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# CDER Policy on Gelatin Capsule Shell Supplier Changes
- URL: https://www.fdaweb.com/cder-policy-on-gelatin-capsule-shell-supplier-changes/
- Published: 2016-08-15T12:00:00.000Z
- Updated: 2026-09-14T21:24:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136509

CDER has posted a new internal [policy](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM516649.pdf?ref=fdaweb.com) on drug sponsors who seek approval for a “Change in Hard Gelatin Capsule Shell Supplier.” When an applicant changes the supplier of a hard gelatin capsule shell, with no change in capsule composition or appearance, the information should be submitted in an annual report, according to the document. Any change in capsule composition or appearance, including change in size, color or dye, or a change from gelatin to non-gelatin alternative, should be categorized as a prior approval supplement, it says.