Description
This guidance elaborates on the standards for the interoperable exchange of transaction 16 information, transaction history, and transaction statements required by section 582 of the 17 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1). Section 582 was 18 added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and 19 facilitates the tracing of products through the pharmaceutical distribution supply chain by 20 requiring trading partners ( manufacturers, repackagers, wholesale distributors, and dispensers) 21 to exchange transaction information, transaction history, and transaction statements (referred to 22 collectively in this guidance as product tracing information) when engaging in transactions423 involving certain prescription drugs. This requirement took effect on January 1, 2015, for 24 manufacturers, repackagers, and wholesale distributors, and on July 1, 2015, for dispensers.
Scope & Applicability
Product Classes
6Finished dosage form for administration to a patient
Products that entered the pharmaceutical distribution supply chain before January 1, 2015
Products exempt from certain tracing requirements under section 582(a)(5)(B)
products subject to DSCSA tracing requirements
Regulated by CDER and CBER
Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
Stakeholders
10Entities subject to verification requirements for saleable returned 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
Entities considered trading partners but with specific requirement exemptions
Entities defined in section 581(23) of the FD&C Act involved in drug distribution
Entity that may provide notification regarding illegitimate product.
Responsible for declaring acceptable market names on labels.
responsible for assigning new NDC or lot numbers to repackaged products
Regulatory Context
Attributes
3The physical form of the drug product.
Entity having applicable registrations and licenses
defined in section 581(11)(B) of the FD&C Act
Identified Hazards
Hazards
1Product determined to be counterfeit, diverted, stolen, or unfit for distribution.
Related CFR Sections (2)
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR207.33§ 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
(a) What is the NDC for a drug and what products must have unique NDCs ? The NDC for a drug is a numeric code. Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Supergoop!
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
K & Care Organics
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Fallien Cosmeceuticals Ltd. dba Fallene Ltd.
- 2025-05-27
Failure to List/Misbranded
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
- 2025-04-29
Electronic Drug Registration and Listing System (eDRLS)/Violations
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
- 2025-02-18
CGMP/Finished Pharmaceutical/Adulterated
Jagsonpal Pharmaceuticals Limited
- 2024-10-22
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
Omni Lens Pvt. Ltd.
- 2024-08-20
Failure to Register and List
Media Networks Sydney Pty Limited
- 2024-04-23
Failure to Register and List
Zen Enterprises LLC
See Also (8)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (Status: Final)
- Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (Status: Final)
- Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for Industry (Status: Final)
- Nonproprietary Naming of Biological Products Guidance for Industry (Status: Final)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)