Regulatory Open Forum

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

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Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
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Hi Gloria.

My first thought on this is that either "Federal" or "United States" would be acceptable provided that the product does not leave the jurisdiction of the US FDA.  If it goes to international cites, then you might be best to have the term "United States" in your caution statement.

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Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
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Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------

Hi Gloria,

It is acceptable to use either "Federal" or "United States" in the investigational caution statement.  You don't need to have both.  For multinational studies that include sites outside the US, I prefer "United States", as it is more specific than "Federal".

Julie

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Julie Broderick
Broderick Regulatory Consulting, LLC
Winchester MA
United States
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Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------

Gloria,

Whenever I read and interpret statutory or regulatory provisions, I try to exercise judgment in a way to be the best (e.g., what is OK is not the same as what is the best).

As for your question, if you look at the way it is written, it states "Caution: New Drug Limited by Federal (or United States) law to investigational use."

What should be best is to use exactly as it is without being creative or modifying the Caution statement in any way.  

David

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------

Julie Broderick is correct - one or the other but it is not necessary to use both for products distributed in the US.
If the product leaves the US, be careful, though because if it is in another Federation, the user would think you are referring to that federal law. Of course, if it leaves the US, you probably need to comply with that jurisdiction's label requirements in any event and you would require a different label.

This represents my experience as a RAPS Fellow and instructor, and I am not speaking as an FDA employee.

Good luck!

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Andrea Chamblee RAC, FRAPS
Adjunct Professor, Johns Hopkins University
Silver Spring MD
United States
-------------------------------------------


Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------

FYI:

For those in medical device industry, there is an FDA guidance on this question.  You may refer to http://www.regulatorydoctor.com/preparing-notices-of-availability-of-investigational-medical-devices-and-for-recruiting-study-subjects/

FDA clarifies how the availability of investigational medical devices should be made including "Caution" statement.

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 09-30-2014 08:21
From: Andrea Chamblee
Subject: Investigation Product Labels- CFR compliant statements

Julie Broderick is correct - one or the other but it is not necessary to use both for products distributed in the US.
If the product leaves the US, be careful, though because if it is in another Federation, the user would think you are referring to that federal law. Of course, if it leaves the US, you probably need to comply with that jurisdiction's label requirements in any event and you would require a different label.

This represents my experience as a RAPS Fellow and instructor, and I am not speaking as an FDA employee.

Good luck!

-------------------------------------------
Andrea Chamblee RAC, FRAPS
Adjunct Professor, Johns Hopkins University
Silver Spring MD
United States
-------------------------------------------


Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------

If the product in question is referring to US Federal law 21CFR ... It is an implied statement and (or US law) can be dropped. In the USA the term Federal Law is the highest governing authority.

The term US law can also mean state law. Fedreal laws override state laws of the same subject matter. Here again, when referring to 21CFRs...those are Federal law which pertain to governing Authorities (i.e. Federal Food & Drug Admistration)

Hope this helps.
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Penny Houston
Regulatory Affairs Project Manager
Wright Medical Technology
Memphis TN
United States
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Original Message:
Sent: 9/30/2014 8:21:13 AM
From: achamblee@yahoo.com
Subject: RE: Investigation Product Labels- CFR compliant statements

Julie Broderick is correct - one or the other but it is not necessary to use both for products distributed in the US. If the product leaves the US, be careful, though because if it is in another Federation, the user would think you are referring to that federal law. Of course, if it leaves the US, you probably need to comply with that jurisdiction's label requirements in any event and you would require a different label. This represents my experience as a RAPS Fellow and instructor, and I am not speaking as an FDA employee. Good luck! ------------------------------------------- Andrea Chamblee RAC, FRAPS Adjunct Professor, Johns Hopkins University Silver Spring MD United States -------------------------------------------
Original Message: Sent: 09-26-2014 07:56 From: Gloria Miller Subject: Investigation Product Labels- CFR compliant statements Is is acceptable to drop the (or United States) and just use Federal in the caution statement? When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law? ------------------------------------------- Gloria Miller RAC QA Senior Auditor Premier Research Wilmington NC United States -------------------------------------------

Note the EU requirements from Annex 13 of the GMP directives for labeling of investigational products;
 

Key is the "for clinical trial use"; if this is a US study then include US, if this is a global study, drop the US use Federal for a global label. I have had success globally with this language.  Alternatively, ex-US is OK with investigational use rather than for "Clinical trial use Only", note "or similar wording" in the above section (h).

Dar
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Darlene Rosario, BS, MBA, RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 09-30-2014 08:21
From: Andrea Chamblee
Subject: Investigation Product Labels- CFR compliant statements

Julie Broderick is correct - one or the other but it is not necessary to use both for products distributed in the US.
If the product leaves the US, be careful, though because if it is in another Federation, the user would think you are referring to that federal law. Of course, if it leaves the US, you probably need to comply with that jurisdiction's label requirements in any event and you would require a different label.

This represents my experience as a RAPS Fellow and instructor, and I am not speaking as an FDA employee.

Good luck!

-------------------------------------------
Andrea Chamblee RAC, FRAPS
Adjunct Professor, Johns Hopkins University
Silver Spring MD
United States
-------------------------------------------


Original Message:
Sent: 09-26-2014 07:56
From: Gloria Miller
Subject: Investigation Product Labels- CFR compliant statements

Is is acceptable to drop the (or United States) and just use Federal in the caution statement?
When confirming an investigational product label's 21 CFR 312.6 compliance: the label should read: "when confirming label's 21 CFR 312.6 compliance: the label should read: "Caution: New Drug Limited by Federal (or United States) law to investigational use."." Is is acceptable if it just reads "Caution: New Drug Limited by Federal  law to investigational use." or if it leaves of Federal and just uses "or United States law?

-------------------------------------------
Gloria Miller RAC
QA Senior Auditor
Premier Research
Wilmington NC
United States
-------------------------------------------