Re: Rule Change at FDA would raise compounded drug prices by 300% or more #legalityofpergolide
Here is the FDA document: https://www.fda.gov/media/132567/download . It was published in November of last year.
Several important points: This is a guidance document which means it tells the industry how the FDA thinks they should proceed. It is not a law and is nonbinding.
Secondly, this is nothing new. It is not a new rule. There is nothing pending in Congress. As the document explains, existing laws can be interpreted to prohibit compounding from bulk drugs when an FDA approved drug already exists. This has come up multiple times on this list [#legalityofpergolide]. Two state level district courts have ruled against the FDA on this issue in the past. Those rulings are only binding within their jurisdictions but it does not bode well for the FDA attempting to enforce their opinion .
At this point it's a matter for the courts to decide unless Congress was to pass a clarifying modification to the existing laws. In the meantime, the best we can hope for is that the FDA will look the other way. There is little to no chance they will ever change their guidance document.
Eleanor in PA