Thursday, July 11, 2013

In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.

source found here
The Food and Drug Administration (FDA) has asked Congress to extend its oversight of large pharmacies that manufacture and distribute drugs, called compounding pharmacies. Currently, licensing for many of these facilities is the same as a mom-and-pop local pharmacy that sells one prescription at a time to customers. However, because these plants are actually making, storing and distributing drugs, their impact is more widespread and costly when a contamination issue exists.
Recently, authorities have linked a Tennessee pharmacy that makes and distributes steroids to an outbreak of fungal infections. During an inspection of the facilities, the FDA found spiders in a supposedly clean room, fungus and bacteria in vials of steroids, and no quality control procedures to monitor batches of the drugs being processed. There were 25 patients from four different states that that have developed infections after receiving injections of products from the Tennessee compounding pharmacy. The FDA says that the contamination may be similar to the 2012 case of the New England Compounding Center in which as many as 58 patients died after receiving steroid injections.

Not the First Time the FDA Has Tried

According to the Huffington Post, attempts by the FDA to increase its regulation of compounders date back to the 1990s. After strong pushback from the compounding industry, the FDA and the American public are left with the same vulnerabilities.
As reported by its trade group, the compounding pharmacy industry, which creates custom medicines by mixing drugs, does $3 billion of business in the U.S. and operates 7,500 pharmacies. In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.
- See more at: http://1800theeagle.com/dangerous-drugs-news/2013/07/fda-inspection-unearths-utter-chaos-fungal-debacle/#sthash.BJ8WM00x.dpuf
The Food and Drug Administration (FDA) has asked Congress to extend its oversight of large pharmacies that manufacture and distribute drugs, called compounding pharmacies. Currently, licensing for many of these facilities is the same as a mom-and-pop local pharmacy that sells one prescription at a time to customers. However, because these plants are actually making, storing and distributing drugs, their impact is more widespread and costly when a contamination issue exists.
Recently, authorities have linked a Tennessee pharmacy that makes and distributes steroids to an outbreak of fungal infections. During an inspection of the facilities, the FDA found spiders in a supposedly clean room, fungus and bacteria in vials of steroids, and no quality control procedures to monitor batches of the drugs being processed. There were 25 patients from four different states that that have developed infections after receiving injections of products from the Tennessee compounding pharmacy. The FDA says that the contamination may be similar to the 2012 case of the New England Compounding Center in which as many as 58 patients died after receiving steroid injections.

Not the First Time the FDA Has Tried

According to the Huffington Post, attempts by the FDA to increase its regulation of compounders date back to the 1990s. After strong pushback from the compounding industry, the FDA and the American public are left with the same vulnerabilities.
As reported by its trade group, the compounding pharmacy industry, which creates custom medicines by mixing drugs, does $3 billion of business in the U.S. and operates 7,500 pharmacies. In recent years, the International Academy of Compounding Pharmacists has invested over $1 million in lobbying efforts with Congress.
- See more at: http://1800theeagle.com/dangerous-drugs-news/2013/07/fda-inspection-unearths-utter-chaos-fungal-debacle/#sthash.BJ8WM00x.dpuf

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