The regulation of Compounding in Iowa

The Regulation of Compounding
The practice of pharmacy compounding, and particularly
sterile compounding, has been the center of attention since the
outbreak of fungal meningitis cases across the United States due
to the distribution of contaminated products. At the center of the
storm is a compounding pharmacy located in Massachusetts that
holds an Iowa nonresident pharmacy license. The Board wishes
to take this opportunity to remind all pharmacists who engage
in sterile compounding of the importance of complying with
the minimum standards of practice. The Board’s rules for sterile
compounding practices can be found in 657 I.A.C. Chapter 13,
which is a 13-page document. Chapter 13 incorporates most of
the United States Pharmacopeia Chapter 797 standards and was
adopted by the Board after a long and thoughtful process, with
patient safety being the number one concern. While the Board
supports compounding by pharmacies to meet unique patient
needs, it has always taken the enforcement of sterile compounding
requirements very seriously. Between 1993 and 2012, the
Board took formal disciplinary action in approximately 52 cases
involving compounding and/or sterile compounding. Actions
were taken against 18 pharmacies, 22 pharmacists, and two
pharmacy technicians. In addition, eight emergency orders were
issued. These cases involved a myriad of issues, including the
compounding of inhalation/nebulizer products, intrathecal products,
fertility products, and animal drug products; the preparation
of commercially available products; the improper delegation of
pharmacist functions to technicians; the lack of proper training;
the lack of policies and procedures; and the absence of appropriate
product testing. Some of the cases resulted in the closure
of pharmacies or the discontinuance of compounding services.
Of further concern are the out-of-state pharmacies that hold
Iowa nonresident licenses and ship compounded products into
Iowa. The Board estimates that it has as many as 200 compounding
pharmacies licensed outside of Iowa. In the past,
the Board has relied on the home states of those pharmacies
to conduct inspections and ensure compliance with all applicable
regulations. The Board is now exploring the feasibility
of conducting out-of-state inspections under its own authority,
with the goal of protecting Iowans from injurious products and
harmful practices. Pharmacists and consumers who become
aware of problems with any drug product are encouraged to file
a report with the Board and with the Food and Drug Administration
through the MedWatch program, located online at www
.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

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