H.R. 9011House117th Congress (2021-2023)In Committee

Updated Drug Labeling for Patient Safety Act

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Updated February 8, 2026 at 5:55 PM UTC

The Updated Drug Labeling for Patient Safety Act amends the Federal Food, Drug, and Cosmetic Act to let manufacturers of generic drugs (holders of abbreviated new drug applications) add new or updated safety information to their product labels. It creates a formal process for these labeling changes to be made even before the Secretary of Health and Human Services formally approves them. The rule aims to improve patient safety by getting important safety updates to the market faster. It affects generic drug makers and the patients who use those drugs.

Key Provisions

Adds paragraph (14) to section 505(j) of the FD&C Act, allowing ANDA holders to change labeling to include new or updated safety‑related information before Secretary approval.
Requires the HHS Secretary to issue a final rule implementing this new labeling process within 18 months of the law’s enactment.
The rule must outline how to align labeling for the specific drug, any listed reference drug, and other drugs that reference it.
The final rule becomes effective no later than 180 days after it is issued.

Legislative Activity

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2 earlier actions

HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

September 29, 2022

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HouseIntro Referral

Introduced in House

September 28, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

September 28, 2022

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

September 29, 2022

Bill Text

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Introduced in HouseIssued September 28, 2022

117th CONGRESS

2d Session

H. R. 9011

IN THE HOUSE OF REPRESENTATIVES

September 28, 2022

Mr. McEachin introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes.

Short title

This Act may be cited as the Updated Drug Labeling for Patient Safety Act.

Safety labeling changes initiated by ANDA holders

(a)

In general

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following:

(14)

Notwithstanding paragraphs (2)(A)(v), the Secretary shall establish a process to allow the holder of an abbreviated new drug application to change the labeling of the drug that is the subject of the application to include new or updated safety-related information, including a process to make such changes prior to being approved by the Secretary.

(b)

Regulations

(1)

In general

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a final rule to implement paragraph (14) of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), as added by subsection (a).

(2)

Contents

The final rule issued under paragraph (1) shall include a process for conforming the labeling of a drug that is labeled pursuant to such paragraph (14), the listed drug (as such term is used in such section 505(j)), and other drugs approved under such section 505(j) that reference such listed drug.

(3)

Effective date

The final rule issued under paragraph (1) shall become effective not later than 180 days after the date on which such final rule is issued.