Storage of Pharmacy-only Medicines in a Retail Pharmacy Business

Regulatory notice 01/2017   Issued: 23 October 2017
Circulation list: All registered pharmacists and pharmacy owners  
Responsibility for action: Superintendent pharmacist   


The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) has been amended by S.I. No. 80 of 2016 and Regulation 5(1)(ea) has been inserted. Under this regulation the pharmacy owner and the superintendent pharmacist shall, inter alia, ensure that pharmacy-only medicines “are stored in a part of the premises to which the public does not have access”.

Professional role in supply of pharmacy-only medicines

Pharmacists, through their interaction with patients, play an important role in ensuring that medicines are used rationally, responsibly and safely in our society, as well as referring patients to other healthcare professionals where necessary. Pharmacists have a professional role and statutory duty to carry out, or personally supervise, the sale and supply of all non-prescription medicines from the pharmacy to ensure that the patient/purchaser is made aware of the safe and appropriate use of the product and that it is not intended for misuse or abuse. It is essential when supplying medicines that relevant information and advice is provided to establish the medical needs of the patient and to support them and ensure the appropriate selection and use of these medicines.

Medicines are categorised in national law into three categories; namely, medicines requiring a medical prescription, pharmacy-only medicines and general sale medicines (which may also be sold from non-pharmacy outlets). Pharmacy-only medicines are a category of medicines which are only available to the public under the personal supervision and guidance of a pharmacist.

Storage of pharmacy-only medicines

As per the amended legislation (S.I. 80/2016), pharmacy–only medicines must be stored in an area of the pharmacy to which the public does not have access. The PSI is aware that there are a number of ways in which pharmacies can comply with the requirements of the legislation including:

  • Storage of pharmacy-only medicines behind the medicines counter/OTC counter
  • Any other arrangements within the premises that ensures that the public does not have direct or physical access to pharmacy-only medicines

If a member of the public is able to self select (i.e. physically access / pick up) a pharmacy-only medicine from a publicly accessible part of the pharmacy, then it is the view of the PSI that the medicine is not stored in a part of the premises to which the public does not have access.

Please note that:

  • pharmacy-only medicines do not need to be stored in the dispensary
  • medicinal products on the general sales list are not affected by this legislation


Many pharmacies already store pharmacy-only medicines in the manner described above. However, if any pharmacy has pharmacy-only medicines stored in an area of the pharmacy that is accessible to the public, it is the responsibility of the pharmacy owners and superintendent pharmacists to review their storage arrangements, to ensure that compliance with these legislative provisions is achieved. There are various ways in which pharmacies can comply with these legislative provisions and it is open to each pharmacy to adopt an approach which is appropriate to their pharmacy and ensures compliance with the legislation.

As of 1 April 2018, the PSI will expect that all pharmacies will demonstrate full compliance with this legislation.

Failure to comply with this regulation constitutes an offence under section 18(3) of the Pharmacy Act 2007.

The PSI will shortly update the “PSI Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business” to reflect the amended legislation and above information.

You can read the amended legislation here.

Information about this amendment was previously communicated to pharmacists in the PSI newsletter in March 2014 and April 2016.