BFAD MEMORANDUM CIRCULAR NO. 10

: The main subject is the clarification of the responsibility to indicate the lot number and expiry date of drug products on sales invoices, as required under earlier FDA/BFAD regulations.
: Both the drug outlet and the drug distributor/supplier, as well as the drug distributor/supplier and the manufacturer or importer, bear the responsibility to ensure that these details are indicated on the invoice.
: The invoices covering the sales or transactions of drug products must include the lot number and expiry date.
: They are liable for the failure to indicate the lot number and expiry date on the invoice unless the distributor or manufacturer can prove by substantial evidence that the invoice is spurious or was not issued by them.
: They can avoid liability by proving with substantial evidence that the invoice in question is spurious or was not issued by them.
: It clarifies FDA (BFAD) Memorandum Circular No. 001 S. 1983, Section 4.2.2 of Chapter I, and Section 4.2.1 of Chapter II of Administrative Order 56 Series of 1989.
: The legal concept of shared liability and burden of proof concerning accurate product documentation on invoices.
: To ensure traceability, authenticity, and safety of drug products in the supply chain and to prevent the circulation of spurious or expired drugs.
: A spurious invoice refers to a false or fraudulent invoice that is not genuine and was not legitimately issued by the distributor or manufacturer.