Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Topics Covered
- OTC Drug Listing Updates and Validation
- Drug Amount Reporting for Listed Drugs
- Who Should Not Register or List
Presenters
Leyla Rahjou-Esfandiary, PharmD
Branch Chief
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Obinna Ugwu-Oju, MS
Division Director
Office of Pharmaceutical Quality (OPQ)
Office of Surveillance
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Yogesh Paruthi, PharmD
Consumer Safety Officer
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Abstract
These virtual conference presentations offer crucial updates on OTC drug listing requirements, drug amount reporting, and exemptions from registration and listing. Effective October 1, 2023, new marketing categories and monograph IDs for OTC drugs are in place; consequently, all OTC drug listing submissions must be updated to these new identifiers by December 31, 2024, for the annual certification period, to avoid inactivation in January 2025 if the product remains on the market. Regarding OMUFA facility fees, companies that solely manufactured hand sanitizers under the COVID-19 Public Health Emergency can avoid fiscal year 2025 fees by discontinuing production and deregistering by December 31, 2024. The Drug Amount Reporting Program clarifies submission timelines, with Calendar Year 2023 reports due by July 31, 2024, and subsequent years by March 31 of the following calendar year; contract manufacturers are now explicitly required to submit drug amounts for what they produce. Finally, the sessions detail exemptions from registration and listing, encompassing entities like pharmacies or those involved only in research, emphasizing that these do not engage in manufacturing for U.S. commercial distribution. The FDA stresses that registration and listing do not imply product approval, and incorrect submissions can lead to serious compliance obligations, including user fees and inspections.