Description
This guidance is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). Requirements for enhanced drug distribution security, commonly referred to as the “enhanced system” go into effect on November 27, 2023.
Scope & Applicability
Product Classes
2Finished dosage form for administration to a patient
Product returned to a trading partner that is intended for further distribution
Stakeholders
6Entity that may provide notification regarding illegitimate product.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Trading partner defined in section 581(16) of the FD&C Act
Entity required to verify saleable returned product.; Required to verify product identifier for saleable returned product
Entity required to verify product identifier of suspect or illegitimate product.; Must verify product identifiers when investigating suspect or illegitimate product
Entity meeting conditions specified in section 581(23)
Regulatory Context
Attributes
3Smallest individual saleable unit of product
Refers to centralized, distributed, or semi-distributed models for data storage
Required label element for outsourcing facilities
Identified Hazards
Hazards
2Product where physical security features have been compromised; product for which there is reason to believe it is potentially counterfeit, diverted, or stolen; Product that is subject to investigation and verification
Subject of investigation by FDA or state officials; product for which there is credible evidence that it is counterfeit, diverted, or stolen; Product that requires verification and response to officials
Related CFR Sections (1)
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
See Also (8)
- Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry (Status: Final)
- Master Files Part III - Guidance on Scientific and Technical Information (Status: Final)
- Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (Status: Final)
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry (Status: Final)
- Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)