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Contaminated medicine - It just gets worse!

October 27, 2012

Pharmacy Faulted Further by FDA



The Food and Drug Administration on Friday painted the most troubling picture yet of the drug-mixing pharmacy behind the deadly meningitis outbreak, citing greenish-yellow discoloration on sterilizing equipment and non-sterile raw ingredients.

An FDA report on the New England Compounding Center found that about one-fourth of the steroid vials that inspectors examined during October was contaminated by "greenish black foreign matter," and that all of the 50 vials sent for microscopic analysis contained fungus.

The FDA said the pharmacy director of NECC, based in Framingham, Mass., told federal inspectors that the firm used non-sterile active pharmaceutical ingredients and raw materials, with the exception of sterilized water for injection, to make the injectable steroid linked to the fungal meningitis. FDA representatives said the pharmacy wasn't able to provide documentation that its steam autoclaves, the linchpin of its effort to make sterile products, were capable of achieving product sterility.

NECC said in a statement Friday that it is cooperating with the FDA, had just received a copy of the report and plans to "provide our comments to the FDA after we have had adequate time for a complete review of the report." NECC has recalled all the products it made immediately prior to the meningitis outbreak and isn't currently operating.

The unsanitary conditions cited in the report Friday were in line with findings about the facility that Massachusetts state health officials released earlier this week. But the FDA's report showed several previously unreported safety issues, including that NECC's own processes for monitoring the cleanliness of its facilities had detected microbial contamination. So far, health officials haven't pinpointed exactly how the steroids became contaminated with the fungus causing meningitis.

The death total in the outbreak rose to 25 people on Friday after an additional death was reported in Tennessee. Health officials have identified 328 cases of meningitis throughout 18 states. An estimated 14,000 people were exposed to the tainted lots of steroid, used generally to treat pain.

In their examination of the drug-mixing pharmacy, inspectors focused on 321 vials of the steroid methylprednisolone acetate, which came from one of the three recalled lots. They found discoloration in 83 of the vials. The FDA inspectors also found that 17 vials from that same bin contained "what appeared to be white filamentous material" contaminating the medicine.

Steven Lynn of the FDA's center for drug evaluation and research said that the use of non-sterile material to make such products isn't necessarily unsafe if it becomes sterilized at some point in the process.

But inspectors raised issues about the sterilization methods used at the facility. FDA representatives found "greenish yellow" discolorations within one cleaning autoclave and a "tarnished discoloration" within another, the report said. FDA officials said they hadn't analyzed the makeup of the stains on the sterilizing equipment yet.

The inspectors also found that the "clean rooms" where the steroid injections and other medicines were made had been flagged by NECC's own monitoring program. Starting in January, the pharmacy's monitoring had detected bacteria and molds in the rooms, the report said. Inspectors said they couldn't find evidence the pharmacy had moved to fix the problems.

The FDA also found that the firm shut off air-conditioning from 8 p.m. to 5:30 a.m. nightly in the clean room. The FDA's Mr. Lynn said that "is not a typical practice for a clean room," adding it is important that a clean room be kept at low humidity and proper temperature.

Past marketing materials from NECC had said the firm's "high quality" products were made from "quality ingredients" by "extensively trained" pharmacists in a facility adhering to industry standards.

Compounding pharmacies, which custom-mix medications such as liquid versions of pills, fall into a gray area of federal regulation. The FDA has to a great extent left their supervision to state boards of pharmacy. Some lawmakers are now calling for the FDA to be given more authority to regulate the industry.

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