The Royal Pharmaceutical Society has published guidance to pharmacists on their responsibilities in relation to unlicensed medicines or ‘Specials’.

To take all reasonable steps to ensure that:

  • Patients receive medication that is safe, effective, appropriate for their condition and their circumstances, with minimal clinical risk;

  • An unlicensed medicine is supplied only when there is no available licensed medicine which fully meets the patient’s clinical needs;

  • The appropriateness of continued prescription of an unlicensed medicine is reviewed and that continued supply is justified by continued special clinical need;

  • Any unlicensed medicine supplied is fit for purpose – is of the appropriate quality and clinically appropriate for the individual patient;

  • They understand their professional responsibilities when supplying unlicensed medicines i.e. ensure the patient receives a medicine of assured quality;

  • They minimise risk to patients and themselves: the expectation is that pharmacists will supply an unlicensed product only by exception and with the full knowledge of the prescriber and the patient.

A pharmacist shares with the prescriber, accountability for supplying an unlicensed medicine to a patient. They must be able to demonstrate that they have acted with due diligence in regards to patient safety, and that they have taken all reasonable steps to ensure:

  • Procurement from an appropriate source;

  • That the product is of appropriate quality;

  • That the product meets the particular clinical needs of the patient: this may require dialogue with the manufacturer, and if relevant the hospital pharmacy, about all criteria such as formulation and strength.

Meeting all of these responsibilities is made very much easier if the unlicensed medicine (Special) is procured from an ethical, compliant and reputable manufacturer such as IPS Pharma.


It is recommended for pharmacists to keep the following records for a minimum of 5 years:

  • A record of the purchase and supply of an unlicensed medicine;

  • The specification of the unlicensed medicine agreed with the supplier. This should be documented and kept on file in the pharmacy;

  • Verification of the specification of the unlicensed medicine, such as a certificate of analysis or a certificate of conformity from the manufacturer. This should be obtained on delivery and must include the batch number and expiry details of the product kept on file in the pharmacy;

  • Patient details, such as name and address linked to the unlicensed medicine should also be maintained to provide an adequate audit trail;

  • The source of the product i.e. manufacturer details;

  • The quantity of each sale or supply;

  • The batch number and expiry date of the product. This will be listed on certificate of analysis or a certificate of conformity;

  • If the product is in response to a prescription, the records must also include the patient’s details, prescription details and the date of dispensing;

  • The date the product was supplied – as this may differ from the date of manufacture.

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Unlicensed Medicines (Specials)

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