March 28, 2024

Yes, we’re reviewing that ‘demonstrably difficult’ proposed rule

It’s been breathlessly anticipated for months, and this week it finally published: an FDA proposed rule regarding the Demonstrably Difficult to Compound list.  

First: It does not restrict compounded hormone therapy, as some feared it might. FDA CDER OCQC Director Gail Bormel had hinted in comments at last years’ Compounders on Capitol Hill event that the rule would not affect compounded hormones. (But that sure doesn’t mean the threat to restrict compounded hormone therapy has gone away.)

So: The proposed rule would classify as “demonstrably difficult to compound” three particular types of compounding: oral solid modified-release drug products that employ coated systems; liposome drug products; and drug products produced using hot melt extrusion. 

APC is still evaluating the proposed rule, in particular the six criteria the FDA indicates it will use to evaluate inclusion of additional substances on the Demonstrably Difficult to Compound List. Stay tuned.