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New FDA Reporting Requirement For Oxygen Transfillers

DME providers who transfill oxygen appear to now be required to submit reports to the FDA to show how many units of certain drugs, including medical gases (oxygen) they dispensed. Until now, providers who transfilled oxygen were required to simply register with the FDA, but there was no reporting requirement. The new reporting requirement stems from the CARES Act, which modified the Food, Drug, and Cosmetics (FD&C) Act.

In 2022, the first year of the reporting requirements, there will be two reports due, one for 2020 and one for 2021. Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for calendar year 2021 should be submitted no later than May 16, 2022. Reports for subsequent calendar years should be submitted no later than February 15 of the following year. Each report submitted must include the listed drug, identified by its National Drug Code (NDC), and be organized by the amount of drug released each month. DME providers reporting on the amount of oxygen they dispensed will need to report quantities for each size of gaseous cylinder or liquid reservoir that was transfilled.

Based on our interpretation of the guidance, the term “transfiller” would include companies that fill liquid and/or gaseous oxygen reservoirs/cylinders/containers, etc.

The full draft guidance from the FDA can be found here: https://www.federalregister.gov/documents/2021/11/01/2021-23722/reporting-amount-of-listed-drugs-and-biological-products-under-section-510j3-of-the-federal-food. An excerpt from that guidance reads: The “FDA is announcing the availability of a draft guidance for industry entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.” On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 (COVID-19). In addition, the CARES Act included authorities to enhance FDA's ability to identify, prevent, and mitigate possible drug shortages by, among other things, improving FDA's visibility into drug supply chains. Section 3112(e) of the CARES Act (Pub. L. 116-136) added section 510(j)(3) of the FD&C Act (21 U.S.C. 360(j)(3)) to require that each person (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

This draft guidance is intended to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the FD&C Act. The draft guidance addresses the content of reports, the timing of reports, and the process for report submission.

This draft guidance describes the process that should be used for reporting by each person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug (including a finished dosage form product, an active pharmaceutical ingredient, and other listed drugs), except for biological products or categories thereof exempted by an order under section 510(j)(3)(B)). The process described in this guidance applies to such reporting with respect to listed drugs, including medical gases…”

The definition of “medical gas” in Section 575 of the FD&C Act includes oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air.

Some helpful links that provide additional information related to this topic are listed below:

Portal that providers will initially register and ultimately submit their reports to the FDA: https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=1097800867_1640719521396&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

Draft guidance issued by the FDA: https://www.fda.gov/media/153665/download

CARES Act: https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf

FD&C Act: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf

Once you have registered in the portal using the link provided above, you will login and follow the instructions within that portal and will ultimately upload your report there as well. It appears providers will be reporting oxygen quantities in terms of cylinders/tanks/reservoirs, etc. rather than by the lb. or liter, etc.

While there are still several unanswered questions around this reporting requirement, the first reporting deadline of February 15 is not far away. We wanted to make sure you were all aware of the new requirement in case it impacts you directly, and we will let you know if and when we receive additional information or clarification regarding this requirement.