The drug-compounding industry scored a major victory this week as a federal court ruled compounded drugs are outside U.S. FDA reach.
A federal district court in Midland, Texas, held Thursday that compounded preparations are not "new, unapproved drugs," according to a statement issued Friday by the non-profit group International Academy of Compounding Pharmacists.
The decision spares drug-compounding pharmacies from having to meet strict Food and Drug Administration regulations on drug safety and efficacy before they can market their products.
"This landmark ruling stops the FDA's encroachment on the authority of state boards of pharmacy in its tracks and it ensures that patients and physicians will continue to have access to compounded medicines on which they rely," said L.D. King, IACP's executive director.
"For years, FDA told pharmacists that what they were doing -- compounding medicines to fill doctors' prescriptions -- was illegal," the group said.
"This ruling lifts the veil of uncertainty from pharmacy compounding and once again allows pharmacists to serve their patients confidently. That the judge ruled from the bench shows us just how strong the plaintiffs' case was."
However, two other issues still remain before the court: the scope of the FDA's authority to inspect pharmacies' records and the pharmacies' ability to compound using bulk active ingredients for the manufacture of drugs not intended for food animals, including treatments for companion animals and zoo animals.
The case -- Medical Center Pharmacy, et al. vs. Gonzalez -- was originally filed by nine pharmacies in September 2004. The IACP was not a party to the action but said it filed Amicus Curiae briefs in support of the plaintiffs.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
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