Why did it take the death of several patients from systemic fungal infections to publicize the fact that there are so-called “Compounding Pharmacies” which are actually operating as un-approved drug manufacturers throughout the US? Due to loopholes and vague legislation, FDA has been restricted from applying the rules of GMP to these organizations by the fact that they are not required to be registered under the Food & Drug Act and, even more importantly, they are not required to report adverse reactions to their products. There is a long-established practice and legitimate need for pharmacies to be allowed to compound drugs for a specific patient on a doctor’s prescription. This enables the doctor to avoid potentially allergenic constituents of the standard product or adjust the dose, or the means of administration. The problem arises when organizations like the New England Compounding Center (NECC) go beyond providing a custom formulation for the individual patient to distribute low-cost versions of frequently-used drugs to many doctors and hospitals and do not comply with the standards for purity and efficacy laid down by the FD&C Act. Arecall notice for all products was issued by NECC on October 6, finally prompting inspection by FDA who issued a Form 483 on October 26 listing shocking examples of contaminated products, environmental contamination and poor sanitary practices in areas dedicated to the manufacture of sterile products.
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