The only FDA regulation related to labeling an investigational product is the "Caution: New Drug--Limited by Federal (or United States) law to investigational use" (21 CFR 312.6). However, best practice is to include additional information that includes the protocol number, instructions for use, storage conditions, expiration date or shelf life, etc. The most important consideration in my thinking is whether the potential for adverse reaction can be evaluated if the study subject ends up unconscious in an emergency room and they have to find out what medication the subject is taking and whether it requires an antidote. There should be some indication of how to contact the investigator or Sponsor, with or without the protocol number.
------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------
Original Message:
Sent: 14-Aug-2019 11:31
From: Anonymous Member
Subject: IND Label for USA clinical study-question!
This message was posted by a user wishing to remain anonymous
For a phase 2-4 studies conducted in the USA, does the Protocol Number have to be printed on the IP label? I don't see a regulation that specifies this requirement? Thanks so much!