Liabilities for Drug Invoice Lot and Expiry Dates

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BFAD MEMORANDUM CIRCULAR NO. 10: Liabilities for Drug Invoice Lot and Expiry Dates

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Title Supreme Court: Liabilities for Drug Invoice Lot and Expiry Dates

Law: Bfad Memorandum Circular No. 10

Decision Date: May 27, 1992

The BFAD mandates that drug outlets, distributors, and manufacturers are jointly responsible for ensuring that invoices for drug products clearly indicate the lot number and expiry date, holding them liable for any omissions unless proven otherwise.

administrative law

drug regulation

A

Joint Liability for Non-Compliance

The drug outlet, drug distributor/supplier, and manufacturer are all liable if the invoice for the drug products delivered fails to indicate the required lot number and expiry date.
This liability persists unless the drug distributor or manufacturer can provide substantial evidence proving that the invoice in question:
- Is spurious (forged or counterfeit), and/or
- Was not issued by the same distributor or manufacturer

Evidentiary Standard for Defense

To be exempt from liability, the distributor or manufacturer must present substantial evidence convincing enough to establish the spurious nature of the questioned invoice or that it was not issued by them.

Official Communication and Adoption

This clarification was issued to ensure compliance with FDA regulations and existing administrative orders specified in Memorandum Circular No. 001 s. 1983, Section 4.2.2 of Chapter 1, and Section 4.2.1 of Chapter II of Administrative Order No. 56 s. 1989.
The memorandum was adopted and signed by Dr. Quintin L. Kintanar, Director of the Bureau of Food and Drugs (BFAD), on May 27, 1992.

Scope and Application

Applies to all sales and transactions involving drug products within the Philippines.
Ensures traceability and quality control by mandating lot number and expiry date documentation on sales invoices.

Key Legal Concepts

Joint liability among drug outlets, distributors, suppliers, manufacturers, and importers
Requirement of documentary evidence (invoice) with specific product information
Defense prospects based on proving invoice forgery or misattribution
Regulatory enforcement by the Bureau of Food and Drugs

This memorandum circular serves as a regulatory measure to reinforce accountability and transparency in the distribution and sale of pharmaceutical products to safeguard public health and adherence to quality control standards.

END