Controlled Drugs (CDs) are classified into five schedules under the Misuse of Drugs Regulations 2001 (SI 2001 No. 3998). Each schedule has different legal requirements governing possession, supply, prescription, storage, and record-keeping. The classification is based on potential for misuse, medical use, and risk of dependence.
Overview of the Five Schedules
| Schedule | Examples | Legal Requirements | Legal Reference |
|---|---|---|---|
| Schedule 1 | LSD, raw cannabis (unless prescribed as CBPM), ecstasy (MDMA) | No recognized medical use. A Home Office license is required for possession or supply. | Misuse of Drugs Regulations 2001, Reg. 6 |
| Schedule 2 | Morphine, oxycodone, fentanyl, methadone | Subject to full CD prescription requirements. Must be stored in a CD cabinet. Records must be kept in the CD register. | Misuse of Drugs Regulations 2001, Reg. 7 |
| Schedule 3 | Tramadol, midazolam, buprenorphine, pregabalin | Prescription requirements apply. Safe custody required for some drugs. No CD register entry needed. | Misuse of Drugs Regulations 2001, Reg. 8 |
| Schedule 4 (Part I) | Diazepam, lorazepam, clonazepam | Prescription required but exempt from most CD controls. No storage or register requirements. | Misuse of Drugs Regulations 2001, Reg. 9 |
| Schedule 4 (Part II) | Anabolic steroids, growth hormones | Can be possessed without a prescription but cannot be supplied without one. | Misuse of Drugs Regulations 2001, Reg. 10 |
| Schedule 5 | Low-strength codeine (e.g., co-codamol 8/500), pholcodine | Available over the counter. Exempt from CD prescription requirements. | Misuse of Drugs Regulations 2001, Reg. 11 |
Legal Requirements by Schedule
| Requirement | Schedule 1 | Schedule 2 | Schedule 3 | Schedule 4 | Schedule 5 | Legal Reference |
|---|---|---|---|---|---|---|
| Prescription Required | No recognized medical use | Yes | Yes | Yes (Part I) | No | Misuse of Drugs Regulations 2001, Reg. 15 |
| Safe Custody Required | Not applicable | Yes | Some drugs | No | No | Misuse of Drugs (Safe Custody) Regulations 1973 |
| CD Register Entry | Not applicable | Yes | No | No | No | Misuse of Drugs Regulations 2001, Reg. 19 |
| Prescription Validity | Not applicable | 28 days | 28 days | 28 days | No expiry limit | Misuse of Drugs Regulations 2001, Reg. 15 |
| Emergency Supply Allowed? | No | No | No | Yes (Part I) | Yes | Human Medicines Regulations 2012, Reg. 225 |
| Repeatable Prescriptions? | No | No | No | Yes (Part I) | Yes | Misuse of Drugs Regulations 2001, Reg. 16 |
| Destruction Witness Required? | Not applicable | Yes | No | No | No | Misuse of Drugs Regulations 2001, Reg. 27 |
Key Points for Pharmacists
- Schedule 1 CDs require a Home Office license and cannot be prescribed unless designated as a cannabis-based medicinal product (CBPM) (Misuse of Drugs Act 1971, Section 7).
- Schedule 2 CDs have the strictest controls, requiring prescription validation, safe storage, and CD register entries (Misuse of Drugs Regulations 2001, Reg. 7).
- Schedule 3 CDs still require prescriptions but do not need to be recorded in the CD register (Misuse of Drugs Regulations 2001, Reg. 8).
- Schedule 4 (Part I) drugs, such as benzodiazepines, have prescription validity restrictions but are exempt from CD register requirements (Misuse of Drugs Regulations 2001, Reg. 9).
- Schedule 5 drugs, like low-dose codeine, are widely available without a prescription but still need responsible supply controls (Misuse of Drugs Regulations 2001, Reg. 11).
This guidance provides an overview of the classification system for Controlled Drugs. Pharmacists must be aware of the specific legal requirements for each schedule to ensure compliance with the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.