Guidance for controlled drugs documentation, storage and security requirements 

We published guidance on 31st July 2026 for operators on the documentation, storage and security requirements for controlled drugs. These are requirements under the Misuse of Drugs Act 1977 (as amended), and various Orders and Regulations made under it. 

The aim of this guidance is to give operators of controlled drugs information on how to meet the requirements. An operator is any entity that holds or intends to hold a controlled drug licence or registration. This could be a manufacturer, wholesaler, forensic laboratory, pre-hospital emergency care provider, and other types of entities.

Consultation to inform guidance 

We assess applications for controlled drug licences and registrations and also carry out inspections of operators. We do this on behalf of the Department of Health, who are the Competent Authority in this area. 

We held a targeted consultation in February 2026. We asked for feedback from a number of controlled drug operators, and certain groups that represent various operators. We are grateful to all the participants who took part and provided their comments.

We reviewed and considered all the comments received and have updated the Guide where appropriate. These are the key points from our review of the comments.

Controlled Drug Register for Schedule 1 and 2 – electronic registers

The Misuse of Drugs Regulations 2017 (as amended) allows manufacturers and wholesalers to use an electronic computer system as a controlled drug register to keep a running stock balance of controlled drugs in Schedule 1 and 2. This is allowed as long as the electronic computer system is validated in line with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements.

We received a number of comments and questions about electronic registers, and what form they should take. We have considered this, and updated the guidance to describe electronic computer systems that could be considered acceptable. Examples of these are a warehouse management system, or a stock inventory system which have been validated and can record and retrieve the required information in accordance with the Misuse of Drugs Regulations 2017 (as amended).

Personnel – background checks

Section 5.2.3 of the guide includes the requirement for a company to carry out background checks when hiring personnel to handle controlled drugs.

We received a number of comments asking for clarification on how to do this, with difficulties regarding personnel vetting, and General Data Protection Regulation (GDPR) being highlighted. We recognise that the method of how this can be done across operators can vary a lot, depending on the operation, and the level of complexity. It is up to the operator to determine how best to do this at their site. Methods could include, for example, reviewing their recent employment history and references, and not allowing immediate access to controlled drugs when they start working there.

The guide has been updated to add this clarification.

Transportation

Sections 5.4 and 5.4.1 describe the requirements and expectations for transport of controlled drugs. This section of the guide describes what is expected if an operator uses a transport provider to transport controlled drugs. Following comments received we have updated this section to make it clear that wholesalers and manufacturers of human medicines, and veterinary medicines must comply with their respective GDP Guidelines for medicinal products. The section then describes best practices for other types of operators who are not required to comply with GDP. 

Terms ‘Operator’ and ‘Responsible Officer’

Throughout the guidance, the terms ‘Operator’ and ‘Responsible Officer’ are used. We received questions regarding both terms. The guide has been updated to clarify these terms and to clarify that there is no legal definition of either term. The 'Responsible Officer' is a role that we recommend an operator should appoint. They would be responsible for making sure that the operator meets the requirements of the Misuse of Drugs Act 1977 (as amended) and the various Orders and Regulations made under this Act, principally of which is the Misuse of Drugs Regulations 2017 (as amended). They would also be responsible for making sure the operator follows the conditions of their licence or registration.

Guidance document

Download a copy of the guide below.