| Misuse of Drugs (Safe Custody) Regulations 1973, regulation 3 | Controlled drugs not exempted by Schedule 1 are kept in a locked safe, cabinet or room built and maintained to prevent unauthorised access, unless the drug is under the direct personal supervision of the pharmacist or, on the other premises listed, the person in charge or a member of staff they designate. | The premises the regulation lists, including retail pharmacies and the nursing homes and similar establishments it names. CQC says the regulations apply to all care homes providing adult social care in England. |
| Misuse of Drugs Regulations 2001, regulations 19 and 20 | A register of every quantity of a Schedule 1 or 2 drug obtained and supplied, with a separate page for each strength and form, entries on the day or the next day, no alterations, and corrections only by a dated marginal note or footnote. | People authorised to supply Schedule 1 or 2 drugs. Regulation 19(3)(c) excludes the senior registered nurse in charge of a ward in a hospital or care home. CQC asks care homes to keep a register for Schedule 2 drugs. |
| Misuse of Drugs Regulations 2001, regulation 27 | A Schedule 1 to 4 drug is destroyed only in the presence of a person authorised by the Secretary of State or an accountable officer, and the record shows the date, the quantity and that person’s signature. | People required to keep records under the regulations. CQC says Schedule 2 stock in a care home with nursing must be destroyed in the presence of an authorised witness. |
| Controlled Drugs (Supervision of Management and Use) Regulations 2013, regulations 7 and 8 | Each designated body appoints a controlled drugs accountable officer, and NHS England appoints one for each local intelligence network area. | In England: NHS trusts, NHS foundation trusts, independent hospitals and NHS England. Care homes report to the NHS England accountable officer. |
| NICE guideline SC1, Managing medicines in care homes | A medicines policy with written processes (1.1.2), storage temperatures and monitoring in the storage process (1.12.2), MAR contents (1.14.8), a trained witness for controlled drug doses (1.14.16), the covert administration process (1.15.3) and an annual competency review (1.17.5). | Care homes, and the commissioners and practitioners who work with them, in England. |
| NICE guideline NG5, Medicines optimisation | Medicines information shared when a person moves between settings, ideally within 24 hours (1.2.2), and medicines reconciliation within 24 hours in an acute setting (1.3.1). | All care settings, in England. |
| CQC medicines information for adult social care services | Guidance on controlled drugs, storage, MARs, ‘when required’ medicines, covert administration, medicines reconciliation and reporting medicines incidents. | Adult social care providers registered with CQC in England. |
| 42 CFR 483.45, pharmacy services | A monthly drug regimen review by a licensed pharmacist, controlled drug records that allow an accurate reconciliation, PRN psychotropic orders limited to 14 days, medication error rates below 5 percent, locked storage under proper temperature controls, and separately locked, permanently affixed compartments for Schedule II drugs. | Skilled nursing facilities in Medicare and nursing facilities in Medicaid (United States). |
| 21 CFR 1301.75, 1301.76, 1304.04 and 1304.11 (DEA) | Controlled substances in a securely locked, substantially constructed cabinet, theft or significant loss notified within one business day and DEA Form 106 filed within 45 days, records kept for at least two years, and an inventory at least every two years. | DEA registrants, such as practitioners and pharmacies (United States). |