Compounding Update
At its December 2012 meeting, the Wyoming State Board of
Pharmacy had an extensive discussion about sterile and nonsterile
compounding due to the recent deaths in other states
from fungal meningitis caused by contaminated products from
the New England Compounding Center. Richard Johnson, RPh,
from Pharmaceutical Compounding Specialists of Wyoming
discussed his policies and procedures and testing protocols.
Dave Pestotnik, RPh, from Pharmacy Solutions, Inc, described
his sterile compounding for home infusions. His pharmacy is
also registered through Food and Drug Administration (FDA) as
a “re-labeler” with unique National Drug Code (NDC) numbers
on products. Leith Culver, RPh, from Care Trust IV in Casper,
WY, also described compounding that is certified to medium-risk
sterile products as defined in Chapter 17 of the Board’s rules and
in United States Pharmacopeia (USP) Chapter 797. The Board
members had many questions and appreciated the expertise of
the pharmacists.
The Board directed agency staff to send a letter to each pharmacy
in Wyoming to determine what type(s) of compounding
is being done, whether or not products are shipped out of state,
if the pharmacies or personnel have been accredited or certified,
and to ask for copies of the pharmacy’s policies/procedures so
compliance officers can review them before the 2013 inspections.
Mary Walker, RPh, executive director, attended a meeting
in December at FDA along with all other state boards to discuss
compounding. Chapter 13 of the Board’s Rules is being reviewed
against USP Chapter 795 for possible revisions
Source found here
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