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Advice on breaking down bulk paracetamol for retail sale

The National Pharmacy Association has issued advice on how large POM packs of paracetamol and similar medicines can be broken down for retail for sale.

While pharmacies may still be able to source POM packs of paracetamol, shortages of P and GSL packs of paracetamol tablets 500mg have been reported.

The NPA has taken advice from the MHRA and its professional indemnity advisors on the repackaging the POM packs of paracetamol (pack size of 100 or more) to create smaller packs of containing a maximum of 32 tablets for over-the-counter sale to patients.

Under Regulation 4 of the Human Medicines Regulations 2012 (HMR), a pharmacist is able to break down a larger pack to prepare a single supply of a non-prescription item for retail sale.

The labelling requirements set out in Part 2 of Schedule 26 to the HMR will apply. This means the label of repackaged medicines should include:

  • The name and address of the person who sells or supplies the product
  • The date on which the product is sold or supplied
  • the name of the product or its common name
  • directions for use of the product
  • precautions relating to the use of the product.

If the product contains paracetamol specific additional labelling requirements also apply as set out in Part 4 of Schedule 25 to the HMR:

  • Except where the name of the product includes the word “paracetamol” and appears on the outer packaging, the words “Contains paracetamol” must appear on the label.
  • The words: “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor” must appear adjacent to either the directions for use or the recommended dosage.
  • Unless the product is intended for children 12 years old or younger, the words “Do not take anything else containing paracetamol while taking this medicine” and “Talk to a doctor at once if you take too much of this medicine, even if you feel well” should appear on the label.
  • If the product is intended for children twelve years old or younger, the words “Do not give anything else containing paracetamol while giving this medicine” and “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well” should appear on the label.

Patients must be supplied with the corresponding patient information leaflet (PIL) – this must be of the exact Product Licence (PL) used. This must be a printed or photocopied PIL - sending the patient an electronic link to access the PIL remotely is not acceptable, says the NPA. There are additional labelling requirements if a PIL is not supplied.

The NPA advises that pharmacies should keep an audit trail/record of broken bulk supplies with their business continuity plan. Additionally the total quantity sold to any patient must not exceed 100 tablets, and different batches of medicine must not be mixed when repackaging into smaller packs.

The decision to repackage medicines should only be considered if a pharmacy has completely run out of the ready-made ‘P’ and ‘GSL’ packs of paracetamol, and repackaging larger packs will support patient care during this public health emergency, says the NPA.

Repackaged medicines should only be used within the same pharmacy business/legal entity.

Repackaging should not be carried out in the normal course of business, or because of financial reasons only. OTC packs should be procured and supplied whenever available.

When making a decision to re-package POM packs for supply over the counter, pharmacies should consider the impact on their ability to meet prescription demand.

NPA professional indemnity insurance will indemnify members who are required to break bulk of the typical OTC painkillers and medicines - paracetamol, ibuprofen and aspirin - in circumstances where they are unable to obtain original packs of those medicines in ‘P’ and ‘GSL’ pack sizes, provided the guidance given by the NPA is followed.

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