The FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement. The document indicates that the FDA’s decision to take this action was based on the fact that “…some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date.”
The core of the guidance is found in the last few paragraphs:
“FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act. This compliance policy does not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history, as required by section 582(d)(1)(A)(ii). If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information. FDA believes that product tracing information serves as an important tool for dispensers to meet their obligation under section 582(d)(4) to identify suspect product, quarantine the product, and investigate whether that product is illegitimate.
“Prior to November 1, 2015, FDA also does not intend to take action against dispensers who do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.
“This compliance policy does not extend to other requirements of the FD&C Act, including those in section 582, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.”
The FDA also posted a new webinar recording entitled “DSCSA Updates and Readiness Check: Requirements for Dispensers and other Trading Partners Webinar“, dated July 2015.
I guess the FDA is able to pull together an action like this and get it approved in less than two weeks (see “Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline”). I’ll have more to say about this guidance and its implications in a future essay.