Two regimes, not one
Wholesale distribution of controlled drugs requires compliance with both the medicines regime — the wholesale dealer’s licence and GDP — and the misuse of drugs regime administered by the Home Office. The two have different regulators, different inspection routes and different record requirements.
The practical consequence is that a GDP-compliant quality system is necessary but not sufficient. Sites that treat controlled drugs as a subset of GDP procedures usually have gaps in safe custody, licensing scope and statutory record keeping.
Home Office licensing
A domestic licence is required to produce, supply, possess or import and export controlled drugs in the schedules that require it. The licence is site-specific and activity-specific, and it lists the substances covered.
Applications are assessed on the premises security, the competence of the personnel and the suitability of those in control. Compliance checks are carried out, and licences are renewed rather than held indefinitely, so the renewal cycle needs to be tracked as a business-critical date.
Separate import and export licences are required for individual consignments crossing borders, and these are transaction-level rather than annual.
Safe custody and security
Storage requirements depend on the schedule of the substance. Safe custody obligations dictate the physical standard of the storage, and the Home Office publishes security guidance covering the expectations for licensees, including construction standards, alarm systems, access control and key management.
Security is assessed against the quantity and attractiveness of the stock held, not against a single standard. A site increasing its holdings should reassess whether its existing arrangements remain adequate rather than assuming the original approval still applies.
Records and registers
Statutory record keeping under the misuse of drugs regime is separate from GDP documentation. Registers must be kept in the prescribed form, entries made within the required period, and records retained for the statutory period.
Requirements that commonly cause problems include the prohibition on alterations — corrections are made by marginal note or footnote rather than obliteration — and the requirement that running balances be maintained and be capable of reconciliation against physical stock.
Destruction
Destruction of controlled drugs requires denaturing so the substance is irretrievable, and depending on the schedule and circumstances must be witnessed by an authorised witness. The record should identify the substance, quantity, date, method and the persons present.
Stock awaiting destruction remains subject to safe custody and must remain on the register until destroyed.
Transport
The Home Office publishes specific guidance on safe custody in transit, covering vehicle security, route planning, avoidance of predictable patterns, driver arrangements and what to do in the event of a theft or hijack. Transport of controlled drugs should be covered by its own procedure rather than folded into the general GDP transport SOP.
Standard operating procedures
The Home Office publishes SOP guidelines for licensees setting out what procedures it expects to see. Reviewing your documentation set against those guidelines is a more direct route to compliance than inferring the requirements from GDP.
Common questions
- Does a WDA(H) allow us to handle controlled drugs?
- No. The wholesale dealer’s licence addresses the medicines regime. Handling controlled drugs in the schedules that require it also needs the relevant Home Office licence.
- Which schedules require a Home Office licence?
- The requirement varies by schedule and by activity. The Home Office domestic licensing guidance sets out which activities and substances require a licence, and it should be checked against the specific substances you intend to handle.
- Can GDP records serve as the controlled drugs register?
- Generally not. The register has a prescribed form and content that GDP records are not designed to meet. Most operators maintain both.