Early this morning the FDA published a revised version of its “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy“, originally published on July 6, 2015 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“). That original document established the FDA’s intention to exercise “enforcement discretion” on dispenser transactions that fall under the Drug Supply Chain Security Act (DSCSA) dispenser requirements to receive Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.
The revision published today pushes that delay in enforcement until March 1, 2016, an additional four month delay, extending the full delay in enforcement to a total of eight months from the date mandated by Congress.
The reason stated for the additional delay is:
“…because some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time. “
However, companies should be aware of the limits to this revised guidance:
“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.”
In the guidance, FDA also warns dispensers that this delay in enforcement:
“…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.”