Supply Disruption Alert: Danazol 100mg and 200mg capsules

Supply Disruption Alert: Danazol 100mg and 200mg capsules

May 29, 2020

Department of Health and Social Care (DHSC) has issued a medicine supply disruption alert for Danazol 100mg and 200mg capsules.

  • Danazol 100mg and 200mg capsules have been discontinued in the UK and remaining supplies of both strengths are now exhausted.
  • Danazol has several licensed indications and off-label uses. The management of patients prescribed danazol for licensed indications will differ to those prescribed danazol for an off-label use.
  • A limited quantity of unlicensed supplies of danazol 100mg and 200mg capsules have been sourced.

There is currently no listing on dm+d for the imported product for prescribers to select using their prescribing systems so an EPS prescription for unlicensed Danazol 100mg or 200mg capsules cannot be issued. Where a prescriber wishes to prescribe an unlicensed import, an FP10 paper prescription should be issued as ‘Danazol 100mg capsules (Special Order) or Danazol 200mg capsules (Special Order) ‘ and endorsed by the pharmacy as a non-Part VIIIB special with the following information:

  • Amount dispensed over pack size used;
  • Invoice price per pack size from which the order was supplied less any discount or rebate;
  • Manufacturers’/importers’ MHRA licence number;
  • Batch number of the product supplied;
  • SP

The DHSC Medicine Supply Team provide a monthly update on potential supply issues affecting both primary and secondary care. This update is uploaded on the Specialist Pharmacy Services (SPS) website. To register, you will need  an NHS email address. Once set up and logged in, you will be able to access it online.

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