New Jersey Board of Pharmacy Reminds pharmacists: "The compounding of domperidone without utilizing FDA’s Expanded Access IND program is a direct violation of Board regulations N.J.A.C. 13:39-7.5, N.J.A.C. 13:39-6.2(f)(9), and N.J.A.C. 13:39-4.18(a) and may result in the Board imposing disciplinary action against pharmacies and pharmacists participating in this unauthorized activity."

Compounding of Domperidone It has come to the Board’s attention that some pharmacists may be compounding domperidone. According to FDA, domperidone is currently not approved for human use in the United States. Although there are restrictions on domperidone, FDA recognizes that there are patients with severe gastrointestinal motility disorders refractory to standard treatment who might benefit from domperidone and in whom the benefits of the drug may outweigh its risks. Domperidone is currently available to these patients through FDA’s Expanded Access to Investigational New Drug (IND) program. This Expanded Access IND program ensures that the appropriate safeguards are in place to protect patients treated with domperidone from the drug’s serious adverse effects, including QT prolongation and cardiac arrhythmias. Information on this Expanded Access IND program can be found at http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/HowDrugsAreDeveloped andApproved/ApprovalApplications/InvestigationalNew DrugINDApplication/ucm368736.htm. The compounding of domperidone without utilizing FDA’s Expanded Access IND program is a direct violation of Board regulations N.J.A.C. 13:39-7.5, N.J.A.C. 13:39-6.2(f)(9), and N.J.A.C. 13:39-4.18(a) and may result in the Board imposing disciplinary action against pharmacies and pharmacists participating in this unauthorized activity.

source New Jersey Board of Pharmacy April 2016 Newsletter