Guidance on Paracetamol and Aspirin on General Sale

The Prescription only Medicines (Human Use) Amendment Order 1997

The Medicines(Sale or Supply)(Miscellaneous Provisions) Amendment (No 2) Regulations 1997

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Why was the legislation introduced?

The new aspirin and paracetamol pack sizes are designed to improve the safety of over-the-counter painkillers following concern about the number of deaths connected with overdosing. The government took these measures following evidence that many patients, who intentionally overdose, use products that are readily available in the home. It was thought that a reduction of the pack size would reduce the left over quantities in the home.

What are the main legal requirements?

This legislation came into force on 16 September 1998. It limits the maximum pack size of solid doses of paracetamol and aspirin for general sale to 16 tablets or capsules. It also limits the maximum pack size of solid doses of paracetamol and aspirin to 32 tablets or capsules in pharmacies. The sale or supply of more than 100 aspirin or paracetamol tablets or capsules at one time requires a doctor's prescription.

Can more than one pack be sold?

The sale of more than one pack is not illegal, but where it resulted in an overdose the adverse publicity would of course be serious for the vendor. These measures will not stop anyone from going from shop to shop to buy as many packets as they wish. However, since the purpose of these changes is to reduce the quantities of these products stored in the home, it would be sensible to limit general sale of paracetamol or aspirin to one pack at a time. Some retailers have introduced a Code of Practice or have programmed their tills to prevent multiple sales.

What happend if I don't comply with the legislation?

The maximum pack size of tablets and capsules containing paracetamol or aspirin or both on the general sale list, which may be sold or supplied from outlets other than registered pharmacies, is 16. A person who contravenes this legal requirement will be guilty of an offence under the Medicines Act 1968. The Medicines Act also prohibits a person from selling or supplying by retail a prescription only medicine. As such, The sale or supply of more than 100 aspirin or paracetamol tablets or capsules, without a doctor's prescription is made an offence. Prosecutions under the Medicines Act 1968 are usually tried in the Crown Court, with fines ranging from £1000 to imprisonment.

How will the legislation be enforced?

The Medicines & Healthcare Products Regulatory Agency and local food and drug authorities, such as Trading Standards Departments are under a duty to enforce breaches in relation to the maximum pack sizes of aspirin and paracetamol tablets or capsules. The sale or supply of more than 100 aspirin and paracetamol tablets or capsules would be reported to the Royal Pharmaceutical Society of Great Britain.

What further guidance is available?

For specific information and assistance, please contact:

Royal Pharmaceutical Society of Great Britain
1 Lambeth High Street
London
SE1 7JN

Tel: 020 7735 9141
Email: enquiries@rpsgb.org.uk

Medicines & Healthcare Products Regulatory Agency
Information Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 723 0000
Email: info@mca.gsi.gov.uk

Reproduced with the kind permission of Rochdale Trading Standards

 

This advice is designed to provide basic guidance to traders. It is not a complete or authoritative statement of the law. For further assistance on this or any other Trading Standards legislation, please contact your nearest office. We will be pleased to offer this information in larger print or translated into any language on request.