Dale and Appelbe’s Pharmacy and Medicines Law: covering ‘essential ground in the most highly regulated areas of healthcare’

For generations of pharmacy students and pharmacists, Dale and Appelbe’s Pharmacy and Medicines Law has been the go-to guide for understanding how the law influences day-to-day practice. 

The book is published by Pharmaceutical Press, which also publishes The Pharmaceutical Journal. It was first published in 1976 as Pharmacy Law and Ethics and, in July 2025, its final print publication will mark the 13th edition of the book. All future updates will be available online, through MedicinesComplete.

To mark the occasion, The Pharmaceutical Journal spoke to Chris Langley and David Reissner, who authored the latest edition, to find out what’s changed in the 13th edition and why it remains an essential resource for anyone studying, and working in, pharmacy. 

Can you tell our readers a little bit about your professional backgrounds — how did you get involved in the book? 

CL: I am a pharmacist, but I’ve worked in academia now for 25 years. I got involved with Pharmacy and Medicines Law in its 12th edition. It’s a book with which I’m very familiar; I used it as a student and I use it in the teaching that I now undertake. I was asked to get involved when the previous pharmacist academic who was involved, Karen Pitchford, passed away.

DR: I’m the only author of the book ever in its life, I think, who isn’t a pharmacist — I’m a solicitor. I was in practice for 40 years and my clients were mostly pharmacy owners, pharmacists and pharmacy organisations. I dealt with a wide range of pharmacy law issues when I was in practice. Chris mentioned Karen Pitchford, who edited the book with Joy Wingfield. Joy had been editing the book for quarter of a century and I’d contributed a couple of chapters to the book in previous editions. Joy asked me if I would take over from her, which is how I got involved with Chris in writing the 12th edition, and now the 13th.

Can you give a brief overview of the book itself? 

DR: When I was in practice as a lawyer, there was always a copy of the book, either on my shelf or in the office library, and it was a constant reference source. Its original title was Pharmacy Law and Ethics and it was first published 1976. There has, mostly, been a new addition every four years. 

It’s really not possible to ignore the applicability of pharmacy and pharmacy law across society. Just as a couple of examples, puberty blockers have been a key issue. Online pharmacy is a key issue, and the use of medicinal cannabis. So it is a book where inevitably the scope has broadened, and pharmacy practice has broadened as well. 

From next year, every graduating pharmacist will be an independent prescriber, so there’s a lot going on that has quite a wide applicability.

Could you pull out some things that you think are particularly significant or important in this latest edition? 

DR: In the previous edition we had five new chapters, so you can see that that’s already quite a substantial change from previous editions. In its 13th edition, we have a new chapter on hospital pharmacy. A lot of the focus has been on community pharmacy, but we wanted to recognise that there are other areas of pharmacy practice with different laws that apply and we felt it was time to draw things together into a dedicated chapter on hospital pharmacy. 

We also felt, for reasons I think will largely be obvious, that it was time for a chapter on online pharmacy. Many of the legal issues and the professional conduct issues that are arising now relate to online pharmacy. Even though for a lot of things you might think the law for an online pharmacy ought to be the same as a community pharmacy that you walk into, the differences in practice and the differences in the way that services are provided have widened considerably, I think, which has obviously led to a lot of regulatory problems and other fitness to practise cases. 

The chapter on veterinary medicines was always there, but the law was so radically changed in the past 12 months that the chapter’s been almost completely rewritten, and there are a lot of different focuses in the veterinary medicines regulations now. For example, a lot of focus on controlling the use of antimicrobials in veterinary practice.

CL: The other thing that’s worth mentioning is changes following Brexit. We were completing and submitting the previous edition at the end of the transition period following Brexit. We had to anticipate what the situation would be. We had some indications as to what the law would look like, but it wasn’t necessarily set in stone until after we’d submitted.  Since that’s happened, there’s been a lot of changes following further legislative amendments, which have had an impact. 

DR: The deal with the EU was done in the last few days before we delivered the text of the 12th edition. And during the lifetime of this edition, we’ve had the deal that Rishi Sunak did with the EU, the Windsor framework. That’s meant a lot of changes. We have a chapter which, among other things, deals with the licensing of medicines marketing authorisations, and there’s been a lot of change in that area.

The latest edition includes new case law on pharmacist supervision. Could you tell us about that?

DR: There have been several new cases in confidentiality and data protection, and obviously that’s a key area because patient data are protected under data protection law. We’ve also brought in some cases on the meaning of supervision.

Supervision has been a hot topic in pharmacy for almost as long as I can remember. We do know that the law is going to be changed, but one of the things that the new law won’t do is tell us what supervision means. So we’ve unearthed some cases that hadn’t previously seen the light of day, at least not in the pharmacy sphere. 

Are you prepared for the supervision legislation, or is that something you’ll have to change with the next edition?

[NB: draft legislation was published on 17 July 2025, shortly after this interview took place]

DR: We first started planning this edition back in late 2023, and there was already talk about hub and spoke and about the law on supervision. We knew that the veterinary medicines regulations would be changed, that the clinical trials regulations would be changed, that the regulations on medical devices would be changed. What we didn’t know was when those changes would actually be made. We had to make a decision about whether to go ahead with the new edition with a view to bringing it out in 2025, or whether to wait for 12 months, for example.

But we couldn’t know in 2023 whether changes in the law would in fact be brought into force by 2026 or 2027, so we decided we should just get on with it. There were already a lot of other updates to be made and we wanted to future-proof the book. 

So what we have done, particularly in relation to hub and spoke law and supervision, is: state the law as it was at the time of going to print, but told readers that there were proposals to change the law. The proposed changes are then stated in a box below the text so that people can read what the changes were going to be. We knew, exactly, in most cases what the changes were and we have also included information in that box about how readers can check whether the new law has been brought in.

In 2026, anyone joining the register will be an independent prescriber, has that fed into any changes? Is there any aspect of law that particularly relates to independent prescribing that pharmacists should be particularly aware of?

CL: There have been general updates in relation to what various different non-medical prescribers can prescribe within their own spheres of practise. So there have been changes — for example, within the chapter on controlled drugs — as to which particular non-medical prescribers can prescribe which particular controlled drugs in certain situations. 

The main difference is in the journey to registration: the standards which pharmacy degrees have to work to so that graduates from their programmes can ultimately register with the regulator include aspects around prescribing now.

But there’s not been a huge change in the law because of course, as I say, pharmacists were already able to train as prescribers.

DR: Where it does feature to some extent in the new edition is in the chapters on professional conduct and fitness to practise, because there are already fitness to practise cases where pharmacists have been, for example, prescribing beyond their competence. 

I think it’s quite possible in future editions we may be looking at liability for negligent prescribing. We already look at liability for negligent dispensing, but I think it’s possible that we’ll be looking in a future edition at cases where pharmacists have made prescribing errors, and not just dispensing errors. One would hope they’ll be the minority of cases, to illustrate the potential pitfalls for teaching purposes.

Assisted dying proposals are going through Holyrood and Westminster. Is that something this edition touches, or will that be included in the next edition? 

DR: It’s for the next edition because we would have had to have covered too many different scenarios, and it’s better to know exactly what the law is going to be. It’s touched on in chapter one of the book, which is an introduction to the law that includes the European Convention on Human Rights, so it covers briefly the right to life, and refers to the fact that assisted dying is one of the potential issues that may be affected by the European Convention.

Is there anything that you’re particularly proud of? Any chapter that you think, ‘yes, that’s really important. I’m glad we’ve got that in there for this edition’?

DR: The chapter on online pharmacy was an important thing to cover. I’m pleased we’ve got that in there and I’m think we’re happy with the way that looks. You could say the same about the chapter on hospital pharmacy: it felt important. We also had some interesting moments when writing where we found that there were aspects of the law that were stated by other people, which we felt they had got wrong.  

When you’re writing the book, you’re always double checking, triple checking, quadruple checking something that’s written to make sure that you have stated the law correctly. And then you find somewhere it says something different and you then have to go back to the source and check it out. But if we find these anomalies then we have to think about how we are going to address these incorrect statements.

CL: The other thing probably worth mentioning is that unlike the previous editions, we haven’t had contributing authors to any of the chapters. We found over the past few editions that the number of chapters that were being written by other authors was reducing as people stepped away from contributing. We felt it got to a tipping point where it made more sense for us to write the whole thing, and therefore you have a particular style and consistency throughout the chapters right from the beginning of the authoring, rather than retrospectively through an editing process. 

DR: Another thing to mention is that we have tried to avoid being too England-centric, because the book deals with the law across the whole of Great Britain. We’ve tried hard to make sure that we cover Wales and Scotland and the differences in aspects of pharmacy law in each country.

Do you have a final message to people who are interested in the book? 

CL: I hope people appreciate it. I know it’s not going to be an Amazon bestseller, but I think people who work within the field of pharmacy law and regulation appreciate it as a source that is authoritative and uniquely covers essential ground in the most highly regulated areas of healthcare. 

David Reissner is a deputy district judge and chair of the Pharmacy and Ethics Association. Chris Langley is professor of pharmacy law and practice and deputy dean of the College of Health and Life Sciences, Aston University