New FDA Reporting Requirement For Oxygen Transfillers

Published in Government Relations on January 07, 2022

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The full draft guidance from the FDA can be found here: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 An excerpt from that guidance reads: The “FDA is announcing the availability of a draft guidance for industry entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.”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


TAGS

  1. general
  2. regulatory

From Our Experts

NAAOP Hosts First Ever In-Person Legislative Fly-In thumbnail NAAOP Hosts First Ever In-Person Legislative Fly-In Last week, 33 stakeholders, advocates, and leaders from around the O&P industry convened at the offices of Powers Pyles Sutter & Verville PC in Washington, D.C., as part of The National Association for the Advancement of Orthotics and Prosthetics's (NAAOP) first ever in-person legislative fly-in. Co-sponsored by OPGA, the fly-in kicked off with an in-depth discussion and strategy session surrounding several legislative priorities affecting O&P providers and patients. VGM Government Relations Unveils Grassroots Advocacy Toolkit to Empower DME Champions of Change thumbnail VGM Government Relations Unveils Grassroots Advocacy Toolkit to Empower DME Champions of Change The VGM Government Relations team is proud to announce the launch of its Grassroots Advocacy Toolkit, thoughtfully crafted to support durable medical equipment (DME) professionals, caregivers, industry partners, and patient advocates in advancing legislative initiatives that impact home medical equipment and services. Featuring Two Champions Of Change: Robert Beard of YD Home Medical & Rob Minicucci Jr. of Health System Services thumbnail Featuring Two Champions Of Change: Robert Beard of YD Home Medical & Rob Minicucci Jr. of Health System Services Today, we're proud to spotlight two outstanding durable medical equipment (DME) champions whose advocacy efforts are making a meaningful difference: Robert Beard of YD Home Medical of Alabama and Rob Minicucci Jr. of Health System Services of New York. These individuals took time out of their busy schedules to personally connect with elected officials, demonstrating how local action can spark national change. Survey: Share Your Thoughts on Proposed Accreditation Rule Changes thumbnail Survey: Share Your Thoughts on Proposed Accreditation Rule Changes CQRC, VGM, and AAHomecare are requesting your feedback on a new proposed rule that could significantly impact accreditation procedures. Under the proposal, accreditation organizations would be required to conduct site visits every year—a major shift from the current once-every-three-years schedule. WEBINAR: Navigating New CMS Guidelines: Unlocking Opportunities in NIPPV and RAD Coverage for COPD Care thumbnail WEBINAR: Navigating New CMS Guidelines: Unlocking Opportunities in NIPPV and RAD Coverage for COPD Care The Centers for Medicare & Medicaid Services (CMS) has revised the NCD for Noninvasive Positive Pressure Ventilation (NIPPV) in the home setting for treating Chronic Respiratory Failure (CRF) due to Chronic Obstructive Pulmonary Disease (COPD). The changes aim to establish clear coverage policies for devices such as Respiratory Assist Devices (RADs) and home mechanical ventilators (HMVs), potentially expanding access to these critical therapies for eligible patients. Adapting to new CMS guidelin Bipartisan Medicare O&P Bill Introduced thumbnail Bipartisan Medicare O&P Bill Introduced In a timely move ahead of next week's NAAOP Legislative Fly-In, a bipartisan group of lawmakers introduced the Medicare Orthotics and Prosthetics Patient-Centered Care Act, a bill aimed at improving access to high-quality orthotic and prosthetic care for Medicare beneficiaries. The Patient-Centered Care Act seeks to address critical gaps in Medicare coverage for orthotic and prosthetic (O&P) services. Under current rules, beneficiaries may receive devices without the necessary clinical services Proposed Rule Suggests Significant Change To Accreditation Process thumbnail Proposed Rule Suggests Significant Change To Accreditation Process The recently released proposed rule CMS-1828-P contains a significant change that could reshape how suppliers navigate accreditation. The rule proposes a major change that would require suppliers to be surveyed and reaccredited annually instead of the current three (3) year cadence. This proposal raises substantial questions about both operational feasibility and cost implications. August Of Action: Your Chance To Connect With Congress thumbnail August Of Action: Your Chance To Connect With Congress It's time to take advantage of August Of Action—a perfect opportunity to make your voice heard. Every summer, federal legislators return to their home states during the Congressional recess. While it gives them a break from Washington D.C., it's primarily a time for them to connect with constituents like you.