Your confusion is completely understandable, Susan. It truly is confusing.

Have a look at my early post which addresses your first two scenarios. Those are drugs that are FDA approved for some use - therefore have a label - and are prescribed for a use other than the FDA approved use. That is the definition of "off-label." Happens all the time and carries with it some liability risk but isn't unlawful in and of itself. Never having been approved for *any* use in the US, Domperidone has no label, therefore can't be said to be prescribed "off-label." Can't legally be prescribed at all.

Concerning compounding pharmacies, there was a legal battle fought and won by the FDA relatively recently. What you probably heard about at a conference was a case brought in Texas by several compounding pharmacies challenging the FDA's authority to regulate and sanction them. I am sitting in my car on my iPad so don't have access to the case itself but I do have copies of all these cases on my hard drive at home. In, I think, 2006, there was a federal district court opinion that was partially in favor of the compounding pharmacies. I don't recall the holding precisely (none of it concerns domperidone specifically) but it was very unclear. Regardless it was used by many in the lactation community to assert that the court had decided the FDA could not regulate compounding. I don't think that is really the holding but the point is now moot. The case was appealed to the circuit court and in 2008 the arguably pro-compounding pharmacies holdings were reversed. That final court decision (there was no appeal or if there was the Supreme Court didn't take it) is *extremely* dull and frankly coma-inducing. Dense stuff about regulatory schemes and antitrust. But in there is also the holding that when a compounding pharmacy makes a drug from constituent parts (rather than changing the form, like solid to liquid, or dosage, like very small doses for children) it is indeed engaged in manufacture and regulation of pharmaceutical manufacture is indeed legally within the purview of the FDA. So, no, compounding pharmacies can't manufacture drugs approved by the FDA because then they run into the ownership rights of the patent holders and can't manufacture *unapproved* drugs, like domperidone, because it is unlawful per the FDA and a myriad of federal and state laws governing drug manufacture.

Okay, so if you are still with me ;) since that ruling, the FDA has done virtually nothing to sanction compounding pharmacies other than send out warning letters which you can find by sticking "domperidone" into the tragic excuse for a search engine on the FDA site. So indeed, compounding pharmacies do make domperidone because neither the FDA nor state authorities are doing anything about it. But it isn't legal.  

A bit more clear? :)

Yours,
Jake 





__________
Jake, 
I am confused.  I could perhaps be misremembering what I heard at a conference.  What I understood from that conference is:

* a huge proportion of drugs prescribed by pediatricians for use in infants and young children are not specifically FDA approved for that purpose
* many of the drugs prescribed for fertility treatments are not specifically FDA approved for that purpose
* that compounding pharmacies are legally allowed to compound and dispense domperidone -- and while the FDA doesn't like it, they lost the fight over controlling compounding pharmacies

There are several MDs, including a breastfeeding medicine specialist who do prescribe domperidone in our area.

Has there been some battle that was won by the FDA that I am unaware of? And are they now going to crack down on pediatricians who prescribe the many drugs that have not gone through thorough trials in infants and young children? 

Best regards, 

Susan Burger, MHS, PhD, IBCLC

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