Navigating Controlled Substances in Kenya

Managing controlled substances in Kenya demands attention to detail, strong systems and full regulatory compliance. This article walks you through the key steps—from licences to safe-storage to record-keeping—so you can operate confidently and legally.

Understanding Controlled Substances in Kenya

In Kenya, the regulation of drugs and poisons falls under the Pharmacy and Poisons Board (PPB) established via the Pharmacy and Poisons Act (Cap 244).
The Act gives the Board powers to make rules relating to “safe custody and storage of poisons” and to require registers and books to be kept.
Controlled substances typically include Part I poisons and other regulated medicines. You must treat them with stricter control.

Licensing: Getting Authorised to Handle Controlled Substances

Before you handle controlled substances, you must ensure proper licensing:

1. Apply for the correct licence via the PPB’s Online Licensing portal.

2. Ensure your business registration and professional staff (e.g., a registered pharmacist) are in place.

3. Submit documentation for premises, storage, and security arrangements.

4. Await inspection and approval before stocking or dispensing controlled substances.

By securing the correct licence, you mitigate risks of non-compliance and enforcement action.

Storage & Safe Custody: Protecting Controlled Substances

Once licensed, proper storage becomes crucial.

Key Storage Practices

• Store controlled substances in a separate room or compartment locked and clearly labelled “Poisons Only”.

• Restrict access so that only authorised personnel can reach the controlled substance area.

• Keep storage physically apart from food or drink, and maintain environmental conditions (temperature, light, humidity) appropriate for the medicines.

• Ensure containers are appropriate, secure, and clearly labelled. The law demands poisons be placed in impervious containers and sealed properly.

• Periodic inspections—within your own facility—help monitor storage integrity and prevent diversion or theft.

By applying these measures you maintain integrity of your stock and protect public health.

Record-Keeping: Tracking, Auditing & Compliance

Accurate records form the backbone of your system for controlled substances.

What to Document

• Maintain a Poison Book or equivalent register for Part I poisons as required under the Act and Rules.

• Log incoming quantities (batch numbers, expiry dates), outgoing supplies, prescriptions filled, returns and destructions.

• Ensure records are retained for the time period specified by law and are readily available for inspection.

• Conduct internal audits regularly to reconcile stock, compare with records and identify discrepancies early.

Records help you trace each unit of controlled substance from receipt to dispensing or disposal.

Inspection & Audit: What Regulators Expect

The PPB and authorised officers hold statutory powers to inspect your premises, paperwork and storage.
During an inspection they will check:

• Licence validity and display

• Storage conditions (locked, labelled, separated)

• Record-books and registers

• Proof of authorised personnel handling the substances

• Compliance with rules on supply and possession

Preparing in advance reduces risk of penalties and operational disruptions.

Common Compliance Mistakes & How to Avoid Them

Here are typical pitfalls—and how you can avoid them:

• Mistake: Storing controlled substances alongside general stock or food.
  Solution: Create a dedicated locked compartment and train staff accordingly.

• Mistake: Failing to maintain up-to-date registers.
  Solution: Use daily logs and reconcile monthly.

• Mistake: Operating without the correct licence or registration.
  Solution: Verify licencing status before handling any controlled substance.

• Mistake: Delayed inspection preparation.
  Solution: Implement regular mock audits and keep documentation ready.

Avoiding these helps you stay compliant and safeguard your business.

Best Practices: Building a Robust Compliance System

To operate at a high standard, follow these practices:

• Develop standard operating procedures (SOPs) for receipt, storage, dispensing and destruction of controlled substances.

• Train all staff in the rules: Part I poisons, lock-and-key storage, record-keeping.

• Schedule regular internal audits (weekly/monthly) to check logs and stock.

• Review licences and registrations annually and renew on time.

• Display your licence and relevant signage prominently in your facility.

• Use technology where possible: digital registers, barcode systems, alerts for expiry and stock discrepancies.

By embedding compliance into your daily operations you stay ahead of regulation and reassure stakeholders.

How Clarity Pharma Consultancy Can Support You

If navigating licences, storage rules and record-keeping for controlled substances seems complex, you’re not alone. At Clarity Pharma Consultancy we support Kenyan health-sector businesses with:

• Regulatory gap analyses and readiness checks

• Licence application assistance with the PPB

• Designing secure storage facilities and SOP documentation

• Staff training on controlled substance handling and record systems

• Internal audit frameworks and mock inspections

Partner with us to ensure you stay compliant, minimise risk and maintain smooth operations.

Handling controlled substances in Kenya requires more than just compliance—it demands a system. Licensing under the PPB, secure storage, meticulous record-keeping and proactive auditing form the core of a strong compliance programme.

When you build solid practices and partner with knowledgeable consultants, you safeguard your business, patients and reputation.

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