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

Office Use in Kansas

Office Use Prescriptions
The Board has been asked on occasion whether
an “office use” prescription is valid. The answer is
no. Medications prescribed must be dispensed to a
patient. When medication is sent from a pharmacy to a
practitioner for administration, the transfer is considered
a distribution.
The transfer of a prescription medication is permitted
from one pharmacy to another pharmacy or practitioner.
The transfer must be documented with an invoice record.
The invoice record must have the name, strength, form of
the medication, the name and address of both the seller
and the purchaser, and the date of the sale. This record
should be maintained for five years with your pharmacy
records.
If the transfer is a controlled substance, the invoice
must also include the DEA number of both the seller
and the purchaser. If the medication is a Schedule II
medication, the purchaser must provide a DEA Form 222
to the seller before the transfer is completed.
A retail pharmacy may transfer prescription drugs to
another retail pharmacy to alleviate a temporary shortage,
except that the gross dollar value of these transfers
shall not exceed 5% of the total prescription-only drug
sales revenue of either the transferor or the transferee
pharmacy during any period of 12 consecutive months.
If a pharmacy is selling more than 5% they should be
registered as a wholesale distributor
Source found here

Kansas Board of Pharmacy to Discuss Dispensing of Animal Prescriptions

The Kansas Board of Pharmacy is scheduled to discuss the dispensing of animal prescriptions during its September 13-14, 2012 board meeting.  This topic is currently on the agenda to be discussed on September 13th at 2:20.  The agenda can be found here.

Kansas Board of Pharmacy Disciplinary Records

Kansas Board of Pharmacy disciplinary records for both pharmacies and pharmacists can be viewed here.