DIVERGENCES IN REGULATORY REQUIREMENTS FOR COMPOUNDED FORMULATION AND INDUSTRIALIZED MEDICINES

Abstract

Compounding medication are important in the supply of drugs not commercially available to patients with special needs. However, quality control requirements diff er from those applied to industrialized medicines. This study aimed to elucidate diff erences between Anvisa RDC nº 67/2007, which regulates the compounding medicines, and RDC nº 310/2019, which regulates the production of industrialized medicines. The main diff erences related to quality control were highlighted. Whereas for the compounding preparations only quarterly content and uniformity analyzes are required, processed products are only released for commercialization or distribution after satisfactory quality has been proven for all the batches produced, and it is mandatory to carry out full testing with validated methods. As a consequence of lower regulatory requirements, several reports are found in the literature about quality deviations of drug compounding. Among the most common are drugs with asset swaps, fraud by adding undeclared substances, dosage errors leading to poisoning and death. Solutions to these problems include updating RDC No. 67, with pertinent adjustments for stricter quality control, constant sanitary inspection of establishments and market monitoring.