Pharmacy Reaches Deal Over Colchicine Deaths

     DALLAS (CN) – Texas has settled claims that a mail-order pharmacy killed three people in Oregon and Washington with “adulterated and misbranded Colchicine.”
     Gary Osborn, of Dallas, and his companies, Apothecure Inc. and SpectraPharm Inc., agreed to pay the state $200,000, with $100,000 assessed as civil penalties for violations of the Texas Food, Drug and Cosmetic Act and the Texas Deceptive Trade Practices Act, the attorney general’s office said Tuesday.
     Texas sued the Osborn and the companies five years ago in Dallas County Court, accusing them of making an unauthorized painkiller, of using substandard practices in making over-the-counter drugs and illegally marketing dietary supplements to treat diseases.
     “The state’s investigation found that the defendants’ injectable product Colchicine had eight times the potency level listed on the label,” the attorney general’s office said. “Further, the state found that the defendants failed to safeguard patients by testing the mixture for potency – even knowing the ingredient to be toxic.”
     Although drugs can be legally compounded to create a customized medication for individual patients based on a physician’s prescription, state law requires U.S. Food and Drug Administration approval for the compounded drug.
     “Apothecure’s actual activities exceeded the authorized scope for compounding pharmacies, resulting in numerous unapproved drugs and adulterated and misbranded drugs on the market, and crossed the line into prescription drug manufacturing,” the attorney general’s office said.
     Under the settlement described by prosecutors, the defendants have agreed to comply with a permanent injunction that forbids them from:
     “Compounding a drug before receiving a prescription order for an individually identified patient from a physician;
     “Compounding a drug which appears on an FDA list as a drug which has been withdrawn from the marketplace because the drug has been found to be unsafe or ineffective;
     “Compounding a drug with an active ingredient that is not in an FDA-approved drug; “Compounding any drugs for wholesale distribution rather than for a specific patient; “Advertising or selling any drug unless the drug has been approved by the FDA, or the drug is compounded in compliance with the judgment;
     “Advertising that a FDA-approved drug is effective for uses other than the uses approved by FDA;
     “Making any claim in the labeling or advertising of a dietary supplement that it can cure, mitigate, treat, or prevent disease in humans.”
     In October, Apothecure and Osburn were sentenced to a $100,000 fine, each, and probation for violating the federal Food, Drug and Cosmetic Act regarding the Colchicine deaths. Osborn was additionally placed under house arrest.

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