medicaid ServicesProposed ruleApr 6
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction
2026-04797 · significant
Centers for Medicare & Medicaid ServicesFinal ruleMar 12
Revising the National Drug Code Format and Drug Label Barcode Requirements
2026-04368
Food and Drug AdministrationFinal ruleMar 5
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
2026-03286
Food and Drug AdministrationFinal ruleFeb 19
Revocation of Methods of Analysis Regulation
2026-03285
Food and Drug AdministrationFinal ruleFeb 19
Listing of Color Additives Exempt From Certification; Spirulina Extract
2026-02314
Food and Drug AdministrationFinal ruleFeb 6
Listing of Color Additives Exempt From Certification; Beetroot Red
2026-02313
Food and Drug AdministrationFinal ruleFeb 6
Statutory Updates to Branded Prescription Drug Fee Regulations
2025-24153
Internal Revenue ServiceProposed ruleJan 2
The Sunset Rule
2025-21784 · significant
Nuclear Regulatory CommissionFinal ruleDec 3, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
2025-21767 · significant
Centers for Medicare & Medicaid ServicesFinal ruleDec 2, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2025-19787 · significant
Centers for Medicare & Medicaid ServicesFinal ruleNov 5, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
2025-19166
Food and Drug AdministrationFinal ruleOct 1, 2025
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
2025-18655
Food and Drug AdministrationFinal ruleSep 25, 2025
Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2025-18023
Food and Drug AdministrationProposed ruleSep 17, 2025
Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
2025-16629
Food and Drug AdministrationFinal ruleAug 29, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
2025-16047
Food and Drug AdministrationFinal ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
2025-16046
Food and Drug AdministrationFinal ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
2025-16045
Food and Drug AdministrationFinal ruleAug 21, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2025-13271 · significant
Centers for Medicare & Medicaid ServicesProposed ruleJul 16, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
2025-13175
Food and Drug AdministrationFinal ruleJul 15, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
2025-12347 · significant
Centers for Medicare & Medicaid ServicesProposed ruleJul 2, 2025
Listing of Color Additives; Myoglobin; Confirmation of Effective Date
2025-09680
Food and Drug AdministrationFinal ruleMay 29, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
2025-08250
Food and Drug AdministrationFinal ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate
2025-08249
Food and Drug AdministrationFinal ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
2025-08248
Food and Drug AdministrationFinal ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Myoglobin
2025-01239
Food and Drug AdministrationFinal ruleJan 17, 2025
Special Registrations for Telemedicine and Limited State Telemedicine Registrations
2025-01099 · significant
Drug Enforcement AdministrationProposed ruleJan 17, 2025
Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
2025-00830
Food and Drug AdministrationFinal ruleJan 16, 2025
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2024-30261 · significant
Food and Drug AdministrationFinal ruleDec 26, 2024
Clinical Trials Registration and Results Information Submission
2024-28475
Health and Human Services DepartmentFinal ruleDec 9, 2024
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments
2024-25382 · significant
Centers for Medicare & Medicaid ServicesFinal ruleDec 9, 2024
Color Additive Certification; Increase in Fees for Certification Services
2024-25974 · significant
Food and Drug AdministrationFinal ruleNov 8, 2024
Technical Corrections to the TTB Regulations
2024-23662
Alcohol and Tobacco Tax and Trade BureauFinal ruleNov 6, 2024
Health and Human Services Adoption of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
2024-21984
Health and Human Services DepartmentFinal ruleOct 2, 2024
Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program
2024-21254
Centers for Medicare & Medicaid ServicesFinal ruleSep 26, 2024
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
2024-21559
Food and Drug AdministrationProposed ruleSep 20, 2024
USDA Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
2024-18544
Agriculture DepartmentFinal ruleAug 26, 2024
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products
2024-18343
Food and Drug AdministrationProposed ruleAug 16, 2024
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments
2024-14828
Centers for Medicare & Medicaid ServicesProposed ruleJul 31, 2024
Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees
2024-15136
Food and Drug AdministrationFinal ruleJul 10, 2024
USDA Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
2024-13845
Agriculture DepartmentProposed ruleJul 1, 2024
21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking
2024-13793
Centers for Medicare & Medicaid ServicesFinal ruleJul 1, 2024
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
2024-13190
Food and Drug AdministrationFinal ruleJun 18, 2024
Administrative Destruction
2024-11564
Food and Drug AdministrationFinal ruleMay 31, 2024
Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees
2024-11811
Food and Drug AdministrationFinal ruleMay 30, 2024
Medicaid Program; Ensuring Access to Medicaid Services
2024-08363 · significant
Centers for Medicare & Medicaid ServicesFinal ruleMay 10, 2024
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
2024-08262 · significant
Health and Human Services DepartmentFinal ruleApr 19, 2024
Poison Prevention Packaging Requirements; Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More Than 80 mg of the Drug
2024-07651
Consumer Product Safety CommissionFinal ruleApr 19, 2024
Medicaid Program; Streamlining the Medicaid, Children's Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes
2024-06566
Centers for Medicare & Medicaid ServicesFinal ruleApr 2, 2024
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
2024-05801
Food and Drug AdministrationProposed ruleMar 20, 2024
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
2024-04840
Food and Drug AdministrationProposed ruleMar 12, 2024
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
2024-04751
Food and Drug AdministrationFinal ruleMar 6, 2024
Medicaid Program; Disproportionate Share Hospital Third-Party Payer Rule
2024-03542
Centers for Medicare & Medicaid ServicesFinal ruleFeb 23, 2024
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
2024-03618
Food and Drug AdministrationFinal ruleFeb 22, 2024
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program; Corrections
2024-02705
Centers for Medicare & Medicaid ServicesFinal ruleFeb 12, 2024
Medical Devices; Quality System Regulation Amendments
2024-01709
Food and Drug AdministrationFinal ruleFeb 2, 2024
Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date
2024-01106
Food and Drug AdministrationFinal ruleJan 23, 2024

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Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.