DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND).

Statement from the North Carolina Board of Pharmacy found here:
TUESDAY, AUGUST 14, 2012
DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND). Board staff have received calls and questions about the compounding of domperidone. Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. The FDA has long provided clear guidance on this point, which may be found here: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm073070.htm

As FDA’s information further states, "FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women." Domperidone may be useful for "some patients with severe gastrointestinal disorders . . . that are refractory to standard therapy." A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). An FDA-authorized IND would "allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S."
Pharmacists are expected to conform their conduct to these legal requirements.