DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Government Regulation Guidelines as Topic Information Dissemination Legislation, Drug Prescription Drugs -- standards United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance is issued subject to sections 582(h)(4)-(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(h)(4)-(5)), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). In November 2014, FDA issued a draft guidance for industry, titled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information, as required by section 582(a)(2)(A) of the FD&C Act. In July 2022, FDA issued a revised draft guidance for industry, titled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, that updated the policies articulated in the 2014 draft guidance. This guidance finalizes the policies articulated in the July 2022 revised draft guidance to reflect the enhanced drug distribution security requirements in section 582(g)(1) of the FD&C Act that will go into effect on November 27, 2023, including that only electronic methods of product tracing will be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies. It also makes certain changes to improve clarity. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (9 unnumbered pages))
- NLM Unique ID:
- 9918716788506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716788506676