Quality Control of Formulated Medicines

A pharmaceutical drug is technically obtained or prepared for prophylactic, curative, pallia‐ tive or diagnostic purposes. The final product must meet quality standard, be safe and effec‐ tive. In Brazil, there is a high demand for formulated drugs. This is mainly due to their lower price compared to manufactured drugs, evidenced by the rapid growth – an increase of 350% from 1998 to 2010. Even after the ANVISA’s (Agency National Health Surveillance) establishment of the new handling standards to be followed by the magistral pharmacies, several serious cases, in‐ cluding death reports, caused by the consumption of formulated drugs have recently be‐ come public [1-5]. Other problems related to this subject occurred in 2004, when deaths caused by manipulated medicines of low therapeutic index (clonidine and levotiroxine) led ANVISA to modify the regulation for manipulated medicines. The concentration of each compound was not totally assured and the contamination by impurities, not included in the original formula, were present in the final product. In a previous work, we have also observed the presence of impurities – such as metals in different kinds of medicines. The ingestion of metals, even at low levels, can be very harm‐ ful to humans. Besides this, the long-term uptake of some drugs is also risky. This should require attention and surveillance from the public health-related agencies [6-10]. The quality and safety of drugs must follow the specifications described in the official compendia among them, the pharmacopoeias. Medicines cannot contain impurities or