Law Summary

1. Introduction

This Circular, issued by the Food and Drug Administration (FDA) on April 24, 2014, addresses inquiries regarding the sale and distribution of empty gelatin capsules. It sets forth the classification and regulatory framework governing these capsules, emphasizing their status as raw materials rather than finished products.

2. Classification of Pharmaceutical Industry

• Legal Principle: The pharmaceutical industry is categorized into drug establishments and drug outlets as per Administrative Order No. 56 s. 1989, which outlines licensing regulations.

  • Drug Establishments: Includes manufacturers, traders, and distributors (importers, exporters, wholesalers).
  • Drug Outlets: Comprises drugstores, pharmacies (including hospital pharmacies), and retail outlets for non-prescription drugs.

• Key Definitions:

  • Drug Establishments: Entities that can procure raw materials and finished products for manufacturing or distribution.
  • Drug Outlets: Entities that are limited to procuring, selling, and distributing only finished products.

3. Status of Empty Gelatin Capsules

• Legal Principle: Empty gelatin capsules are classified as components (raw materials) and not as drugs or finished products.

• Important Requirements:

  • Only drug establishments are permitted to procure empty gelatin capsules for the manufacture of solid dosage forms in capsule.
  • Drug outlets are expressly prohibited from procuring, selling, or distributing empty gelatin capsules.

4. Compliance and Enforcement

• Legal Principle: Non-compliance with the stipulations of this Circular may lead to administrative actions.

• Penalties and Consequences:

  • Violations may result in administrative charges and sanctions, which can include:
    • Fines
    • Suspension, cancellation, or revocation of the License-to-Operate of drug outlets.

5. Relevant Cross-References

• Administrative Order No. 56 s. 1989: This order provides the framework for the licensing of drug establishments and outlets, which is essential for understanding the classification of pharmaceutical entities.

Key Takeaways

• The FDA Circular No. 2014-010 delineates the regulatory status of empty gelatin capsules as raw materials, restricting their procurement to drug establishments only.
• Drug outlets are prohibited from handling empty gelatin capsules, with strict penalties for violations.
• Compliance with the provisions set forth in this Circular is mandatory to avoid administrative sanctions.