Let the dissecting and digesting of this compounding legislation begin. I would love to hear what the readers think about this version.
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
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My quick glance of the first 30 pages of the bill say to me:
1. Anticipatory compounding is still allowed, so the big "manufacturing compounders" will still be in business.
2. Even though compounded drugs aren't to be "resold" - there are already state laws and rules that say the same thing - and rogue compounding pharmacies get around this in two ways (both are illegal, but rarely are the pharmacies disciplined, sanctioned, or face criminal charges). One, - they claim that they are acting as a "centralized prescription filling pharmacy" - sending the prescription to a physician's office, and having the physician's office act as the "originating pharmacy". The second way is that they "drop ship" the prescription to the patient, but accept payment from the physician for the drugs (at a wholesale price), allowing the physician to charge the patient a higher "retail price" for the drugs.
Both ways are "fee-splitting", and illegal under state laws and rules, but are done all the time (with the pharmacies getting away with it). I see nothing in this bill that will stop that "scheme" from continuing.
Kenneth Woliner, MD
www.holisticfamilymed.com
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