FDA CIRCULAR NO. 2014-010

: Empty gelatin capsules are composed of gelatin, sugar, water, and sometimes colorants and opaquants.
: They are commonly used as (1) components of finished drug products in capsule form, or (2) as placebo in clinical trials to determine the efficacy of an investigational drug product.
: It classifies the pharmaceutical industry into (1) drug establishments, which include manufacturers, traders, and distributors, and (2) drug outlets, which include drugstores, pharmacies, hospital pharmacies, and retail outlets for non-prescription drugs.
: Drug establishments may procure both raw materials and finished products either for their own use or for distribution.
: Drug outlets may only procure, sell, and distribute finished products.
: Empty gelatin capsules are classified as raw materials and are not considered drugs or finished products.
: Only drug establishments are allowed to procure empty gelatin capsules for the manufacture of solid dosage forms in capsules.
: No, drug outlets are not allowed to procure, sell, or distribute empty gelatin capsules.
: Violations may lead to administrative charges and sanctions such as fines, suspension, cancellation, or revocation of the License-to-Operate of drug outlets.