Appendix 4: Manufacture that would require a manufacturing licensed pharmacy under Option C2 Medicine type Examples Dosage forms required to comply with a sterility terminally sterilised medicines standard aseptic compounding total parenteral nutrition Radiopharmaceuticals Dosage forms required to comply with Uniformity of micro dose products Dosage Units standard using Content Uniformity Medicines where segregation of activities is required penicillins cytotoxics hormones Medicines where special facilities/equipment are special lighting arrangements needed to maintain efficacy of the product nitrogen blanketing Medicines that may not be interchangeable when sustained release medicine made by different pharmacies / manufacturers modified release medicine liposomal products medicines with low therapeutic index Appendix 5: Manufacture that would require a manufacturing licensed pharmacy under Option C3 Manufacturing activity above the following limits
Appendix 4: Manufacture that would require a manufacturing licensed pharmacy under Option C2 Medicine type Examples Dosage forms required to comply with a sterility standard terminally sterilised medicines aseptic compounding total parenteral nutrition Radiopharmaceuticals Dosage forms required to comply with Uniformity of Dosage Units standard using Content Uniformity micro dose products Medicines where segregation of activities is required penicillins cytotoxics hormones Medicines where special facilities/equipment are needed to maintain efficacy of the product special lighting arrangements nitrogen blanketing Medicines that may not be interchangeable when made by different pharmacies / manufacturers sustained release medicine modified release medicine liposomal products medicines with low therapeutic index Appendix 5: Manufacture that would require a manufacturing licensed pharmacy under Option C3 Manufacturing activity above the following limits