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The deadly outbreak of fungal meningitis has resulted
in a public health crisis. More than 500 individuals across 19 states have
become infected by contaminated vials of injectable steroid drug from the New
England Compounding Center (NECC). Dozens have died.
From a legal and regulatory point of view, the crisis has exposed a void in the world of drug manufacturing versus compounding pharmacy to which few pay attention, although there has been significant litigation in this area even before this latest crisis.
Traditional compounding pharmacy practices involve admixing or altering prescription ingredients to make custom medications that fit the needs of an individual patient, whether sterile or non-sterile products. These pharmacies have historically fallen under the jurisdiction of the state pharmacy boards.
In 1997, Congress attempted to clarify the role of FDA in the oversight of compounding pharmacies as a part of the FDA Modernization Act.
However, before the law was to take effect, seven compounding pharmacies sued to block its enactment. Since then, the law, as well as FDA's existing authority to regulate compounding pharmacies under the federal Food, Drug and Cosmetic Act, became mired in litigation and uncertainty. To attempt to remedy some of the ambiguity, FDA issued guidelines in 2002 to try to draw a line between manufacturing and traditional compounding.
The tragedy has caused legislators to call for Congressional hearings on the issue of pharmacy compounding. Congressman Ed Markey of Massachusetts is quoted as stating: "A state's ability to protect patients is limited only to activities that take place within its borders. Because the new age of compounding pharmacies involves shipping drugs across state lines, the federal government — specifically the FDA — needs the authority to ensure that patients that rely on compounded drugs are kept safe. The FDA has said clearly that it needs new authority to effectively protect patients and oversee these companies. This authority can only be provided by Congress."
Although Markey believes that traditional small compounding pharmacies should continue to operate as they currently do, and should continue to be regulated by the states as long as they use safe drugs, undertake safe practices, and get valid prescriptions for the drugs they make, he is proposing new legislation that is intended to address when a pharmacy should be regulated by FDA when it engages in certain drug preparation activities.
In general, the NECC crisis has federal legislators and regulators calling for greater accountability of certain compounding pharmacies. Some examples include:
1. Registration with FDA as drug manufacturers,
2. FDA inspections of compounding pharmacies at any time,
3. Transparency to the public, with appropriate labeling of compounded drugs, and
4. Mandatory reporting to the FDA when adverse reactions occur so patients aren't given drugs that are known to have caused health problems.
Although it is well known at this time that both federal and state investigation and inquiry have been undertaken against NECC, recent reports indicate that a grand jury has been convened to assess any criminal culpability of individuals associated with NECC.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also Vice-Chairman of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com
Source found here
From a legal and regulatory point of view, the crisis has exposed a void in the world of drug manufacturing versus compounding pharmacy to which few pay attention, although there has been significant litigation in this area even before this latest crisis.
Traditional compounding pharmacy practices involve admixing or altering prescription ingredients to make custom medications that fit the needs of an individual patient, whether sterile or non-sterile products. These pharmacies have historically fallen under the jurisdiction of the state pharmacy boards.
In 1997, Congress attempted to clarify the role of FDA in the oversight of compounding pharmacies as a part of the FDA Modernization Act.
However, before the law was to take effect, seven compounding pharmacies sued to block its enactment. Since then, the law, as well as FDA's existing authority to regulate compounding pharmacies under the federal Food, Drug and Cosmetic Act, became mired in litigation and uncertainty. To attempt to remedy some of the ambiguity, FDA issued guidelines in 2002 to try to draw a line between manufacturing and traditional compounding.
The tragedy has caused legislators to call for Congressional hearings on the issue of pharmacy compounding. Congressman Ed Markey of Massachusetts is quoted as stating: "A state's ability to protect patients is limited only to activities that take place within its borders. Because the new age of compounding pharmacies involves shipping drugs across state lines, the federal government — specifically the FDA — needs the authority to ensure that patients that rely on compounded drugs are kept safe. The FDA has said clearly that it needs new authority to effectively protect patients and oversee these companies. This authority can only be provided by Congress."
Although Markey believes that traditional small compounding pharmacies should continue to operate as they currently do, and should continue to be regulated by the states as long as they use safe drugs, undertake safe practices, and get valid prescriptions for the drugs they make, he is proposing new legislation that is intended to address when a pharmacy should be regulated by FDA when it engages in certain drug preparation activities.
In general, the NECC crisis has federal legislators and regulators calling for greater accountability of certain compounding pharmacies. Some examples include:
1. Registration with FDA as drug manufacturers,
2. FDA inspections of compounding pharmacies at any time,
3. Transparency to the public, with appropriate labeling of compounded drugs, and
4. Mandatory reporting to the FDA when adverse reactions occur so patients aren't given drugs that are known to have caused health problems.
Although it is well known at this time that both federal and state investigation and inquiry have been undertaken against NECC, recent reports indicate that a grand jury has been convened to assess any criminal culpability of individuals associated with NECC.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also Vice-Chairman of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com
Source found here
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