No ruling coming in compounding dispute

A Florida pharmacy and federal drug authorities have fought for 2 1/2 years over the legality of compounding animal drugs from bulk pharmaceutical ingredients. Now, it appears the dispute has ended, but without a final decision.

In October, an appellate court delivered orders that not only ended a pending appeal without ruling on the legality of the practice but also vacated the prior ruling of the district court judge.

The Food and Drug Administration had, since April 2010, sought a court order to prohibit Franck’s Lab Inc. and company founder, president, and CEO Paul W. Franck from compounding animal drugs from bulk ingredients rather than approved finished drugs. The agency accused Franck and his company of manufacturing unapproved drugs under the guise of compounding.

The district court judge in that case ruled in September 2011 that the FDA had overreached in interpreting its authority and erred in construing federal laws to allow the agency to “eradicate the line between manufacturing and traditional compounding of animal medications.” The FDA had appealed the decision.

Franck sold his compounding business assets to Wells Pharmacy Network July 5. He and the U.S. government jointly filed on Oct. 16 a motion that urged the court to dismiss the appeal as moot and vacate the previous ruling.

“Franck’s Compounding Pharmacy has turned in the permits required by Florida law to operate as a compounding pharmacy, sold all its assets, and terminated all its employees,” the motion states. “In these circumstances, Franck’s Lab, Inc., cannot ‘reasonably be expected’ to engage in the compounding that the government seeks to restrain.”

Franck said in a court declaration that financial strain from the ongoing litigation was a reason he sold much of his business, and it was the only specific reason listed.

“I no longer own or operate any company or business engaged in compounding animal medications from bulk ingredients,” his declaration states.

Wells compounds drugs for human and veterinary medicine, and it bought many of the assets owned by Franck’s Lab, Franck’s Healthy Lifestyles, and Paul Franck, including pharmaceutical inventory, prescription files and records, pharmaceutical supplies, and drug sales business, court documents state. On July 30, Walgreens also bought assets—including prescription files and records—that were connected with the Franck’s Pharmacy retail business.

Franck maintained ownership of Trinity Healthcare, which sells intravenous or continuous drip medications as well as intravenous nutrition products, his declaration states.