By: Dr. Ashley Morgan, assistant director, Governmental Relations Division
On Nov. 27, President Obama signed into law an important piece of legislation that mandates how compounding for human medicine will be regulated in this country.
Sparked by the fungal meningitis outbreak last fall, the Drug Quality and Security Act (H.R. 3204) establishes a voluntary category of “outsourcing facilities” under which the Food and Drug Administration can provide the necessary oversight to those pharmacies that conduct large-scale compounding of sterile drugs. The FDA will conduct risk-based inspections of these facilities to ensure that the drugs are being produced in a safe manner. Traditional compounding pharmacies will continue to be regulated by the states.
The new law does not address compounding for animals and does not change the laws which govern prescribing of compounded medications by veterinarians. As such, the AVMA did not take a position on H.R. 3204. However, AVMA’s Governmental Relations Division has worked closely with congressional offices over the past year in the hopes of addressing challenges faced by the veterinary profession with respect to compounding for animals.
Earlier this year, AVMA’s Executive Board reviewed and approved the association’s compounding policies. For more information, see this AVMA@Work blog post.
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