The voice for compounding pharmacy  |  August 27, 2019

USP has rejected three appeals by compounding pharmacy groups, including one to which IACP was a party, regarding beyond-use date restrictions in the new <795> and <797> chapters set to take effect December 1.  Read USP's response here.
 
"USP's response fails to address the lack of scientific basis for the BUD restrictions they are imposing, and thus is insufficient," said IACP's Executive Vice President Scott Brunner, CAE. "We are working with our coalition partners to determine next steps, including requesting a hearing, which is the proper next step under USP's bylaws."
 
You can read the appeal here. Also, you'll find our member briefing on the <797> BUD extension issue here.

Want to be helpful? Read on...
CALL TO ACTION: USP <795> and <797> BUD Restrictions
We seek your immediate help in seeing that expert input and perspective are shared with USPC in advance of the expected hearing. USPC needs to hear from you, your state pharmacy association, and -- perhaps most importantly -- your state board of pharmacy.

ASAP, PLEASE:
  1. Contact your state board of pharmacy, alert them to the problems with the new chapters, and urge them to write to USPC to share their concerns.
  2. Email USPC yourself: [email protected].
  3. Urge your state association to write to USP, too.
  4. Educate your patients and other stakeholders about our concerns. Utilize your social media channels, and don't forget to tag USPC. It's @USPharmacopeia. (Tag IACP, too: @iacpRx.)
To help, here's a briefing paper you can adapt into a letter if you wish.
 
Together, we can make a big difference for your compounding members and patients they serve.

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