Kansas Adopting New Rules and Regulations, Hiring and Training Inspector, Additional Inspections for Holders of Nonresident Permit in Another State

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 Kansas Board of Pharmacy March 2013 Newsletter