Legal regulations

Slide 2
Gesetzliche Bestimmungen

Legal regulations

New Pharmacy Operating Regulations came into force in 2012. The legislator made far-reaching changes, especially with regard to the individual production of pharmaceutical preparations (custom formulation). The main objective was to transfer the high quality standards that apply in the industry to the production of custom formulations in the pharmacy. This amendment was essential because the production of medicines is a fundamental right of the profession of pharmacist and pharmacists may have to " fill in" for industry in times of crisis.

As a result of the amendment to the law, quality standards in the areas of

  • Hygiene,
  • Analytics and
  • Documentation

were raised, which led to considerable additional costs for pharmacies. The following criteria must be complied with for the production of custom formulations, especially in the area of documentation:

  1. A prescription must be presented for each custom formulation.
  2. The custom formulation must be checked for plausibility.
  3. Production instructions and protocols must be established.
  4. Approval must be given by a pharmacist.
  5. In the case of bulk formulations (= production of up to 100 units per day), the end product must also be tested and the prescriptions must be archived.

Burg-Apotheke LAB is ideally equipped for this. We have optimised processes in the fields of analysis as well as logistics in such a way that we are able to deliver any custom formulations that need to be produced in a timely manner throughout Europe. Because treatment cannot wait. Nevertheless, to be on the safe side, always ask about delivery times when placing your order.

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