Regulates sale of empty gelatin capsules

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FDA CIRCULAR NO. 2014-010: Regulates sale of empty gelatin capsules

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Title Supreme Court: Regulates sale of empty gelatin capsules

Law: Fda Circular No. 2014-010

Decision Date: Apr 24, 2014

The Food and Drug Administration mandates that only licensed drug establishments may procure, sell, or distribute empty gelatin capsules, classifying them as raw materials rather than finished products, with violations subject to administrative penalties.

gelatin capsules

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Classification Under Administrative Order No. 56 s.1989

Pharmaceutical industry entities are classified into:
1. Drug establishments: manufacturers, traders, distributors (importers, exporters, wholesalers).
2. Drug outlets: drugstores, pharmacies (including hospital pharmacies), and retail outlets for non-prescription drugs.
Drug establishments can procure raw materials and finished products.
Drug outlets are limited to procuring, selling, and distributing only finished drug products.

Regulatory Status and Procurement Restrictions of Empty Gelatin Capsules

Empty gelatin capsules are neither drugs nor finished products; they are components and thus classified as raw materials.
Only drug establishments are authorized to procure empty gelatin capsules for manufacturing solid dosage capsule forms.
Drug outlets are expressly prohibited from procuring, selling, or distributing empty gelatin capsules.

Legal Consequences for Non-Compliance

Violations of this FDA Circular may lead to administrative charges.
Possible sanctions include fines, suspension, cancellation, or revocation of the License-to-Operate of drug outlets.
These enforcement measures aim to ensure compliance with FDA regulations concerning the handling of empty gelatin capsules.

END