Beyond use dating for compounded pharmaceuticals
These direct testing studies use stability indicating methods (SIM) to ensure therapeutic effectiveness of compounded drug products.
A SIM is a reliable, meaningful, and specific analytical procedure that accurately and precisely measures active pharmaceutical ingredients (API) by separating the API from its degradation products and excipients.
, the long-standing concept of drug stability (beyond-use dates and expiration dates) came to the forefront of pharmacy compounding practice.
Beyond-use date extension can only be done if end-point sterility testing is done on compounded sterile preparations.
This article discusses the unique skill set required by pharmacists to accomplish and maintain these processes.
A SIM must be validated for the exact formulation being tested.
High performance liquid chromatograph (HPLC) is one of the most commonly used techniques for examining the chemical stability of compounded product, but not all HPLC tests are stability indicating.
Beyond use dates should be in accordance with the manufacturer's approved labeling.
This means that the product was formulated according to the manufacturer's directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date.