Guidelines for Retail Pharmacy Businesses

All retail pharmacy businesses (pharmacies) must be conducted in compliance with the Pharmacy Act 2007 and the Regulation of Retail Pharmacy Businesses Regulations 2008 (amended).

The Regulation of Retail Pharmacy Businesses Regulations 2008 (amended) sets out certain requirements to be complied with by persons carrying on a pharmacy on the sourcing, storage, sale, supply and keeping of records, in respect of medicinal products. Requirements relating to staff, premises, equipment and procedures are also stipulated. In addition, the Regulations specify responsibilities that must be discharged by the pharmacy owner, superintendent pharmacist and supervising pharmacist.

The PSI has produced the following guidelines to facilitate compliance with the requirements of the Regulations.

Please click on the relevant guidelines

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Keeping of Records in Respect of Medicinal Products
- Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business (Undergoing update to reflect 1 March 2024 legislative amendments).
Pharmacists are the healthcare professionals authorised in legislation for the safe keeping and supply of medicinal products to patients. The keeping of accurate records which clearly show when prescription-only medicines are supplied, and to whom, is a key requirement of this role. The keeping of appropriate records also supports the provision of safe and quality services to patients, allows for continuity of patient care and assists the provision of evidence-based healthcare, good professional practice and management of the medicines supply chain.

These guidelines assist in facilitating compliance in relation to the keeping of records when conducting a retail pharmacy business. The requirements for some other important records that ensure safe pharmacy practice are also detailed.
Counselling and Medicine Therapy Review
- Guidelines on Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business (Version 4, October 2019)
Prior to the dispensing and supply of a prescribed medicinal product, a pharmacist must review the prescription having regard to the pharmaceutical and therapeutic appropriateness of the medicine therapy for the patient. These guidelines are intended to assist pharmacists in fulfilling this responsibility by outlining what to consider when performing a therapeutic assessment of a prescription and counselling the patient on their prescribed medicine, in order to optimise the use of medicines and safety of patients.
Equipment
- Guidelines on the Equipment Requirements of a Retail Pharmacy Business (Version 3, April 2019)
These guidelines detail the equipment needed for the safe and effecitve dispensing of medicines, including extemporaneously prepared medicines. It also details the reference materials that must be present on site within the pharmacy and the requirements that must be met for the controlled drug safe/cabinet.
Premises
- Guidelines on the Premises Requirements of a Retail Pharmacy Business (Version, Oct 2017)
These guidelines detail the standards and requirements for the internal and external pharmacy premises, including guidance on the space and layout of the dispensary, storage areas within the pharmacy and the external appearance of the premises.
Patient Consultation Area
- Guidelines on Patient Consultation Areas in Retail Pharmacy Businesses (Version 2, Jan 2015)
These guidelines outline the requirements for a consultation area in a pharmacy and the standard expected by the PSI.
Sourcing, Storage and Disposal of Medicinal Products
The Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business, published in May 2011, have been separated into three separate documents.
Sale or Supply of Non-Prescription Medicinal Products
- Guidelines on the Sale or Supply of Non-Prescription Medicinal Products from a Retail Pharmacy Business (Version 1, November 2018)
These guidelines set out the requirements for effective patient consultations to ensure the safe and appropriate supply of non-prescription medicines. They include additional considerations when supplying a non-prescription medicine to a patient representative, or for an infant or child. The guidelines are applicable to a situation when an individual attends the pharmacy in person, or makes an online request for a non-prescription medicine through a pharmacy website.

The PSI has also produced the following information and resources for pharmacy owners, superintendent pharmacists and supervising pharmacists.

Other Useful Information and Resources

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Security Assessment Template

This Security Assessment Template has been created by the PSI, in conjunction with An Garda Síochána to aid pharmacy owners and superintendent pharmacists in assessing the security of their pharmacies.
Safe Keeping of Medicines and Associated Records during Pharmacy Cleaning and/or Merchandising

The PSI Policy on the Safe Keeping of Medicines and Associated Records during Pharmacy Cleaning and/or Merchandising sets out the circumstances and conditions that must be in place where cleaning and merchandising is undertaken when the pharmacy is closed to the public and it is impracticable for a pharmacist to be physically present.
Advertising, Promotion and Pricing Transparency of Medicinal Products
Upcoming Guidelines
The PSI will continue to issue guidelines to facilitate compliance with the requirements of legislation. This will include:
- Management and Supervision of a pharmacy (Regulation 5)
- Counseling in the supply of Medicinal Products other than on Foot of a Prescription (Regulation 10)