Despite court ruling, FDA still warning compounders

January 8, 2007

The Food & Drug Administration continues to warn pharmacies that compounded medications are new drugs under FDA jurisdiction. The FDA is insistent, despite a U.S. District Court ruling in August 2006 that called into question the federal agency's authority to regulate compounded medications. In at least eight instances covering a range of compounded medications, the FDA has warned pharmacies that the compounded drugs either posed danger to patients or too closely resembled FDA-approved products.

The Food & Drug Administration continues to warn pharmacies that compounded medications are new drugs under FDA jurisdiction. The FDA is insistent, despite a U.S. District Court ruling in August 2006 that called into question the federal agency's authority to regulate compounded medications. In at least eight instances covering a range of compounded medications, the FDA has warned pharmacies that the compounded drugs either posed danger to patients or too closely resembled FDA-approved products.

The concern over topical anesthetic creams emerged in 2005 following the deaths of two students. Blanca Bolanos, a 25-year-old student in Tucson, Ariz., died in November 2004 after spending two years in a coma. Prior to her death, Bolanos had applied a 6% lidocaine and 6% tetracaine topical anesthetic cream she had received prior to a laser hair-removal treatment at a clinic. The cream was compounded by University Pharmacy. Bolanos received the cream from the clinic even though she did not have a prescription and was never examined by the clinic's doctor. The death of Shiri Berg, a 22-year-old student, occurred just months after Bolanos' death and under similar circumstances. Berg also had received the Triangle Compounding Pharmacy's compounded medication without a prescription or examination prior to laser hair removal.

What role the FDA has, if any, remains murky. In August, a U.S. District Court judge in the Medical Center Pharmacy v. Gonzalez case issued a preliminary ruling that called into question the FDA's jurisdiction over compounded medications. Still, the FDA continues to insist that compounded medications are new drugs and subject to FDA regulation, a point contested by the agency's critics. "A federal court ruled that FDA's position is unfounded, and, in fact, compounded medicines are vital and legal," insists L. D. King, executive director of the International Academy of Compounding Pharmacists. "To the extent there are patient safety issues, state boards of pharmacy are well equipped to deal with them."

The FDA also warned Wedgewood Village Pharmacy, Swedesboro, N.J., about compounding animal drugs and Health Dimensions Inc., Farmington Hills, Mich., and Spoonamore Drug Co., Louisville, Ky., about selling compounded medications-including domperidone, which has not been approved by the FDA. In its letter to Wedgewood, the FDA argued that the pharmacy, which had its DEA license revoked in 2006, "is engaged in large-scale manufacturing of unapproved drugs, including copies of FDA-approved drugs, which raises safety concerns and poses a significant threat to the new drug approval process."

Wedgewood CEO George Malmberg told Drug Topics that he plans to fight FDA. "We are concerned about the FDA's intrusion into the practice of pharmacy," he said. "The [Medical Center Pharmacy] case stated that compounded medications are not new drugs, and FDA seems to have ignored that. This isn't about Wedgewood; this is about FDA's continued attempt to regulate compounding pharmacies."

Malmberg's willingness to fight the FDA is hardly surprising. In 2002, a group of compounding pharmacies, including Wedgewood, fought the FDA in a case that went all the way to the Supreme Court. In Thompson v. Western States Medical Center, the Court upheld the legitimacy of compounding and struck down a marketing restriction.