SOP for Pharmacy in Botswana (Free PDF Download)

Pharmacy SOP for Botswana (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Botswana — covering Botswana Medicines Regulatory Authority (BoMRA) licensing, the standalone pharmacy guidelines, controlled-medicine handling, recall management, recordkeeping and adverse drug reaction reporting. 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 standalone pharmacy in Botswana in line with BoMRA requirements under the Medicines and Related Substances Act, 2025.

2. Scope

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

3. Regulatory Background

• The Botswana Medicines Regulatory Authority (BoMRA) licenses standalone pharmacies under the Medicines and Related Substances Act, 2025.
• BoMRA's Guidelines for Operating a Standalone Pharmacy (effective 15 April 2026) require a defined list of SOPs covering hygiene, receipt and storage, dispensing, cold chain, expired-drug handling, complaints, recalls, supplier verification, ADR reporting, controlled substances and substandard or falsified products.
• Schedule 1A, 1B and 1C medicines may be dispensed only on written prescription, with each transaction entered in a controlled-medicines register and a prescription record book.
• Continuous temperature monitoring records for the 7 days before the pre-licensing inspection must be available at inspection time.
• The pharmacy must hold the required reference materials: MIMS or BNF, a medical dictionary, the Medicines and Related Substances Act and access to the human medicines register on the BRIMS portal.
• Suspected adverse drug reactions are reported per BoMRA's ADR reporting SOP, and records must be kept for the period BoMRA requires — confirm the current retention period with BoMRA.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the company and secure premises meeting BoMRA's structural and equipment requirements (dispensing area, compounding equipment where applicable, cold chain, secure storage).
2. Appoint the responsible pharmacist who will supervise the pharmacy.
3. Apply to BoMRA for the standalone pharmacy licence with the prescribed form, company documents, details of the responsible pharmacist and the application fee.
4. Display the current BoMRA licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from registered products and licensed suppliers; verify supplier authenticity as a standing SOP.
2. Verify product registration 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 continuous temperature monitoring.
2. Separate quarantined, expired and recalled stock in a clearly marked area, and manage expired drugs per the expired-drug SOP.

5.4 Dispensing

1. Dispense Schedule 1A, 1B and 1C medicines only on written prescription; enter each transaction in the controlled-medicines register and prescription record book.
2. Label every dispensed container with the patient name, medicine name and strength, dosage instructions, date of dispensing, dispenser name and pharmacy name.
3. Counsel every patient on dosage, duration and storage, and follow up where the guidelines require.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (BoMRA, manufacturer or internal finding), the responsible 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 per BoMRA's ADR reporting requirements.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, controlled-medicine registers, purchase invoices, temperature logs, recall files and ADR reports for the period BoMRA requires.
2. Make all records available to BoMRA inspectors on demand.

6. Pro Tips

• Adopt the full BoMRA SOP list. The guidelines name the SOPs you must have — hygiene, recalls, ADR reporting, controlled substances, substandard and falsified products — so implement all of them before the inspection, not after.
• Start temperature logging early. You need 7 days of continuous records before the pre-licensing inspection; start the loggers the week you apply.
• Treat the controlled-medicines register as sacred. Every Schedule 1A/1B/1C transaction goes in twice — the register and the prescription book — with no gaps.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Stock the reference shelf. MIMS or BNF, a current medical dictionary, the Act itself and BRIMS access — inspectors check the references.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Botswana? A: The Botswana Medicines Regulatory Authority (BoMRA) licenses standalone pharmacies under the Medicines and Related Substances Act, 2025.

Q2: Which SOPs does BoMRA require? A: The standalone pharmacy guidelines require SOPs for hygiene, cleaning, receipt and storage, dispensing and patient follow-up, cold chain, returned and expired drugs, complaints, recalls, supplier verification, ADR reporting, controlled substances and substandard or falsified products.

Q3: How are controlled medicines dispensed? A: Schedule 1A, 1B and 1C medicines are dispensed only on written prescription, with each transaction entered in a controlled-medicines register and a prescription record book.

Q4: What temperature records are needed? A: Continuous temperature monitoring records for the 7 days prior to the pre-licensing inspection must be available at inspection time, and cold-chain logging continues in operation.

Q5: How are adverse drug reactions reported? A: Per BoMRA's ADR reporting SOP, with a copy of each report filed 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.