SOP for Pharmacy in Sierra Leone (Free PDF Download)

Pharmacy SOP for Sierra Leone (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Sierra Leone — covering Pharmacy Board of Sierra Leone (PBSL) licensing, the premises location and distance rules, staffing, procurement, dispensing, recall handling 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 Sierra Leone in line with the Pharmacy and Drugs Act 2001 and Pharmacy Board of Sierra Leone guidelines.

2. Scope

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

3. Regulatory Background

• The Pharmacy Board of Sierra Leone (PBSL), under the Pharmacy and Drugs Act 2001, issues marketing authorisation, licenses premises, conducts inspections, controls the pharmaceutical market and runs pharmacovigilance.
• Opening a new pharmacy follows a staged process: payment of the application and location-clearance fees, a location-clearance inspection, a monthly interview before a Board subcommittee, then a suitability inspection of the premises (with a re-inspection fee if the first fails).
• The premises must be at least 300 metres from other existing registered pharmaceutical premises, and must not be located in an open market place, a motor park or a clustered area — to preserve the dignity of the profession and avoid unhealthy competition.
• The FY 2026 licence application fee for a retail pharmacy is Le 6,000 (non-refundable) — confirm the current fee schedule with the Board before applying, as fees are revised.
• Dispensing must remain under the effective control of a pharmacist registered with the Board.
• A Pharmacy Council is planned to take over professional regulation (education, licensing of pharmacists and technicians) from the Board — confirm the current split of responsibilities with the PBSL.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Choose a site at least 300 metres from any registered pharmaceutical premises, outside open markets, motor parks and clustered areas.
2. Pay the non-refundable application and location-clearance inspection fees to the Board.
3. Undergo the location-clearance inspection and the monthly interview before the Board's Quality Assurance subcommittee.
4. Prepare the premises for the suitability inspection (storage areas, security, sanitation, equipment); pay the re-inspection fee and correct defects within 3 months if the first inspection fails.
5. Appoint a registered pharmacist in effective control of dispensing before opening.
6. Display the current Board licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from Board-licensed suppliers and verify product registration status.
2. 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 (Board, 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. A product withdrawal fee applies — confirm the current fee with the Board.

5.6 Pharmacovigilance

1. Report every suspected adverse drug reaction to the Board's pharmacovigilance department.
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 the period the Board requires — confirm the current retention period with the PBSL.
2. Make all records available to Board inspectors on demand.

6. Pro Tips

• Measure the 300 metres first. The distance rule kills more applications than any other criterion — verify against the Board's register of premises before signing a lease.
• Budget the fee chain. Application, location clearance, suitability inspection and possible re-inspection fees stack up — the Le 6,000 application fee is only the first line.
• Don't open in the market. Open marketplaces, motor parks and clustered areas are explicitly excluded — pick a dignified, compliant site.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Diary the renewals. Premises and professional licences renew on a cycle — a lapsed licence means a closed pharmacy.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Sierra Leone? A: The Pharmacy Board of Sierra Leone (PBSL), under the Pharmacy and Drugs Act 2001. The Board licenses premises, inspects them, controls the market and runs pharmacovigilance.

Q2: How far must a new pharmacy be from existing ones? A: The premises must be at least 300 metres from other registered pharmaceutical premises, and must not be in an open market place, motor park or clustered area.

Q3: What is the application fee for a retail pharmacy licence? A: The FY 2026 licence application fee for a retail pharmacy is Le 6,000 (non-refundable). Confirm the current schedule with the Board before applying, as fees are revised.

Q4: What does the licensing process involve? A: Payment of application and location-clearance fees, a location-clearance inspection, an interview before a Board subcommittee (held monthly), and a suitability inspection — with up to 3 months to correct defects after a failed inspection.

Q5: Who must supervise dispensing? A: Dispensing must remain under the effective control of a pharmacist registered with the Pharmacy Board.

Q6: How are adverse drug reactions reported? A: To the Board's pharmacovigilance department, with a copy of each report filed in the pharmacy's records.