How to Check if a Drugstore, Distributor or Manufacturer Is FDA-Licensed in the Philippines
Quick Answer: Every drugstore, distributor and manufacturer of medicines in the Philippines must hold an FDA License to Operate, and every product a Certificate of Product Registration. Both can be checked in a minute on the FDA Verification Portal. Here is what the terms mean, how to search, and what to do when something is missing.
Every business that makes, imports, distributes or sells medicines in the Philippines must hold a Food and Drug Administration License to Operate (LTO), and every medicine on its shelves must have a Certificate of Product Registration (CPR). Both requirements come from the FDA Act of 2009 (Republic Act 9711), and both can be checked in about a minute on the FDA Verification Portal. This guide explains what the licences mean, how to search the portal for a drugstore, distributor or manufacturer, how to read the result, and what to do when something is missing. Directory listings for the businesses concerned: pharmacies, drugstores, distributors, manufacturers and pharmaceutical companies.
What do LTO and CPR mean?
| License to Operate (LTO) | Certificate of Product Registration (CPR) | |
|---|---|---|
| What it covers | The establishment: a drugstore, drug distributor (importer, exporter, wholesaler), drug manufacturer, or a business handling other health products | One product: a specific medicine, supplement, cosmetic or medical device, by brand, strength and form |
| Who must have it | Any establishment that manufactures, imports, exports, distributes, sells, promotes or advertises health products | The company placing the product on the market, which must itself hold an LTO |
| Validity | One to three years depending on establishment type; renewal filed at least 90 days before expiry | Typically five years; renewable |
| Where it appears | Displayed at the establishment; listed on the verification portal with number, address, owner and validity | Printed on the label as the FDA registration number; listed on the portal's product lists |
| Legal basis | Republic Act 9711 and the FDA's licensing regulations | Republic Act 9711 and product-specific regulations |
The two work together. A distributor with an LTO may not sell a product without a CPR; a product with a CPR may not be sold by an establishment without an LTO. Advisories on the FDA website name both unlicensed establishments and unregistered products.
How do you check a drugstore, distributor or manufacturer?
- Open the FDA Verification Portal, or the FDA service inside the eGovPH app, where the FDA announced the portal's integration.
- Choose the establishment list: drugstores, drug distributors, drug manufacturers, medical device establishments, food or cosmetic establishments as appropriate.
- Search by establishment name (try the registered corporate name as well as the trade name) or by the LTO number printed on the certificate in the shop or on the supplier's invoice.
- Read the record: LTO number, establishment name, address, owner, activity (retail, wholesale, import, manufacture) and validity dates. The address should match the branch you are dealing with; chains list branches individually.
- Check the validity date has not passed. The FDA updates the lists every Tuesday, so a recent renewal appears within a week.
For a product, choose the drug products list, search by brand or generic name, and compare the registration number, manufacturer and strength with the label. A mismatch in any of the three is a red flag.
What does each type of business need?
- Drugstore or pharmacy: an LTO as a drugstore, a registered pharmacist on duty for prescription sales (Philippine Pharmacy Act, Republic Act 10918), the LTO and the pharmacist's licence displayed, and only CPR-registered products on sale. Our pharmacy guide covers the consumer side.
- Distributor, importer or wholesaler: an LTO as a drug distributor with the relevant activities, a CPR for each product or a licence agreement with the registration holder, and Good Distribution Practice compliance. Hospitals and pharmacies buying from a distributor should verify the LTO before the first order; listings are under distributors.
- Manufacturer: an LTO as a drug manufacturer, a Good Manufacturing Practice certificate, and CPRs for every product. Listings are under manufacturers and pharmaceutical companies.
- Online seller: the same LTO as a drugstore or distributor; there is no separate licence for selling online, and a seller without an LTO is unlicensed regardless of platform.
What if something is missing?
If a drugstore is not on the portal, or its LTO has expired, buy nothing that needs a prescription there and report it to the FDA's regional field office or through the complaint channels on fda.gov.ph. If a product is not registered, do not use it; the FDA publishes advisories on unregistered products and counterfeits, and its Regulatory Enforcement Unit acts on reports. For businesses, an unverified supplier is a compliance risk: the FDA can seize unregistered stock from the buyer as well as the seller.
Healthcare Philippines lists thousands of pharmacies, distributors and manufacturers with addresses and contact details; use the portal alongside the directory, and see pharmacy chains compared for the licensed chains near you.
Frequently asked questions
- What is an FDA License to Operate?
- The Food and Drug Administration's authorisation for an establishment to manufacture, import, export, distribute, sell or otherwise handle health products, required under the FDA Act of 2009 (Republic Act 9711). Drugstores, drug distributors, importers, wholesalers and manufacturers each hold their own LTO, valid for one to three years depending on the establishment type, renewable at least 90 days before expiry.
- What is a Certificate of Product Registration?
- Product-level approval: the FDA's certificate that a specific drug, food supplement, cosmetic or medical device may be sold in the Philippines. Only establishments with a valid LTO can apply for one, and the CPR number appears on the product label. An LTO says the company may operate; a CPR says the product may be sold.
- How do I check a licence?
- Open the FDA Verification Portal at verification.fda.gov.ph or the FDA section of the eGovPH app, choose the establishment type (drugstore, drug distributor, drug manufacturer and so on) and search by name or LTO number. A licensed establishment shows its LTO number, address, owner and validity. For products, search the drug list by brand or generic name and compare the registration number with the label. The lists are updated weekly.
- What if a drugstore is not on the portal?
- Do not buy prescription medicines there. Check the spelling and the establishment type first; a pharmacy inside a hospital is licensed under the hospital. If it is still missing, or the LTO has expired, report it to the FDA through its complaint channels or the regional field office.
- Are online sellers licensed?
- Only if they are licensed drugstores or distributors selling through their own channels or platforms, and they appear in the portal like any other establishment. Social media accounts and marketplace sellers with no LTO are unlicensed, whatever their reviews say, and the FDA issues advisories against them regularly.
- What licences does a distributor or wholesaler need?
- An LTO as a drug distributor (importer, exporter or wholesaler as applicable) from the FDA, product registrations for every product it carries or a licence agreement with the registration holder, and compliance with Good Distribution Practice. Buyers such as hospitals, pharmacies and clinics should ask for the LTO number and verify it before ordering.
