AABP bans bulk drug compounders


AABP bans bulk drug compounders

May 01, 2004
By dvm360.com staff

Rome, Ga.-The American Association of Bovine Practitioners (AABP) recently banned bulk drug compounders from any affiliation with the national association.

AABP says, "Businesses producing compounded products from bulk drugs for use in food animals will not be permitted any affiliation with the AABP."

Although compounding with Food and Drug Administration (FDA)-approved drugs is an accepted practice, federal law prohibits the compounding of unapproved drugs for use in food animals.

The association says its new policy will not allow businesses or organization that produce, advertise, promote and/or sell products compounded from bulk drugs for use in food animals to purchase a booth or exhibit at its convention or advertise in its publication.

Dr. Mark Spire, AABP president, says, "Illegal compounding and distribution of unapproved new animal drugs is a bane to the livestock industry. "At one time compounding had a place, as practitioners had a limited number of approved products to address legitimate medical concerns. Today there is limited need for compounding."

AABP says the ban includes only those individuals and organizations that engage in illegal compounding. But certain compounding is necessary. The association says, "Formulation of compounded preparations in limited amounts using drugs approved by the FDA is legal and at times necessary when the health of a livestock patient is at risk."

When a specific need arises, veterinarians can prescribe other FDA-approved drugs on an extra-label basis, according to the Animal Drug Use Clarification Act (AMDUCA).

Spire explains that it's a bad message for the industry.

"In a time when quality assurance and consumer confidence in the safety of food derived from livestock products are two of our greatest concerns, the use of facsimile products of federally approved products for whatever reason by veterinary professionals and producers alike is not justifiable. The risks are too great and the reward is too limited."

Illegal compounding, AABP says, circumvents the FDA-approval process and puts consumers and livestock at risk.

Drug concentrations in illegally compounded products are often highly variable, increasing the chances of inappropriate dosing and violative tissue residues. The bulk materials are often shipped into this country from foreign countries and has not been inspected by the FDA.