Transfusion act

The Transfusion Act (TFG) is a legal text which has been in force in the Federal Republic of Germany since 1998 and regulates all aspects of blood donation, the collection of blood products and blood components and therapy by means of blood transfusion. The most important concern here is the protection of all parties involved against health risks from infections (e.g. HIV, hepatitis).

The Pharmacy Operating Regulations (ApBetrO) stipulate that the purchase and dispensing of blood preparations must be documented for the purpose of traceability. The name of the medicinal product, the batch number, the date of purchase and dispensing, the name and address of the prescribing physician as well as the name or company and address of the supplier, the patient's last name, first name, date of birth and address or, in the case of dispensing intended for the doctor's practice, the name and address of the prescribing physician (Section 17 (6a) ApBetrO) must be written down. These records must be kept for at least thirty years (§ 22, Subsection 4 ApBetrO).

With the German Act for Greater Safety in the Supply of Medicines (GSAV) a further reporting obligation was introduced with effect from 16.08.2019. According to this, the pharmacy must report the following information to the prescribing physician by electronic or written means: name of the drug, batch designation and quantity of the drug, date of delivery and surname, first name, date of birth and place of residence of the patient.

See below for details. Law on Transfusion.