Guidance

Guidelines for standard operating procedures

Updated 2 July 2025

General principles

It is an expectation that a controlled drug (CD) or drug precursor chemical (DPC) licensee or prospective licensee has a set of Standard Operating Procedures (SOPs) should exist which sets out the end-to-end CD or DPC management by the organisation at that site. This document or documents should cover the manner in which CDs and/or PCs are possessed, produced, manufactured, stored and handled on site, subjected to periodic stock checks and, where relevant, supplied to customers, third party suppliers etc noting this list is not exhaustive.  

Expected practice is that SOPs should be regularly reviewed and updated ensuring that all employees are able to access them and are familiar with their contents where relevant to their role. All employees, where it is relevant, ensure that their actions in relation to controlled drugs are as per the SOPs. You may wish to ensure that a hard copy is available for reference in the case of technical failures of IT and/or emergencies.

SOPs should take account of regulatory requirements and security practices. They should be written in a way that staff without prior knowledge of the role or organisation can read and understand how to complete the specific tasks documented.

The format of an SOP depends on the individual organisation and their requirements. For example, these can be formatted as a ‘Working Instruction’ (WI) that details each stage of the process, in a bullet point format, to a full explanation of how each action is conducted. You should consider a format that is tailored to your specific requirements e.g. flow charts/checklists. You may even consider the inclusion of photographs illustrating the action/s that you wish an employee to take or to sign post.  

Document structure

A well-designed SOP offers clear, precise instructions, supporting staff with executing their specific duties for the organisation in line with the requirements in legislation, regulation, Home Office Policy and best practice. Any jargon used or acronyms should be clearly explained.

Although documents can be either elaborate or simple, depending on your company/organisation’s needs, most SOPs use at least some of the structural elements listed below:

• document control: each page of the SOPs should include document control information. Often, this information appears in the header and should include the following details:

  • a short title or document ID number
  • a revision number and date

• title page: frequently, the title page of an SOP includes not just identification information, but also approval signatures and version information 

• purpose: very briefly describe your goal in assembling the document
• scope: scope delineates who is responsible for the procedure or what activities the procedure describes. It can also be helpful to describe what is out of scope for the document
• table of contents: a table of contents helps readers find the sections of the document they need
• procedures: procedures include the step-by-step descriptions of how to perform tasks
• terminology, glossary, definitions and reference: define words, phrases, acronyms, abbreviations, and activities that could have ambiguous meanings or that might not be understood by the document’s audience
• roles and responsibilities: specify what roles are responsible for performing these activities
• revision history: this often appears in a dedicated block on the cover or on one of the first few pages of the document
• approval signatures: your organisation may require an authorising officer to sign off on SOPs. This signature block often appears on the cover or on one of the first few pages of the document

Controlled drugs / precursor chemicals licence SOPs

For the purpose of a Controlled Drugs (CD’s) / Precursor Chemicals (PC’s) licence, it is expected that the following should form the basis of your SOPs where applicable:

• applicability of relevant Regulations:
  • Misuse of Drugs Regulations 2001
  • Misuse of Drugs Act 1971
  • Misuse of Drugs (Safe Custody) Regulations 1973
  • The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019
• ordering / procuring stocks of CD’s/PC’s (including ensuring minimum stock to meet operational requirements in Mountain Rescue settings)
• customer and supplier checks (due diligence)
• acceptance of deliveries and procedures upon receipt
• safe storage (where CD’s / PC’s are self-stored in addition where stored away from main base by employee)
• customer order processing
• transport (deliveries and internal transfers)
• third party agreements (logistics/distribution, storage, testing/sampling etc.)
• record keeping, audits and cross-checking processes (including drugs audit trail of drugs on the hill for Mountain Rescue operations)
• annual drugs returns (statistical/NIL returns)
• controlled drug destructions
• Controlled Drugs Accountable Officer (CDAO), qualification of their role and any/all interactions in respect of the controlled drugs licence
• accidental return of CD’s/PC’s (where items are returned to a head office or other similar location)
• theft, loss or adverse incident reporting and handling
  • reporting breaches
  • investigation and remediation
• security (access and storage arrangements, staff vetting, third party company access, loan working in the context of access to CD’s/PC’s, CCTV / access records retention and access)
• managing the licence application process
• prescribing
• clinical trials
• destruction
• physical and digital security of intellectual property (IP)
  • restricted access (password protection)
  • VPN connections
  • audit trails
  • physical storage
  • encryption
  • system monitoring
  • data backups
• training and staff compliance
  • training matrix
  • competency tests

The above guidance also applies to organisations that consider themselves virtual i.e. no physical possession of CD’s/PC’s. Whilst there may be no physical possession, if an organisation is directing the flow of CD’s/PC’s and operating virtually the above should also form part of your SOPs. Virtual companies may wish to pay particular attention to ensuring hand-offs between various companies operating in the chain are clearly documented and that any ‘Technical Agreements’ for example between Third Party Logistics (3PL) companies are referenced so there is no misapprehension of responsibilities.

Please note that the above list is not exhaustive. This document can be used as a guide to support applicants in writing a set of SOPs that are specific to their business type. Whilst we are willing to provide any help and guidance we can, any guidance given by us represents the Home Office view based on our best judgement at the time in light of the information available. Such views are not a definitive statement of law, which may only be given by the Courts. Accordingly, we would always advise you to take your own independent legal advice.