Compliance background
Core module Odoo Enterprise: Quality app 3PL add-on For: Administrator, Compliance manager
The public sources behind the Rx Tracking features, listed by topic: the sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA), and the FDA documents about them. Each topic also links to the part of this manual that describes what the modules do. The pages of this manual cite these topics where they explain why a feature exists.
This page lists sources; it doesn't explain or interpret them. The list is how the publisher of the modules matched each topic to its sources; the section numbers and documents have not been checked at the source, and the matching has not been reviewed by counsel. See the disclaimer.
The Act's sections named below, in the United States Code:
- FD&C Act § 581, definitions: 21 U.S.C. 360eee
- FD&C Act § 582, requirements for trading partners: 21 U.S.C. 360eee-1
- FD&C Act § 584, national standards for third-party logistics providers: 21 U.S.C. 360eee-3
Timeline
Sources:
- FD&C Act § 582(g)(1)
- FDA, Exemptions under the Drug Supply Chain Security Act
- FDA, exemption letter of 2024-10-09
- FDA, exemption letter of 2026-08-06
In the modules: DSCSA documents, and Ship at lot level to an exempt small dispenser.
Authorized trading partners
Sources:
- FD&C Act § 582(c)(3) and § 581(2)
- FD&C Act § 584(a) and (b), for third-party logistics providers
- FDA, Identifying Trading Partners Under the Drug Supply Chain Security Act, revised draft guidance (2022)
- FDA, public database of wholesale distributor and third-party logistics provider reports
In the modules: Authorized trading partners and the gates, and Record and verify a trading partner's license.
Receiving
Sources:
- FD&C Act § 582(c)(1)(A)(i) and § 582(g)(1)
- FDA, interoperable exchange guidance (September 2023)
- FDA, package-level enhanced drug distribution security guidance (August 2023)
In the modules: Receive in the core guide.
Shipping
Sources:
- FD&C Act § 582(c)(1)(A)(ii) and (iii), and § 582(g)(1)(A) and (B)
- FD&C Act § 581(22), (24), (26) and (27)
In the modules: DSCSA documents, and Ship in the core guide.
Returns
Sources:
- FD&C Act § 582(c)(1)(B) and § 582(c)(4)(D)
In the modules: Returns in the core guide.
Suspect product
Sources:
- FD&C Act § 582(c)(4)
- FDA, Identification of Suspect Product and Notification, guidance (June 2021)
- FDA, Notify FDA of illegitimate products (Form FDA 3911)
In the modules: Quarantine and holds, and the Suspect product guide (Odoo Enterprise).
Records
Sources:
- FD&C Act § 582, its record-keeping provisions
In the modules: Records in the core guide, and Records that are kept.
3PL and title
Sources:
- FD&C Act § 581(6), (22), (24), (26) and (27)
- FD&C Act § 582(a)(1) and (a)(7)
- FD&C Act § 584(d)
In the modules: Owner stock and own stock, and The title model.
Trace requests
Sources:
- FD&C Act § 582, its provisions on requests for information
In the modules: Log a trace request from the FDA, a state or a trading partner, and Trace requests with owners.
3PL facility
Sources:
- FD&C Act § 584(a), (b) and (d)
- FDA, Annual licensure reporting by wholesale drug distributors and third-party logistics providers
- FDA, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers, guidance
In the modules: Facility compliance records in the 3PL guide.