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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-50/
- Published: 2021-08-15T12:00:00.000Z
- Updated: 2026-09-14T17:10:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149896

**FDA Implementing Fallout from Drug/Device Case**  
8/13/2021 *Federal Register* notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in *Genus Med. Techs., LLC v. FDA.* The 4/16 decision affirmed a district court ruling that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug. The notice provides information for stakeholders and solicits public comment to inform the agency’s deliberations about products potentially impacted by the *Genus* decision and the way in which impacted products should be transitioned from drug to device status. For example, implementation will require FDA to transition some approved products from drug status to device status. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16944.pdf?ref=fdaweb.com).

**MOU Period Extended for Compounded Drugs**  
8/13/2021 *Federal Register* notice: FDA is extending the period for states to decide whether to sign the final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the \[insert State Board of Pharmacy or Other Appropriate State Agency\] and the U.S. Food and Drug Administration” before the agency intends to begin enforcing the statutory 5% limit on distribution of compounded human drug products out of the state in which they are compounded in states that do not sign the final standard MOU. The period was scheduled to end on 10/27 and now is extended until 10/27/2022\. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16937.pdf?ref=fdaweb.com).

**Covid EUA Listing Updated**  
8/11/2021 *Federal Register* notice: FDA is updating its listing of Emergency Use Authorizations (EUAs) for use during the Covid-19 pandemic. It has been updated to reflect a 5/26 EUA for GlaxoSmithKline’s sotrovimab, and a 6/24 EUA for Genentech’s Actemra (tocilizumab). To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16705.pdf?ref=fdaweb.com).

**Votrient Not Withdrawn Due to Safety/Efficacy: FDA**  
8/11/2021 *Federal Register* notice: FDA has determined that Novartis’ Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Votrient is a kinase inhibitor indicated for treating patients with advanced renal cell carcinoma. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16692.pdf?ref=fdaweb.com).

**Info Collection on Device Recall Authority**  
8/10/2021 *Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Recall Authority--21 CFR Part 810” (Control Number 0910-0432). Section 518(e) of the Federal Food, Drug, and Cosmetic Act provides FDA with the authority in certain instances to issue an order requiring companies to: (**1**) immediately cease distribution of such device and (**2**) immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16635.pdf?ref=fdaweb.com).