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A pharmacy needs an FDA License to Operate as a drugstore, filed online through the FDA eServices Portal, because medicines may be sold to the public only through FDA-licensed outlets. Each outlet selling prescription medicines must be under the direct control of a registered, licensed pharmacist, and only a pharmacist may dispense those drugs. Sign your pharmacist before you file, since the application asks for your qualified personnel.[1,4]
How to apply for the FDA License to Operate
New drugstores file the initial LTO application on the FDA eServices Portal. The online application runs through these parts, ending with the Order of Payment:[4]
- Declaration and Undertaking
- General Information
- Establishment Information
- Site Address
- Authorized Officer
- Qualified Personnel (your pharmacist)
- Self-Assessment Review
- Order of Payment
How long it takes and what to display
FDA's 2023 citizen's charter listed a total of 7 working days for an initial drugstore LTO, with the Order of Payment emailed after pre-assessment.[5]
Once approved, the LTO must be displayed in a conspicuous place where customers can see it.[4]
How much is the FDA LTO for a drugstore?
FDA fees for every application filed from 12 January 2025 follow AO 2024-0016. The drugstore amount is assessed by FDA and appears on the Order of Payment in the portal.[3,4]
FDA's 2023 charter still shows ₱1,000 plus a 1% legal research fee per year under the older AO 50 s.2001. That figure no longer applies to new applications.[5,3]
The pharmacist rule
The Pharmacy Act requires the direct and immediate control and supervision of a registered, licensed pharmacist for each establishment selling prescription or pharmacist-only OTC medicines, in-store or online. Only a licensed pharmacist may dispense those medicines, except in emergencies. Category B outlets, such as stores selling only household remedies and OTC drugs, need a licensed pharmacist's supervision and oversight.[1]
In the FDA application, you also undertake that the store stays open only under the supervision of a PRC-registered pharmacist or authorized personnel at all times.[4]
Decide your category and sign your pharmacist before you file. It shapes their hours, pay and the floor plan.
Staff who handle medicines
Pharmacy assistants and other non-pharmacist staff who handle medicines must be certified after an accredited training program. The pharmacist must display the original Certificate of Registration in a prominent place in the store.[1]
Budget time for assistant training before opening. Ask your pharmacist which accredited programs they know.
Price tags on shelves
Medicines and other goods sold at retail need price tags under the Consumer Act. If you sell basic necessities or prime commodities, a missing tag counts as prima facie evidence of profiteering under the Price Act.[2]
Drugstore prep list
- Choose your category: prescription or OTC and household remedies only
- Sign a licensed pharmacist and agree on hours
- Create your FDA eServices account and file the initial LTO
- Enroll assistants in an accredited training program
- Plan a spot to display the LTO and the pharmacist's original certificate
- Plan storage for medicines that need cool, dry conditions
- Prepare shelf price labels
Questions people ask
- What does the FDA License to Operate cost?
- For applications filed from 12 January 2025, FDA assesses the fee under AO 2024-0016 and shows it on the Order of Payment in the eServices Portal. The ₱1,000 plus 1% figure in FDA's 2023 charter no longer applies to new applications.
- How long does the LTO take?
- FDA's 2023 citizen's charter listed 7 working days in total for an initial drugstore LTO. Check the portal for the current timeline when you file.
- Can a pharmacy assistant dispense prescription medicines?
- No. Prescription drugs and pharmacist-only OTC medicines may be dispensed only by a registered, licensed pharmacist, except in emergencies.
- Can I sell paracetamol in my sari-sari store without a pharmacist?
- Medicines may be sold to the public only through FDA-licensed retail drug outlets. Category B outlets selling household remedies and OTC drugs still need a licensed pharmacist's supervision and oversight. Ask FDA what applies to your store.
- Do I need a special licence for controlled drugs?
- Controlled and dangerous drugs follow separate rules that this page does not list. Ask FDA and PDEA before you stock them.
Sources
Checked 13 November 2026. We link the agency's own page for every requirement. Rules change; confirm with the office before you pay.
- Republic Act No. 10918 (Philippine Pharmacy Act) · Lawphil (text of RA 10918) · 21 July 2016
- DTI warns business owners, establishments that price tag is a must · Department of Trade and Industry · 6 May 2022
- FDA Advisory No.2025-0032 || Effectivity of Administrative Order No. 2024-0016 · Food and Drug Administration Philippines · January 2025
- FDA eServices Portal - Drugstore Initial · Food and Drug Administration Philippines
- Citizen's Charter: License to Operate - Initial Application for Drug Traders, Drug Distributors, Drugstores, RONPD, CROs and Sponsors · Food and Drug Administration Philippines · August 2023
The extra permits, in one table
| Permit or registration | Agency | When it applies | Fee |
|---|---|---|---|
| FDA License to Operate as retail drug outlet[1] | FDA | always | assessed by FDA under AO 2024-0016 (see the fee rows below) |
| Registered, licensed pharmacist in direct and immediate control (outlets selling prescription medicines)[1] | PRC / FDA | if selling prescription medicines | Not published |
| Pharmacist supervision and oversight (Category B outlets selling household remedies/OTC drugs)[1] | PRC / FDA | if selling only household remedies / OTC drugs | Not published |
| Certified training for pharmacy assistants and staff handling pharmaceutical products[1] | FDA / accredited training | always | Not published |
| Pharmacist's original Certificate of Registration displayed in the store[1] | PRC | always | Not published |
| Price tags on all consumer products sold at retail[2] | DTI | always | Not published |
| Price tag on basic necessities/prime commodities[2] | DTI | if selling basic necessities | Not published |
| FDA fees follow the AO 2024-0016 schedule for applications filed from 12 January 2025[3] | FDA | all FDA LTO applications filed from 12 January 2025 | assessed by FDA under AO 2024-0016 (the old ₱1,000 + 1% LRF rate no longer applies to new applications) |
| License to Operate (LTO) as a drugstore, filed online on the FDA eServices Portal[4] | FDA | always (drugstore) | assessed by FDA at the Order of Payment step |
| Display the approved LTO where customers can see it[4] | FDA | always (licensed drugstore) | no fee (display rule) |
| Drugstore initial LTO processing time and payment step (FDA citizen's charter, 2023)[5] | FDA | drugstore initial LTO via eServices | assessed by FDA under AO 2024-0016 (the old ₱1,000 + 1% LRF rate no longer applies to new applications) |
Rules and exemptions
Selling rules that apply
- Sale only through an FDA-licensed retail drug outlet: RA 10918 s.30: pharmaceutical products may be sold to the public only through an FDA-licensed retail drug outlet[1]
- Registered and licensed pharmacist per establishment: RA 10918 s.31 (Pharmacist Requirement), Category A: a registered and licensed pharmacist must directly control and supervise each outlet selling prescription or pharmacist-only OTC medicines, in-store or online[1]
- Prescription and pharmacist-only OTC drugs dispensed only by a licensed…: Prescription drugs and pharmacist-only OTC medicines may be dispensed only by a registered, licensed pharmacist[1]