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December 29, 2016
FDA 11th-Hour Guidance on Compounding

As we shared with the Trump transition team and with Congress earlier this month, the AAAAI has been watching for an 11th-hour action from the Food and Drug Administration (FDA) regarding compounding. We have been particularly concerned about any further action on the August 2016 draft guidance entitled “Insanitary Conditions in Compounding Pharmacies” that suggested that state boards of pharmacy should enforce extreme standards on physician offices by, inexplicably, applying them equally to physician offices as to commercial compounding manufacturing facilities.  
 
The FDA issued a final guidance yesterday afternoon on compounding, focused on prescription requirements. While the final guidance does specifically include physician in-office compounding, it does not appear to reflect the overreaching approach taken in the “Insanitary Conditions” document. Yesterday’s finalized guidance on prescription requirements acknowledges that compounding in the physician’s office reflects a physician/patient relationship. It requires that the patient’s individual prescription needs to be documented, with the patient’s name, in the patient’s medical record. While we recommend that you review the document for yourself, we are pleased to tell you that we find it encouraging.
 
We are hopeful that this finalized guidance reflects an appreciation for the importance of our ability to provide safe and effective patient care by preparing allergen extract in our offices. Meanwhile, we will certainly continue to remain vigilant for any additional 11th-hour FDA regulations, but we are pleased to share with you what we see as an encouraging step from the FDA.
 
You can read the final guidance, Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act, here:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496286.pdf


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