In order to achieve interoperability, "the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format."
The U.S. Food and Drug Administration (FDA) continues to publish draft guidances implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidances for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale distributors and/or third-party logistics providers and product tracing compliance.
Interoperable Exchange of Information
After reviewing information and comments received in the public dockets and a public workshop (see April 11, 2014, Alert), the FDA has issued its draft Guidance for Industry entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information." This guidance "establishes initial standards for the interoperable exchange of product tracing information, in paper and electronic format," for all "transactions" concerning "products," as those terms are defined in section 581 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA, however, intends to issue additional guidances related to such exchanges in the future. Initially, the FDA states that "'interoperability' encompasses the ability to exchange product tracing information accurately, efficiently, and consistently among trading partners." In order to achieve interoperability, "the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format." Therefore, trading partners can use "current paper-based or electronic-based methods" for exchanging information, such as email or web-based platforms, including:
- Paper or electronic versions of invoices;
- Paper versions of packing slips;
- Electronic Data Interchange (EDI) standards; and
- EPCIS (Electronic Product Code Information Services).
Annual Reporting by Wholesale Distributors and/or Third-Party Logistics Providers (3LPs)
In another draft Guidance for Industry, entitled "DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers," FDA will require the following information for each facility in an initial report from wholesale distributors and/or 3LPs.
- Name of company, address of facility, contact information and all trade names that the company does business as (i.e., any other names listed as "dba"); and
- Licensure information for each state from which the drug products are distributed with state licensure programs and for each state that requires a license to ship products into that state, including the state, state license number and any significant disciplinary action by any state or federal agency (i.e., action "that limits or prevents a wholesale distributor … from distributing or facilitating the distribution of prescription drugs, including for-cause revocation, termination, or suspension of a license").
- Name of company, address of the facility, all trade names that the company does business as (i.e., any other names listed as "dba"); and
- Licensure information for each state from which the drug products are distributed with state licensure programs and for each state that requires a license to ship products into that state and the state license number.
The FDA also requests the following voluntary information for each facility in these initial reports.
- Unique facility identifier (i.e., D-U-N-S® number),
- Expiration date for the license and
- Documents associated with the disciplinary action.
- Name of contact person to interact with FDA;
- Email address and telephone number;
- Unique facility identifier (i.e., D-U-N-S® number);
- Expiration date for the license; and
- Significant disciplinary actions by any state or federal agency in the 12 months preceding the initial report (i.e., action "that limits or prevents a … 3PL from distributing or facilitating the distribution of prescription drugs, including for-cause revocation, termination, or suspension of a license"), including the state where the disciplinary action occurred, date of final action, type of disciplinary action, description of violation and documents associated with the disciplinary action.
Any significant disciplinary action should be reported within 30 days of a final action or ruling by the state or federal licensing authority. Other voluntary reports sought by the FDA include notification of a facility that goes out of business or decides to voluntary withdraw its license. Any subsequent report should include the required and voluntary information discussed above. The FDA will make all information collected in these reports publically available on its website to the extent allowable by law.
Product Tracing Compliance
In a Guidance for Industry entitled "DSCSA Implementation: Product Tracing Requirements—Compliance Policy," the FDA reacted to industry concerns regarding readiness to comply with the DSCSA's tracing requirements. In order "[t]o minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by" the DSCSA for manufacturers, wholesale distributors and repackagers. This policy does not extend to other requirements, such as "verification related to suspect and illegitimate product" or "requirements related to engaging in transactions only with authorized trading partners."
For Further Information
If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.