In late 2021, the US Food and Drug Administration (FDA) is instited a new annual distribution report, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, for all listed drugs. According to the FDA, “Each registrant that lists a drug must report to FDA annually on the amount of such drug that it manufactured, prepared, propagated, compounded or processed (including repacking and relabeling) for commercial distribution.” This data will need to be submitted in a comma-separated file or manually entered and identified by national drug codes (NDC) tied to establishment registration (ER) and include the correct single business operation. At the time, it was understood the deadline for reporting 2020 data would be February 15, 2022. Since then FDA has explained this was a suggested deadline rather than a required deadline because the final guidance is not yet approved.
Recently, Reed Tech subject-matter experts, Gary Saner and David Wilson, hosted a webinar to provided a recap of what this new deadline means for pharma companies and how to ensure compliance, as well as explained the implications of recent updates and the progress of the draft guidance.
They also spent much of the webinar reviewing real frequently asked questions that have been coming to us from our customers. Take a look below to find answers to these common questions. Need more clarification? Contact [email protected].
Frequently Asked Questions
Q: We have a product that we have not manufactured for at least (x) years, which we are maintaining the licenses for, do we need to report that there were zero quantities distributed this product?
A: A drug product that was active during any part the reporting year, then it needs to be included within this new annual report. If no product was released or distributed, then the FDA has instructed companies to enter “0” for the month or annual totals.
Q: If a manufacturer submits info on the amounts distributed in the annual report, do they also have to submit this separate drug distribution report?
A: Application holders of NDAs, ANDAs, and BLAs, must include drug distribution annual totals in the Annual Report submission required under 21 CFR 314.81. These prevailing Annual Reports do not have the monthly breakdowns, or the level of detail required by the new Drug Distribution Report. The FDA requires the Drug Distribution Report to be submitted for these products, but the application holder may use the more granular Drug Distribution Report as an alternate reporting process for the distribution data required for the Annual Report.
Q: Should we report the total amount of product released or only that amount that was released for U.S. use? Does the manufacturer report quantities exported?
A: The registrant should report both the quantities for the U.S. market and, as appropriate, report the quantities for the non-U.S. market. There are fields in the report to input non-U.S. volumes.
Q: Does the Quantity Released include just the U.S. market or does it include the U.S. and non-U.S. total quantities?
A: It is our understanding that the registrant should report by month the total of the U.S. market and the non-U.S. market in the “Quantity Released” field and, as appropriate, report the portion of the released total that was distributed to non-U.S. regions in the “Quantity Distributed (Non-US)” field.
Q: Are we reporting on the amount manufactured, released or distributed per month?
A: The Drug Distribution Report does not include the amount manufactured, only the amount placed into commercial distribution. The report includes the quantity of product released to the U.S. market and the quantity distributed to the non-U.S. market.
Q: Can a “Physician’s Sample” be excluded from the Drug Distribution Report since they are not sold?
A: Drug samples whether sold or provided free must be listed with an NDC as they are technically placed into commercial distribution. Following the FDA guidance, distributed quantities of the Physician’s Samples must be reported in the Drug Distribution Report.
Q: Would you need to report quantity made for drug validation testing? Specifically, product made prior to distributing for commercial sale.
A: Products used and contained within the control of the Manufacturer are not considered in commercial distribution so are not in scope for the DDR.
Q: Would you need to list the establishment the product is registered under or the establishment that manufactures the product?
A: The Establishment DUNS where the product is manufactured should be included in this report.
Q: We are the registrant but do not manufacture, package, or label, we contract out; so, should the contractors or the registrant submit the DDR?
A: It is our understanding, that if you are a Private Label Distributor (PLD) and contract out the drug manufacture, pack and label operations to registered establishments, then the Contract Manufacturing Organization (CMO) that performs the final business operation prior to commercial distribution has the responsibility to submit the Drug Distribution Report and use the manufacture business operation. However, the PLD may submit the report in agreement with the CMO and follow the precedent used for drug listing.
Q: Are there fines for either not filing or filing errors?
A: Any potential fines or penalties are unknown at this moment. As of March 2022, the DDR documentation is still a draft guidance and not yet required.
More questions about the basics of the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act? Check out our additional blog with more detailed background, requirement, and timing information.
Also, take advantage of the free recordings of our two, full webinars:
For more information or help with your submissions, contact Reed Tech at +1 (215) 557-3010 or [email protected].