On October 29, 2021, FDA released a draft guidance and a final guidance on reporting manufacturing volume data for drugs and biologics as required under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). In August 2020, FDA provided notice that registrants of drug establishments were relieved from the September 2020 statutory deadline for reporting volume data because FDA’s reporting portal was not operational. Based on these new guidances, FDA now advises that registrants are required pursuant to the CARES Act to report 2020 calendar year production volumes by February 15, 2022 and 2021 calendar year production volumes by May 16, 2022. For the years thereafter, the reports are due annually by February 15 of the following calendar year.
Section 3112 of the CARES Act requires manufacturers to report drug substance and product volume data to help FDA identify, prevent, and mitigate drug shortages. Specifically, Section 3112(e) requires manufacturers to report the “amount of each drug … that was manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling)… for commercial distribution.” The reporting requirements covers drug products, including prescription and OTC, and active pharmaceutical ingredients (“APIs”). The statute allows FDA to exempt certain biological products from the reporting requirements, and FDA has issued a Proposed Order to exempt (1) blood and blood components for transfusion and (2) cell and gene therapy products, where one lot treats a single patient.
I. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Draft Guidance
This draft guidance is intended to help registrants comply with the requirement to submit reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. The reporting requirements apply to each drug establishment registrant, including repackers and relablers. Each registrant must report to FDA annually. The draft guidance provides deadlines for submitting reports for 2020 and 2021 data.
The content of the report should provide the amount of each listed drug, identified by National Drug Code (“NDC”), that was released by each registrant during the reported year, organized by the amount of drug released in each month. Repackers and relabelers should, if applicable, include the source NDC (i.e., the full three-segment NDC assigned to the drug received by the repacker/relabeler for repacking or relabeling).
Despite the statute’s requirement that “[e]ach person who registers with the Secretary . . . with regard to a drug shall report annually to the Secretary on the amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution,” FD&C Act § 510(j)(3)(A), and the apparent ambiguity in the statute whether reporting must be submitted for each facility, the draft guidance specifies that reporting should be specific to the volumes manufactured at each registered facility.
Reporting Based on Types of Products:
- Finished Dosage Form Products:
- For a listed product with a single level of packaging, the registrant should report the quantity of the package type associated with the NDC assigned to the product released and not, for example, the number of tablets.
- For a listed product with multiple levels of packaging and where the product is not listed as a kit, then the product should be reported using the NDC assigned to the outermost layer of packaging, and the amounts reported should correspond to the package types associated with both the outermost layer of packaging and the innermost layer of packaging.
- For a listed product listed as a kit, the registrant should report based on the outermost layer of packaging associated with the NDC assigned to the kit released.
- API:
- Registrants should report the amount in terms of the unit containers as reported in the drug listing (e.g., tanks, drums, cylinders, and bags).
- Other Listed Drugs:
- For registrants that list a product that consists of API and other ingredient(s) and that is not in a finished form product, the amount should be reported in the unit container as reported in the drug listing.
- Private Label Distribution:
- For drugs that are manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) by a registrant for commercial distribution under the trade name or label of a private label distributor, the data should be submitted separately using the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.
Reporting under the CARES Act satisfies annual volume reporting requirements under 21 C.F.R. § 314.81 in some cases, and establishments that only sterilize, analyze, conduct particle size reduction, or salvaging do not need to report. Registrants need only report product distributed in the United States, unless volumes are distributed in multiple countries and the registrant does not know how much went to the United States.
Regarding the submission of these reports to FDA, the draft guidance provides that any agent who has knowledge regarding the amount of drug released and who has been authorized by the registrant to submit the manufacturing volume data report, such as a private labeler distributor, may submit the report. In addition, a holder of an NDA or a BLA who has been authorized as an agent on behalf of a contract manufacturer (i.e., the registrant) may submit this on the contract manufacturer’s behalf.
FDA requests that any comments concerning this draft guidance be submitted by December 29, 2021.
II. Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Final Guidance
This final guidance provides detailed instructions on how to submit manufacturing volume data reports to FDA through the CDER NextGen Portal at edm.fda.gov.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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