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 In this section:

                Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act (DSCSA)

                        Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen
          Drug Supply Chain Security Act Law and Policies
          Drug Supply Chain Security Act Public-Private Partnership
          The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
          Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
          Drug Supply Chain Security Act Public Meetings
          Drug Supply Chain Security Act Webinars and Presentations
          Pharmacists: Utilize DSCSA Requirements to Protect Your Patients
          What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
          Drug Supply Chain Security Act Resources for State Officials Home
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          Drug Supply Chain Security Act (DSCSA)
          The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and ExemptionsDrug Supply Chain Security Act (DSCSA) The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
  
  	
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    PrintFDA has the authority under section 582(a)(3) of the Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), to grant waivers, exceptions, and exemptions from certain requirements in section 582 of the FD&C Act, as appropriate.

An authorized trading partner or other stakeholder may request a waiver, exception, or exemption from certain requirements related to product tracing, product identifier, authorized trading partners, and verification in section 582 of the FD&C Act.

All requests should be submitted through FDA’s CDER NextGen Portal, which can be found on the CDER NextGen Portal page.

FDA recommends following the processes outlined in FDA’s guidance to request a waiver, exception, or exemption from the requirements in section 582 of the FD&C Act: Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.  The guidance also describes a process whereby FDA intends to review and, as appropriate, renew certain waivers, exceptions, and exemptions on a biennial basis.

Please contact FDA at DSCSA-WEER@fda.hhs.gov if you have any questions.

**Frequently Asked Questions**

**When can I request a waiver from DSCSA requirements?**
			An authorized trading partner may request a waiver if the requirements would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act.**When can I request an exception from DSCSA requirements?**
			A manufacturer or repackager may request an exception to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with section 582 of the FD&C Act.**When can I request an exemption from DSCSA requirements?**
			An authorized trading partner or other stakeholder may request an exemption for other products or transactions from certain section 582 requirements to maintain public health or is otherwise appropriate.How do I submit a request for a waiver, exception, or exemption to FDA for CDER-regulated products?
			All requests should be submitted through FDA’s CDER NextGen Portal, which can be found on the CDER NextGen Portal page.

			For more information about the submission and FDA review process, review the guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.**FDA-Initiated DSCSA Exceptions or Exemptions**

Under section 582(a)(3)(A)(ii) and (iii) of the FD&C Act, FDA has established a process by which the Agency may determine certain products or transactions shall be excepted or exempt from certain requirements in section 582.  FDA establishes exemptions under section 582(a)(3)(A)(iii) on its own initiative where it determines that the exemption is appropriate to maintain public health or is otherwise appropriate.  FDA will communicate the information in writing using an appropriate method (e.g., a letter to the affected trading partners or, when addressing a broad segment of industry, a posting on the FDA website). An exception or exemption that is established by FDA may be limited in duration or valid until further notice from FDA.

**Date Issued**
			**Exception or Exemption**
			**Other Information**5/11/2023
			DSCSA Exemptions From Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products
			The U.S. Department of Health and Human Services (HHS) has announced that, based on current COVID-19 trends, HHS is planning for the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act to expire on May 11, 2023. In the Federal Register of March 13, 2023, FDA published a notice addressing the Agency’s COVID-19–related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the PHE.

                                                                                  Content current as of:
      08/03/2023
              
              
Regulated Product(s)
		 DrugsDrug Supply Chain Security Act (DSCSA)

          
                        Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen
          Drug Supply Chain Security Act Law and Policies
          Drug Supply Chain Security Act Public-Private Partnership
          The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
          Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
          Drug Supply Chain Security Act Public Meetings
          Drug Supply Chain Security Act Webinars and Presentations
          Pharmacists: Utilize DSCSA Requirements to Protect Your Patients
          What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
          Drug Supply Chain Security Act Resources for State Officials
 
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