OMB.report

Federal forms, ICRs, and supporting documents

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 can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Form
Supporting Statement A
All Historical Document Collections
 Reinstatement with change of a previously approved collection 2025-05-02
Approved without change
 Revision of a currently approved collection 2022-01-26
Approved without change
 Extension without change of a currently approved collection 2018-12-06
Approved without change
 New collection (Request for a new OMB Control Number) 2015-09-21
OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-productsInstruction
Form 3911Drug Notificationwww.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-productsForm

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