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FDA position on Online, Internet or Mail Order Pharmacy

Food and Drug Administration(FDA) has released its policy regarding Online, Internet or Mail Order Pharmacy doing business around the country, as posted in DOH Facebook page.

Acting Director Kenneth Hartigan-Go issued the following advisory:DOH logo

FDA position on Online, Internet or Mail Order Pharmacy

Republic Act No. 5921 or the Act Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines and for other Purposes,as amended by Republic Act No. 9502, otherwise known as the Cheaper Medicines Act provides that:

“No medicine, pharmaceutical, or drug, except for those which are non-prescription or over-the-counter, of whatever nature and kind or device shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drugstore or hospital pharmacy, duly established in accordance with the provisions of this Act. Non-prescription or over-the-counter drugs may be sold in their original packages, bottles, containers or in small quantities, not in their original containers to the consuming public through supermarkets, convenience stores and other retail establishments.”

Also, Republic Act No. 5921 defines “Pharmacy” or “Drug Store” to mean a place or establishment where drugs, chemical products, active principles of drugs, pharmaceuticals, proprietary medicines or pharmaceutical specialties, devices, and poisons are sold at retail and where medical, dental and veterinary prescriptions are compounded and dispensed.

Upon the other hand, Republic Act No. 3720 as amended by Republic Act No. 9711 or the Food and Drug Administration (FDA) Act of 2009 expressly prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, or retail of any drug, device or in-vitro diagnostic reagent; the manufacture, importation, exportation, transfer, or distribution of any food, cosmetic or household/urban hazardous substance by any natural or juridical person without the license to operate from, and the health products not registered with, the FDA.

However, technology has introduced innovations in the sale of pharmaceutical products which brought about the concept of Online pharmacies, Internet pharmacies, or Mail Order pharmacies. These are pharmaciesthat offer for sale pharmaceutical products over the internet and send the orders to Filipino customers. While these practicesmaybe recognized, it cannot be argued that these mode of transactionsare well within the regulatory jurisdiction of the FDA. They are covered by, and should comply with, the rules provided by the above-mentioned laws. As such, the FDA, in its relentless quest to ensure that the right to health of the people is protected, will exercise every available legal remedy and strategies to ensure its monitoring and regulatory coverage over these types of transactions.

In the meantime and considering that Online pharmacies, Internet pharmacies, or Mail Order pharmaciespresent risks and concerns, such as, but not limited to:

Illegal or unethical pharmacies sometimes send outdated, substituted, or counterfeit medications;
Sometimes an online pharmacy may not be located in the country that is claimed;
Minors or children can order controlled substances without adult supervision; or
Other concerns that include potential lack of confidentiality, improper packaging, inability to check for drug interactions, and several other issues;

The FDA hereby warns the public to be extremely cautious in purchasing their drugs and medicines through Online, Internet,or Mail Order Pharmacies. Any information about the location of unscrupulous establishments dealing illegally with the sale or offer for sale of drugs and medicines through the above modes of transaction should be reported immediately to the FDA at these numbers: 807-8275; 165-FDA; 0909-2080-500, or through emails:ireport.fda@gmail.comormedsurveillance@yahoo.comfor immediate action.

KENNETH Y. HARTIGAN-GO, MD
Acting Director IV

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