SOP for Pharmacy in Uganda (Free PDF Download)

Pharmacy SOP for Uganda (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Uganda — covering National Drug Authority (NDA) licensing, the Certificate of Suitability of Premises, supervising pharmacist requirements and drug schedule controls. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage and recordkeeping procedures required to operate a retail pharmacy in Uganda in line with National Drug Authority requirements.

2. Scope

Applies to the supervising pharmacist, all dispensers and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• The National Drug Authority (NDA) regulates pharmacy premises and medicines in Uganda.
• A retail pharmacy must be operated by a company registered with the URSB (Uganda Registration Services Bureau).
• The premises require an NDA Certificate of Suitability of Premises.
• A supervising pharmacist — registered and resident — must oversee the pharmacy.
• The premises must have a minimum 20 sqm floor area.
• Medicines are controlled by drug schedules: A (narcotics), B (controlled), C (licensed), and exempted categories.

4. Responsibilities

5. Procedure

5.1 Company and premises setup

1. Register the operating company with the URSB.
2. Secure premises of at least 20 sqm meeting NDA structural requirements (dispensary, storage, counselling space).
3. Apply to the NDA for the Certificate of Suitability of Premises; do not stock or trade before it is issued.
4. Display the certificate prominently in the pharmacy.

5.2 Staffing

1. Appoint a supervising pharmacist who is registered and resident — they must genuinely oversee daily operations.
2. Define deputy cover so the pharmacy is never without professional supervision during opening hours.

5.3 Procurement

1. Source only from NDA-licensed suppliers; verify product authorisation on incoming stock.
2. Record batch numbers and expiry dates at goods-inwards; quarantine anything suspect.

5.4 Storage and schedule controls

1. Store per label conditions; maintain cold-chain logs for thermolabile products.
2. Apply schedule controls strictly:
   • Schedule A (narcotics): locked safe, separate register, balance reconciliations.
   • Schedule B (controlled): restricted access, full prescription records.
   • Schedule C (licensed): pharmacist-supervised sale with records.
   • Exempted: general sale under the NDA's conditions.
3. Segregate expired, damaged and recalled stock in a marked quarantine area.

5.5 Dispensing

1. Verify prescriptions against the correct schedule before dispensing.
2. Counsel patients on dosage, duration and storage.
3. Enter every scheduled-drug transaction in the appropriate register the same day.

5.6 Inspection readiness

1. Keep the Certificate of Suitability, company registration, staff credentials, registers, invoices and temperature logs in one inspection file.
2. Ensure the supervising pharmacist is available during NDA inspections.

6. Pro Tips

• Certificate before stock. Trading before the Certificate of Suitability is issued is one of the fastest routes to enforcement action — sequence the setup correctly.
• Resident means resident. The supervising pharmacist must actually be there; NDA inspectors test this.
• Respect the schedules. Schedule A discrepancies trigger the deepest scrutiny — reconcile narcotics balances daily, not monthly.
• 20 sqm minimum is enforced. Measure the selling and storage areas properly; corridors and toilets don't count.
• URSB first. Company registration precedes the NDA application — get the sequencing right to avoid rework.

7. Frequently Asked Questions

Q1: Who regulates pharmacies in Uganda? A: The National Drug Authority (NDA), which licenses premises and regulates medicines.

Q2: What is the Certificate of Suitability? A: The NDA's certificate confirming the premises meet structural and professional standards. A retail pharmacy may not operate without it.

Q3: What company structure is needed? A: The pharmacy must be operated by a company registered with the Uganda Registration Services Bureau (URSB).

Q4: Who must supervise the pharmacy? A: A registered, resident supervising pharmacist who genuinely oversees daily operations.

Q5: What are the drug schedules? A: Schedule A covers narcotics (strictest control), Schedule B covers controlled medicines, Schedule C covers licensed medicines sold under pharmacist supervision, and exempted medicines may be sold generally under NDA conditions.

Q6: What is the minimum premises size? A: 20 square metres of floor area meeting NDA structural requirements.