Are you ready for OIG?
Recently one of our clients received a letter from the Office of Inspector General (OIG) regarding DSCSA. The letter (detailed below) was sent to a dispenser. We have heard previously that some of these letters went to wholesalers. The letter states that the Department of Health and Human Services, Office of Inspector General is conducting a study on implementation of product tracing requirements and describe what dispensers are doing to meet DSCSA requirements. They are asking for an hour long interview, examples of transaction documents, and your standard operating procedures. Remember as of March 1, 2016 dispensers are required to follow DSCSA regulations and this was after two consecutive four month delays to give dispensers time to implement processes to be compliant. Even though this is study you want to ensure your organization can speak accurately to OIG about your experience with DSCSA and what you are doing to ensure compliance with the law.
The U.S. Department of Heal
th and Human Services, Office of Inspector General is conducting a study on early implementation of product tracing requirements outlined by the Drug Supply Chain Security Act (DSCSA).
The purpose of this study is to describe the variety of ways in which dispensers are meeting requirements as detailed in the DSCSA §582(c)(1) and by guidance governing product tracing published by the Food and Drug Administration (FDA) in November 2014. We plan to issue a public report that will summarize obstacles to and best practices for dispenser implementation at a general level. The report also may include recommendations to the FDA about ways to improve program operations to assist with implementation (e.g., clarify product tracing guidance, provide technical assistance, etc.).
For the study, we are interviewing a sample of dispensers about their product tracing practices. Your organization was selected to participate in the study, and we are requesting the following:
1. An hour long interview—to take place <timeframe>
2. Examples of traceability documents (i.e., transaction information, transaction history, transaction statement) for two product transactions from <date>
3. Standard operating procedures for product tracing processes, if available
An OIG staff member will contact you shortly to schedule the interview and answer any questions you may have. Please send traceability documents and standard operating procedures to <OIG inspector> at the email below by <date>
How can Drug Track IQ help?
First as part of signing up for our service we will give you a set of policies and procedures written by pharmacy leaders who understand DSCSA and pharmacy operations. We will also update those for you as new regulations around DSCSA are rolled out. If you want to purchase these independently we offer them here and will give you updates up to a year after your purchase.
Second if you sign up and begin to use the Drug Track Engine to receive and store all of your DSCSA transaction documents you will have no problem producing DSCSA compliant documents for OIG.
Finally, as a customer, if you would like us to be involved or help you prior the interview we will ensure someone from our team works with you so you know what to expect. We want to ensure you are compliant to all regulations when the real audits for DSCSA begin.