# 2025-15786: Rifampin Capsules Cleared for Generics by FDA

2025-15786, Determination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-08-19 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-15786
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-15786
- Title: Determination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 40373
- Published: 2025-08-19
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

Rifampin Capsules Cleared for Generics by FDA

## Summary

The FDA says RIFADIN capsules (150 mg and 300 mg) weren’t pulled from the market because of safety or effectiveness problems. This means generic versions can keep getting approved as long as they meet safety rules, especially about tiny impurities. Patients and drug makers can keep counting on these meds without any sudden changes or extra costs.

## Abstract

The Food and Drug Administration (FDA or Agency) has determined that RIFADIN (rifampin) capsules, 150 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness to the extent that the drugs can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements, including satisfying any applicable acceptable intake limit for nitrosamine impurities.

## Effects PRIA read

- RIFADIN Capsules Stay Available: benefit, medium. You can keep using RIFADIN (rifampin) capsules, 150 mg and 300 mg, because FDA determined they were not withdrawn from sale for reasons of safety or effectiveness. That availability is conditional on the drugs being manufactured or formulated so they satisfy any applicable acceptable intake limit f…
- Generic Approvals Can Continue: benefit, medium. Drug makers can continue to get abbreviated new drug application (ANDA) approvals that refer to RIFADIN 150 mg and 300 mg because FDA will not start withdrawing those ANDA approvals. Continued approvals are allowed only if the products meet legal and regulatory requirements, including satisfying an…
- Nitrosamine Limits Required for Approval: benefit, low. FDA will allow the products to remain on the market and allow ANDA approvals only to the extent the drugs can be manufactured or formulated to satisfy any applicable acceptable intake limit for nitrosamine impurities. That requirement focuses regulatory approval on meeting acceptable intake limits…

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## Sources
- [2025-15786 on federalregister.gov](https://www.federalregister.gov/documents/2025/08/19/2025-15786/determination-that-rifadin-rifampin-capsules-150-milligrams-and-300-milligrams-were-not-withdrawn)
- [2025-15786 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-08-19/pdf/2025-15786.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-15786 (as of 2026-06-08).