Recently FDA issued the first sanction and enforcement action against McKesson for a violation of the Drug Supply Chain Security Act. There are several examples outlined in FDA’s warning to McKesson, the very specific language from FDA relates to the DSCSA as the mechanism for FDA to secure the legitimate pharmaceutical supply chain specifically as it relates to Opioid controlled substances is a new interpretation of the ACT from the agency. The specific example involves several Rite Aid pharmacies describing several instances where Oxycodone was replaced with Naproxen.
Clearly, this attempt at diversion and replacement was not crafted and executed by criminal masterminds and after simple inspection trained pharmacy professionals identified and reported back to McKesson what they found. There are several examples outlined in FDA’s warning to McKesson but the very specific language from FDA relating to utilizing DSCSA as the mechanism for FDA to secure the legitimate pharmaceutical supply chain specifically as it relates to Opioid controlled substances is a new interpretation of the ACT from the agency. It is very clear that McKesson is being made an example of by the agency and their lack of proper controls, procedures, and systems should sever as a wakeup call for other wholesale drug distributors.
Additionally, after careful review of the warning letter, we have seen that there are instances where the dispensers (pharmacies) themselves could have created exposure for their organizations by not notifying the agency either through MedWatch or submitting FDA form 3911. Provisions under the DSCSA and require that dispensers who encounter a suspect of illegitimate drug product quarantine the product, begin an investigation, and submit to FDA their findings within 24 hours of discovery. The process and the timing are very explicit and the agency recommends that all healthcare providers need to be vigilant diligent in protecting patients in their care.
As you know I personally work closely with the agency to stay ahead of any and all regulatory issues and interpretations which resulted in us adding generation of FDA Form 3911 directly from the RXTransparent application in 2018. With that being said I can assure you that all of your members utilizing the RXTransparent platform will be forerunners in staying ahead of DSCA.
If you have any questions about this action from FDA or about DSCSA please feel free to reach out to me anytime.
Dwight de Vera
The link to the FDA warning letter is: