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Data / Federal rules / Prescription drugs

Federal rules on prescription drugs: 24 since January 2024

14 final rules and 10 proposed rules since January 11, 2024, 12 of them marked significant. 2 are open for comment now. Most come from the Centers for Medicare & Medicaid Services (11), Food and Drug Administration (5), Drug Enforcement Administration (4), Health and Human Services Department (4).

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 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
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots
2026-13656
Centers for Medicare & Medicaid ServicesProposed ruleJul 7
Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
2026-12059
Centers for Medicare & Medicaid ServicesProposed ruleJun 16
Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
2026-11526 · significant
Drug Enforcement AdministrationFinal ruleJun 9
Modification of Certain Terminology in Title 21
2026-08826
Food and Drug AdministrationProposed ruleMay 6
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges
2026-07205 · significant
Centers for Medicare & Medicaid ServicesProposed ruleApr 14
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
Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017
2026-02288 · significant
Drug Enforcement AdministrationFinal ruleFeb 5
Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
2025-24123 · significant
Health and Human Services DepartmentFinal ruleDec 31, 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
Controlled Substances Ordering System (CSOS) Modernization
2025-19325
Drug Enforcement AdministrationFinal ruleOct 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
2025-13271 · significant
Centers for Medicare & Medicaid ServicesProposed ruleJul 16, 2025
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; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment
2025-08676
Centers for Medicare & Medicaid ServicesFinal ruleMay 16, 2025
Special Registrations for Telemedicine and Limited State Telemedicine Registrations
2025-01099 · significant
Drug Enforcement AdministrationProposed ruleJan 17, 2025
Expansion of Buprenorphine Treatment via Telemedicine Encounter
2025-01049 · significant
Health and Human Services DepartmentFinal ruleJan 17, 2025
Continuity of Care via Telemedicine for Veterans Affairs Patients
2025-01044 · significant
Health and Human Services DepartmentFinal ruleJan 17, 2025
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
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
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
2024-13190
Food and Drug AdministrationFinal ruleJun 18, 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
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program
2024-00895 · significant
Centers for Medicare & Medicaid ServicesFinal ruleFeb 8, 2024
Safeguarding the Rights of Conscience as Protected by Federal Statutes
2024-00091
Health and Human Services DepartmentFinal ruleJan 11, 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.