Defect

Under Paragraph 1a(9) of the Apothekenbetriebsordnung (ApBetrO), the definition of a defect is as follows:

"Pharmaceutical product which is manufactured in advance in the course of normal pharmacy operations on one day in up to one hundred ready-to-dispense packages or in a quantity corresponding thereto.

In contrast to a prescription, which is a custom-made product, the pharmacy can therefore manufacture a defectule up to a certain quantity (the so-called "100-pack rule") in advance. According to § 8 ApBetrO, a manufacturing instruction and, in addition, a test instruction must be written before the manufacture of a defect. During the manufacturing process, the procedure is then documented in a manufacturing protocol and a test report is prepared.

According to § 21 paragraph 2 of the German Drug Law (AMG), there is an exception from the obligation to obtain a marketing authorization for defected drugs: