Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, January 28, 2014
Fourth Question of the Day January 28, 2014 How likely will IACP's (David Miller's) prediction come true and the "office use" issue end up in court? What are the odds the FDA will will win? Which, if any, compounding pharmacy will be willing to spend the money to litigate this issue? What if the issue is litigated all the way to the United States Supreme Court and the answer is the FDA is right on its position? If the FDA is not right, then how quick, if at all, can a legislative fix be enacted?
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Office use compounding will end up in court in a unique way. When a patient suffers a complication from a doctor administering a compounded drug to them (often by injection), and the medical malpractice lawyer finds out that the compounded drug came from a "regular compounding pharmacy", not an "FDA-registered outsourcing facility", they will strong-arm the doctor to settle the case "for the medical malpractice policy limits" in a "confidential settlement". The doctor's medical malpractice insurance company will either settle, or will try to weasel out of paying the claim at all, due to the doctor not using an FDA-registered outsourcing facility (and violating the Federal Food, Drug and Cosmetic Act).
Either way - these cases will be "hush-hush" - often resolved confidentially, and do not really help develop case law.
As for legislative fixes, I'm attempting to get the Florida Legislature to prohibit "office use compounding" from any pharmacy that is not also registered with the FDA as an outsourcing facility. Odds don't look good this year. It is a lot easier to break a law (and get away with it), than to make one.
Kenneth Woliner, MD
www.holisticfamilymed.com
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