Medication fridge: everything you need to know.

It is not enough that the medicines are stored at the correct temperature, but that the refrigerators for pharmacy comply with the current regulations and certain technical requirements:

    • the Community guideline CPMP/QWP609/96;

    • Good Conservation Practice with the HACCP method (Dir. CE 852/2004 and D.L.vo 193/07).

The latter shall require that medicinal products subject to controlled temperature are stored in an environment which ensures a constant temperature throughout the storage period. The maximum temperature variation is 1°C. The drugs must be stored at a temperature between 2 and 8°C and must never be frozen.

What does the legislation provide?

The reference legislation for the storage of medicinal products is the Community guideline "CPMP/QWP609/96" and the HACCP method for pharmacy.

    • CPMP/QWP609/96. The Community guideline has been transposed in Italy with the D.Dirett. "Provisions on indications of storage conditions in printed medicinal products" (OJ U. 24.7.2001, No. 170). It has been established that the definition "ambient temperature" is not admissible, but the conservation grades must be indicated (Do not store above 30°C; Do not store above 25°C; Store between 2°C and 8°C; Do not freeze or refrigerate; Below zero - store in the freezer). The temperature may not be reported when the product has been stable at 40°C ( 2°C) and 75% ( 5%) relative humidity for more than six months.

    • HACCP (Dir. EC 852/2004 and D.L.vo 193/07). Pharmacists and health care professionals also work in compliance with EC Dir. 852/2004 and D.L.vo 193/07 for the self-control of critical points of product storage. To ensure the correct storage of the pharmics, which must have a constant controlled temperature with a maximum variation of 1°C, Refrigerators used must be able to maintain the set temperature for several hours, even in the event of a breakdown or power failure.

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