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TSCA Inventory Reset Rule

Client Alert | 1 min read | 06.29.17

Last week EPA issued the pre-publication version of its much-anticipated final TSCA Inventory re-set rule. Because the new regulation affects every company that manufactures, imports, or processes chemical substances in the U.S., a wide swath of industry will be impacted by the rule including almost every company in the manufacturing sector. The main purpose of the Inventory Reset rule is to provide EPA with a clear picture of all chemical substances that are active in commerce in the U.S. To accomplish this, the rule establishes both “retrospective” and “forward-looking” reporting requirements for manufacturers, importers and processors of chemical substances that are listed on the TSCA Inventory. These designations are key—a substance designated as inactive can no longer be manufactured or processed in the U.S. until the certain reporting requirements are satisfied. Click here for more information on how your company may be affected by the rule and to identify specific steps you can take to minimize disruption caused by the rule.

Insights

Client Alert | 6 min read | 04.29.26

CMS Seeks to Expand Interoperability Requirements to Drug Pre-Authorization (FAQ)

On April 10, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (2026 CMS Interoperability Standards and Prior Authorization for Drugs, or CMS-0062-P) outlining the agency’s plans to impose new interoperability requirements on payors participating in certain Medicare and Medicaid programs. As described by the agency in a recent press release, the proposed rule “builds on” prior rulemaking by clarifying and enhancing interoperability requirements for payors’ prior authorization processes, specifically those associated with coverage requests for pharmaceutical therapies....