CLARIFYING FDA (BFAD) MEMORANDUM CIRCULAR NO. 001 S. 1983, SEC. 4.2.2 OF CHAPTER 1 AND SECTION 4.2.1, CHAPTER II OF A.O. 56 S. 1989
National Administrative Register [ BFAD MEMORANDUM CIRCULAR NO. 10, May 27, 1992 ]
The burden of ensuring that lot number and expiry date of drug product are indicated on the invoice covering the sales/transaction of said drug product shall rest on both the drug outlet and the drug distributor/supplier, and drug distributor/supplier and the manufacturer or importer, as the case may be.
The drug outlet, drug distributor/supplier and manufacturer are therefore liable for the failure to indicate the lot number and expiry date on a given invoice covering the drug products delivered, unless the drug distributor or manufacturer can prove by substantial evidence that the invoice subject to question is spurious and/or was not issued by the same distributor/manufacturer.
For the information of all concerned.
Adopted: 27 May 1992
(SGD.) QUINTIN L. KINTANAR, M.D., PH.D.
Director – CESO I
Director – CESO I