The third section of the Narcotics Law (BtMG) regulates the obligations relating to handling narcotics. In accordance with Section 15 of the Narcotics Law (BtMG), everyone involved in handling narcotics must keep the narcotics in their possession separate and secure against unauthorised access.
What this actually means for doctors and employees in practices, clinics, pharmacies and care facilities has been laid out by the German Federal Institute for Drugs and Medical Devices (BfArM) in two of its guidelines.
In the guidelines on measures for storing narcotics supplies as a licensed owner according to Section 3 of the German Narcotics Act, the BfArM stipulates the following when it comes to storing narcotics in cupboards:
Certified strongboxes with a resistance grade of I or higher are to be used according to EN 1143-1. Strongboxes with a dead weight of below 1000 kg much be anchored in place according to EN 1143-1. In the event that storage in a strongroom is provided rather than a safe, then certified strongroom doors with a resistance grade of III or higher according to EN 1143-1 must be used to secure the room.
The guidelines on measures for storing narcotics supplies as a licensed owner according to Section 3 of the German Narcotics Act can be downloaded here:
According to the guidelines of the German Federal Institute for Drugs and Medical Devices (BfArM), when it comes to hospital pharmacies and public pharmacies, the same requirements for storing narcotics apply as for licensed owners: Safes must have a minimum resistance grade of I according to EN 1143-1 and be anchored in place in the case of those with a dead weight of below 1000 kg. If the narcotics are stored in a room, then the room door must have a minimum resistance grade of III according to EN 1143-1.
In the case of hospital subunits (such as individual wards), doctor’s practices, and retirement and care homes, narcotics safes must have a minimum resistance grade of N (0) or higher according to EN 1143-1, and anchoring the safe in place is mandatory for those weighing under 200 kg. Only the storage of smaller quantities of narcotics, such as those for the daily requirements of a subunit, may be exempt from these requirements. In such cases, a locked container shall be considered sufficient.
The guidelines on measures for storing narcotics supplies in hospitals, public pharmacies, doctor’s surgeries, SAPV bodies, and retirement/care homes can be downloaded here:
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