FDA Issues Drug Supply Chain Security Act (DSCSA) Guidances for 2023 Implementation

In preparation for the final complex interoperable electronic tracking phase for the Drug Supply Chain Security Act (“DSCSA”)[1]  provisions, FDA released two Guidances the week of July 5, 2022.

DSCSA Standards for Interoperable Exchange of Information for Tracing for Certain Human, Finished, Prescription Drugs  

(Draft Guidance) (Revision of Nov 2014 Guidance) Comment period ends 9/06/2022.

Identifies standards to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards.

Identifying Trading Partners Under the DSCSA

(Revision of August 2017 Guidance)

Addresses the status of some entities as trading partners (e.g., private-label distributors, salvagers, returns processors and reverse logistics providers) and provides clarification on certain drug distribution scenarios. Addresses 3PL licensure status.

The Interoperable Exchange Guidance is the culmination of various industry pilot projects for electronic product tracing. When enhanced product tracing requirements using electronic tracing at the product level go into effect on November 27, 2023, paper product tracing will no longer be permitted without a waiver or exemption. The Guidance details a uniform methodology which protects confidential commercial information and trade secrets using GS1’s Electronic Product Code Information Services (EPCIS) standards.  Manufacturers have been waiting on FDA’s endorsement before committing to GS1.

The second Guidance is yet another revision of the guidance on identification of trading partners. This guidance provides clarity with regard to the confusion as to trading partner status of certain entities, including co-licensed partners (now includes private label distributers) or affiliates of a manufacturer, brokers, jobbers, solution providers and salvagers (including re-packagers).  For example, private label distributers who obtain product directly from manufacturers are required to adhere to all DSCSA product tracing (e.g. T3 requirements), product identifier, trading partner and verification requirements.  Importantly, the Guidance clarifies when these entities are considered to be engaging in wholesale drug distribution (WDD) and identifies some specific activities excluded from WDD. FDA excludes from the definition of WDD “the distribution of minimal quantities (defined as 5% of dollar volume of annual prescription drug sales) of drug by a licensed retail pharmacy to a licensed practitioner for office use.”  Distribution of drugs for research purposes only also does not constitute WDD, and the seller would not be required to adhere to T3 and WDD registration requirements. Returns processers or reverse logistics providers may be considered a 3PL, a WDD, or neither, depending on the activities performed.  Finally, pharmacy to pharmacy transfers of product not pursuant to a specific patient need may constitute WDD. Where wholesalers and 3PLs have been licensed on the state level, FDA is currently drafting regulations for Federal licensing standards.

How Frier Levitt Can Help

Trading partners and other stakeholders should consider assessing current policies, procedures, systems and processes to analyze potential implications by these new and revised documents. Comments may be provided on the electronic data exchange guidance until September 6, 2022. Frier Levitt’s FDA and Life Sciences Regulatory Practice teams have the necessary experience to navigate the evolving implementation of the DSCSA. Contact us for a consultation with a member of our team.

[1] P.L. 113-54.