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# Guide on Animal Drug Mfg. Batches
- URL: https://www.fdaweb.com/guide-on-animal-drug-mfg-batches/
- Published: 2024-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:25:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156572

FDA has posted a [draft guidance](https://www.fda.gov/media/176991/download?ref=fdaweb.com) entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.” The document says that a minimum of three primary batches of drug product should be manufactured under current good manufacturing practice to support application approvals, noting that the batches should be of the same formulation and packaged in the same container closure system as intended for marketing.

The guidance says that for animal drugs intended for a minor use or a minor species (MUMS animal drugs), sponsors should contact the Office of New Animal Drug Evaluation’s Division of Manufacturing Technologies (DMT) to discuss the appropriate number of batches. “In some cases, and with appropriate justification, bracketing can be used in the selection of the primary batches manufactured and placed on stability,” it says. “Bracketing is the strategy of only manufacturing batches on the extremes of certain design factors of the marketed product (e.g., strength, container size, and/or fill).

“In cases where the drug product application includes a single product formulation with multiple fill sizes and/or multiple container sizes,” the guidance continues, “each batch may be split into multiple fill or container sizes.” If the application includes multiple product strengths, the document says three manufacturing batches each of the lowest and highest strength may be acceptable. “CVM does not recommend using a bracketing approach for new biotechnological or biological animal drug products of different strengths,” it says, adding that applicants should consider submitting a protocol with the proposed bracketing approach or requesting a meeting to discuss with DMT.