Is an electronic CD register legal?
Yes, and it has been since 14 November 2005. The Misuse of Drugs Regulations 2001 (SI 2001/3998) originally required every register entry to be made in ink or otherwise indelibly. SI 2005/2864, the Misuse of Drugs and Misuse of Drugs (Supply to Addicts) (Amendment) Regulations 2005, added a second option. Regulation 20(d) now allows an entry to be "in a computerised form" that follows "best practice guidance endorsed by the Secretary of State".
The 2005 amendment set two tests for that computerised form. Every entry must be "attributable and capable of being audited". And the register must be accessible from the premises it relates to. The amendment also allowed records to be kept in their original form or copied into a computerised form. And it allowed an authorised person to ask for a copy of a computerised register "in computerised or other form".
Nothing else changed. The content rules in regulation 19, the form rules in regulation 20 and the retention rules in regulation 23 apply to an electronic register exactly as they apply to a bound book. Going paperless does not relax a single requirement. It changes how you meet them, and it removes some of the excuses a paper book allows.
What must a CD register record?
Regulation 19 lists the fields, and the list grew in 2008. Anyone who supplies a Schedule 1 or 2 controlled drug must keep a register and enter every quantity obtained and every quantity supplied. A separate register, or a separate part of one, is used for each class of drug. Each drug named in the schedules, with its salts and preparations, counts as its own class. Under regulation 20(a), each strength and form of a drug has its own page, headed with the class, strength and form.
The fields below come from regulation 19 as amended by SI 2007/2154, in force from 1 February 2008. That amendment added the collection and identity fields for Schedule 2 drugs.
| Transaction | What the register must show |
|---|---|
| Drug obtained | Date the supply was received; name and address of the supplier; quantity received. |
| Drug supplied | Date supplied; name and address of the person or firm supplied; details of the authority to possess, meaning the prescriber's or licence holder's details; quantity supplied. |
| Schedule 2 drug supplied | Whether the person collecting was the patient, the patient's representative or a healthcare professional; whether proof of identity was requested; whether proof of identity was provided. |
| Timing | Entry made on the day of the transaction or, if that is not reasonably practicable, the next day. |
A register may hold more than the minimum. Regulation 19 allows extra information, subject to regulation 20(e), which says the register may be used only for the purposes of the Regulations. That matters for software design. A PMR that stores dispensing notes, delivery scans and clinical records is fine, as long as the register itself is a defined record within it. Cannabis-based products for medicinal use in Schedule 2 go in the register like any other Schedule 2 drug, as our guide to CBPM dispensing rules explains.
Can you edit an entry in a CD register?
No. Regulation 20(c) is blunt: "no cancellation, obliteration or alteration of any such entry shall be made". A correction is made "only by way of marginal note or footnote which shall specify the date on which the correction is made". In a paper book that means the original stays legible and a dated note sits beside it. The 2005 amendment carried the same principle into software by requiring every entry to be attributable and auditable.
An electronic register therefore has to do three things. It must keep the original entry visible. It must add the correction as a new entry that names the user and the date. And it must show both in the audit trail without a way to hide either. That is why a spreadsheet fails. A cell can be overwritten, a row deleted and a file saved over, with no record of who did it or what was there before. Nothing in a spreadsheet is attributable, and nothing is capable of being audited in the sense the Regulations use.
The test of an electronic register is not whether it can record a supply. It is whether it can refuse to forget one.
The same logic applies to logins. If three staff share one account, no entry is attributable to a person. Each user needs their own credentials, and the register needs to record which credentials made each entry. From 10 December 2026, when pharmacists may authorise registered pharmacy technicians to carry out or supervise dispensing, that attribution will matter more. The supervision Order, SI 2025/1249, will add pharmacy technicians to regulation 19 when its remaining articles commence.
Do you need a running balance?
The 2001 Regulations do not require one, but every serious guide assumes one. NICE guideline NG46, Controlled drugs: safe use and management, expects organisations to run stock checks that involve "checking the balance in the controlled drugs register against current stock". For liquids it describes "visual inspection of liquid balances, periodic volume checks and checks to confirm the balance on completion of a bottle". Stock checks must be recorded "along with the date and signature of the health professional carrying out the check".
You cannot check a balance you have not kept. That is the practical answer. An electronic register calculates the balance after each entry, which removes arithmetic errors. It does not remove the need for a physical check, and it makes liquid discrepancies more visible, not less. Overage in a bottle of oral morphine still has to be reconciled by a person and recorded as such.
SPS records the government's stated intention: once electronic registers are in widespread use, it intends to require anyone who must keep a register to hold secure copies for up to 11 years. That has not been enacted. The current legal period remains two years from the last entry. A pharmacy that keeps its electronic register longer loses nothing, provided its retention policy says so.
How long is the register kept, and who can demand it?
Two years from the date of the last entry, under regulation 23. Because the clock starts at the last entry, a register that stays open for three years is kept for five in total. An electronic register never fills up. The practical rule is to define each register by premises and class, and to keep every entry for at least two years after the most recent one. The table below gathers the periods that apply to controlled drug records.
| Record | Keep for | Basis |
|---|---|---|
| CD register | 2 years from the last entry | Misuse of Drugs Regulations 2001, reg 23. |
| Requisitions | 2 years | Misuse of Drugs Regulations 2001, reg 23; NICE NG46 1.5.13. |
| Invoices for Schedule 3 and 5 drugs | 2 years from issue | Misuse of Drugs Regulations 2001, reg 24. |
| Private prescriptions for Schedule 2 and 3 CDs | Not kept: sent to the NHSBSA | Misuse of Drugs Regulations 2001, reg 23 as amended in 2006. |
| Records of destroying patients' own CDs | 7 years (suggested) | NICE NG46 1.5.14. |
| CD invoices generally | 6 years (suggested) | NICE NG46 1.5.14. |
Access is the other half of retention. Regulation 20 requires the register to be kept at the premises it relates to, and the 2005 amendment requires a computerised register to be accessible from those premises. An authorised person, such as a police controlled drugs liaison officer or a GPhC inspector, can ask to see it and can ask for a copy in computerised or other form. A register hosted in the cloud passes that test only if someone at the counter can open it and produce it on the day. Wider retention rules for prescriptions, the POM register and clinical records are in our guide to pharmacy record retention periods.
What do GPhC inspectors look for?
Compliance with the Regulations, not a particular format. The GPhC's standards for registered pharmacies, published in June 2018, are outcome-based. Standard 1.6 requires that "all necessary records for the safe provision of pharmacy services are kept and maintained". Standard 4.3 requires medicines to be obtained from a reputable source, stored securely, safeguarded from unauthorised access and supplied safely. Neither mentions paper or software. An electronic register is judged on whether it meets the law and whether the pharmacy team can use it.
Records and medicines handling are two of the seven standards behind most failed inspections, as our analysis of why pharmacies fail GPhC inspections shows. For controlled drugs the questions are predictable. Are entries complete and in date order? Are corrections dated footnotes rather than alterations? Are balances kept and checked, with the checks recorded? Is there one register per premises, with a page or section per strength and form? Can the responsible pharmacist produce it now? Our guide to what GPhC inspectors look for in 2026 covers the wider visit.
Electronic registers change the character of those findings. A paper book fails on missing signatures and arithmetic. Software fails on shared logins, missing backups, balances nobody physically checks and a register that the locum cannot open. The medium moves the risk; it does not remove it.
What should an electronic register do before you switch?
Test any system against the Regulations before you test it against your workflow. The list below turns regulations 19, 20 and 23, the 2005 amendment and NICE NG46 into questions a supplier should answer in writing. Most PMR-integrated registers now pass. A generic document, spreadsheet or note-taking app does not.
- Every entry is tied to a named user with their own login, so it is attributable.
- Entries cannot be edited or deleted; corrections are added as dated, attributable footnotes and both versions stay visible.
- The register is separated by premises, by class of drug, and by strength and form, as regulations 19 and 20 require.
- Every Schedule 2 supply captures who collected, whether ID was requested and whether it was provided.
- A running balance is calculated per strength and form, and physical stock checks can be recorded with date and user.
- The register can be opened and printed or exported at the premises, including when the internet or the main PMR is down.
- Every entry is retained for at least two years after the last entry in that register, with backups you have tested restoring.
- The full audit trail can be exported in a readable form if you change supplier.
The hardest test is the sixth. A register that lives only in a browser is unavailable the moment your connection drops, and regulation 20 still expects it to be accessible from the premises. Ask the supplier what happens during an outage and how entries made offline are timestamped. Then ask how you would produce the register for a police officer at 4pm on a Friday with the internet down. If the answer is "wait", keep a paper contingency register and write the procedure into your SOP.
How do you switch from paper without losing the audit trail?
Treat the switch as a stock transfer with a date. Pick a cut-over day. On that day, carry out a full physical stock check of every Schedule 2 drug and record it in the paper register, with the date and the signature NG46 expects. Enter each closing balance into the electronic register as an opening balance entry, attributed to the pharmacist who counted it and cross-referenced to the paper page. Rule off the paper register and keep it for two years from that final entry.
Then update the documents around it. Your controlled drugs SOP should name the system, the login rules, the correction method, the stock-check frequency and the outage procedure. Every team member who makes entries needs their own account and a record of training on the new process. If your pharmacy has more than one set of premises, each needs its own register within the system. Testosterone is a Schedule 4 controlled drug and needs no register entry, as our guide to whether testosterone is a controlled drug explains. Do not let the software create one.
Finally, decide who checks the balances and how often. The software will count. It will not open the cabinet.
Key takeaways
- Electronic CD registers have been lawful since 14 November 2005, when SI 2005/2864 amended regulation 20 of the Misuse of Drugs Regulations 2001.
- Every computerised entry must be attributable and capable of being audited, and the register must be accessible from the premises it relates to.
- Regulation 19 sets the fields, including who collected a Schedule 2 drug and whether identity was requested and provided.
- Regulation 20(c) bans any alteration: corrections are dated footnotes, and a spreadsheet that allows overwriting is not a register.
- The register is kept for two years from the last entry under regulation 23; the government's stated aim of 11-year secure copies is not yet law.
- Running balances are not in the Regulations, but NICE NG46 expects stock checks against the register balance, recorded with date and signature.
- GPhC inspectors judge the register against the law and standards 1.6 and 4.3, not against its format.
Sources and further reading
- Misuse of Drugs Regulations 2001 (legislation.gov.uk)
- Misuse of Drugs Regulations 2001, regulation 20: requirements as to registers (legislation.gov.uk)
- Misuse of Drugs and Misuse of Drugs (Supply to Addicts) (Amendment) Regulations 2005, SI 2005/2864 (legislation.gov.uk)
- Standards for registered pharmacies (GPhC, June 2018)
- Controlled drugs: safe use and management, NG46 recommendations (NICE)
- Controlled drugs records in pharmacy (Specialist Pharmacy Service)
- Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025, SI 2025/1249 (legislation.gov.uk)
FAQs
A CD register that cannot be quietly altered.
Put the eight tests in this article to Dataforge PMR, or to any supplier, and ask to see each one demonstrated on a live register before you close the paper book.
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