Regulatory Open Forum

Ladies and Gentlemen,

I hope everyone is safe and doing well.  I was hoping you could help me with advice regarding the labeling of convenience kits.  I have been asked to look into it, and the guidance documents seem fairly straightforward.  But when you kit do you put a consolidated package insert, individual inserts per product?  I have the same question for the actual label or labels for the kit.  Any guidance or examples would be appreciated.

Respectfully,

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William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
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Original Message:
Sent: 9/18/2020 9:28:00 AM
From: William Coulston
Subject: Labeling and Convenience Kits

Ladies and Gentlemen,

I hope everyone is safe and doing well.  I was hoping you could help me with advice regarding the labeling of convenience kits.  I have been asked to look into it, and the guidance documents seem fairly straightforward.  But when you kit do you put a consolidated package insert, individual inserts per product?  I have the same question for the actual label or labels for the kit.  Any guidance or examples would be appreciated.

Respectfully,

------------------------------
William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
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As a general principle, think about what the kit users​ need to know, when they're looking at a row of kits on a shelf, or when they've just opened a kit to do something with it.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 19-Sep-2020 12:04
From: Joy Frestedt
Subject: Labeling and Convenience Kits

Hello William Coulston

For convenience kitting in the US, best to keep all labeling intact as provided for each item without change and all required component labeling should be included as part of the kit. We do not recommend any labeling changes to individual kit components (e.g. to consolidate labeling, etc. since these types of labeling changes are expected to increase regulatory risk beyond simply kitting together "Intact" components for convenience). In addition, the CONVENIENCE KIT labeling WHICH IS BEING CREATED NEW FOR THE KIT ITSELF needs to meet the various guidance documents to have a complete list of components, INCLUDING intact labeling, use information, expiration dating for each component, etc.

Joy Frestedt,PhD, CPI, RAC, FRAPS, FACRP

President and CEO

Frestedt Inc.

Sent from my iPhone

Sent from my iPhone

Original Message:
Sent: 9/18/2020 9:28:00 AM
From: William Coulston
Subject: Labeling and Convenience Kits

Ladies and Gentlemen,

I hope everyone is safe and doing well.  I was hoping you could help me with advice regarding the labeling of convenience kits.  I have been asked to look into it, and the guidance documents seem fairly straightforward.  But when you kit do you put a consolidated package insert, individual inserts per product?  I have the same question for the actual label or labels for the kit.  Any guidance or examples would be appreciated.

Respectfully,

------------------------------
William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
------------------------------