A coalition of pharmacies from Texas, Arizona, Alabama, Wisconsin, California, and Col-orado filed suit against the Food and Drug Administration in September, claiming that the agency is illegally enforcing an arbitrary regulation that is out of its jurisdiction. The suit accuses the FDA of conducting unlawful inspections, illegal interventions, and intimidation of law-abiding pharmacies.
At issue is the centuries-old practice of compounding medications from bulk ingredients. In this process, a pharmacist combines, mixes, or alters the administration of ingredients to prepare a medication, prescribed by a physician or veterinarian, that is tailored to an individual patient’s needs. Compounding protection laws were enacted in 1962 to ensure the best health care for patients and pets.
The FDA has no legal authority over pharmacies, whether or not they prepare compound preparations. Last year, however, the FDA issued a compliance policy guideline that made the use of bulk ingredients in the preparation of medications illegal. The agency has since waged an aggressive inspection campaign to enforce the guideline.
Ten compounding pharmacies have petitioned a US District Court in Texas to be able to continue filling prescriptions from doctors and veterinarians using pure “bulk ingredients” that are manufactured in facilities that are registered, inspected, and approved by the FDA.
“If the FDA is successful, this would deprive veterinarians and physicians of critical treatment options that relieve the suffering of their patients and improve their health,” said Steven F. Hotze, MD, president of Premier Pharmacy in Katy, TX.
Compounded drugs typically offer superior treatment options because they are tailored to the individual patient. Moreover, restrictions on compounded medications prevent many prescription drugs from being offered at more affordable prices. The FDA’s illegal actions work to the benefit of large pharmaceutical companies, which continually lobby the agency in efforts to stifle competition and keep prices high.