PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
We write today to express our deep support for excluding three items from the 503B bulks list: liraglutide, semaglutide, and tirzepatide. Medicines compounded by 503Bs are not subject to the requirements of the Drug Supply Chain Security Act (DSCSA).1 This means that compounded drugs are unserialized and therefore not traceable in the U.S. drug supply through the DSCSA. The DSCSA has been critical in protecting patient safety, but if these ingredients were on the 503B bulks list, there would be significantly more untraceable medicines in the U.S. drug supply.
