Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). The protection of the pharmaceutical supply chain is one of the FDA’s highest priorities, and chain of custody is one of the FDA’s primary tools in this mission. Chain of custody, when correctly executed, allows determination of “who, what, and when” with a high level of confidence. For advanced therapies—those derived or generated through biotechnology—chain of custody not only includes verification of “who, what, and when,” but also “at what temperature.”
Manufacturers of advanced large-molecule therapies have determined that the efficacy of a drug can deteriorate with increasing exposure to time out of temperature, and this data is often included in regulatory filings. For this reason, chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.