Pharmacy Controlled Drugs Register

Controlled Drugs Register & Record Keeping

Controlled Drugs (CDs) are among the most tightly regulated medicines in UK pharmacy practice. Accurate record keeping is not just a legal obligation – it is a fundamental patient safety mechanism that creates a traceable audit trail for every CD that enters or leaves a pharmacy.

Understanding how CD registers work, what must be recorded, and how running balances are maintained is essential knowledge for your MPharm exams, OSCEs, and every placement you attend.

See how CD registers➚ are maintained in other places like wards.

Which Controlled Drugs Require A Register?

A CD register is a legal requirement for all Schedule 1 and Schedule 2 CDs received or supplied by a pharmacy.

Sativex (a Schedule 4 Part 1 CD) is a notable exception – pharmacists are legally required to keep records for it, and the Home Office strongly recommends using a CD register for this purpose, though it is not currently a statutory requirement to do so.

Schedule 3, 4 (excluding Sativex), and 5 CDs do not require register entries, though other record-keeping requirements may still apply.

What Must Be Recorded?

When Receiving A Controlled Drug

Every time a CD is received into the pharmacy, you must record:

The date the supply was received
The name and address of the supplier
The quantity received

When Supplying A Controlled Drug

Every time a CD is supplied from the pharmacy, you must record:

The date of supply
The name and address of the person receiving the supply
The authority to possess – this means the prescriber’s details or the licence holder’s details
The quantity supplied
For Schedule 2 CDs specifically: whether the person collecting was the patient, a patient representative, or a healthcare representative (if the latter, their name and address must also be recorded)
Whether proof of identity was requested
Whether proof of identity was provided

These represent the minimum legal requirements. Additional information can and should be added where relevant.

What Does The Register Look Like?

Physical Format

The register must be a bound book – loose-leaf formats are not legally compliant. Each page must clearly state the class, strength, and form of the CD at the top. Different drug classes must be kept in separate sections, and within each class, different strengths and formulations must each have their own dedicated page.

Multiple registers for the same CD class are permitted, provided the Home Office has approved this arrangement.

Electronic Registers

Electronic CD registers are a legally recognised alternative to bound books, provided the software meets strict requirements. An electronic register must ensure that:

Every entry can be attributed to a specific, identifiable author
Entries cannot be altered or deleted after they have been made
A complete log of all data entered is retained and can be recalled for audit purposes

The register must be accessible from the premises at all times and capable of being printed. Access controls must be in place to prevent unauthorised access, and regular backups are mandatory.

Rules For Making Entries

All entries in a CD register – whether paper or electronic – must follow these rules:

Chronological order – entries must follow the sequence of transactions
Prompt entry – records must be made as soon as possible
Permanent ink or indelible format – no pencil, no erasable entries
No alterations – entries must never be crossed out, overwritten, or obliterated. If a correction is needed, it must be made as a dated marginal note or footnote, clearly attributed to the person making the amendment (name, initials or signature, and GPhC number where applicable)

Keeping And Storing The Register

The register must be kept at the premises it relates to – it cannot be held elsewhere
Registers must be retained for two years from the date of the last entry
Records can be kept in their original form or transferred to an approved computerised format
Authorised individuals – such as GPhC inspectors or CD liaison officers – must be able to access the register and related stock records upon request

Running Balances And Stock Checks

A running balance is an ongoing tally of CD stock that allows discrepancies to be identified as quickly as possible. It is a recommendation from the Shipman Inquiry and is widely regarded as essential good practice – with the expectation that it will become a legal requirement once electronic registers are in widespread use.

How often should stock checks happen?

For most settings, stock checks should take place at least once a week, though this may increase based on:

The volume of CDs being dispensed
A history of past irregularities or incidents
Frequent changes in the pharmacist in charge
Local risk assessments

It is also good practice to visually check the running balance each time a CD is dispensed – confirming that the figure in the register matches what you can physically see on the shelf.

Liquid CDs require visual checks, periodic volume checks, and a balance check on completion of each bottle.

All stock checks must be signed, dated, and recorded by the healthcare professional carrying them out. Where possible, two people should perform checks together.

What If The CD Balance Reaches Zero?

A zero balance does not automatically indicate a problem. Common reasons include the drug not being reordered, the drug being destroyed (e.g. expired stock – see the section on CD Destruction), or discontinuation by the manufacturer. Pharmacists can use professional judgement, in line with local SOPs, to decide whether weekly balance checks for long-standing zero-balance CDs should continue or be paused.

Dealing With CD Discrepancies

The pharmacist holds overall responsibility for maintaining running balances and addressing any discrepancies – though these tasks can be delegated to appropriately trained and competent staff.

If a discrepancy is identified and then resolved following investigation, a marginal note or footnote should be added to the register explaining the correction.

Liquid CDs in particular can show minor variances due to residue in containers, overfill, or accidental spillage – these should be noted and monitored.

One practical note: where a Schedule 2 CD entry has already been made in the CD register, a separate entry in the POM register is not required.

Quick Reference – CD Register Summary

Requirement	Detail
Schedules requiring a register	Schedule 1, Schedule 2 (+ Sativex)
Format	Bound book or approved electronic system
Entry timing	Same day or following day
Entry format	Ink or indelible – no alterations
Corrections	Dated marginal note, attributed to author
Retention period	Two years from last entry
Stock check frequency	At least weekly (risk-assessed)
Who is responsible	Responsible Pharmacist (can delegate)

Table 1. A Quick Reference For CD Registers

OSCE Tips – Controlled Drugs Record Keeping

CD registers record keeping appears in OSCEs most often as a scenario-based question or a written station. Examiners are testing whether you understand the legal framework and can apply it under pressure.

Know your schedules – be clear on which schedules require register entries and which do not
The bound book rule is frequently tested – electronic registers are permitted but must meet specific criteria
Entries must be in ink and cannot be altered – corrections via marginal notes only; this is a common exam catch
The two-year retention rule is a reliable exam fact – learn it
Running balances are best practice and Shipman Inquiry – recommended – not yet a legal requirement, but treat them as if they are
For Schedule 2 collection, know the three categories of collector (patient, patient representative, healthcare representative) and what additional detail is needed for each
If asked what you would do on discovering a discrepancy – investigate first, then document via a marginal note if resolved; escalate if not

Medicines Prep

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