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News & Press: Breaking News

Ask Your Senators to Sign onto the Paul/Brown Letter to the FDA on Biologic Repackaging by July 8th!

Monday, July 06, 2015   (0 Comments)
Posted by: Dagmar Anderson
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Member Alert


Deadline Extended - Contact your Senators by Wednesday, July 8th!


Ask them to sign on to the Paul/Brown letter to the FDA on Biologic Repackaging.

In May, IACP filed formal comments with the Food and Drug Administration in response to proposed industry guidance that severely limited the repackaging of biologics by pharmacists. As part of our efforts during the recent Compounders on Capitol Hill event, the House of Representatives issued a bipartisan letter of concern to the FDA about the very restrictive nature of that guidance document and the impact it would have on patients as well as practitioners. Their comments and concerns mirror those of IACP.

Of particular concern to us are the following components of the guidance document:

•    A pharmacy may repackage a biological in advance of receiving a prescription – but may only dispense based upon receipt of either the individual patient prescription or the written order in the patient’s chart.


•    Repackaging of biological in single-dose vials must be done in accordance with the FDA approved product labeling.  For example, Avastin® may be repackaged into smaller units if other sections of the labeling including diluents and storage conditions are met.


•    For §503A compounders:  repackaged biological will have a 4-hour or less BUD or up to a 24-hour BUD if a microbial challenge study has been completed in accordance with specified requirements.

Senators Rand Paul (R-KY) and Sherrod Brown (D-OH) drafted a similar letter, and IACP is working to gain as main additional cosignatories from other Senators as possible. Please click here to view this letter.

What Can You Do To Help?


Please contact your Senators today and ask them to sign on to the Paul/Brown letter to the FDA on Biologic Repackaging. If your Senator is willing to add his or her signature to this important statement, their staff can contact in Senator Paul's office or in Senator Brown's office.


Drop IACP a Line


Once you've had a chance to contact your Senators, please let IACP know by emailing us at

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