FDA mulls next move in compounding court decision

FDA mulls next move in compounding court decision

Oct 01, 2006

WASHINGTON — While compounding proponents claim victory to a recent district court decision, the Food and Drug Administration (FDA) is weighing its options.

FDA spokesperson Susan Cruzan says the agency "will consider all options, including seeking an appeal."

The Aug. 30 decision in the United States District Court, Western District of Texas Midland-Odessa Division, issued a partial summary judgment in a cased filed in 2004 by 10 pharmacies against FDA.

As part of the ruling, Judge Robert Junell states compounding is a legal practice, adding compounding from bulk ingredients for non-food animals does not violate the Federal Food, Drug and Cosmetic (FD&C) Act, as asserted by FDA.

"Congress intended to declare that compounding is an approved and legal practice," Junell says.

The judge's comments were lauded by compounding advocates.

L.D. King, executive director of the International Academy of Compounding Pharmacists, reports, "FDA took a hard-line approach. The big issue is compounding is not illegal. The compounding of a medication pursuant to a valid prescription is not creating a new drug. That's the biggest point coming out of this decision."

The 26-page decision makes others.

"The court finds that the exemption for compounded drugs from the new drug definition is limited to compounds which are made in reasonable quantities upon receipt of a valid prescription for an individual patient from a licensed practitioner," the decision states.

It begs the question: What's reasonable?

Ron Phillips, vice president of legislative affairs for the Animal Health Institute, a group that represents animal health drug makers, says: "The main points are consistent with what we and AVMA have been saying; compounding is legal in reasonable quantities and in response to a prescription. It is easy to agree that manufacturing is not legal, but where is the line and how do you tell the difference?"

Other court findings include:

  • If compounding is a legal activity, a process approved by the Supreme Court (albeit in dicta), "then any drugs created through the compounding process must exempt from the new drug definitions found in the (FD&C) Act."
  • FDA also draws a line between compounding for an individual patient and compounding that rises to the level of manufacturing in its compliance policy guide. The court found "this distinction further supports the exemption of compounded drugs from the new drug definitions, if the drugs are created for an individual patient on the basis of a prescription from a licensed practitioner."
  • Pharmacies may compound drugs from legal bulk ingredients for non-food animals, the judge adds. "Drugs compounded from legal bulk ingredients do not violate the (FD&C) Act's unsafe, adulterated or misbranded provisions."