119th Congress · introduced in the Senate · Feb 5, 2026
CLEAR LABELS Act
Official title from Congress.gov
Latest action (Jul 27, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Reported to Senate (Jul 27, 2026)
Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act
This bill requires drugs and active pharmaceutical ingredients made available in the U.S. market to be labeled with the names and locations of their manufacturers.
Specifically, a finished, packaged drug product must be labeled with the name and place of business of (1) the original manufacturer (or manufacturers) of each active pharmaceutical ingredient; (2) the original manufacturer of the finished drug product; and (3) the packer or distributor, if any. This information must be printed on the product label or made available electronically. Active pharmaceutical ingredients (which are generally sold to manufacturers and researchers, not consumers) must also be labeled with the name and place of business of their original manufacturers.
Under the bill, the original manufacturer is the establishment that conducts the majority of the significant phases of manufacturing to produce the ingredient or product.
The Food and Drug Administration (FDA) has discretion to determine whether a violation of these requirements constitutes misbranding and to assess a civil fine. The FDA must consider certain factors in determining whether to assess a fine, including whether the violator was notified of their noncompliance and was provided an opportunity to correct the violation.
Finally, the FDA must coordinate with U.S. Customs and Border Protection to address any overlap between these requirements and existing requirements for imported drugs.
Show the full summary (1 more paragraphs)Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Hearings held.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Actions from Congress.gov, newest first.
Consumer affairs · Manufacturing · Prescription drugs · Supply chain
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
47 citations; showing the 25 most recently posted.
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION · lobbying firm or registrant: NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Pharmacy
$370,000
Spent on own lobbying
…-N-6869]"; H.R.6509/S.3794, the SAFE Drug Act; H.R.5316, the Drug Shortage Compounding Patient Access Act; H.R.8779/S.4509, the Patients Before Monopolies Act; S.3788/H.R.8269, the CLEAR LABELS Act; S.1941, the Cure Hepatitis C Act of 2025; Comments to Senate Finance "Re: Request for Information: Commonsense Policy Options t…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMGEN · lobbying firm or registrant: THE NICKLES GROUP, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…related to pharmacy benefit management reforms. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$2,560,000
Spent on own lobbying
…Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE UNITED STATES PHARMACOPEIAL CONVENTION · lobbying firm or registrant: THE UNITED STATES PHARMACOPEIAL CONVENTION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$120,000
Spent on own lobbying
S. 1784, H.R. 4191 - Mapping America's Pharmaceutical Supply (MAPS) Act: Provisions regarding supply chain security and resilience and drug shortages. S. 3788 - Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act (CLEAR LABELS) Act: Provisions regarding drug labelin…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$7,040,000
Spent on own lobbying
…edication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act S. 3794: SAFE Drugs Act of 2026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1:…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,530,000
Spent on own lobbying
…edication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act S. 3794: SAFE Drugs Act of 2026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1:…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$340,000
Paid to lobbying firm
…egislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; Americ…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BAYER CORPORATION (CONSOLIDATED REPORT) · lobbying firm or registrant: BAYER CORPORATION (CONSOLIDATED REPORT)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,710,000
Spent on own lobbying
…ause Care and Mid-Life Womens Health Act. S. 2903, Safe Step Act. S. 3122, Better Food Disclosure Act of 2025. S. 3677, Dietary Supplement Listing Act of 2026. S. 3788, CLEAR Labels Act. S. 4503, Advancing Menopause Care and Mid-Life Womens Health Act. S. 4587, Dietary Supplements Access Act. S. 5260, Stroke Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL ASSOCIATION OF CHAIN DRUG STORES · lobbying firm or registrant: NATIONAL ASSOCIATION OF CHAIN DRUG STORES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$480,000
Spent on own lobbying
…ealth Insurance Affordability Act H.R. 5256 340B ACCESS Act H.R. 4581 340B PATIENTS Act S. 2372 340B PATIENTS Act H.R. 6400 Rx ACCESS Act S. 4106 Rx ACCESS Act S. 3788 CLEAR LABELS Act S. 4509 Patients Before Monopolies Act H.R. 8779 Patients Before Monopolies Act S. 3822 Break Up Big Medicine Act H.R. 8800 National Defense A…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NOVARTIS · lobbying firm or registrant: NOVARTIS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$840,000
Spent on own lobbying
…gotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
TWIN RIVERS PAPER COMPANY · lobbying firm or registrant: FIERCE GOVERNMENT RELATIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Manufacturing
$50,000
Paid to lobbying firm
Paper industry issues; General business issues; H.R.8646 - FY 2027 Agriculture; Rural Development FDA and Related Agencies Appropriations Act, 2027; S.3788 - CLEAR LABELS Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA · lobbying firm or registrant: PROFESSIONAL COMPOUNDING CENTERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$190,000
Spent on own lobbying
…l supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788/ H.R. 8269 The Clear Labels Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHATTEM, INC. DBA OPELLA · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$70,000
Paid to lobbying firm
…Financial Services and General Government Appropriations Act, 2027 (H.R. 8495); State of Men's Health Act (H.R. 7602, S. 5113); GRAS reform; CLEAR LABELS Act (S. 3788, H.R. 8269).
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION OF ACCESSIBLE MEDICINES (FORMERLY KNOWN AS GPHA) · lobbying firm or registrant: FIERCE GOVERNMENT RELATIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…atent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; General Business Issues.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL ASSOCIATION OF CHAIN DRUG STORES · lobbying firm or registrant: VAN SCOYOC ASSOCIATES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Pharmacy
$70,000
Paid to lobbying firm
…h and Human Services, and Education, and Related Agencies Appropriations Act, 2026, Implementation of PBM Reform S.882, Patients Before Middlemen Act, Entirety S.3788, CLEAR LABELS Act, Entirety
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Pharmacy
$770,000
Spent on own lobbying
…formation Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid T…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Trade (domestic/foreign)
$770,000
Spent on own lobbying
…ffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 13, 2026 · issue area: Health Issues
$146,407
Paid to lobbying firm
…th respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule H.R. 10336…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HEALTH CARE SUPPLY CHAIN ASSOCIATION · lobbying firm or registrant: THE D MAJOR GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 3, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
Work on drug shortage issues affecting outpatient and inpatient settings. Also work on drug visibility supply chain issues including S. 3788, "the CLEAR Labels Act."
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Health Issues
$2,360,000
Spent on own lobbying
…zation Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$870,000
Spent on own lobbying
…051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid T…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Trade (domestic/foreign)
$870,000
Spent on own lobbying
…on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BAYER CORPORATION (CONSOLIDATED REPORT) · lobbying firm or registrant: BAYER CORPORATION (CONSOLIDATED REPORT)
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$1,820,000
Spent on own lobbying
…Defend Our Military Personnel and Their Families Act. H.R. 7366, Dietary Supplement Regulatory Uniformity Act. S. 3677, Dietary Supplement Listing Act of 2026. S. 3788, CLEAR Labels Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMGEN · lobbying firm or registrant: THE NICKLES GROUP, LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
Issues related to pharmacy benefit management. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE UNITED STATES PHARMACOPEIAL CONVENTION · lobbying firm or registrant: THE UNITED STATES PHARMACOPEIAL CONVENTION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · amended · posted Jul 20, 2026 · issue area: Health Issues
$130,000
Spent on own lobbying
S. 1784 - Mapping America's Pharmaceutical Supply (MAPS) Act; H.R. 4191: Provisions regarding supply chain security and resilience and drug shortages. S. 3788 - Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act (CLEAR LABELS) Act: Provisions regarding drug labelin…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing