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# Rule on Master Files and Biologics
- URL: https://www.fdaweb.com/rule-on-master-files-and-biologics/
- Published: 2024-02-09T12:00:00.000Z
- Updated: 2026-09-14T14:22:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156329

FDA is issuing a [final rule](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZlZGVyYWxyZWdpc3Rlci5nb3YvcHVibGljLWluc3BlY3Rpb24vMjAyNC0wMjc0MS9iaW9sb2dpY3MtbGljZW5zZS1hcHBsaWNhdGlvbnMtYW5kLW1hc3Rlci1maWxlcz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwMjA5Ljg5OTcxNTAxIn0.Nf0H1bMCNsYFGUBSsReNm4FQ972l5jHKujCI2hMI9-4/s/1255931999/br/236844392799-l?ref=fdaweb.com) to amend its regulations about the use of master files for biological products. The agency describes a [master file](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvZHJ1Z3MvZm9ybXMtc3VibWlzc2lvbi1yZXF1aXJlbWVudHMvZHJ1Zy1tYXN0ZXItZmlsZXMtZG1mcz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwMjA5Ljg5OTcxNTAxIn0.i--GDuUf%5FNPhwpzdjusimc-XmFumTyP9ylYkgTAph6k/s/1255931999/br/236844392799-l?ref=fdaweb.com) as a submission that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Information contained in a master file can be used to support a submission to FDA by an applicant or sponsor.

“The rule codifies FDA’s existing practice that applications for a biological product under the Public Health Service Act (PHS Act) may rely on a master file for information other than \[drug substance, drug substance intermediate, or drug product\] DS/DSI/DP information,” an [agency notice](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDQsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZlZGVyYWxyZWdpc3Rlci5nb3YvcHVibGljLWluc3BlY3Rpb24vMjAyNC0wMjc0MS9iaW9sb2dpY3MtbGljZW5zZS1hcHBsaWNhdGlvbnMtYW5kLW1hc3Rlci1maWxlcz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwMjA5Ljg5OTcxNTAxIn0.cPkBE6It3Jc77quzlnyHNpFb8Uuo7U6mrDfnfYDZn6U/s/1255931999/br/236844392799-l?ref=fdaweb.com) says. “Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), certain drug applications for biological products approved under section 505 of the FD&C Act were deemed to be biological licenses under section 351 of the PHS Act on 3/23/2020\. This rule also codifies that such deemed biological license applications (BLAs) that originally referenced DMFs for DS/DSI/DP information in an approved new drug application can continue to do so after 3/23/2020.”