This post is Part 5 of the Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies. Click here for Part 1, Click here for Part 2, Click here for Part 3 and Click here for Part 4.
The DSCSA outlines specific requirements to develop and enhance drug distribution security, including establishing national standards for the licensing of prescription drug wholesale distributors and 3PLs. Part of these requirements includes annual reporting. Essentially, as of January 1st, 2015, the DSCSA implemented a requirement around wholesale distributors reporting on licensure and other applicable information to the FDA annually. This requirement was implemented for 3PLs beginning November 27, 2014.
Based on the current information available, any establishment that engages in prescription wholesale distribution must report to the FDA and provide the appropriate contact information. The FDA requests additional information on a voluntary basis, which makes this requirement somewhat open to interpretation. As such, this post provides highlights from the DSCSA Guidance in order to help distributors better understand who must report, what should be reported, when to report, and how to report. The FDA and CDER released a 13-minute webinar – Annual Reporting using CDER Direct – that provides additional information about the process.
Who Must Report?
- Prescription Drug Wholesale Distributors – “any person who owns or operates an establishment that engages in wholesale distribution of prescription drugs”
- Manufacturers that engage in wholesale distribution. However, if the manufacturer is distributing only their own drug, they do not need to report.
- Wholesale distributors distributing bulk prescription drug substances.
- Pharmacies that are also licensed as a wholesale distributor.
- 3PL’s only providing services related to bulk prescription drug substances do not need to report unless the substance is in finished dosage form.
- Wholesale distributors and 3PL’s that distribute only over-the-counter drugs do not need to report.
- Wholesale distributors and 3PL facilities only distributing and providing services related to animal drugs do not need to report.
What Should Be Reported?
Wholesale distributors should report all licenses that authorize wholesale distribution. This includes licenses the wholesale distributor holds from any state that the wholesale distributor ships human prescription drugs from, and any licenses the wholesale distributor holds from states that the wholesale distributor ships into.
The initial report submitted to the FDA by the wholesale distributor must include the following information:
- Name of the company
- Address of the facility
- Contact information
- All trading names the company does business as
- Licensure information for each state, license number and expiration date for the license
- Significant disciplinary actions by any state or federal agency and any documents associated with a disciplinary action(s)
- Unique facility identifier – this is the D-U-N-S® number
- Wholesale distributors are not required to report DEA registration numbers or state controlled substance licenses
When to Report
The initial reporting period was between January 1, 2015, and March 31, 2015, for wholesale distributors. Subsequent annual reporting takes place between January 1st and March 31st each year.
A company must submit any significant disciplinary action reports to the FDA when a final action is made. A company must also notify the FDA if a facility goes out of business or decides to withdraw their license.
How to Report
The FDA provides a portal (FDA’s CDER Direct Electronic Submissions Portal) for submission of applicable information. The first time a business submits a report, it requires that they create an account on the portal.
The information in this post should be used as a reference only. It is meant to provide readers an overview of the DSCSA requirement and provide easy access to FDA documentation needed to comply. The information contained in this post was extracted from the FDA Draft Guidance “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” and a newly released (Jan. 2017) supplementary guidance “Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers” that addresses many of the questions being asked.