Monday, January 28, 2013

New Regulations Proposed In Response To Meningitis Outbreak


State officials have been urged by federal drug regulators to close loopholes that could affect the safety of compounded drugs. FDA has approached state health and pharmacy board officials with a plan that will hopefully be turned into legislation by Congress. The new regulations would give the agency clearer congressionally mandated authority to regulate the compounding pharmacies.
Drug compounding occurs when a licensed pharmacist alters or recombines drug products in response to a physicians’ prescription for a specific patient. This is generally used when the patient is unable to take the standard version of a treatment due to age, allergies and other conditions. Some compounding pharmacies have dramatically expanded into large-scale production, but regulations have not kept up with the expansion, leaving these pharmacies without the stringent safety and efficacy standards that are imposed on drug makers by the FDA.

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