The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum

The sterility control challenges that pharmacy compounding presents stretch from practitioners trying to handle continually changing procedures and preparations, to the laboratories trying to do quality control testing in the context of these shifting targets and sample constraints, to the array of distribution and storage avenues – and limiting the risks rather than eliminating them should be the goal, participants at a US Pharmacopeia (USP) forum agreed.

While the US Congress wrestles with shaping legislation that will better define the broad regulatory boundaries and FDA cracks down on GMP compliance at the more manufacturing-like sterile operations (see “related stories” below), USP committee experts are taking a hard look at the realities of the environment in which typical pharmacy compounding takes place to see where the main contamination control problems lie and what can realistically be done to address them.

An opportunity for advancing the dialogue took place at USP headquarters in Rockville, Maryland in March, where a panel of experts was convened as part of a two-day forum on microbiology to review the compounding issues and help inform the efforts to strengthen the sterile compounding-related standards in the compendia.

Participating on the panel were two members of USP’s Sterile Compounding Committee, Keith St. John and Erik Kastango, and two members of the USP Microbiology Expert Committee to which it reports, Jim Agallaco and Russ Madsen. Introductory statements by the panelists helped define the dialogue that ensued at the session (see box below).

Also engaged in the discussion were other members of USP’s Microbiology Expert Committee, including its chair Jim Akers, Scott Sutton, and FDA field lab microbiologist Dennis Guilfoyle.

In focus during the session were the aseptic practice, training, laboratory and regulatory concerns that have surfaced among sterile compounders in the US and how the 2008 version of USP’s sterile compounding chapter <797> should be refined to help address them.

The discussion of what is going wrong in these operations and how the risks can realistically be mitigated shed valuable light on the need for – and the limitations of – the current Congressional and FDA actions in this arena.

A basic message that emerged is that, compared to pharmaceutical manufacturers, the technicians doing sterile pharmacy compounding have a much harder job with generally much less training and expertise to accomplish it.

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See related IPQ stories:

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

IPQ November 2012 Special Report on the Crisis in Pharmacy Compounding and its Implications