Blogs: For the Record

Meningitis Outbreak Raises Questions Regarding Oversight of Compounding Pharmacies

Published Online: Friday, October 26, 2012
Introduction
The recent outbreak of fungal meningitis caused by contaminated steroids produced by a compounding facility in Massachusetts known as the New England Compounding Center (NECC) has raised questions about the operations of such compounding facilities and how they are overseen by regulators. NECC claims to have followed appropriate steps to protect the interests of its patients. Nevertheless, the outbreak of fungal meningitis resulting from its products has, as of October 24, 2012, resulted in 24 deaths and 317 people being infected. It appears that, rather than producing custom medications for individual patients, NECC was effectively manufacturing medications on a large scale and selling them in bulk. As a result, its products have infected patients across the entire country. The ongoing outbreak has prompted criminal investigations into the deaths and calls for congressional inquiries.
 
The big question for many is whether there NECC was subject to adequate oversight and how oversight of compounding pharmacies can be improved in the future.
 
Franck’s Pharmacy
The FDA has previously been frustrated in its efforts to exert authority over compounding pharmacies, leading to confusion over whether and to what extent the agency has the power to do so. In 2009, Franck’s Pharmacy, located in Ocala, Florida, made an error in compounding a veterinary preparation, which led to the deaths of 21 horses. In response to this incident, the FDA tried to assert authority over Franck’s Pharmacy and its compounding practice. However, a Federal District court in Ocala, Florida, ruled in favor of Franck's Pharmacy, holding that for the most part the practice of compounding falls under the jurisdiction of state boards of pharmacy, not the FDA.
 
Concerns
In light of the issues raised in the Franck’s Pharmacy case as well as the NECC case, there remain concerns that many compounding pharmacies and pharmacists have taken advantage of ambiguities in their legal and regulatory status. These pharmacies and pharmacists have gone from being “one-off” compounders making customized drug products for “an identified individual patient based on the unsolicited receipt of a valid prescription order or notation approved by a prescriber,” as the FDA describes them, to effectively manufacturing large batches of medications.
 
Role of Compounding
Compounding has played a valuable role in the history of pharmacy. Historically it has been used to provide customized medications to meet an individual patient’s needs, and more recently it has helped provide hospitals with drugs, such as the pain medications fentanyl and midazolam, that have been unavailable or in short supply due to shortages.
 
What Happens Next?
In light of the NECC tragedy, many have questioned whether compounding pharmacies are subject to inadequate or inappropriate oversight. As discussed before, there have been congressional calls for inquiries into the current outbreak and calls for increased oversight of compounding. Some have suggested that Good Manufacturing Practices (GMP) requirements akin to those used by pharmaceutical manufacturers should be applied to compounding as well. However, GMP requirements apply to the creation of standardized methods for repeated processes. Since compounding is supposed to be for “one-off” prescriptions, applying standardized methods could be a case of fitting a square peg in a round hole. Several other standards may be more applicable and appropriate.  For example, first issued in 2004 and revised in 2008, USP <797> established the first comprehensive quality standards surrounding the design of and procedures used in sterile compounding areas. It is hence likely that a new patchwork of criteria and increased enforcement by a variety of organizations, including the FDA, the state boards of pharmacy, and the Joint Commission, will be necessary to ensure that USP<797> and other criteria are adhered to by compounding pharmacies and applied appropriately.
About
Darshan Kulkarni, Kulkarni Law firm
Blog Info
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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