The responsible pharmacist regulations were laid on 29 October 2008, under the Health Act 2006. Click here for a copy of the regulations. The regulations come into effect on 1 October 2009.
For a briefing document about the content of the regulations, please click here.
Responsible pharmacist: Then and Now To assist and support pharmacists as they adjust to the changes brought in by the Responsible Pharmacist requirements, the Society has prepared a Then and Now document to illustrate the legal and practical changes that have taken place between the 30 September 2009 (Then) and 1 October 2009 (Now). Click here to view the document.
The responsible pharmacist and the 'responsible' inspector Read below about the role of the Inspectorate and how the Inspectors will support pharmacists with the implementation of the responsible pharmacist requirements. Also find out more about how the Inspectorate will handle non-compliance and allegations of breaches of the responsible pharmacist requirements.
• The responsible pharmacist and the 'responsible' inspector
Responsible pharmacist requirements: What activities can be undertaken? The guidance has been developed in collaboration with the UK Health Departments and the Pharmaceutical Society of Northern Ireland (PSNI) and in accordance with the prevailing national or country specific legislation, and case law. To view the statement and guidance, click on the links below:
Hospital pharmacy guidance The RPSGB and PSNI have produced guidance to assist those in positions of authority within the hospital sector to identify which acitivities occurring in hospital pharmacies require registration within the RPSGB or PSNI, and/or which activities require an appropriate licence from the MHRA and which require neither.
This guidance has been developed in conjunction with the UK Departments of Health, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Guild of Healthcare Pharmacists.
Where a hospital pharmacy registers their premises with the RPSGB they will have to comply with the same responsible pharmacist requirements as their colleagues in the community sector. To view the guidance click on the link below:
• Hospital pharmacy practice in the UK and the responsible pharmacist requirements
Requirement to register premises statement This statement, issued by the RPSGB, should be read in conjunction with the guidance. To view the statement, click on the link below:
Requirement to obtain an appropriate license from the MHRA This statement, issued by the MHRA, should be read in conjunction with the guidance. To view the statement, click on the link below:
Responsible pharmacist toolkit To view a practical guide and support tool to help you understand the responsible pharmacist regulations, visit the Responsible Pharmacist Toolkit website.
Q&As For questions and answers on responsible pharmacist regulations, click here.
In December 2004 the Department of Health issued a consultation paper, Making the best use of the pharmacy workforce, which outlined proposals for changes to the personal control and supervision requirements that govern the preparation, sale and supply of medicines from registered pharmacy premises. The purpose of the consultation was to establish ways of providing a more flexible basis for the development of pharmacy services, to allow pharmacists and pharmacies to make the best use of available skills and improve the public’s access to medicines. These aims support the Government’s wider health policy of improving patient choice and experience, increasing access and convenience, improving public health, supporting long-term conditions and ensuring the more flexible use of staff.
Changes to the current legislative requirements will be achieved by a combination of amendments to primary legislation (Medicines Act and NHS legislation), order making powers and new regulations.
Amendments to the Medicines Act 1968 to replace the concept of 'personal control' with that of a 'responsible pharmacist' were announced as part of the Health Bill laid before Parliament on 27 October 2005. The Bill also contained provisions to allow regulations to be made under the Act relating to the supervision of the preparation, dispensing, sale and supply of medicines by pharmacists.
The Health Bill received Royal Assent on 19 July 2006 and became the Health Act 2006. Once brought into force, its amendments to the Medicines Act will establish the overarching requirements for the preparation, sale and supply of medicines from registered pharmacy premises. The detail of the parameters and conditions of the new requirements (parameters for the responsible pharmacist's absence from the pharmacy; restrictions on delegation of supervision) and exceptions to the requirements circumstances where a pharmacist may be responsible for more than one pharmacy) will be contained in regulations to be made under the Act.
In preparation for the work to develop regulations for the responsible pharmacist and supervision requirements, the Society's Council agreed in February 2006 that a small working group of Council members should be formed. The Health Bill Working Group used the Society's existing policy (as outlined in the response to the consultation Making the best use of the pharmacy workforce) as the starting point for its discussions and began to build on this by considering the areas where regulations are expected to be made. Council agreed the recommendations of the Working Group in October 2006 and the consolidated policy was used as the basis for the Society's discussions in both the informal and formal consultations.
For more information click on the links below:
Work began on the regulations to be made under the Act in early 2007. The Department of Health proposed to have a phased implementation, first developing regulations in respect of the responsible pharmacist, and then developing regulations for the supervision provisions.
Department of Health consultation: Responsible pharmacist A series of consultation events about the responsible pharmacist provisions were held during February and March 2007, followed by a formal three-month written consultation. The same approach will be used in due course for consulting on the other provisions of the Health Act 2006 relating to supervision requirements.
The Department of Health consultation on the responsible pharmacist regulations closed on 20 January 2008. For more information click on the link below:
For the Society's response to the consultation, click here.
For the key points of the Society's response to the consultation, consolidated into a concise document, click on the link below:
Contact:
Tel: 020 7572 2308
Fax: 020 7572 2510
e-mail: leadvice@rpsgb.org