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# Voluntary Consensus Standards Guidance
- URL: https://www.fdaweb.com/voluntary-consensus-standards-guidance/
- Published: 2023-07-26T12:00:00.000Z
- Updated: 2026-09-14T18:46:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154962

FDA has published a guidance, *CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality*, to describe the agency’s participation in the development and use of technical voluntary consensus standards that are integral to its mission. The [document](http://www.fda.gov/media/121305/download?ref=fdaweb.com) says FDA has used such standards to develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.

The guidance has an Introduction, Background, Scope of the Program, Purpose of the Program, The Recognition Program for Voluntary Consensus Standards Related to Pharmaceutical Quality, and 11 Questions and Answers About the Program.

An accompanying online [statement](https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-cders-program-recognition-voluntary-consensus-standards-related-pharmaceutical?ref=fdaweb.com) says the program was first outlined in a 2/2019 draft guidance and is intended to promote innovation in pharmaceutical development and manufacturing. “FDA encourages manufacturers to use FDA-recognized consensus standards for their premarket submissions of drug applications,” the statement says. “By recognizing voluntary consensus standards related to pharmaceutical quality, FDA can leverage accepted standards to support efficient drug development and oversight of drug quality.”

In the statement, Office of Pharmaceutical Quality Compendial Operations and Standards Staff director **Pallavi Nithyanandan** says the program will help promote innovation in pharmaceutical development and manufacturing by providing transparency about CDER’s thinking on new technologies or approaches that are applicable to a product type. “This may help stakeholders more predictably meet regulatory expectations for CDER-regulated products and streamline product development and the preparation of an application,” she says. “Once CDER has recognized a standard, applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and acceptance criteria.”

Nithyanandan discusses earlier voluntary consensus standards, how the process works, the scope of the quality standards program, and how a standard can be submitted for recognition.