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Busted! Mold and Rust at Compounding Pharmacies

FDA Finds More Mold and Rust at Compounding Pharmacies

Moldy Steroid Shot:  Compounding Pharmacies

Source:  Associated Press, April 12, 2013

FDA finds more mold and rust at compounding pharmacies spelling more trouble for compounding pharmacies. The FDA has uncovered potential safety issues at 30 recently inspected specialty pharmacies as follow-up to recent outbreak of fungal meningitis due to contaminated drugs.

FDA inspectors inspected 31 compounding pharmacies that produce sterile drugs. Compounded drugs must be produced in highly sterile conditions. FDA issued inspection reports all but one of the compounding pharmacies. 30 compounding pharmacies received inspection reports  noting the following issues.

Quality Control and Sanitary Issues Noted in Sterile Areas at Compounding Pharmacies

Issues Noted:

1. Unsanitary conditions and Quality Control Conditions:

FDA Inspects 31 Pharmacies in 18 States

The FDA typically issues reports before taking formal action. Inspectors visited 31 pharmacies in 18 states, including: Florida, Arizona, Colorado, Tennessee, and New Jersey.

These inspections come after outbreak of fungal meningitis from contaminated steroid shots produced by New England Compounding Center, Massachusetts pharmacy. The Steroid shots were used to treat back pain. The shots were linked to 53 deaths and 733 illnesses last summer.

Protocol for compounding pharmacies is to mix customized prescriptions based on an individual doctor’s instructions. However, pharmacies like New England Compounding Center, became a much larger business supplying large quantities of inject able drugs to hospitals throughout the United States. These actions were not specific to an individual doctor’s script.

FDA Inspections Slowed by State/Federal Overlapping Law

At this point, the FDA has stepped up oversight of the compound pharmacies since the outbreak in September, last year. Due to complex overlapping of federal and state laws that govern compounding pharmacies, the FDA’s actions have been slowed.  Compounding pharmacies are licensed and overseen by state pharmacy boards. However, the FDA will intervene when major safety issues arise.

FDA Commissioner, Margaret Hamburg, noted in a blog post Thursday,that 4 pharmacies initially refused admission of FDA inspectors. In two cases, inspectors returned armed with search warrants and US marshals to complete inspections.

“These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health,” Hamburg stated.

FDA Asking For Explicit Oversight Over Large Compounding Pharmacies

In wake of potential safety issues with large compounding pharmacies, Hamburg is asking Congress to pass new laws granting the FDA explicit oversight over large compounding pharmacies. Under the proposal, large compounding pharmacies would have to become part of a FDA registry and undergo routine inspections.

House Republicans are questioning whether FDA could have used existing powers to prevent the meningitis outbreak.

A second meeting on the issue is to be held next Tuesday by the House Energy and Commerce Subcommittee for Oversight and Investigations. Hamburg is scheduled to testify.

Authors comments;  What role the state pharmacies board will have is yet to be seen.  Another inquiry should occur on the state level of compound pharmacies. More cost efficient for the states to inspect compound pharmacies on a regular basis.  Who knows whether the state pharmacy boards ever inspected these facilities. It sounds like no one ever stepped foot in these compound pharmacies. Obviously, this will change probably with the FDA taking over as the federal government continues to grow.


ABC News






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