FDA Offers Draft Guidance to Further Secure Drug Supply Chain

Regulatory NewsRegulatory News
| 21 August 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.


The DSCSA outlines the path to better secure the US drug supply chain via an electronic, interoperable system by 2023 to track and trace certain prescription drugs as they are distributed.

The law helps FDA ensure that drugs distributed in the US are not counterfeit, stolen, contaminated or otherwise harmful, and requires distributors to notify FDA and trading partners within 24 hours if a product is illegitimate.

It also establishes product tracing requirements for certain trading partners in the supply chain, including manufacturers, repackagers, wholesale drug distributors (WDDs), third-party logistics providers (3PLs) and dispensers.

And the DSCSA directs FDA to establish national licensure standards for WDDs and 3PLs, which the agency says it is working on, and requires these companies to report licensure and other information to FDA annually.

Draft Guidance

Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means.

"For example, there has been confusion as to whether DSCSA licensure and reporting requirements apply to certain types of entities, such as but not limited to jobbers, brokers, and certain contractors and solution providers," FDA says, explaining when manufacturers, repackagers, WDDs, 3PLs and dispensers are considered trading partners under the DSCSA.

The agency notes that manufacturers, repackagers, WDDs, 3PLs and dispensers are considered trading partners when each "accepts or transfers direct ownership of a product from or to a manufacturer, repackager, wholesale distributor or dispenser."

Thursday’s Meeting

In addition, FDA on Thursday will kick off the first of three public meetings on provisions related to the DSCSA. Topics to be discussed at the meeting will include supply chain security in 2023 and enhanced drug distribution needs.

The other meetings will take place 5-6 December 2017 and 28 February 2018.


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