Knowledge Center

Category: Regulatory

FDA News

Increased Regulations And Inspections Of Sterile Compounding Pharmacies In light of recent events from the New England Compounding Center Pharmacy tragedy, both state and federal agencies have increased regulations and inspections of sterile compounding pharmacies. Specifically, the FDA has initiated a significant program of inspecting sterile compounding pharmacies nationwide. For reference, pharmacies are regulated by […]

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Workers’ Compensation IDD Treatment: Call To Action

Some of you may be aware of a possible trend occurring with a state agency’s policies affecting the treatment of chronic pain. In December of 2014, the Division of Workers’ Compensation proposed new guidelines that would affect injured workers’ access to implantable drug delivery (IDD) and spinal cord stimulation (SCS) for the treatment of chronic […]

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Pain Lawsuit

The District Attorney of Orange County and the Office of Santa Clara County Counsel have filed suit against pharmaceutical manufacturers that produce pain medications. The complaint specifies violations of California false advertising law, unfair competition, and public nuisance for which they are seeking restitution and civil penalties. The volume of this complaint is quite alarming […]

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Proposition 46

On November 4, 2014, residents of California will be voting on Proposition 46, an initiative that has the potential to greatly impact physicians and pharmacies in this state. According to the California Official Voter Information Guide, the Medical Malpractice Lawsuits Cap and Drug Testing of Doctors Initiative proposes five amendments to current healthcare practices: Require […]

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Revisiting HR 3204: The Drug Quality and Security Act of 2013

In the past, I have discussed the recent passage of HR 3204, the Drug Quality and Security Act of 2013. I am still receiving calls from individuals who are confused with this law and how it affects their clinical practice.  This federal legislation was enacted in response to the New England Compounding Pharmacy tragedy of […]

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Bill HR 3204: The Drug Quality and Security Act

I wish to discuss with you the recent passage of federal legislation as it relates to sterile compounding. In November 2013, President Obama signed a bill – HR 3204, The Drug Quality and Security Act – in response to the New England Compounding Center tragedy of 2012. With all of the fanfare and publicity surrounding […]

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Sterile Compounding: New Laws and Regulations: A Review

  I recently attended a symposium conducted by Western University of Health Sciences, College of Pharmacy entitled, Sterile Compounding New Laws And Regulations. This took place at the Newport Beach Hyatt on January 18 of this year, and it was truly rewarding. There were great speakers who had up-to-date information on the new laws – […]

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IACP’s Response to Washington Post Article

In February 2013, Washington Post published that IACP’s Executive Vice President David G. Miller stated, “We want to enable and clarify for the FDA that those businesses that are involved in the manufacturing of compounded drugs, regardless of size, be regulated like drug manufacturers.” This was an alleged change of view by IACP regarding industry […]

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FDA Conducts Surprise Inspections at Compounding Pharmacies

The FDA has begun surprise inspections at compounding pharmacies that, so far, have included four national compounding pharmacies: 1) AnazaoHealth Corp., 2) Central Admixture Pharmacy Services (CAPS), 3) Lee Pharmacy, and 4) PharMEDium Services. According to reports, quality and safety issues were uncovered at each facility.[1] According to the Washington Post, “The FDA inspection report […]

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A Message from the President: Regulatory Updates

In an ongoing effort to keep you updated with regulatory news that may affect your practice, I present the following information. In light of last year’s NECC tragedy, compounding pharmacies across the United States have been affected on many fronts. Insurance companies are currently evaluating the practices of compounding pharmacies to determine whether or not […]

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