On January 22, 2016, FDA announced its list of new and revised draft guidance documents that CDER is planning to publish in calendar year 2016. Included in this list are the following six DSCSA-related documents (see p. 4/Procedural Category):
1. DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
2. DSCSA Implementation: Products Eligible for Grandfather Status
3. DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs–Standardization of Data and Documentation Practices
4. DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
5. DSCSA: Verification Systems for Prescription Drugs
6. DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
While all of these documents address important issues, I’m most interested in FDA’s planned guidance on the DSCSA’s verification requirements. According to section 582 of the DSCSA, trading partners, excluding 3PLs, are required to have systems in place for promptly investigating suspect product incidents and validating any transaction history or transaction information in their possession to determine whether a suspect product is an illegitimate product. But what constitutes an appropriate investigation for purposes of meeting this DSCSA requirement? Moreover, although validation is a key component of suspect product investigations, it was apparently not worthy of a definition in the DSCSA, unlike its equally important cousin, verification.
Indeed, most manufacturers and large national wholesalers have sufficient expertise and resources to fully comply with the DSCSA’s verification requirements. But what about hundreds of smaller wholesalers and repackagers, and thousands of independent and privately owned pharmacies? It’s likely that many are ill-equipped to conduct the type of investigations and validations expected of them under the DSCSA.
Hopefully, FDA’s guidance will provide all trading partners, both big and small, with the information they need to develop comprehensive policies and procedures aimed at meeting the DSCSA’s verification requirements, especially those related to suspect product investigations and corresponding validations of certain product tracing records. Without clear guidance from FDA in this area, it will be difficult for state and federal regulatory authorities to establish a trading partner’s compliance with these federal requirements or to pursue potential criminal violations under the FD&C Act against trading partners which fail to do so. Further, our nation’s pharmaceutical distribution supply chain will remain increasingly vulnerable to fraudulent transactions and drug products of unknown safety and origin until a commitment to implementing robust verification systems is demonstrated by increasing numbers of trading partners. Fortunately, FDA’s intent to issue guidance on this DSCSA requirement shows the agency understands how crucial these systems are to realizing the supply chain security aspirations of the DSCSA.