Federal Department of Health plans to set higher standards for compounding pharmacies

A cabinet paper in reference to the Pharmacy Act raises the standards for pharmacies preparing parenterals.

The bill allows for the mandatory introduction of a quality management system; furthermore, the following will need to be regulated: medications to be used, measures to prevent cross contamination, requirements for cleaning the instruments and the specific area set aside for it, as well as hygiene measures.

Additionally, there will have to be an area to act as a buffer zone between a cleaning room category A and its surrounding area; the ventilation system to be used must have filters. Pharmacies will have two years to construct the buffer zone with a one-year transitional time period to obtain validation for the surrounding area.

Commentary: According to the Federal Department of Health there are about 400 dispensing pharmacies and 300 hospital pharmacies producing parenterals. Most pharmacies comply with the standards of the planned Pharmacy Act, however, as yet many – about 30 hospital pharmacies and 280 public pharmacies – do not have a QM system. Pharmacies are established players in the compounding market. However, it is uncertain how the market will develop in the next few years and whether market shares will shift between pharmacies, manufacturers like Baxter, Fresenius, B.Braun and other suppliers like GHD.

[ilink url=“http://www.apotheke-adhoc.de/nachrichten/politik/schleusen-fuer-blister-und-zyto-apotheken“]Link to source (pharmacy Adhoc)[/ilink]