Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                News & Events for Human Drugs

News & Events for Human Drugs

                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective Home
          Drugs
          News & Events for Human Drugs
          Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - 09/08/2022News & Events for Human Drugs Virtual
    Event Title
              Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act


                  September 8, 2022

  

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting InformationDate:
          
  


     
           

September 8, 2022   

 
 
        
                                      Time: 
                                      
9:30 AM
    - 3:30 PM
ET

 

  



Topics & Presentations
			SpeakersReporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Opening Remarks and Session 1Opening Remarks (PDF - 222 KB)
			**Jennifer Forde***Regulatory Counsel*  
			Office of Regulatory Policy (ORP)
			Center for Drug Evaluation and Research (CDER) | FDADrug Amount Reporting Regulatory Background (PDF - 222 KB)
			**Jennifer Forde***Regulatory Counsel*
			Office of Regulatory Policy (ORP)
			Center for Drug Evaluation and Research (CDER) | FDARegistration and Listing Regulatory Background and Requirements (PDF - 223 KB)
			**Leyla Rahjou-Esfandiary***Lead Consumer Safety Officer* 
			Office of Compliance (OC)
			Center for Drug Evaluation and Research (CDER) | FDAPurpose of Drug Amount Reporting (PDF - 1 MB)
			**Matthew Rosenberg***Economist*
			Office of Strategic Programs (OSP)
			Center for Drug Evaluation and Research (CDER) | FDABasic Framework for Reporting (PDF - 223 KB)
			**Jennifer Highland***Operations Research Analyst*
			Office of Pharmaceutical Quality (OPQ)
			Center for Drug Evaluation and Research (CDER) | FDAQuestion & Answer Panel
			**Jennifer Forde, Leyla Rahjou-Esfandiary, Matthew Rosenberg**, and **Jennifer Highland**Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Session 2CARES Drug Amount Report Examples (PDF - 310 KB)

			

			Further Details on using CSV Files (PDF - 393 KB)
			**Obinna Ugwu-Oju***Division Director*
			Office of Pharmaceutical Quality (OPQ)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Edward Hallissey***Project Management Officer*
			Office of Strategic Programs (OSP)
			Center for Drug Evaluation and Research (CDER) | FDAQuestion & Answer Panel
			**Obinna Ugwu-Oju***Division Director*
			Office of Pharmaceutical Quality (OPQ)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Edward Hallissey***Project Management Officer* 
			Office of Strategic Programs (OSP)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Daniil Graborov***Computer Scientist*
			Office of Business Informatics (OBI)
			Center for Drug Evaluation and Research (CDER) | FDAReporting Drug Amount Under Section 510(j)(3) of the FD&C Act – Session 3 and Closing RemarksCARES Act OTC Drug Volume Reporting – Perrigo (PDF - 1 MB)
			**Kim Armstrong***Associate Director*
			Perrigo OTC Regulatory Affairs OperationsJohnson & Johnson Consumer Inc. - CARES Act Drug Amount Reporting – OTC Products (PDF - 351 KB)
			**Gracy Tirado***Associate Director RA Compliance*
			Johnson & Johnson Consumer Inc.Reporting Drug Amounts Under Section 510 of the FD&C Act as an Authorized Agent and cGMP Consultant (PDF - 493 KB)
			**Ken Coleman ("KC") Stevenson II***VP of Regulatory*
			Ceutical Laboratories, Inc.Drug Volume Reporting: Industry Perspective (PDF - 419 KB)
			**Ben Harpster***QA Compliance Manager*
			GlaxoSmithKlineQuestion & Answer Panel
			**Jennifer Forde***Regulatory Counsel*
			Office of Regulatory Policy (ORP)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Jennifer Highland***Operations Research Analyst*
			Office of Pharmaceutical Quality (OPQ) 
			Center for Drug Evaluation and Research (CDER) | FDA

			**Obinna Ugwu-Oju***Division Director*
			Office of Pharmaceutical Quality (OPQ)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Edward Hallissey***Project Management Officer*
			Office of Strategic Programs (OSP)
			Center for Drug Evaluation and Research (CDER) | FDA

			**Daniil Graborov***Computer Scientist*
			Office of Business Informatics (OBI)
			Center for Drug Evaluation and Research (CDER) | FDAClosing Remarks
			**Jennifer Forde***Regulatory Counsel*
			Office of Regulatory Policy (ORP)
			Center for Drug Evaluation and Research (CDER) | FDA



Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS CONFERENCE

In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal 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.

In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations). FDA will also provide a discussion of registration and listing requirements, and how they pertain to the drug amount reporting program. The event will also include industry presenters, who will provide feedback regarding the drug amount reporting program. Conference participants will also have an opportunity to ask questions during question-and-answer sessions.

TOPICS COVERED:

Scope and purpose of drug amount reporting
	Connection between drug registration and listing requirements and section 510(j)(3) reports (including with respect to contract manufacturer reporting)
	Who in the supply chain is required to submit section 510(j)(3) reports
	Recommendations for how to report drug amount data, including for:
	non-US manufactured drugs
		private label distributed drugs
		multi-level packaged drugs
		applicant submitting report on behalf of a registrant
	Scenarios presented by industry regarding the drug amount reporting program

INTENDED AUDIENCE

Registrants (including contract manufacturer registrants) of listed drugs, including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs. The types of listed drugs also include medical gases, homeopathic products, over-the-counter drugs, and animal drugs.

FDA RESOURCES

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance
	Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
	Proposed Order: Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
	NextGen Portal
	https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-miti
	drugamountreporting@fda.hhs.gov

                                                                                  Content current as of:
      03/23/2023
         
                   
Regulated Product(s)
		 DrugsMore Meetings,
      Conferences, and
      Workshops
        
        News & Events for Human Drugs

          
                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop