SOP for Pharmacy in Nigeria (Free PDF Download)

Pharmacy SOP for Nigeria (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Nigeria — covering Pharmacy Council of Nigeria (PCN) licensing, NAFDAC product requirements, recall handling, recordkeeping and pharmacovigilance. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, recall and recordkeeping procedures required to operate a retail pharmacy in Nigeria in line with PCN practice standards and NAFDAC product regulations.

2. Scope

Applies to the superintendent pharmacist, all pharmacists, pharmacy technicians and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• The Pharmacy Council of Nigeria (PCN) regulates pharmacy practice and premises licensing.
• NAFDAC regulates the registration and quality of medicines and medical products sold in Nigeria.
• The premises must be registered by the PCN and owned by a registered pharmacist.
• A superintendent pharmacist with at least 5 years of experience must directly supervise the premises.
• A written product tracking and recall SOP is required, and records must be kept for 5 years.
• Adverse drug reactions are reported through yellow forms to the national pharmacovigilance system.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the company and secure premises that meet PCN structural requirements.
2. Appoint a superintendent pharmacist (registered, 5+ years experience, in direct supervision).
3. Apply to the PCN for premises registration in the name of a registered pharmacist owner.
4. Display the current PCN premises licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from NAFDAC-registered products and licensed suppliers.
2. Verify NAFDAC registration numbers on every incoming consignment.
3. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; maintain the cold chain for thermolabile products with twice-daily temperature logs.
2. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense only against valid prescriptions for prescription-only medicines, verified by a pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record each dispensing in the prescription register.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (NAFDAC, manufacturer or internal finding), the superintendent pharmacist initiates the recall immediately.
3. Identify and quarantine all affected batches, notify patients where required, and return stock per the recall notice.
4. Document the entire recall: batches, quantities, notifications, returns.

5.6 Pharmacovigilance

1. Report every suspected adverse drug reaction on the national yellow form to the pharmacovigilance centre.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, temperature logs, recall files and ADR reports for a minimum of 5 years.
2. Make all records available to PCN and NAFDAC inspectors on demand.

6. Pro Tips

• Vet suppliers quarterly. NAFDAC numbers can lapse — re-verify your top suppliers' product registrations every quarter, not just at onboarding.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Yellow forms at the counter. Keep blank ADR forms where dispensers can reach them — reporting dies when the form is in a locked office.
• Temperature logs are legal evidence. Twice-daily fridge logs, signed — inspectors ask for them first after a cold-chain complaint.
• Own the licence chain. The premises must be owned by a registered pharmacist — sort the ownership paperwork before signing a lease.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Nigeria? A: The Pharmacy Council of Nigeria (PCN) licenses the premises and regulates practice; NAFDAC regulates the medicines themselves (registration and quality).

Q2: Who can own a pharmacy in Nigeria? A: The premises must be registered by the PCN and owned by a registered pharmacist.

Q3: What experience must the superintendent pharmacist have? A: At least 5 years of experience, and they must directly supervise the premises.

Q4: How long must pharmacy records be kept? A: A minimum of 5 years, including prescription registers, purchase records, recall documentation and ADR reports.

Q5: How are adverse drug reactions reported? A: On the national yellow forms submitted to the pharmacovigilance centre, with a copy kept in the pharmacy's records.

Q6: Is a recall SOP mandatory? A: Yes — a written product tracking and recall procedure is required, with batch-level traceability from supplier to patient.