
Standard Operating Procedures in Community Pharmacies
Every registered pharmacy in Great Britain must have written pharmacy procedures. Most pharmacies call them standard operating procedures, or SOPs, and they are the first thing a General Pharmaceutical Council inspector asks to see.
The procedures decide who can do which task, what happens when the Responsible Pharmacist steps out, and how controlled drugs are handled. Out-of-date or unsigned SOPs are one of the most common findings at inspection.
Supervision law is also changing. The remaining provisions of the pharmacy supervision reforms take effect on 10 December 2026, and most pharmacies will need to rewrite several SOPs before then.
Pharmacy SOPs at a Glance
| Area | Source of the requirement | Typical SOPs |
|---|---|---|
| Medicines handling | Responsible Pharmacist Regulations 2008, reg 4 | Ordering, storage, dispensing, sale, delivery, disposal |
| Staff competence | Reg 4 and GPhC standards | Roles, competencies, advice by non-pharmacists |
| Responsible Pharmacist | Reg 4 | RP absence, change of RP, the RP record |
| Controlled drugs | Misuse of Drugs Regulations 2001; CD Regulations 2013 | CD register, storage, destruction, discrepancies |
| Incidents and complaints | Reg 4 and GPhC standards | Error reporting, near misses, complaints |
| Supervision changes | SI 2025/1249, in full from 10 December 2026 | Delegation to pharmacy technicians |
What the Law Requires
Regulation 4 of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 requires every pharmacy to have procedures covering how medicines are ordered, stored, prepared, sold or supplied, delivered outside the pharmacy and disposed of.
The same regulation requires procedures for when non-pharmacists may give advice, how competent staff are identified, record-keeping, the Responsible Pharmacist's absence, a change of Responsible Pharmacist, complaints, incidents, and how staff are told about changes.
The procedures can be on paper, electronic or both, must be available at the premises for staff to see, and "must be reviewed regularly". The Responsible Pharmacist is responsible for making sure they are in place and followed during their time in charge.
How the GPhC Inspects SOPs
The GPhC's standards for registered pharmacies expect services to be managed and delivered safely, by staff who are competent for their roles. Inspectors check that SOPs exist, but also that they match what actually happens at the counter and in the dispensary.
Common findings include SOPs past their review date, SOPs not signed by staff who carry out the task, and procedures that describe a process the pharmacy no longer uses. Each of these suggests the SOPs are a file on a shelf rather than a working system.
The Core SOP Set
Dispensing
Dispensing SOPs cover the whole route of a prescription: receipt, clinical check, labelling, assembly, accuracy check and hand-out. They should name which roles can do each step and what must be checked at each stage.
Include how electronic prescriptions are downloaded and how owings, part-supplies and repeat dispensing are handled. Errors cluster at these hand-offs.
Sales of Medicines
Pharmacy medicine sales need a protocol for counter staff, usually built around a set of questions to ask before supply. Include high-risk products such as codeine-containing painkillers, and when to refer to the pharmacist.
Responsible Pharmacist
Set out how the Responsible Pharmacist signs in and out, how the record is kept, what can and cannot happen during their absence, and what the incoming pharmacist checks at a change-over. These SOPs change most under the new supervision law.
Controlled Drugs
Controlled drugs need their own SOPs: ordering, safe custody, the CD register, running balance checks, destruction with an authorised witness, and handling patient returns.
Where a pharmacy provides NHS services, regulation 11 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013 requires commissioners to make sure providers have up-to-date SOPs for the management and use of controlled drugs.
Delivery Services
Home delivery needs a procedure for packing, delivery, confirming the right patient, and what the driver does if nobody is home. Controlled drugs and fridge lines need extra steps.
Cold Chain
Fridge temperatures must be recorded daily, with a procedure for an out-of-range reading. Vaccines and insulin are the usual products at risk.
Incidents, Near Misses and Complaints
Every pharmacy needs a way to record dispensing errors and near misses, review them, and learn from patterns. The complaints procedure should set out response times and how to escalate.
The Supervision Changes
The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 is being brought in two stages. Since 7 January 2026, a pharmacist can authorise the team to hand out checked and bagged prescriptions when the pharmacist is absent.
The commencement order brings the remaining provisions into force on 10 December 2026. They allow pharmacists to authorise pharmacy technicians to undertake or supervise the preparation, assembly, dispensing, sale and supply of medicines.
The change does not remove the need for a Responsible Pharmacist at each pharmacy. It does mean every new delegation needs a written procedure: who can be authorised, for which tasks, how the authorisation is recorded, and how it is withdrawn.
New GPhC Rules and Standards
The GPhC consulted until March 2026 on new standards for Responsible and Superintendent Pharmacists and on new rules for Responsible Pharmacists, which will eventually replace the 2008 Regulations. Until the final rules are published and in force, the 2008 Regulations still apply.
Plan to review your Responsible Pharmacist and supervision SOPs twice: once for 10 December 2026, and again when the final GPhC rules take effect.
Writing SOPs Staff Will Use
An SOP works when it is short, specific and written for the person doing the task. Numbered steps, plain language and a clear note of who is responsible beat long narrative documents.
Each SOP should show its version, owner, review date and the staff who have read and signed it. Our guide to what an SOP is and what a good one contains covers the general structure.
Review every SOP at least every two years, and straight away after an incident, a change in law or a change in how the pharmacy works. Keep previous versions, because an investigation may need to see the procedure in force on a given date.
Who Signs Off the SOPs
The Superintendent Pharmacist usually approves SOPs for a multiple, and the pharmacy owner and Responsible Pharmacist for an independent. Whatever the structure, the sign-off route and the person accountable for each SOP should be written down.
Locum pharmacists need to be able to find and follow the SOPs on their first shift. A short locum pack with the key procedures and the local quirks saves time and reduces errors.
SOPs for Clinical Services
Clinical services such as vaccinations, minor illness consultations and blood pressure checks each come with a service specification from the commissioner. Each service still needs a local SOP showing how your pharmacy delivers it.
The SOP should cover who can provide the service, the training and competence they need, consent, the consultation record, referral routes and how equipment is checked. Where a service runs under a patient group direction, each pharmacist using it must have read and signed the PGD.
Training Staff on SOPs
Reading a document is not the same as being competent. Each SOP should be part of induction for the roles it covers, with a short check that the person can actually do the task.
Record who has read and signed each SOP and when. When an SOP changes, the procedure for notifying staff, which regulation 4 requires, should trigger a fresh sign-off.
Agency staff, Saturday staff and delivery drivers are easy to miss. They need the SOPs for their tasks before they start, not after an incident.
Preparing for an Inspection
- Check every SOP has an owner, a version number and a review date that has not passed.
- Check the signature sheets match the people who actually do each task.
- Walk through one prescription and one counter sale against the SOPs, and fix any gap.
- Check the Responsible Pharmacist record and the controlled drug register are complete.
- Pull the last three months of near misses and show what changed as a result.
An inspector who sees SOPs that match practice, and evidence of learning from errors, is far more likely to rate the pharmacy as meeting or exceeding the standards.
Common Gaps We Find
- SOPs past their review date, or with no review date at all.
- Staff carrying out tasks without having signed the relevant SOP.
- No procedure for the Responsible Pharmacist's absence, or one that does not match practice.
- Controlled drug destruction not described, or no record of the authorised witness.
- Near misses recorded but never reviewed.
- No plan for the 10 December 2026 supervision changes.
Pharmacy SOP Writers
We write and review SOPs for independent community pharmacies and small groups, built around your premises, your services and your team. They form part of our policies for pharmacies service, priced from £65 per document.
If your SOPs need updating for the supervision changes, our policy review service will check them against the 2008 Regulations, the new supervision law and current practice. Get a quote to start.
Frequently Asked Questions
Are SOPs a legal requirement for pharmacies?
Yes. Regulation 4 of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 requires every registered pharmacy to have written or electronic pharmacy procedures covering set matters, available at the premises and reviewed regularly.
Which SOPs does a community pharmacy need?
At minimum: ordering and storage, dispensing, sales of medicines, delivery, disposal, controlled drugs, Responsible Pharmacist absence and change-over, staff competence, record-keeping, incidents and complaints.
How often should pharmacy SOPs be reviewed?
The law says regularly. Most pharmacies review each SOP at least every two years, and straight away after an incident, a change in practice or a change in the law, such as the supervision changes in December 2026.
What changes on 10 December 2026?
The remaining provisions of the 2025 supervision Order come into force, allowing pharmacists to authorise pharmacy technicians to undertake or supervise the preparation, assembly, dispensing, sale and supply of medicines. Pharmacies will need SOPs covering how those authorisations work.
Do locum pharmacists need to follow the pharmacy's SOPs?
Yes. The Responsible Pharmacist on duty, whether employed or locum, must make sure the pharmacy's procedures are followed while they are in charge, so locums need easy access to them from their first shift.