Your guide to Pharmacy Law and Ethics
Explore the legal requirements for sourcing and supplying medicines, including wholesale dealer licences and supply chain regulations.
Labelling is a fundamental legal requirement when supplying medicines in the UK. It ensures that medicines are identifiable, used correctly, and linked to the correct patient.
This article explains:
The legal requirements for labelling dispensed medicines are set out in the Human Medicines Regulations 2012, particularly:
The donation of medicines, particularly internationally, is subject to strict legal and regulatory controls in the UK. While often well-intentioned, inappropriate donation can breach medicines legislation and create risks for both the donor and recipient.
Pharmacists and pharmacy owners must ensure that any donation complies with UK medicines law, wholesale distribution requirements, and recognised international guidance.
Under the Human Medicines Regulations 2012, supplying a medicine to another organisation for onward supply is considered wholesale dealing.
UK law includes statutory powers and controls designed to minimise and manage medicines shortages, including restrictions on:
These controls apply to manufacturers, wholesalers, pharmacies, dispensing doctors and NHS bodies and operate alongside professional and contractual obligations.
Medicines shortages are addressed through a combination of:
When a prescription only medicine (POM) is supplied from a registered pharmacy otherwise than in accordance with a prescription (for example, to healthcare professionals or organisations), the Human Medicines Regulations 2012 impose specific record-keeping requirements.
These requirements differ depending on:
Under regulation 253 of the Human Medicines Regulations 2012, where a POM is sold or supplied otherwise than in accordance with a prescription, the supply must be recorded unless a specific exemption applies.
The wholesale supply of controlled drugs (CDs) in the UK is subject to both medicines legislation and controlled drugs legislation.
Any organisation wholesaling controlled drugs must ensure compliance with:
These legal frameworks operate in parallel and impose separate but cumulative requirements.
The wholesale supply of medicinal products in the UK is governed by the Human Medicines Regulations 2012 (as amended):
https://www.legislation.gov.uk/uksi/2012/1916
Wholesale supply of medicines is restricted by law. A wholesale dealer may only supply medicinal products to persons or organisations who are legally entitled or authorised to receive them.
The principal statutory list of persons and organisations who may receive medicinal products by wholesale is set out in Schedule 22 to the Human Medicines Regulations 2012.
The wholesale supply of human medicinal products in the UK is governed primarily by the Human Medicines Regulations 2012 (as amended):
https://www.legislation.gov.uk/uksi/2012/1916
Under regulation 18 of the Human Medicines Regulations 2012, a person may not engage in the wholesale distribution of medicinal products unless they hold a wholesale dealer’s authorisation (WDA).
Wholesale distribution includes supplying medicinal products otherwise than to the public, where the supply is made by way of a business.
The wholesale supply of veterinary medicinal products in the UK is governed by the Veterinary Medicines Regulations 2013 (as amended):
https://www.legislation.gov.uk/uksi/2013/2033
Regulation 8 of the Veterinary Medicines Regulations 2013 restricts wholesale supply of veterinary medicinal products.