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# CDER Draft Guide on Pharmaceutical Co-Crystals
- URL: https://www.fdaweb.com/cder-draft-guide-on-pharmaceutical-co-crystals/
- Published: 2016-08-16T12:00:00.000Z
- Updated: 2026-09-14T21:24:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136524

CDER has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM516813.pdf?ref=fdaweb.com) on “Regulatory Classification of Pharmaceutical Co-Crystals” that provides sponsors with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. The document also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. the guidance recommendations apply to materials that the agency has not previously evaluated and determined to be pharmaceutical co-crystals, CDER says, adding that they do not apply to materials that it has previously designated as salts, complexes, or other non-co-crystalline forms.