Identifying Trading Partners Under the Drug Supply Chain Security Act | Guideline Explorer

Description

The Food and Drug Administration (FDA or Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance revises the Agency’s draft guidance for industry Identifying Trading Partners Under the Drug Supply Chain Security Act (August 2017) to address the status of some entities as trading partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics providers), provide clarification on certain drug distribution scenarios, and address the interpretation of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which discusses third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards. The DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” Additionally, the DSCSA requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and 3PLs. The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how certain DSCSA requirements apply to entities that are considered trading partners in the drug supply chain.

Scope & Applicability

Stakeholders

10

Manufacturer

Entity responsible for submitting NDINs

Common Carrier

Entity providing transportation services only

Broker

Entity in the supply chain between the receiving facility and the supplier

Jobber

Considered a wholesale distributor if engaging in small scale distribution

Investigator

Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining

Repackager

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute

Wholesale Distributor

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to verify product identifiers with manufacturers; must maintain systems for disposition; must first verify that the product identifier imprinted upon or affixed to the package

Dispenser

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner such as a pharmacy required to verify at least 3 packages or 10 percent of suspect product; must identify and quarantine illegitimate product; may return product, saleable and non-saleable, to the trading partner

Third-party logistics provider

Entity that provides resources for the distribution of a product but does not take ownership.; Entity providing warehousing or logistics services without taking ownership of the product.; Entity providing logistics services without taking ownership of product; Defined as entities providing warehousing or logistics services; Provides warehousing or logistics services without taking ownership

Private Label Distributor

Entity whose status as a trading partner is addressed in the guidance.; Entity that owns and distributes product under its own label but does not manufacture

Regulatory Context

Attributes

1

Minimal Quantities

Total annual dollar volume not exceeding 5 percent of sales

Identified Hazards

Hazards

1

Emergency Situation

Acutely ill or injured persons requiring drugs

Related CFR Sections (2)

21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
21CFR203.3§ 203.3 Definitions.
(a) The act means the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. 301 et seq. ).Read full regulation →

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