[Legal regulations to produce serum eye drops : when is it necessary, and how can it be obtained?].
According to European Union and German legislation, the production of medicines such as eye drops from autologous serum requires a license from an appropriate authority. However, an exemption is granted to medical doctors who produce and apply medications under their immediate responsibility. If doctors do not actually produce such medications themselves, they must select appropriate personnel to do so. These individuals have to be sufficiently qualified and reliable and must be carefully instructed on the standard quality and manufacturing procedures, although the doctors are responsible for controlling the production and quality of the final product. The treating physicians are also responsible for the appropriate application of the produced medications. To dispense medication to patients without an appropriate license is considered a criminal offense. We describe how two German hospitals have established the production of serum eye drops in full compliance with legal regulations.
Geerling
G
G
Universitätsaugenklinik, Julius-Maximilians-Universität, Josef-Schneider-Strasse11, 97080, Würzburg, Deutschland. g.geerling@augenklinik.uni-wuerzburg.de
Grus
F
F
Seitz
B
B
Hartwig
D
D
Schirra
F
F
D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use*; D003316:Corneal Diseases / Q000188:drug therapy; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D009883:Ophthalmic Solutions / Q000592:standards* / Q000627:therapeutic use*; D044967:Serum
D001688:Biological Products; D009883:Ophthalmic Solutions