OMB control number

Pharmaceutical Distribution Supply Chain

OMB 0910-0806 · HHS/FDA.

OMB 0910-0806

This information collection implements the Drug Supply Chain Security Act. Manufacturers, repackagers, wholesale distributors, and dispensers must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate or if a manufacturer when they determine that a product has a high risk of illegitimacy; (2) terminate such notifications after consultation with FDA; (3) notify certain immediate trading partners about an illegitimate product or if a manufacturer about a product with a high risk of illegitimacy; and (4) notify immediate trading partners when such notifications are terminated.

The latest form for Pharmaceutical Distribution Supply Chain expires 2028-08-31 and is listed under ICR 202407-0910-009.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form 3911 Documenting transaction information	Form
0806 Drug Supply Chain SSA 2025 REV.docx	Supporting Statement A
Verification - ID & investigate suspect products; coordinate w/trading partners	Other-21 USC 360eee-1(a)(3)
Product ID & info. exchange w/authorized trading partners	Other-Agency Guidance
Disclosing illegitimate products: notifications to trading partners	Other-Agency Guidance
Documenting transaction information	Form
Reporting: Notifications to FDA; including requests for waiver, exception, or exemption	Other-21 USC 360eee-1

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202407-0910-009	Reinstatement with change of a previously approved collection	2025-05-02
202107-0910-010	Revision of a currently approved collection	2022-01-26	Approved without change
201812-0910-001	Extension without change of a currently approved collection	2018-12-06	Approved without change
201509-0910-006	New collection (Request for a new OMB Control Number)	2015-09-21	Approved without change

OMB Details

Reporting: Notifications to FDA; including requests for waiver, exception, or exemption

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
Form		www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products	Instruction
Form 3911	Drug Notification	www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products	Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.