German pharmacy operating ordinance

What does the ordinance regulate?

The Apothekenbetriebsordnung, or ApBetrO for short, describes day-to-day pharmacy operations in detail: premises, equipment, quality management systems, preparation and testing of extemporaneous products and starting materials, stock-keeping, duty service, delivery service, and documentation. § 1a(3) lists what counts as pharmaceutical activity: development and manufacture of medicinal products, testing of starting materials or medicinal products, dispensing, information and counselling, monitoring and evaluation of medicinal product risks and medication errors, and medication management. It is therefore the legal basis for pharmaceutical care in the pharmacy.

What has changed recently?

The Pharmacy Supply Development Act was promulgated in the Federal Law Gazette on 1 July 2026 and entered into force on 2 July 2026. Among other things it amends the Pharmacy Act, the Pharmacy Operating Ordinance, and the German Medicinal Products Act, including the new § 48a AMG on continuing a therapy for chronically ill patients within narrow limits, and with extended substitution rules for pharmaceutical-technical assistants. Further amendments to the ApBetrO, including provisions on extemporaneous preparations and duty service, were initiated as a separate ordinance in 2026. The out-of-hours supplement rises from €0.20 to €0.41 as of 1 January 2027. Anyone preparing for an examination should therefore always use the current version.

Why is it central for graduates from EU countries abroad?

Those who studied in Bulgaria, Romania, Hungary, or Croatia bring the pharmaceutical foundations with them, but do not know German pharmacy law from their degree. In the knowledge examination (Kenntnisprüfung), the subject Special Legal Areas for Pharmacists is a fixed component, and the ApBetrO provides the largest part of the material. Even after automatic recognition and the grant of the pharmacy licence (Approbation), working through it is worthwhile, because operational responsibility applies from day one. Legal questions in individual cases are clarified by the relevant supervisory authority or through legal advice.

Common misconceptions

The ApBetrO governs operation, not authorisation. Anyone wishing to open a pharmacy additionally requires a licence to operate under the Pharmacy Act. Nor is it limited to the retail pharmacy: it contains separate sections with additional requirements for hospital pharmacies and pharmacies supplying hospitals.