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Clarification is sought on fluorescein issue

Confusion over the supply of fluorescein strips as a medicinal product has prompted the General Optical Council to seek further guidance.

The GOC has contacted the Medicines and Healthcare products Regulatory Agency (MHRA) to find out who should be using fluorescein under current legislation.

As a P category medicine, fluorescein is supplied to optometrists for use by them and contact lens opticians in practice in the UK.

However, last week the European Council of Optometry and Optics (ECOO) reported supply issues after Swiss authorities classified fluorescein as a medicinal product (News 22.06.12).

A spokesperson for the GOC said: 'We are in discussion with MHRA to obtain greater clarity on the implications of the classification of fluorescein in its various forms and to understand the potential impact on its use by our registrants.'

ECOO has called for fluorescein, a key tool for fitting contact lenses and assessing ocular health, to be clearly classified as a medical device only by European regulator Meddev. It has also advised practitioners to continue assessing patients using fluorescein.

The MHRA confirmed to Optician that fluorescein is classified as a medicinal product in the UK.

Bausch + Lomb, which manufactures the Fluorets brand of fluorescein strips, could not provide further comment.

Optician has scheduled an insight from Professor John Lawrenson into the legal use of medicinal products within practice, called Medicines and Medical Device Registration, for the July 27 edition.

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