THE DRUG COMPANY ATTACK DOG: THE FDA
International Academy of Compounding Pharmacists
October 19, 2004
IACP Files Amicus Brief on Behalf of Compounding Pharmacy
HOUSTON, TX - The International Academy of Compounding Pharmacists (IACP), a non-profit organization that advocates on behalf of pharmacists who prepare customized medications, filed an Amicus Curiae brief in a district case on behalf of a Kentucky pharmacy that is charged with unlawfully compounding medications for animals.
IACP's amicus brief refutes the FDA seizure of BET pharmaceuticals as it was based on "the erroneous argument that the compounding of veterinary drugs from bulk active ingredients is illegal because they result in unapproved new drugs which must go through the FDA approval process" and goes on to state that the court should "reject that argument and grant the Motion to Dismiss."
The brief provides important points in an effort to refute FDA's claim against BET that compounded drugs are subject to new animal drug applications (NADA). IACP demonstrates that:
"It is essential that the FDA recognize compounded medications are a vital component of the healthcare industry," said IACP President Eric Vidrine. "In declaring that compounded medications are subject to the NADA process, FDA is effectively stating they are illegal."
Friend of the court briefs provide valuable information about legal arguments, or how a case might affect people other than the parties to the case.
For a copy of IACP's brief, visit www.iacprx.org/pdf/BET_amicus_brief.pdf.