Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availab
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Impurity Specifications for Antibiotics." The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactu
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-20 |
| Summary | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Impurity Specifications for Antibiotics." The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. This draft guidance applies to antibiotic drugs subject to approval under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and associated type II drug substance drug master files (DMFs) referenced in antibiotic NDAs and ANDAs. This guidance also applies to nonprescription antibiotic drugs, often referred to as ov |
| Document number | 2026-07629 |
| Official record | https://www.federalregister.gov/documents/2026/04/20/2026-07629/establishing-impurity-specifications-for-antibiotics-draft-guidance-for-industry-availability |