Showing posts with label A Compounding Problem. Show all posts
Showing posts with label A Compounding Problem. Show all posts

Sunday, April 14, 2013

A Compounding Problem Apr12th 2013 Leave a Comment Written by Justin Walters A Compounding Problem: Lack of Oversight in Compound Pharmacies


The origin of the deadly meningitis outbreak last year was the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Massachusetts. How could such an event have happened in light of the strict regulations on pharmacies and drug manufacturers? As much as it pains me to say, this is an area that might need more regulation.
Compounded drugs are not FDA-approved. This means that FDA does not verify the quality, safety and effectiveness of compounded drugs. This also means that compounded drugs lack an FDA finding of manufacturing quality. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective.
Source: FDA.gov
Although the drugs produced by compound pharmacies, the individual drugs and products used by compound pharmacies are independently approved. Only when they are combined together, or additives such as flavoring are added, do they no longer become FDA approved. So why has the FDA taken a hands off approach to regulating compound pharmacies?
Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary responsibility for day-to-day oversight. . . .Compounded drugs are not FDA approved. . . . [C]ompounding pharmacies are not generally required to register with FDA and therefore do not tell FDA what drugs they are making.
Source: FDA.gov
The Food and Drug Administration does not know what kind of drugs compounding pharmacies are making when they combine different pharmaceuticals or additives, nor are they able to routinely able inspect them because they are so individualized. Include me in the list of people who thought that compounding pharmacies were subject to similar regulations as traditional pharmacies. I was under the [apparently naive] belief that I would be getting a safe product that at least had some FDA oversight

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