THE DRUG COMPANY ATTACK DOG: THE FDA

THE FDA ATTACKS THE GENIUS OF CUSTOM,
CARING, BRILLIANT COMPOUNDING
PHARMACISTS -- THE ABSOLUTE BEST PHARMACISTS

International Academy of Compounding Pharmacists

October 19, 2004
FOR IMMEDIATE RELEASE

Contact: Patricia Paget
IACP
281-933-8400

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:

1. Compounding is legal. The Food and Drug Cosmetic Act (FDCA) of 1938 did not ban compounding. Congress intended, through enactment of sections in FDCA, to control human and veterinary drug manufacturers, not pharmacists or physicians who compound medications to treat unique patient needs.
2. The United States Pharmacopoeia (USP) and National Formulary (NF) both recognized the practice of compounding and have long included instructions for compounding as part of their compendia standards.
3. Colleges of Pharmacy continue to teach compounding to pharmacy students.
4. Kentucky law expressly authorizes and regulates pharmacy compounding, both for animals and humans; this is true for every other state.
5. Compounding for animals fills a critical need. Compounding drugs for non-food animals is necessary because there are often no approved animal drugs in the necessary dose or dosage form to treat the condition.

"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. www.iacprx.org/litigation.html.

About IACP:
The International Academy of Compounding Pharmacists (IACP) is an international, non-profit association established in 1991 to protect, promote and advance the art and science of compounding custom medications. IACP provides support to more than 1,800 members through programs and services including reimbursement/third-party advocacy, government representation, regulatory analysis, public relations support, referral services, literature searches, and a fellowship program. For more information, visit www.iacprx.org.