Labelling of stock preparations and extemporaneous drugs: National and international legislation and practices

Abstract

The pharmaceutical industry has provided drug production of uniform quality, safety and efficacy, and the same is necessary for the preparation of stock preparations and extemporaneous drugs. Therefore, this type of pharmaceutical activity follow relevant legislation and harmonize by applying the relevant standards. In Serbia, production and trade of stock preparations and extemporaneous drugs takes place in accordance with the Zakon o zdravstvenoj zaštiti (Sl. glas. RS 107/2005, 72/2009, 88/2010, 99/2010, and 57/2011), Zakon o lekovima i medicinskim sredstvima Republike Srbije (Sl. glas. RS 30/20120, and 107/2012) and the rulebooks adopted in accordance with these regulations. Labelling of stock preparations in Serbia is regulated by two sets of the rulebooks, but there are no regulations for the labeling of extemporaneous drugs. In the US, labeling of extemporaneous drugs is regulated through Pharmacopoeia, state/federal laws, guides to good practice in the development of extemporaneous drugs. This field is regulated similarly in the EU - through legislation, Pharmacopoeia Supplements, corresponding guidelines and Resolution CMResAP EU (2011)1. Drug labelling is essential for patient safety. Drug signature enables his identification and indicates the way of his administration by the patient. Proper labelling of extemporaneous drugs is especially important for the acceptance of the drug by the patient and can have a significant impact on its safe use and adherence.

Keywords

• extemporaneous drugs
• stock preparations
• drug labeling