In November of 2013, President Obama signed the Drug Supply Chain Security Act (or DSCSA) into law, which incited a ten year roll out plan of new compliance standards for those in the pharmaceutical industry.
The purpose of the act is to strengthen security measures in place regarding the distribution and supply chain of pharmaceutical drug products. The FDA plays a large role in implementing these new measures such as; the planned national track and trace system and new standards in licensing for prescription drug wholesale distributors and 3PLs.
Although different aspects of the DSCSA will be implemented over a ten year period, a new series of penalties are in effect as of November 1, 2015 for failure to comply. Although much of this new information can be somewhat confusing (ie identifying compulsory law vs FDA guidance or suggestions), keep in mind that rules set forth from the DSCSA and the FDA require compliance by law, whereas FDA guidances are suggestions and reflect the current thinking of the Food and Drug Administration.
On October 28, 2015 theFDA issued a guidance to inform industry that they do not plan to take action against dispensers who (prior to March 1, 201) accept ownership of pharmaceutical products without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.
Prior to March 1, 2016, the FDA also does not plan to take any actions 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.
However, an important thing to note about this particular guidance is the fact that this policy does not extend to transactions wherein dispensers must provide the subsequent owner with product tracing information.
Also, other product tracing requirements about authorized trading partners and verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) still apply and are in effect for dispensers.