Controlled Medicines Compliance for Kenyan Wholesalers

Getting licensed to handle controlled medicines in Kenya is only the start. Wholesalers that distribute morphine, other opioids, benzodiazepines and similar products carry continuing obligations on record-keeping, storage, supply and inspection, and the consequences of failure are far heavier than for ordinary medicines. A stock discrepancy that would be an administrative problem for paracetamol can become evidence of trafficking for a narcotic. This guide sets out the compliance framework for controlled medicines compliance at wholesale level and the controls a well-run distributor should have in place.

The Legal Framework

Two statutes apply side by side.

The Narcotic Drugs and Psychotropic Substances (Control) Act (Cap. 245) governs narcotic drugs and psychotropic substances. Section 16 establishes a Board that issues licences for their importation, exportation, sale, manufacture and distribution, names the ports through which they may pass, and prescribes the records that must be kept by anyone who imports, receives, sells, disposes of or distributes them. The Act’s definition of “trafficking” in section 2 covers storing, supplying and distributing these substances, and excludes only activity carried on under, and in accordance with, a licence, or by medical practitioners and registered pharmacists acting within the Act.

The Pharmacy and Poisons Act (Cap. 244) governs the wholesale business generally: the wholesale dealer’s licence under section 27, registered premises under section 23, inspection of licences and books under section 47, and director liability under section 49.

Our guide to importing narcotic and psychotropic medicines into Kenya covers licensing and import authorisations. This guide concentrates on what happens once the stock is in the warehouse.

Records: The First Line of Defence

Records are what separate lawful distribution from trafficking. The section 16 Board can prescribe the records to be kept, and section 18 of Cap. 245 makes it an offence to fail to furnish information or to produce records when lawfully required. Section 17 makes it an offence to wilfully destroy books or documents that must be produced to the police or other authorised persons, or to refuse to produce, or to conceal, such books, documents or stocks of narcotic drugs or psychotropic substances.

A sound records system for controlled medicines typically includes:

• a dedicated register for each controlled product, showing every receipt and every supply, with running balances;
• the import authorisation, supplier details and batch numbers for every receipt;
• the customer, its licence or registration details, quantities and batch numbers for every supply;
• documented reasons for every adjustment, loss, breakage, return or destruction.

Under section 47 of Cap. 244, books kept under that Act must be open to inspection by an authorised officer at all reasonable times, and section 48 makes obstruction an offence. Records should therefore be complete, current and quickly retrievable.

Storage, Access and Reconciliation

Controlled medicines should be stored separately from general stock, in locked storage with access limited to named staff. Keys and access codes should be controlled and logged.

Frequent physical counts reconciled against the register are the single most effective control. Any discrepancy should be investigated immediately, escalated to the registered pharmacist in control of distribution and the board, and documented. Unexplained losses should not simply be written off. Where theft or diversion is suspected, the business should take legal advice promptly on reporting to the regulator and the police.

Supplying Only Authorised Customers

A wholesaler is responsible for who receives its stock. Before supplying controlled medicines, it should confirm that the customer is a licensed pharmacy, hospital or other institution entitled to receive them, and should keep evidence of that check. Volumes should also make sense: orders that exceed what a customer could plausibly use, or that come from new customers with no history, call for questions before shipment. Our AML guide to pharmaceutical diversion red flags sets out the patterns to watch for.

Inspections and Enforcement

Both statutes give officers wide powers. Under Cap. 244, a magistrate may issue a warrant to search premises on reasonable grounds of an offence (section 45), and licences and books must be produced on demand (section 47). Under Cap. 245, obstructing officers or failing to produce records is an offence, and section 19 provides for forfeiture of narcotic drugs and psychotropic substances held without legal authority, or in excess of, or of a different quality from, what the holder is authorised to possess. A register that does not match the shelf is therefore a forfeiture risk, not just a paperwork problem.

Directors cannot treat this as the pharmacist’s problem alone. Section 49 of Cap. 244 makes every director, secretary and manager liable for the company’s offences under that Act unless they prove lack of consent or connivance and proper diligence. Boards should receive regular reports on controlled-substance reconciliations, exceptions and inspection outcomes, and should minute their oversight. Our guide to the superintendent pharmacist explains how responsibility is shared between the pharmacist and the board.

A Practical Compliance Checklist

• Current licences under Cap. 244 and Cap. 245, and registration of every product handled.
• Written procedures for receipt, storage, supply, returns and destruction of controlled medicines.
• Dedicated registers with running balances, reconciled at set intervals.
• Customer licence verification before every first supply and at renewal.
• Locked storage with controlled, logged access.
• Escalation route for discrepancies, with board reporting.
• Periodic independent audit of the whole controlled-substance cycle.

Frequently asked questions

This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.