Republic of the Philippines
Department of Health
BUREAU OF FOOD AND DRUGS
Alabang, Muntinlupa City

BFAD ADVISORY
No. 00-04
Date Issued:  May 10, 2000

Subject:  Warning against Dispensing Expired Drugs

The Bureau of Food and Drugs has monitored several cases of dispensing expired drugs. There seemed to be a misguided notion that a drug  is still effective for an allowable number of days/months beyond its expiration date.

Contrary to this belief, there is no guarantee given that the drug will provide its purported safety, efficacy or good quality after such drug has expired.

Expiry date is defined in A.O. #55 s. 1988, "Requirements for the Labeling of Pharmaceutical Products", as the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency, or after which it is not permissible to sell, distribute or use said product.

Anent to this, Section 8(1) of Executive Order No. 175, amending Section 11 of R.A. 3720, "The Foods, Drugs, Devices and Cosmetics Act", prohibits the sale or offering for sale of any drug or device beyond its expiration date. Such prohibited act is punishable by imprisonment of not less than one year but not more tahn five years or a fine of not less tahn five thousand pesos but not more than ten thousand pesos, or both.

In view thereof, in the interest of the general public and for the safety of patients, the Bureau of Food and Drugs hereby warns all pharmacists in the practice of pharmacy including medical practitioners against dispensing / distributing expired drugs either commercially or for free.
 
 

                                                                                                      (SGD)WILLIAM D. TORRES, Ph.D.
                                                                                                                               Director