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(NAR) VOL. 25 NO. 1 / JANUARY - MARCH 2014

[ FDA CIRCULAR NO. 2013-027, December 17, 2013 ]

WAIVER OF INITIAL AND RENEWAL APPLICATION FEES FOR LICENSE TO OPERATE AS DRUG OUTLETS OR PHARMACIES IN CALAMITY AREAS IN LEYTE AND EASTERN SAMAR UNTIL DECEMBER 31, 2014, AND FOR OTHER PURPOSES



Department of Health (DOH) Secretary, Dr. Enrique T. Ona, has been spearheading efforts to address the medical needs of the victims of super typhoon Yolanda in the Visayas Region, In one of his personal visits to Tacloban City in Leyte, it was noted by his team that Food and Drug Administration (FDA)-licensed drug outlets and pharmacies were destroyed and inventories of medicines were washed away by floods during the height of the super typhoon.

In the DOH effort to improve the patients’ access to essential drugs and other health goods. as well as to facilitate resumption of normal social and economic activities in the worse hit areas by super typhoon Yolanda, and upon instruction of Secretary Ona, to the FDA to waive the initial and renewal application fees for License to Operate as Drug Outlets or Pharmacies in calamity-stricken areas in Leyte and Eastern Samar until 31 December 2014.

The following guidelines, however, shall be observed:

  1. Starting in January 2015, the waiver on initial and renewal application fees shall be lifted and the existing schedule of fees shall be charged accordingly.
  2. The price of medicines shall comply with the published guidelines of the Department of Trade and Industry (DTI) and the DOH. Discounts for the Senior Citizens shall be offered by all drug outlets and pharmacies. There shall be no overpricing of medicines.
  3. Drug owners or pharmacists with current LTO, but who lost their buildings and stocks of medicines may request for a re-issuance of their LTO free of charge and may immediately start rebuilding their shops and inventories.
  4. The DOH-FDA Regional Field Offices/Center for Health Development (CHDs) covering the calamity-stricken areas shall facilitate the processing of new applications within twenty-four (24) hours in time for opening of drug outlets or pharmacies.
  5. All drug outlets or pharmacies shall source or buy their medicines only from legitimate and FDA-licensed distributors, wholesalers and suppliers. Donated medicines shall not be sold or offered for sale or use in FDA-licensed drug outlets or pharmacies.
  6. Field Food and Drug Regulation Officers shall ensure the following:
    1. All medicines that are sold or offered for sale or use are registered with the FDA.
    2. Physician samples as well as donated medicines are not offered for sale or use in the drug outlets or pharmacies.
    3. Medicines are not overpriced.
    4. Discounts are given to Senior Citizens.
    5. Violative products found in the market are confiscated or removed from the market, and reported accordingly to the FDA in Alabang.
    6. Warning or legal actions shall be taken against drug outlets and pharmacies found to be violating the rules and regulations of the FDA.
  7. FDA-licensed drug establishments with chains of drugstores shall be covered by this waiver, provided that generic counterpart of branded products, when available, shall be sold, or offered for sale or use.

This Circular shall take effect immediately.


(SGD) KENNETH Y. HARTIGAN-GO, MD
Acting Director General

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