Controlled drug schedules and record-keeping

Which schedule a drug is in decides what records you keep. This guide goes through the schedules, the register rules and the retention periods, using the text of the regulations.

Where the rules come from

The Misuse of Drugs Regulations 2001 (SI 2001/3998) sort controlled drugs into five schedules and set out who may supply them and what records they must keep. This guide uses the regulations as published on legislation.gov.uk. They are amended from time to time, so go back to the source for anything that matters.

The five schedules, with examples

These examples are names that appear in the schedules' own lists. Each list is longer than this, and the schedules set conditions for some entries.

• Schedule 2: includes morphine, diamorphine, fentanyl, oxycodone, methadone, pethidine and methylphenidate.
• Schedule 3: includes buprenorphine, gabapentin, midazolam, pregabalin, temazepam and tramadol.
• Schedule 4: includes diazepam, clobazam, clonazepam, zaleplon, zolpidem and zopiclone.
• Schedule 5: covers low-strength preparations. A compounded preparation of codeine, for example, falls in Schedule 5 when it is not for injection and holds no more than 100 milligrams of the substance per dosage unit, or no more than 2.5% in an undivided preparation. A preparation of morphine is covered if it holds no more than 0.2% of morphine and cannot be readily recovered.

Regulation 19 also names Schedule 1 alongside Schedule 2. This guide does not cover Schedule 1.

Who has to keep a register

Regulation 19 says that a person authorised to supply a drug specified in Schedule 1 or 2 must keep a register and enter the particulars of every quantity of such a drug obtained and every quantity supplied. A register is not required by regulation 19 for Schedule 3, 4 or 5 drugs. There are exceptions in regulation 19(3), for example for the senior registered nurse in charge of a ward, theatre or department in a hospital, care home or prison.

A separate register, or separate part of the register, is used for each class of drug. Regulation 19(1)(b) treats some drugs, each together with its salts, as a class of its own.

What goes in an entry

For drugs obtained, the headings are the date supply was received, the name and address from whom received, and the quantity received.

For drugs supplied, they are the date supplied, the name and address of the person or firm supplied, the details of authority to possess (the prescriber or licence holder), and the quantity supplied. For Schedule 2 drugs only, there are three more: who collected the drug (patient, patient's representative or a healthcare professional, with their name and address if a healthcare professional), whether proof of identity was requested of the patient or representative (yes or no), and whether proof of identity of the person collecting was provided (yes or no).

Rules for how the register is kept

Regulation 20 sets the standards:

• A separate page for each strength and form of a drug, headed with the class, strength and form.
• Each entry is made on the day the drug is obtained or supplied, or if that is not reasonably practicable, on the next day.
• No cancellation, obliteration or alteration. A correction is made only by a marginal note or footnote that states the date it was made.
• Entries and corrections are made in ink or otherwise indelible, or in a computerised form in which every entry is attributable and can be audited.
• The register is used only for purposes related to the Regulations.
• A separate register for each premises, kept at the premises. A computerised register must be accessible from there.

How long to keep things

• Registers are kept for two years from the date of the last entry in them (regulation 23).
• Prescriptions are treated differently by schedule (regulation 23). A private prescription for a controlled drug other than a Schedule 4 or 5 drug, so in practice Schedule 2 and 3, is not kept: regulation 23(4) requires it to be sent to the relevant NHS agency. A private prescription for a Schedule 4 or 5 drug, and a veterinary prescription for any controlled drug, is kept for two years from the date of the last delivery under it (regulation 23(3)). Health prescriptions are excluded from both rules.
• Invoices. Regulation 24 requires certain people to keep invoices or similar records for Schedule 3 and 5 drugs, for two years from the date of issue.

Four checks of your own

1. A pharmacy makes a mistake in a register entry. Can you cross it out? No. Regulation 20 allows a correction only by marginal note or footnote with the date.
2. A pharmacy supplies temazepam. Does regulation 19 require a register entry? No, as temazepam is in Schedule 3 and regulation 19 refers to Schedule 1 and 2 drugs. Other rules and good practice may still apply, so check them.
3. A Schedule 2 drug is collected by someone other than the patient. What extra does the entry carry? Who collected, and the two identity yes/no answers.
4. A private prescription for a Schedule 2 drug has been fully supplied. Do you keep it for two years? No. Regulation 23(4) says it is sent to the relevant NHS agency. The two-year rule in regulation 23(3) covers private Schedule 4 and 5 prescriptions and veterinary prescriptions.

Law questions often sit inside clinical ones, so practise reading a scenario for the schedule first. Our SmPC guide shows how to read the product information that goes with it.

Sources

• The Misuse of Drugs Regulations 2001, regulation 19 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/regulation/19. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, regulation 20 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/regulation/20. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, regulation 23 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/regulation/23. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, regulation 24 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/regulation/24. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, Schedule 2 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/schedule/2. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, Schedule 3 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/schedule/3. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, Schedule 4 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/schedule/4. Accessed 22 October 2026.
• The Misuse of Drugs Regulations 2001, Schedule 5 (legislation.gov.uk). https://www.legislation.gov.uk/uksi/2001/3998/schedule/5. Accessed 22 October 2026.

The legislation.gov.uk pages listed above only: Contains public sector information licensed under the Open Government Licence v3.0.

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Not affiliated with the General Pharmaceutical Council. Revision only, not clinical or legal advice. Worked examples use invented numbers and products. Every source above was read on 22 October 2026; check anything that matters against a current source. See our terms of use and privacy notice.