The guidance issued by the US Food and Drug Administration (FDA) this week outlines the information that should be transmitted to the agency by prescription drug wholesalers and 3PLs as part of its plan to implement the Drug Supply Chain Security Act (DSCSA) into US law in November 2013.
While the guidance is available for written comments until February, the FDA is demanding that wholesale distributors report State licensure and contact information for each facility annually from the start of 2015. 3PLs are required to provide the same details as well as all of the trade names under which each facility conducts business.
The implementation of the DCSCA will allow the FDA to know the exact number of wholesalers and 3PLs operating in the US. This is currently unknown because the license status information for each facility is maintained by individual States, but the agency estimates there are 5,000 wholesale distributor facilities and, based on the number licensed by Florida, 136 warehouses licensed as 3PLs, located in 28 different states.
Dan Bell, Vice President of Regulatory and Technical Affairs at Marken - one of the larger 3PLs - told Outsourcing-Pharma.com this guidance “goes a long way towards providing additional clarity on the matter of 3PL reporting requirements.
“Because most States do not currently have a licensing program for 3PLS, many may not have information to report about specific State Licensure,” he continued.
“However, the required 3PL reporting requirements are certainly the first step toward strengthening the Prescription Drug Supply Chain, and the reporting requirements will help FDA identify and highlight where and to what extent gaps in the Drug supply chain exist.”
In order to minimise the risk of contaminated or counterfeit drugs entering the supply chain, the DCSCA is bringing in measures to ‘track and trace’ such products including the mandatory use of human or machine readable barcodes by 2017.
This latest guidance demonstrates the FDA’s intention to “emphasize the need for robust track and trace tools, along with chain of custody assurance,” Bell said.
“We are at the beginning stages of a 10 year transformation period for prescription drug supply chain in the US,” he added and 3PLs will play an important part in implementing this.