GPhC seeks views on draft guidance on preparing unlicensed medicines


New draft guidance proposes the steps pharmacy owners and superintendent pharmacists should take to make sure that unlicensed medicines prepared in the pharmacy are of the appropriate level of quality and safety, in order to protect patients.


The General Pharmaceutical Council (GPhC) has developed the draft guidance to advise pharmacy owners and superintendent pharmacists how they can demonstrate that they are achieving the relevant standards and safeguarding patients and the public when unlicensed medicines are prepared.


The guidance once finalised and published should be followed in any registered pharmacy where unlicensed medicines are prepared by or under the supervision of a pharmacist.


The pharmacy owner or superintendent pharmacist will be responsible for ensuring the guidance is followed. The draft guidance proposes a number of areas they will need to consider if their pharmacy will be preparing unlicensed medicines, including:


  • Risk assessment: A risk assessment would need to be undertaken to ensure safe outcomes for patients
  • Record keeping and accountability: Detailed records of the preparation of the medicine must be kept to safeguard patients
  • Staff training: All staff must have the appropriate training to undertake their duties in preparing unlicensed medicines
  • Patient information: Pharmacy staff must communicate with patients to make sure they have all of the information they require about the unlicensed medicine
  • Equipment and facilities: Pharmacies must have the appropriate equipment and facilities available to produce a high quality, safe product.

The guidance covers all unlicensed medicines that would be prepared in a pharmacy, including the extemporaneous preparation of methadone for supply in accordance with a prescription.

The guidance has been published in draft form to give everyone with an interest in the preparation of unlicensed medicines the opportunity to give comments. Feedback can be submitted to the GPhC until 14 March 2014 and will inform the final version of the guidance. 


Duncan Rudkin, Chief Executive of the General Pharmaceutical Council, said:

“Patients have the right to expect that when an unlicensed medicine is prepared in a pharmacy, it is of an equivalent quality to a licensed medicine. This new guidance will help pharmacies to make sure they are achieving the necessary standards and that every unlicensed medicine they prepare is safe and appropriate for their patient.”

“We welcome all feedback about our proposals so the final guidance is as useful as possible for pharmacies wanting to prepare unlicensed medicines.”

The draft guidance is available to read Draft guidance for registered pharmacies preparing unlicensed medicines Jan 2014 [PDF 866.73 KB]


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