Per drug cGMP (21 CFR 201.100(c)(1)), such labeling must be "on or within the package from which the drug is to be dispensed" including "adequate information for its use." (I presume based on the wording and reference to "USPI" that this is a drug/biologic-led combination product - device-led combination products would reference different regulations.)
FDA did propose electronic distribution of prescribing information in 2014 (which was never implemented and has been the subject of pushback from Congress to prevent its implementation), however the proposal "would not apply to patient labeling (including patient package inserts and Medication Guides)" so this proposal would not have applied to an IFU (intended for a patient) anyway.
Note that manufacturers are welcome to supplement physical labeling with electronic information - websites (and, potentially QR codes) can be added to the paper document, however per regulation the paper copy must still be provided.
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Jonathan Amaya-Hodges
Sr. Principal Consultant
jamaya-hodges@suttonscreek.comSuttons Creek, Inc.
United States
https://suttonscreek.com/------------------------------
Original Message:
Sent: 15-Feb-2022 17:34
From: Anonymous Member
Subject: IFU - FDA acceptance for QR codes
This message was posted by a user wishing to remain anonymous
In the US, where a patient IFU is required, in addition to a package insert?
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/instructions-use-patient-labeling-human-prescription-drug-and-biological-products-and-drug-device
Expectations may be different for professional users. The goal is to make the necessary information available at the time and place it's needed.
Original Message:
Sent: 15-Feb-2022 08:10
From: Anonymous Member
Subject: IFU - FDA acceptance for QR codes
This message was posted by a user wishing to remain anonymous
Hello,
Could you please advise whether it is accepted to have the IFU for a combination product as a QR code printed on the USPI or on the outer carton rather than having it as a standalone printed document included in the box?
Thanks