Every UK organisation holding a Schedule 2 controlled drugs licence must keep a Controlled Drugs (CD) register under Regulation 19 of the Misuse of Drugs Regulations 2001. For medical cannabis wholesalers and importers, this register is the single document that demonstrates lawful custody from receipt to dispatch. It is also the first record the Home Office and the MHRA ask to see.

What the register must contain

Every entry for a Schedule 2 receipt or supply must include:

  • Date of the transaction.
  • Name, address and (for supplies) authorisation reference of the person from whom obtained or to whom supplied.
  • Quantity received or supplied.
  • Form and strength of the preparation.
  • Running balance after the transaction.
  • The name or initials of the person making the entry.

Entries must be made in chronological order, in ink, on the day of the transaction (or, where not reasonably practicable, on the next day). Cannabis-based products are recorded under the specific cannabinoid where the licence is granted on that basis.

Bound book or electronic register

Both formats are permitted, with conditions:

  • A bound book is used with no loose-leaf inserts. Entries are not erased — corrections are made by marginal note, signed and dated.
  • An electronic register must be auditable: immutable timestamps, user identification, corrections as separate entries that preserve the original, individual user accounts (no shared logins), and tamper-evident off-site backups.

A common failure pattern is a "hybrid" — paper register with informal spreadsheets used for reconciliation. Inspectors treat the spreadsheet as a parallel record. Pick one source of truth and stick to it.

Daily and weekly reconciliation

The legal requirement is a running balance; the operational requirement for clean inspections is stricter:

  • Physical counts on every receipt and supply, against the register, signed by two people for high-risk lines.
  • A documented end-of-day balance check by the on-shift CD custodian.
  • A weekly full reconciliation: physical stock vs register vs WMS, signed by a named senior person.
  • A monthly trend review by the Responsible Person or CD lead covering discrepancies, write-offs, returns and destructions.

Every discrepancy — even a one-unit variance — should be investigated and documented.

Receipts, returns and destructions

  • Receipts: cross-check supplier invoice, Home Office import licence (if applicable), delivery note and physical count before entry. Resolve discrepancies before goods enter stock.
  • Returns: a Schedule 2 product returned from a customer cannot be re-issued without an RP-led assessment of conditions in transit and storage. Document the assessment with the return entry.
  • Destructions: witnessed by an Authorised Witness for Schedule 2 destruction, recorded in the register with the witness's name and authority, supported by a destruction certificate.

Security and access

  • Storage of the bound register in the CD cabinet area, accessible only to named CD-trained staff.
  • For electronic registers, role-based access tied to individual named accounts.
  • A written list of named persons authorised to make entries, reviewed quarterly.
  • Backups (electronic) held in a separate physical location and tested annually.

What inspectors look for

Inspectors typically pick a random month and trace every entry back to source, pull physical stock for two or three SKUs and reconcile live, test the discrepancy log for investigation and closure, and check destruction witnessing and certificates.

The supporting structure — who the licence is held by, what it permits, and how it integrates with the WDA(H) — sits in our Schedule 2 controlled drugs licence guide and the WDA(H) application checklist.

Common pitfalls

  • Backdated entries entered silently rather than flagged with a marginal note.
  • Initials only, with no key on file mapping initials to named individuals.
  • Running balances reset to a "snapshot" with no audit trail.
  • Multiple registers for the same site with no documented split.
  • No documented annual register review by the RP or CD lead.

How Medicexum helps

Medicexum supports wholesalers in designing the CD register structure (paper or electronic), drafting reconciliation, discrepancy and destruction-witness SOPs, and running mock register audits ahead of inspection — see drills in the MHRA GDP inspection readiness guide, plus Responsible Person services and MHRA compliance. For an independent register review before inspection, get in touch.