ACSA is pleased to report that on the heels of Association discussions with HHS Chief of Staff Brian Harrison and senior HHS leadership, together with an intensive outreach campaign over the past 48 hours to congressional legislators and members of the media, HHS has withdrawn the FDA’s scheduled $14,060 fees to craft distillers who produced hand sanitizer in 2020. ACSA will be a key stakeholder as HHS and FDA review future processes. As such, these alarming and sudden payments will no longer be due on February 11, 2021.
Since early March, ACSA has served as a key liaison to the government agencies who regulate sanitizer production. ACSA’s proactive leadership also provided extensive education regarding safe and compliant sanitizer manufacturing practices. These efforts laid the groundwork for the trade group’s role as a clearinghouse in the industry for updates and assistance. When unexpected fee notices were received by small distilleries, producers immediately sought assistance from ACSA, who reached out to resolve the situation.
Margie A.S. Lehrman, CEO, ACSA: “We are truly a community of craft distillers — who collectively sounded the alarm with legislators and local news outlets as ACSA worked around the clock to speak to regulators here in Washington — and that is more evident than ever tonight as we receive this news.”
Becky Harris, President, ACSA and President, Catoctin Creek Distilling Company: “We are incredibly grateful to HHS for opening a dialogue with us, and look forward to working more collaboratively together in 2021 with FDA to ensure our members are treated fairly for the challenges they face to support their hometowns via hand sanitizer production in the wake of COVID-19.”
REMINDER: DE-REGISTER YOUR DISTILLERY
If your 2021 business plan does NOT include manufacture, marketing, and/or sale of hand sanitizer, distilleries must de-register their facility on the Electronic Drug Registration and Listing System (eDRLS) no later than TODAY, December 31, 2020.
The following are the necessary steps to take to de-register your establishment:
- Login to CDER direct and open up the most recent registration submission. (click on SUBMISSION ACCEPTED)
- Once opened, click on the CREATE NEW VERSION button.
- In the header details section, choose Establishment De-Registration from the drop down list for document type.
- Click submit.
- The table will indicate that the De-registration request is “Awaiting Acceptance”
Existing stock that was manufactured while still registered may be exhausted. The proper way would be to “delist” or discontinue the hand sanitizer product as well. This can be done by the following these instructions:
- Open up the previously accepted version of the product listing
- Click on CREATE NEW VERSION
- In the product data elements, select the Marketing Status “COMPLETED”.
- Provide a Marketing End Date equal to the expiration date of the product and will be a future date.
- Save and submit.