FDA Enforces Five Verification Requirements for Manufacturers Starting November 2019

In the FDA compliance policy final guidance document published on September 23, 2019 , FDA specifically called out that “manufacturer[‘s] verification obligations” will be enforced.

Here, we take you for a deep dive of manufacturer’s verification obligations. Segment by segment, the obligations are stated in DSCSA sections 582 (b)(4)(A), 582 (b)(4)(B), 582 (b)(4)(C), 582 (b)(4)(D), and 582 (b)(4)(E).

FDA “does not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor.” Stated the FDA compliance policy final guidance document.

Translation? All sections are in enforcement today. All sections will also be enforced by the FDA for serial verification requests initiated by the wholesalers when wholesalers are using their VRS and EPCIS (582(b)(4)(C)).

EPCIS AND VRS

In fact, the manufacturer’s verification requirement went into effect the same time as their product serialization requirement. Yes; FDA is already enforcing manufacturer’s verification requirement. But why are manufacturers not ready a year after their verification deadline?

The answers are two-fold. One, most manufacturers have a serial repository, an electronic database that can be used to look up and respond to a serial request in a manual fashion. Two, manufacturers have not seen large volume of serial requests therefore are unclear of business issues and impact brought by high volume verification requests from their downstream trading partners.

Not until the approach of the wholesaler’s deadline of November 2019, we started to see activities from both wholesaler and manufacturers in efforts to put in systems that will enable the request and response for verifications. The sheer volume of verifications initiated by wholesalers demands real time verification and automation. Hence the recognition of VRS for serial verification and furthermore LSPediA’s Investigator® for exception management, suspect product handling, and illegitimate product notification.

Starting November 2019, each wholesale distributor must meet their respective verification requirement.

Again, systems that manage suspect product, illegitimate product, and systems such as EPCIS and VRS are among the implementations to enable verification compliance.

FOCUS ON ENFORCEMENT

I can’t stress enough that manufacturers need to stay the course and focus on the implementation their verification requirement as laid out in section 582 (b)(4)(A), (B), (C), (D), and (E). The specific infrastructure necessary for said implementation are as follows:

1. Systems and processes to manage and handle suspect product
2. Systems and processes to manage and handle illegitimate product
3. Systems and processes to manage and handle requests for verification
4. Systems and processes to manage and handle saleable returned product
5. The electronic database with the capability to respond to request and share data access with trading partners as appropriate

FDA has called manufacturers to action regarding compliance policy, announcing that they “[do] not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor.”[1]

Contrary to taking a breather, both wholesalers and manufacturers need to utilize every available day from now until November 27 to focus on implementing their corresponding verification requirement. The risk of do-nothing? Read my article from July 2018 titled “Penalty of Non-compliance”

INVEST IN CRITICAL ENFORCEMENT ITEMS

We urge all to focus on the enforcement requirement and stay the course of forward momentum. Our call to action goes to both manufacturers and wholesale distributors.

LSPediA’s Investigator® solution provides turnkey compliance for section 582 (c)(4)(A), 582 (c)(4)(B), 582 (c)(4)(C), 582 (c)(4)(D), and 582 (c)(4)(E).. It provides both system capability and automated workflows to manage suspect product investigation and illegitimate drug product notification. Upon receiving a suspect/illegitimate notification, Investigator® has the capabilities to:

• Shelf-check and document all items in procession
• Respond to requests in real time
• Conduct suspect/illegitimate product investigation with in-app email and camera
• Document 3911 initialization, updates, and termination
• Maintain complete investigation history and 3911 reporting history information for six years
• Share data with trading partners as appropriate

LSPediA engages the process of not only preparedness, but the innovative nature of serialization at-hand. LSPediA’s Investigator® fills the system and process gap that was called out by the FDA in this compliance policy. With Investigator®, you can demonstrate clearly to the FDA with confidence that your company took proper steps to perform DSCSA activities in full compliance to the FDA’s requirement.

BOTTOM LINE

LSPediA’s OneScan has been designed since the beginning to address all sections of the verification requirement. Our solution offers a smarter way of working to identify, quarantine, investigate, report, and facilitate the investigation of suspect products. The OneScan solution is a key way that you can ensure your serialization investments are focused on creating business value and/or risk mitigation quality.

Use the discretion period to be thoughtful, innovative, and prepared – not to rest in a manner that finds industry in the same precarious state of unreadiness next year. Your goals should be to work smarter, reduce waste, and generate profitability; and to choose solution partners that share the same vision. Reach out to us today.

[1] Wholesale Distributor Verification Requirement for Saleable Returned Drug Product