Dear David,
The content of the package label for a biologic is found in 21 CFR 610.61.
If a preservative is used, it must be included on the label with
its concentration.
If an excipient is a k
nown sensitizing substances it must be included (or reference to an enclosed circular containing appropriate information).
Inactive ingredients must be included when considered to be a safety factor (or reference to an enclosed circular containing appropriate information).
The adjuvant, if present.
Other than this, excipients need not be included on the package label.
Please let me know if I can be of further assistance.
Sincerely yours, Suzanne
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Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
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Original Message:
Sent: 28-Apr-2017 15:08
From: David Lucking
Subject: Carton Label for Pre-filled Syringe Containing Biologic
Dear Readers,
Must the carton of a pre-filled syringe containing a biologic list the QUANTITATIVE composition of the excipients?
Thank you.
Best regards,
David Lucking
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David Lucking
FL
United States
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