Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
  
DRAFT  
 
FDA Circular  
No. __________      
 
SUBJECT:   Guidelines on the Issuance of License to Operate for Drug  Establishment s  
                      Engaged in E -Pharmacy  
  
I.         BACKGROUND/RATIONALE  
        The World Trade Organization defines Electronic commerce (E -commerce) as the 
production, distribution, marketing, sale, or delivery of goods and services by electronic means 
(WTO). As a member state of the UN and other regional economic blocs like APEC and ASEAN 
that recognizes e -commerce as a tool for further development and intensification of commercial 
transactions to drive inclusive growth and narrow development gaps.  
 
        Republic Act (RA) No. 9792, otherwise known as the “E -Commerce Act”, provides a 
regulatory framework for the legal recognition of electronic contracts under the Philippine law, 
thereby establishing the groundwork for electronic transactions in the country. It also provides 
penalties for violations of RA 7394, otherwise know n as the “Consumer Act of the Philippines”.  
Under the Consumer Act of the Philippines, the DOH -FDA is tasked to protect the consumers 
against deceptive, unfair, and unconscionable sales acts and to establish standards for the 
business and industry’s conduc t. 
 
        In compliance with the RA 9711, otherwise known as the FDA Act of 2009, and RA 10918, 
otherwise known as the “Philippine Pharmacy Act”, there is a need for guidelines not only to 
protect the consumer’s safety and welfare, but also to ensure tha t the Good Distribution Practice 
and Good Storage Practice, among others, are implemented in order to ensure the safety, efficacy 
and quality of the medicines are maintained and handled well along the medicine supply chain 
until it reaches the consumers.  The Pharmacy Act defines “online selling” as pharmaceutical 
services of a duly FDA -licensed pharmaceutical outlet done over the internet. Online selling is 
not only confined to the pharmaceutical outlets operating in the Philippines, but also outside of 
the country and sends orders to consumers through mail and shipping companies, often using 
online pharmacy web portals.  
 
        Currently, the FDA only allows online ordering services provided that the seller has an   
existing FDA -licensed drug outlet with p hysical address. Should the drug outlet want to provide 
online ordering services, the drug outlet needs to apply for online ordering service  subject to 
FDA approval as an additional activity.  
 
          In light of the current situation brought by the COVI D-19 pandemic and forward -looking 
to the “new normal”, e -pharmacy offers a platform where consumers can purchase medicines     
without having to visit conventional/physical pharmacies. However, as the proliferation of digital 
tools increases internet avail ability worldwide, any company can sell medicines online, making 
international e -commerce easier than ever before. FDA Philippines, as the drug regulatory 
authority in the country, deserves its own guidelines. These guidelines shall be in place to ensure 
that medicines in online platforms shall still be offered for sale or use,  dispensed under the Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 supervision of a pharmacist, prescribed  by physicians, transported, distributed, advertised and 
promoted following the provisions of the law of RA 3720, as amended by RA 9711, and RA 
10918.  
 
          The FDA is compelled to draft a guideline in support of local and global trade and 
commerce in  the country. The e -pharmacy guidelines that  will be developed by FDA in 
collaboration with partner agencies/offices aims to ensure the safety, quality, efficacy, purity of 
health products sold online by facilitating responsible e -commerce activities, prov ide licensing 
requirements for online sellers, and introduce regulatory enforcement measures to punish and 
remove illegal online selling.  
 
        In view of the current pandemic state of the country due to COVID -19, there is a surge in 
the use of online p harmacy and E -services. This circular aims to regulate and license e -
Pharmaci es in  accordance with DOH AO no. 2020 - 0017 or the “Revised Guidelines on the 
Unified Licensing and Procedures of the Food and Drug Administration Repealing AO  2016 -
0003 and FDA Circular No. 2020 -0030 or the  “Guideline for the Use of FDA eServices Portal 
System for License to Operation (Application) of Drug Distributors, Drug Traders, Drugstores, 
Retail Outlets For Non -Prescription Drugs (RONPDs, Clinical Research Organizations (C RO), 
and Sponsors” in order to ensure the safety of the public and to develop a more respons ive health 
system for a safe,  equitable , quality , and affordable healthcare goods and services in the different 
online market platforms.  
 
II.         OBJECTIVES  
 This Circular aims  to set guidelines on the License to Operate (LTO) application 
of drug establishments engaged in online pharmacy (E -Pharmacy ) thereby ensuring  the safety, 
health and welfare protection of the public.  
 
 
III.         SCOPE  AND COVERAGE  
 These guidelines shall cover  the licensing of establishments, including drug 
outlets, RONPD, and other entities that w ill engage in online retailing of over-the-counter or 
non-prescription drug products as additional activity or as pure E -Pharmacy.  It sha ll not cover 
prescription drug products.  
 
IV.        DEFINITION OF TERMS  
A. Adverse Drug Event (ADE) or Adverse Drug Experience  - refers to any untoward 
medical occurrence during treatment with a pharmaceutical product but which does not 
necessarily have a causal relationship with such treatment . 
 
B. Adverse Drug Reaction (ADR)  - refers to a response to a drug which is noxious, 
unintended, and which occurs at doses normally used in man for the prophylaxis diagnosis, 
or therapy of disease, or for the modification of physiological function.  
  
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 C. Drugs/Medicines – refer to (1) articles  recognized in the official pharmacopeias and 
formularies, including official homeopathic pharmacopeias, or any documentary supplement 
to any of them, which are recognized and adopted by FDA; (2) articles intended for use in 
the diagnosis, cure, mitigation , treatment, or prevention of disease in man or other animals; 
(3) articles (other than food) intended to affect the structure of any function of the body of 
human or animals; (4) articles intended for use as a component of any articles specified in 
clause s (1) (2), or (3)  but do not include devices or their components, parts or accessories.  
 
D. Drug Distributor  – refers to  the following:  
a. Drug Distributor - Exporter - refers to any establishment that exports raw materials, 
active ingredients and finished pro ducts for distribution to other drug establishments 
outside the country.  
b. Drug Distributor - Importer - refers to any establishment that imports raw materials, 
active ingredients and/or finished products for wholesale distribution to other local 
FDA -license d drug establishments.  
c. Drug Distributor - Wholesale - refers to any establishment that procures raw materials, 
active ingredients and/or finished products from a local FDA -licensed drug 
establishment for local distribution on wholesale basis.  
 
E. Drug Manufacturer  - refers to any establishment engaged in any or all operations involved 
in the production of drug products including preparatory processing, compounding, 
formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeli ng 
with the end in view of its storage, sale or distribution; provided, that the term shall not apply 
to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A 
Drug Manufacturer can distribute and/or export in wholesale its o wn drug products and 
import raw materials for its own production.  
 
F. Drug Traders  - refers to any establishment which is registered owner of a drug product and 
the formulation and procures the raw materials and packing components, and provides the 
production  monographs, quality control standards and procedures, but subcontracts the 
manufacture of such product to a licensed manufacturer.  
 
G. Drugstore/Pharmacy/Botica and similar outlets  - shall refer to drug establishments where 
registered drugs, chemical produc ts, dental, medicinal and household remedies are dispensed 
directly to the general public on a retail basis. Botika ng Barangay and its variants that sell 
the same shall be reclassified and required to secure LTO as a drugstore.  
 
H. E-commerce  - The sale of purchase of goods and services, whether between businesses, 
households, individuals, governments, and other public or private organizations, conducted 
over computer -mediated networks. The goods and services are ordered over those networks, 
but the payment and the ultimate delivery of the goods or services may be conducted on or 
offline.  
 
I. E-commerce Warehouse  - where e -commerce merchandise is stored.  Can be own 
warehouse, third party provider, living room/garage/basement provided that the plac e is 
suitably designed and well -maintained to carry e -commerce/e -pharmacy activities . 
 
J. E-Pharmacy  – refers to a mode of pharmacy services that utilizes information technology 
or online mode of communication to b etter serve patients by providing more convenient  
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 access to pharmacy services.  This mode of service should be provided by a pharmacy that 
is duly -licensed by the FDA through a secured online platform (via own website or via online 
marketplace website).  
 
K. Good Distribution Practices or GDP  - means that part of quality assurance which ensures 
that the quality of a pharmaceutical product is maintained through adequate control 
throughout the numerous activities which occur during the distribution process.  
 
L. Good  Storage Practices or GSP  - means that part of quality assurance which ensures that 
the quality of a pharmaceutical product is maintained through adequate control throughout 
the storage.  
 
M. Home/Household Remedies  - refer s to any preparation containing pharm aceutical 
substances of common or ordinary use to relieve common physical ailments and which may 
be dispensed without a medical prescription in original packages, bottles or containers, of 
which the nomenclature has been duly approved by the FDA . 
 
N. Marketin g Authorization Holder  - the company , corporate or legal entities  in the field of 
pharmaceuticals in whose name the  Certificate of Product Registration (CPR) or  MA for a 
pharmaceutical product has been granted.  
 
O. Online eCommerce Platform  - refers to a natural, or judicial person that solicits the 
purchase of digital products through digital platforms and marketplaces whose business is 
to connect online buyers and online sellers, facilitating sales of products, goods, and services 
through the internet with the presence and use of monetary transactions.  
 
P. Online Pharmacy Service  – refers to pharmaceutical services of a duly licensed 
pharmaceutical outlet done over the internet;  
 
Q. Over the Counter (OTC) medicines  - refer s to medicines used for symptomatic relief of 
minor ailments and which may be dispensed without a prescription;  
 
R. Pharmaceutical Outlets  - refer s to entities licensed by appropriate agencies, and which  are 
involved in compounding and/or dispensing and sellin g of pharmaceutical products directly 
to patients or end -users;  
 
S. Physical Store  - refer s to physical commercial establishments, such as retail stores, by 
which sales are carried out within actual premises of a real estate property owned or leased 
by the r elevant business, it being specified that e -Commerce -related sales should not be 
considered as Physical Stores solely by virtue of a physical pick -up or delivery involving a 
physical establishment.  
 
T. Qualified Personnel - refers to an organic or full -time e mployee of the establishment who 
possesses technical competence related to the establishment's activities and health products 
by virtue of his profession, training or experience. A qualified person has the responsibility 
to comply with the technical requir ements of the FDA or discuss or clarify matters with the 
FDA when submitting technical requirements or engage the FDA officials when conducting 
inspection or post -market surveillance activities. The qualified person may also be the duly 
Authorized Person o f the establishment.   
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 U. Receiving /Dispensing  Orders – refers to activities  performed by a drug retail outlet  or a 
third party with an existing agreement with a drug retail outlet to receive orders that are 
prescription drugs. Receiving and dispensing of orders shall require a medication order or a 
prescription by a prescribing physician. For clarity, posting of orders using online platforms 
shall be limited only to non-prescription drugs.  
 
V. Retail Outlets for Non -Presc ription Drug Products (RONPDs) - refer to drug 
establishments such as a supermarket, convenient store and other similar retail establishment 
authori zed to sell only identified Over -the-Counter (OTC) and household remedy products 
directly to the general public on a retail basis. Botika ng Barangay and its variants that opt 
to sel l the same shall be reclassified and required to secure LTO as a RONPD.  
 
W. Seller / Retailer  - means any establishment which sells or offers to sell any health product 
directly to the general public.  
 
V.         GENERAL GUIDELINES  
1. Posting of advertisements, offers for sale or use, and orders using online platforms shall be 
limite d only to non-prescription drugs.  
 
2. Only FDA -registered products are allowed to be offered for sale/use in online platforms.  
 
3. All drug establishments that intend s to sell and process online ordering and delivery of drug 
product/s must comply with Good Distribution Practices and Good Storage Practices to 
ensure the integrity and stability of the health products supplied.  
 
4. Administrative Order No. 2020 -0017  on the “ Revised Guidelines on the Unified Licensing 
and Procedures of the Food and Drug Administration Repealing AO  2016 -0003” and FDA 
Circular No. 2020 -030 on the “Guideline for the Use of FDA eServices Portal System for 
License to Operation (Application) of Dru g Distributors, Drug Traders, Drugstores, Retail 
Outlets For Non -Prescription Drugs (RONPDs, Clinical Research Organizations (CRO), and 
Sponsors” and FDA Circular No. 2020 -0030 shall apply and shall be expounded in this 
circular.  
 
5. All drug establishments d irectly selling to consumers and patients using online platform shall 
be required to secure an e -LTO as Drugstore and RONPD with an additional activity as e -
pharmacy  or as a pure E -Pharmacy . Approval and issuance of the License to Operate 
applications to C DRR shall require inspection by the RFOs under the FROO.  
 
6. The validity of the e -pharmacy L TO shall coincide with the validity of the previously -issued 
LTO as Drugstore or RONPD.  
 
7. Drug establishments directly selling to a non -retail business establishment , e.g. manufacturer, 
distributor, or trader , shall not be required to secure a License to Operate with additional 
activity as e -pharmacy. Should these type s of establishments venture  into direct selling to 
consumers and patients,  i.e. retailing,  they shall b e required a License to Operate as Drugstore 
or RONPD with additional activity. For emphasis, sub -distributors that direct ly sells to  
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 patients and consumers  without License to Operate as Drugstore or RONPD  are prohibited 
by RA 9711 .   
 
8. All online ordering/ e-pharmacy services rendered by FDA -licensed establishments shall be 
hosted  only in the Philippine domain.  
 
9. All drug establishment s securing License to Operate as Drugstore or RONPD with additional 
activity as e -pharmacy shall appoint a PRC -licensed Pharmacist Q ualified Person  (QP).  The 
current QP of the drug establishment shall be declared and updated with the FDA and he/she 
shall be responsible and accountable for compliance with FDA laws, rules and regulations 
pertaining to product safety, efficac y and quality. The Q P shall act as the Chief Pharmacist 
in case of multiple shifts in a 24/7 operation.  
 
10. All licensed Drugstores and RONPD with additional activity as e -pharmacy shall be subject 
to spot-check inspections by the RFOs under the FROO  anytime.  
 
11. All e -pharmacies may use market online platforms or may create their own website. E -
pharmacies with their own website shall have a consumer complaint button on the navigation 
bar with the statement that “The FDA may be copied with all complaints and reports at 
oddgfroo@fda.gov.ph ” upon clicking of the said button . 
 
12. Drug Outlets that do not have any physical establishment for face -to-face d ispensing shall be 
issued  a LTO as pure E -Pharmacy by the FDA  provided it has a warehouse and an office that 
can hold product inventories or stocks . All additional warehouses  operating under the same 
licensed office address shall be declared and subject to  inspection by the FDA. When 
applicable, existing drug outlets with additional online activity  as E-Pharmacy, they shall 
declare  all warehouses which shall be subjected to inspection by the FDA . 
 
13. The use of online marketplace , such as but not limited to Lazada, Sho pee and Facebook may 
be utilized for receiving orders by e-licensed drug retailers as online platforms in selling their 
products .  Online marketplace s are not drug outlets, hence, they are not required to secure e -
pharmacy LTO  unless they ventur e or operate their own drug retailing business or operation . 
The use of such platforms for promotional purposes shall be allowed only with the approv al 
of the  FDA under the e-promo permit guidelines and subject to compliance to AO on 
advertisement guidelin es, provisions of FDA on non -advertisement of prescription drugs and 
monitoring by the FROO.  
 
 VI.         SPECIFIC GUIDELINES   
1. Filing Of Applications  
 
A. Drug Outlet with Additional Activity  as E-Pharmacy  
 
i. Establishment s must have a valid  LTO of not less than ninety (90) days from the 
application of additional activity.  
ii. Current licensing regulations of the FDA  for additional activity as e -pharmacy shall 
be adopted.   
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 iii. When applicable, a dditional d ocumentary requirements for the application are as 
follows:  
1. Standard Operating Procedure   
2. A screenshot of the website owned and maintained by the drug outlet shall 
be required when receiving orders are made online in addition to orders 
made through telephone/mobile phones or other means. The website shall 
have provisi on for consumer complaint as stated under Section 5, no.  11 in 
the General Guidelines of this Circular.  
 
B. Pure  E-Pharmacy  
 
i. Establishments applying  for Pure E -Pharmacy , that is i.e. , no physical store for 
dispensing medicines and medical devices, shall have an e - commerce warehouse  
and office which maybe owned or leased by a third party. The warehouse or office 
shall be used solely as storage and distribution/dispensing point of duly -registered 
drug products or medical devices.  
ii. Submission of application for LTO as drugstore, pharmacy or botica, establishments 
shall follow current licensing regulations of the FDA  with a  note “e -pharmacy” 
service as a mode of retail pharmacy service.  
iii. Documentary requirements for the application shall be based on the provisions 
stipulated in  A.O 2020 -0017 . 
 
2. Inspection of Establishments  
 
a. A pre -approval inspection shall be conducted for all establishments applying for 
additional activity for online orderi ng and delivery and for Pure E -Pharmacy. The 
pre-approval inspection shall focus on the warehouse, SOP for compliance to Good 
Distribution and Storage Practices, mode of delivery, dispensing of medicines, 
training of personnel, and IT system used. Post-approval inspections may also be 
conducted to ensure continuous compliance to regulations.  
b. Establishments found to be non -compliant may be subjected to appropriate 
regulatory actions such as but not limited to disapproval  of  application of the 
additi onal activity, issuance of warning letter, or suspension, revocation of licenses.  
 
 
VII.         PENALTY CLAUSE  
 
         Establishments/entities who will participate in the conduct of E -pharmacy/Online 
Pharmacy Services without prior authorization or violate provisions of this  Circular shall be 
subject to imposable penalties stipulated in RA No. 10918, RA No. 9711, and their respective 
implementing rules and regulations.  
 
 
VIII.      REPEALING AND SEPARABILITY CLAUSE  
 
          If any provision in th is Circular , or application of such provision to any circumstances, is 
held invalid, the remainder of the provisions in this Circular shall not be affected.  
These guidelines shall be reviewed after three (3) years in collaboration with the concerned 
stakeh olders . 
  
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900  
Fax  +63 2 807 0751  Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 IX.      EFFECTIVITY  
 
        This Circular shall take effect after fifteen (15 days) following its publication in a newspaper 
of a national circulation or upon filing to the University of the Philippines Law Center Office of 
the National Administrative Register.