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
Thursday, October 23, 2014
Third Question of the Day October 23, 2014 Does it seem like the compounding pharmacy industry lacks common sense and logic at times because they are so focused on fighting regulations and keeping the profit following, which makes it appear it is all about them and not all about the patient's safety and health?
Let's Not Forget the that the FDA Gained the Right to a General Inspection of all Pharmacies in the Wedgewood Village Pharmacy, Inc. Case. The underlying district opinion has some key language regarding the FDA's authority. The Third Circuit affirmed the district court decision, rejecting Wedgewood's move to quash an FDA warrant on grounds that FDCA prohibited the FDA from inspecting pharmacies compliant with state law. Both the district court decision and the Third Circuit case affirming should be read
Wedgewood Village Pharmacy--District Court Case
WEDGEWOOD VILLAGE PHARMACY - FindLaw 3rd Circuit Case
WEDGEWOOD VILLAGE PHARMACY - FindLaw 3rd Circuit Case
What is NCPA? According to their recent news release, "The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of nearly 23,000 independent community pharmacies. Together they represent an $88.8 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists. To learn more, go to www.ncpanet.org, visit facebook.com/commpharmacy, or follow NCPA on Twitter @Commpharmacy."
quoted from here
Second Question of the Day October 23, 2014 Isn't the wording of NCPA's New Resolution Interesting? It excludes FDA outsourcing facilities and says prepared pursuant to the state-regulated practice of compounding rather than stating in "Compliance" with "ALL" state and/or federal law. So if I prepare in accordance with Texas law, but ship to Michigan and am not in compliance with its law , NCPA supports reimbursement? What about if I fail to comply with federal law (not just DQSA) but all laws, NCPA still supports reimbursement? What about if it would be against a state or federal law to reimburse for the compounded medication?
Prescription Compounding in Connecticut Safety & Regulatory Changes Effecting Medical Office Administration & An Update On Commonly Compounded Products Seminar to Be Offered at Connecticut ENT Society
Prescription Compounding in Connecticut
Safety & Regulatory Changes Effecting Medical
Office Administration & An Update On
Commonly Compounded Products
- Michael Roberge, RPh
Objective: To describe Connecticut’s new Compounding Laws and review the reporting requirements.
- Michael Roberge, RPh
Objective: To describe Connecticut’s new Compounding Laws and review the reporting requirements.
PDF]Preliminary Program Fall 2014 - Connecticut ENT Society
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