To recipes helpdesk

Question

Posted on: March 6 2013

Is there anyone who knows of incompatibilities between some products and plastic bottles? And which is the correct legal regulations concerning bottles for external use?

Answer

(with the participation of Prof. Insp. Apoth. L. Hombroeckx) On the first question I do not find any data in the literature until now. ' The bottles, vials and other primary packaging containing medicinal products for external use and their eventual outer packaging shall be delivered with a special red-coloured label containing the words ' external use-usage externally ' and of a Embossed warning sign recognizable when touched. ' (This is Article 6 K.B. 31.5.1885 as last amended by K.B. 14.9.1995)

This means that the brown octagonal bottles with embossed the words "external use-usage externally" are no longer compulsory but are still permitted (optional). Only the red-coloured label Woirdt required and the warning sign in relief. But also all other primary packaging and any outer packaging must have this data.

For the label: no problem but the sign embossed?

eg. neobacitracin ointment; Hirudoid, Dakatarin have a warning sign embossed on the box but nothing on the primary packaging! Other ointments do not have any sign in relief at all; Collyria, even external use?

But I suspect the same problem in magistal preparations?