- Latest available (Revised)
- Original (As made)
There are currently no known outstanding effects for the The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
(This note is not part of the Order)
This Order includes new defences relating to preparation errors and dispensing errors by registered pharmacists and registered pharmacy technicians, or persons supervised by them, at retail pharmacy premises. Retail pharmacy premises in the United Kingdom have to be registered by either the General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland – by virtue of provisions of Part 4 of the Medicines Act 1968. Pharmacy technicians are not statutorily registered in Northern Ireland, and so, as regards Northern Ireland, the new defences only apply to preparation errors and dispensing errors by registered pharmacists and persons supervised by them.
Articles 1 to 3 contain general provisions, including powers to make commencement orders and transitional provisions orders – and the procedural requirements relating to them.
Article 4 contains amendments to the Medicines Act 1968 creating new defences to offences of contravening sections 63 and 64 of that Act, and dealing with supplementary matters.
The offences in section 63 relate to adulteration of medicinal products for human use. If the product is not sold or supplied, in order to benefit from the new defence in section 67A, the defendant must prove three things. Firstly, the person who adulterated the product either was a registered pharmacist or registered pharmacy technician who was acting in the course of his or her profession, or was acting under the supervision of such a registrant. Secondly, the adulteration took place at a registered pharmacy. Thirdly, the defendant did not know that the product was being – or (if it was being offered or exposed for sale or supply) had been – adulterated.
If the product is actually sold or supplied, in order to benefit from the new defence in section 67B, in most cases the defendant must prove four things. Firstly, the person who adulterated the product either must have been a registered pharmacist or registered pharmacy technician who was acting in the course of his or her profession, or must have been acting under the supervision of such a registrant. Secondly, the adulteration must have taken place at a registered pharmacy. Thirdly, the product must have been sold or supplied in pursuance of a prescription or directions, or be an emergency sale or supply of a prescription only medicine in circumstances where a prescription could not be obtained without undue delay. Fourthly, if an appropriate person (such as the dispenser) becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.
The offence in section 64 relates to the sale, or supply in pursuance of a prescription, of medicinal products for human use which are not of the nature or quality demanded by the purchaser or as specified in a prescription. The elements of the new defence in section 67C which apply in most cases are similar to those in the new section 67B. Firstly, the person who dispensed the product either must have been a registered pharmacist or registered pharmacy technician who was acting in the course of his or her profession, or must have been acting under the supervision of such a registrant. Secondly, the dispensing of the product must have taken place at a registered pharmacy. Thirdly, the sale or supply must have been in pursuance of a prescription – or possibly directions, in the case of a sale – or be an emergency supply of a prescription only medicine in circumstances where a prescription could not be obtained without undue delay. Fourthly, if an appropriate person (such as the dispenser) becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.
There are also new provisions in section 67D and 67E relating to rules of evidence and interpretation in respect of the new defences, and these include a rule that a registered pharmacist or registered pharmacy technician is not to be considered as acting in the course of his or her profession for the purposes of the new defences if he or she either misuses his or her professional skills for an improper purpose or deliberately fails to have due regard for patient safety.
An impact assessment relating to this instrument has been prepared and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU. It is also available alongside this instrument on www.legislation.gov.uk.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: