Cetraxal® preparations – change to special container status from sub-pack to complete pack

Following representations from Community Pharmacy England, the Department of Health and Social Care (DHSC) has re-determined that the following products will be granted special container status as complete pack sizes from April 2025:

• Cetraxal® 2mg/ml ear drops 0.25ml unit dose (Aspire Pharma Ltd)
• Cetraxal® Plus 3mg/ml + 0.25mg/ml ear drops 0.25ml unit dose (Aspire Pharma Ltd)

Each pack contains 15-unit doses packaged in a single foil pouch but currently the product is classed as a special container in sub-packs of 5-unit doses. From April 2025, the complete pack sizes (15-unit doses) of both Cetraxal® preparations will be classed as special containers and this change will be reflected in the Drug Tariff.

This change to special container status is in accordance with the Original Pack Dispensing (OPD) exceptions in the Human Medicines Regulations (HMR) and the special container criteria outlined in Part II Clause 10B of the Drug Tariff.

For a list of all the monthly changes to the special container status of products please see the following page Notice of changes to special container status of products. More information on dispensing special containers can be found on our webpage Special containers and products requiring reconstitution.

A product is granted special container status if it meets the HMR OPD exceptions and the special container criteria as set out in the Drug Tariff. Once granted, the special container indicator for the relevant pack size (complete pack or sub-pack) is applied to the respective product entries in the dm+d and in the Drug Tariff, where listed.

If you identify any particular product(s) which are not currently classed as special containers but you believe satisfy the requirements (as outlined in HMR OPD exceptions and in Part II Clause 10B of the Drug Tariff), please notify Community Pharmacy England’s Dispensing and Supply Team (0203 1220 810 or ds.team@cpe.org.uk). The Dispensing and Supply Team will investigate and assess if it meets the relevant criteria. Where appropriate, Community Pharmacy England will make an application to the DHSC and the NHSBSA to review of the special container status of the requested product(s).