The latest update on USP 797 standards

The College’s Advocacy Council recently attended a call convened by the American Medical Association (AMA) with the physician community on compounding issues. AMA staff reported on a recent meeting with Food and Drug Administration (FDA) leadership on the FDA Guidance on Insanitary Conditions. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, stated the FDA does not intend to regulate physician offices unless there is evidence of egregious activity and that its current guidance, which states that physician office compounding for administration to patients is not within the scope of the FDA’s regulatory initiative, will remain in place. This allays concerns that the compounding pharmacy organizations were attempting to push the FDA in a different direction.  

Regarding USP, the Dec. 1 effective date for the new Chapter 797 rules has been delayed while USP deals with appeals from compounding pharmacy organizations who have raised concerns about beyond-use-dates and other technical issues. It does not appear that those issues would impact the allergy provisions in the new USP standards. USP does not have a new effective date at this time. There is some concern that the postponement could create problems at the state level, where states have incorporated the new USP 797 rules into their regulations. The Advocacy Council will continue to keep you updated on this issue. The Advocacy Council – we have you covered.

Advocacy Issue: 
Mixing Allergen Extracts