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Compounding Pharmacy, Part 1: Tragedy and Reaction

Friday, May 10th, 2013
What is Compounding?
Compounding occurs when a patient comes into the pharmacy and needs a customized formula to meet their individual needs. The pharmacist then creates an admixture of the medication according to directions provided by the prescriber. Due to recent drug shortages, compounding has also been used as a way to provide drugs in shortage to hospitals and other health care facilities. Theoretically, this “large scale compounding” is performed in anticipation of a prescription. However, there are concerns that this “large scale compounding” is actually inadequately regulated manufacturing by another name.
 
Who Regulates This?
There is an ongoing debate regarding the jurisdiction over compounding pharmacies. Some argue that the state boards of pharmacy—not the FDA—should continue to regulate compounding practices. However, the state boards of pharmacy are often inadequately prepared to audit pharmacy facilities to ensure that appropriate compounding sterility requirements are met.
 
What’s the Problem?
In September 2012, non-sterile conditions at the New England Compounding Center (NECC), a compounding pharmacy in Massachusetts, caused a fungal meningitis outbreak that killed dozens and sickened hundreds. As a result, NECC and its sister company Ameridose were forced to recall products; faced FDA, congressional, and legal scrutiny; declared bankruptcy; and shut down.
 
Current Events
Due to the meningitis outbreak caused by NECC’s products, FDA Commissioner Margaret Hamburg, MD, was twice called to testify before Congress. She explained that the FDA is inadequately empowered to regulate these compounding pharmacies. Most recently, Commissioner Hamburg revealed that inspections by the agency have found appalling conditions in other compounding pharmacies. Inspections carried out from February through April have documented rusty tools, bare-handed employees handling drugs, and black particles in “sterile” solutions. According to the commissioner, these unacceptable conditions cause significant risks to public health.
 
As a result of the meningitis outbreak and subsequent findings, several bills have been proposed in Congress to improve regulation of compounding pharmacy. Some proposals would let the current structure continue as is, while others would require pharmacies to register and operate as manufacturers. While the former approach ignores the tragedies that occurred, the latter seemingly may take regulations too far.
 
This is the first of a 3-part series on issues relating to compounding pharmacy. The next installment will explain how compounding pharmacies can handle an FDA inspection.

—Darshan Kulkarni and Samantha Ricketts
Blog Info
Darshan Kulkarni, Kulkarni Law firm
Blog Description
Darshan Kulkarni, a pharmacist and attorney based out of Kulkarni Law firm (Philadelphia, PA), will provide insights on the legal, regulatory, administrative, and ethical issues that can affect pharmacists in their everyday practice.
Author Bio
This blog will primarily focus on informing pharmacists about how the drugs that they dispense came to be in their hands—including the ethics, the arguments, the laws, and the drama. Among the topics covered are FDA regulations, drug development, clinical trial participation, compounding drugs, social media marketing, and pharmaceutical advertising. This blog will also discuss what pharmacists need to know about dispensing certain medications.

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory, and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years. He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products–Regulatory Considerations.

You can follow him on twitter at @FDALawyers (http://www.twitter.com/FDALawyers) or visit the Kulkarni Law Firm's Web site (http://www.conformlaw.com/).

Disclaimer
The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and/or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney–client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
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