Compounding Issues
Last year’s deadly outbreak of fungal meningitis linked to spinal injections of a pain-relieving steroid product produced by the New England Compounding Center in Massachusetts raised serious questions about the oversight of compounding pharmacies and the appropriate role for federal and state regulators. The Kansas State Board of Pharmacy and Kansas Department of Health and Environment participated in a Food and Drug Administration (FDA) intergovernmental meeting on December 19, 2012. There was discussion on whether the states had the resources to provide oversight of pharmacy compounding and whether there was a way to rebalance federal and state participation in the regulation of pharmacy compounding that would better protect the public health.
The Board is very concerned about whether federal preemptions will be enacted that could possibly undermine the Board’s authority by removing its oversight in this area. The Board has implemented a plan that includes the adoption of rules and regulations for compounding. The regulations have been approved by the Department of Administration and are currently at the Office of the Attorney General for review. The Board has asked the Office of the Attorney General to expedite these regulations. The inspectors are going to receive additional training related to compounding, and the Board is going to work with the National Association of Boards of Pharmacy® and other states to share its limited resources. The Board has also requested that Board staff seek approval for hiring an additional pharmacist inspector.
If you hold a nonresident permit in another state, be advised that your pharmacy may get an additional inspection from the state in which you are licensed. Make sure that you know the laws of each state that you are registered in related to office use because many states do not allow this practice. The Board will cooperate with any state that wants an additional inspection of your premises.
It is the Board’s goal to address the compounding issues in order to adequately protect the public’s health, welfare, and safety.
Source found here