Federal District Court Rules in Landmark Pharmacy Compounding Case: Compounded Preparations are not New, Unapproved Drugs Subject to Food, Drug, and Cosmetic Act

International Academy of Compounding Pharmacists Applauds Decision

MISSOURI CITY, Texas A federal district court judge in Midland, Texas, yesterday ruled that compounded preparations are not new, unapproved drugs.  Two other issues in the case the Food and Drug Administration (FDA)'s broad authority to inspect pharmacies' records and pharmacies' ability to compound from bulk active ingredients for non food-producing animals (e.g. pets, horses, zoo animals) are still being considered by the judge.  The judge ruled from the bench on the first issue and may issue a written opinion.  The case Medical Center Pharmacy, et al. v. Gonzalez was originally filed by nine pharmacies in September 2004.

"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, executive director of the International Academy of Compounding Pharmacists.  "For years, FDA told pharmacists that what they were doing compounding medicines to fill doctors' prescriptions was illegal.  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."

IACP was not a plaintiff in the case but filed Amicus Curiae briefs supporting them.  To view IACP's Amicus Curiae briefs, visit www.iacprx.org/midlandamicus.

In 1938, Congress passed the Food, Drug, and Cosmetic Act to empower the FDA to require approval of new drugs made by pharmaceutical manufacturers.  FDA began arguing in the late 1980's that Congress intended for that law to apply to compounded preparations in addition to manufactured products. This meant that, according to the FDA, each compounded medicine was a "new, unapproved drug" subject to the same requirements as manufactured products.  Because these requirements are inherently impossible for compounding pharmacists to meet, it meant that FDA considered all compounded preparations illegal.  The judge ruled that this is not the case.

Millions of Americans have conditions that off-the-shelf, one-size-fits-all pharmaceuticals cannot meet.  For them, customized, compounded medicines prescribed by physicians and prepared by licensed, trained pharmacists are the only way to better health.  These medications are also critical for treating many non-food producing animals whose medical needs are too unique to be met by mass-produced drugs.

"While the court ruled on the most important issue, the remaining issues in the case are also critical," continued Mr. King.  "Unauthorized FDA inspections create uncertainty and harm pharmacies and the patients they serve.  In addition, many veterinarians and pet owners rely on medications compounded from bulk ingredients to treat their pets.  If FDA is allowed to decide unilaterally that this act is illegal, these animals will suffer and many will die.  We hope the court will rule in favor of plaintiffs on these issues as well."