SOP for Pharmacy in the Philippines (Free PDF Download)

Pharmacy SOP for the Philippines (Free PDF Download)

A complete standard operating procedure template for opening and running a drugstore (botika) in the Philippines — covering the FDA License to Operate (LTO), the key Republic Acts, and the procedures FDA inspectors actually check: procurement, complaints, recalls, dispensing, storage and housekeeping. Adapt the bracketed fields to your outlet and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, housekeeping, complaint and recall procedures required to operate a retail drugstore in the Philippines in line with FDA requirements.

2. Scope

Applies to the registered pharmacist, pharmacy assistants and all staff at [Drugstore Name], [Address].

3. Regulatory Background

• A License to Operate (LTO) from the FDA Philippines is mandatory before opening.
• Key laws: RA 3720 (Food, Drug, and Cosmetic Act), RA 9711 (FDA Act of 2009), and RA 6675 (Generics Act).
• FDA inspectors check written SOPs for procurement, complaints, recalls, dispensing, storage and housekeeping.
• Minimum floor area: 15 sqm.
• Prescription, dangerous-drug and poison record books must be maintained.

4. Responsibilities

5. Procedure

5.1 Licensing and setup

1. Secure premises of at least 15 sqm laid out for dispensing, storage and customer service.
2. Apply to the FDA Philippines for the License to Operate; do not open before it is issued.
3. Appoint the registered pharmacist who will be accountable for the outlet.
4. Display the LTO where customers and inspectors can see it.

5.2 Procurement SOP

1. Purchase only from FDA-licensed suppliers and distributors.
2. Verify product registration with the FDA on incoming deliveries; check batch numbers and expiry dates.
3. Reject and document any unregistered, expired or damaged goods at receiving.

5.3 Storage SOP

1. Store per label conditions; monitor and log temperatures for cold-chain products.
2. Segregate quarantined, expired and recalled stock away from saleable inventory.

5.4 Dispensing SOP

1. Dispense prescription medicines against valid prescriptions, verified by the pharmacist.
2. Apply the Generics Act (RA 6675): offer generic equivalents and inform the customer of their options.
3. Record all transactions in the prescription, dangerous-drug and poison record books as applicable.
4. Counsel every patient on dosage, duration and storage.

5.5 Complaints SOP

1. Log every product complaint with date, product, batch number and complainant details.
2. The pharmacist assesses each complaint; escalate quality defects to the supplier and the FDA as required.
3. Keep complaint records filed and traceable.

5.6 Recall SOP

1. Maintain batch traceability from supplier to customer.
2. On a recall order or internal trigger, immediately quarantine all affected batches.
3. Notify customers where required, process returns, and file a complete recall report.

5.7 Housekeeping SOP

1. Follow a written cleaning schedule for dispensing counters, storage areas and customer areas.
2. Control pests without contaminating stock; keep cleaning logs.

6. Pro Tips

• LTO before launch. Opening while the application is "in process" is still operating without a licence — wait for issuance.
• Write the six SOPs down. Procurement, complaints, recalls, dispensing, storage, housekeeping — inspectors ask to see them; verbal procedures don't count.
• Generics Act compliance sells. Training staff on RA 6675 counselling turns a legal duty into a customer-trust advantage.
• Guard the record books. Prescription, dangerous-drug and poison books are legal documents — bound, sequential, no torn pages.
• 15 sqm is the minimum. Design for workflow within it; cramped backrooms fail storage segregation checks.

7. Frequently Asked Questions

Q1: What licence does a Philippine drugstore need? A: A License to Operate (LTO) issued by the FDA Philippines, obtained before opening.

Q2: Which laws govern pharmacies in the Philippines? A: RA 3720 (Food, Drug, and Cosmetic Act), RA 9711 (FDA Act of 2009) and RA 6675 (Generics Act), among others.

Q3: What SOPs do FDA inspectors check? A: Written procedures for procurement, complaints, recalls, dispensing, storage and housekeeping.

Q4: What is the minimum floor area? A: 15 square metres.

Q5: What record books are required? A: Prescription, dangerous-drug and poison record books, maintained as bound legal records.

Q6: What does the Generics Act require at dispensing? A: Under RA 6675, dispensers must offer generic equivalents and inform customers of their options.