Indiana Board of Pharmacy Statement regarding compounding pharmacies

October 11, 2012
Indiana Board of Pharmacy
Statement regarding compounding pharmacies
The Indiana Board of Pharmacy takes patient safety very seriously, and the Indiana Code
and our administrative rules are aimed at protecting the public.  Compounding is an
integral part of the practice of pharmacy.  Compounding is safe when conducted within
the confines of the law and when it does not extend into the realm of manufacturing.
Sterile compounding is addressed at 856 IAC 1-30, and pharmacies engaging in sterile
compounding must comply with the USP 797 national standards.  In-state pharmacies,
including those engaging in sterile compounding, are subject to inspection by the Board
of Pharmacy’s Compliance Officers.  The Board’s administrative rules and our
inspections of sterile compounding facilities address, among other things: policies and
procedures; engineering controls/physical requirements; personnel training; labeling and
documentation/records and reports; and quality assurance measures.  The Board of
Pharmacy works hard to ensure that our licensed facilities are thoroughly inspected.
Non-resident pharmacies registered in Indiana are required by Indiana Code to comply
with the laws and rules of the state in which they are domiciled.  In order to be registered
as an Indiana non-resident pharmacy, an applicant must submit numerous documents and
fulfill various duties, including verification of the pharmacy’s licensure in its home state.
The Indiana Board of Pharmacy relies on other state Boards of Pharmacy to regulate
licensees in their jurisdiction.
The Board is following the developments of the meningitis outbreak closely.  The New
England Compounding Center is licensed in Indiana as a non-resident pharmacy.  The
Board has referred the matter to the Office of the Indiana Attorney General for
investigation.
Patient safety is of utmost importance to the Indiana Board of Pharmacy.  The Board of
Pharmacy Compliance Officers thoroughly inspect our licensees with the aim of ensuring
patient safety.

Statement can be found here