How to Make Your Private Prescribing Clinic Safe and Compliant (When No One Regulates It)
Great question, and it follows straight on from the regulatory loophole: I’m an independent prescriber, I’ve opened a private clinic, and no one seems to be governing me. The GPhC says it only regulates pharmacies; the CQC says it doesn’t regulate pharmacists. So what do I actually need in place if someone comes knocking? Here’s the honest checklist.
The checklist at a glance
- Training & certification — in place, current and evidenced.
- Indemnity — properly insured, watertight for what you actually do.
- Adopt the standards — GPhC standards for pharmacies and CQC best practice.
- Governance structure — non-executive directors who hold you to account.
- Policies, audits & reflection — and above all, documentation.
This is the written companion to my short video answering exactly this. Watch it here, then read on for the detail.
The situation: no one is “governing” you
You’re an independent prescriber pharmacist. You’ve set up a private clinic. You get in touch with the GPhC and they tell you they only regulate pharmacies. You get in touch with the CQC and they tell you they don’t regulate pharmacists. So the business sits in a gap. That doesn’t mean you do nothing — it means the responsibility for governing it well falls squarely on you. The answer isn’t to relax; it’s to behave as though you’re regulated, because if anything goes wrong, you will be judged as though you were.
The checklist, in order
- Training and certificationMake sure the fundamentals are genuinely in place — the right training, the certificates, the evidence that you’re qualified to do what you’re doing. This is the floor, not the ceiling.
- Insurance and indemnityMake sure you’re properly insured and that everything is watertight for the specific activities you offer. This is not the corner to cut.
- Adopt the nearest standardsLook at the guidelines that do exist and apply them to yourself. If I were setting up an independent clinic, I’d take the GPhC standards for pharmacies and the CQC best-practice standards, and make sure both are implemented within my clinic — even though neither strictly binds a solo pharmacist clinic. When an inspection happens, or something goes wrong, the first question is always: what rules, policies and procedures were you actually following? Adopting recognised standards is your answer.
- Build a governance structureThis is the one people skip, and it’s the strongest. Don’t be the sole decision-maker. Put a structure around yourself: as the prescriber, appoint non-executive directors — a pharmacist, a doctor, a nurse, perhaps someone from outside the profession. Questions go to them, they make a decision, and you go and implement it. That independent oversight is what makes your governance defensible rather than just your own opinion.
- Policies, audits and reflectionBack the structure with written policies and procedures. If you’re prescribing, make sure audits are being done and that you’re reflecting regularly on your practice. This is what turns “I think I’m doing it right” into demonstrable quality.
- DocumentationAnd keep the paperwork. Documentation is the thread running through all of it — the evidence that the training, standards, governance, audits and reflection actually happened. Without it, doing the right thing is almost impossible to prove.
One prescriber deciding alone is a risk. The same prescriber whose decisions pass through a pharmacist, a doctor and a nurse is a governed service — and that difference is everything in an inspection.
Why this matters: the inspection test
Picture the moment something is questioned — an inspection, a complaint, a concern raised. What they’re going to ask is simple and unforgiving: what rules, policies and procedures have you actually been following? If your answer is a shrug, you’re exposed. If your answer is “here are the standards I adopted, here’s my governance structure, here are my audits, my reflections and my documentation,” you’re in a completely different position. Remember, too, the point from the loophole article: the gap is in the business, not in you — the GPhC can still raise fitness to practise. Governance is how you protect your registration.
And don’t forget trust
One last thing that sits underneath all of it: trust. Without the trust of your patients and your community, it’s difficult to run a business at all. Good governance and good documentation aren’t just defensive — done well, they’re exactly what earns and keeps that trust.
How I can help
This is precisely what our GPhC & CQC compliance work is built for — helping clinicians set a private clinic up properly, adopt the right standards, build the governance and documentation, and keep their registration safe. We’re also developing a tool to help pharmacists with compliance. If you’re setting up or already running a clinic, get in touch. (See also how to set up an online prescribing service safely.)
Frequently asked questions
If no one regulates my private clinic, what do I need in place?
Behave as though you are regulated: training and certification, watertight indemnity, adopt the GPhC standards for pharmacies and the CQC best-practice standards, add a real governance structure, written policies and procedures, regular audits, reflection and thorough documentation. That is what protects you if something goes wrong or someone comes knocking.
What standards should a private pharmacist clinic follow if it isn’t CQC-registered?
Adopt the nearest guidelines even if they don’t strictly bind you — the GPhC standards for registered pharmacies and the CQC’s best-practice standards — and implement both in your service. In an inspection the question is always “what rules, policies and procedures were you following?”, and adopting recognised standards is your answer.
What is a governance structure and why does it matter?
It’s a group that holds you to account instead of you deciding alone. As the prescriber you might appoint non-executive directors — a pharmacist, a doctor, a nurse, perhaps someone outside the profession. Questions and decisions go through them, they decide, and you implement. That independent oversight is what makes your governance defensible.
How important is documentation?
Essential. If an inspection happens or a concern is raised, documentation is the evidence that you followed recognised standards, your policies and your governance process. Keep records of training, policies, audits, reflections and clinical decisions — without them, doing the right thing is very hard to prove.
Can I set up a private prescribing clinic as an independent prescriber?
Yes — but do it properly. Even where the business falls outside formal regulation, you remain personally accountable as a pharmacist and must show robust governance, standards and documentation. Set it up as though you’ll be inspected, because the individual pharmacist is always answerable to the GPhC.
Comments
Setting up or running a private clinic — or want me to break down a governance structure or the documentation you need? Leave a comment below; I read them all.