FDA Finds Safety Issues with Compounding Pharmacy
This blog has previously discussed FDA attempts to deal with the potential danger posed by compounding pharmacies in the wake of the national outbreak of fungal meningitis allegedly related to contamination at a compounding pharmacy. A recent report in the USA Today indicated that FDA inspectors have issued a citation that includes multiple violations by a compounding pharmacy in Newbern, Tenn. The new report indicates that the citations were issued after investigators discovered spiders in the clean room at the compounding facility.
The violation of federal regulations in the citation were discovered during a series of FDA inspections by the Centers for Disease Control and Prevention (CDC) and the FDA that revealed drugs compounded by the pharmacy had been contaminated by fungus and bacteria according to the USA Today report. The FDA indicated that it found two closed vials of preservative-free methylprednisolone acetate contaminated by fungal and bacterial growth. The samples came from two separate lots.
According to the report, the violations were related to a number of discoveries during investigations of the drug compounding facility’s clean room, which is the sterile location used for compounding the drugs. The violations were related to the following discoveries:
- Splatter found in multiple locations, such as work surfaces, trash cans and air filters
- Presence of spiders in the clean room
- Not taking appropriate remedial action to correct a vial of methylprednisolone acetate that was overly potent
- Failure of employees to wear protective anti-contamination apparel
- Lack of a written policy for pest control
The FDA also indicated that there have been other problems at the compounding pharmacy. The federal agency reports that there have been as many as 26 people across four states that have become ill after taking drugs from the compounding pharmacy. In the wake of the recent investigations, the pharmacy has recalled all of its sterile drug products according to the article. The report also indicates that those who have been affected by the drugs from the pharmacy have suffered from inflammation at injection sites as well as infections.
The FDA investigation comes after this issue became a cause of national concern following illnesses caused by the now defunct drug compounding pharmacy New England Compounding Center. The compounding pharmacy was identified as the cause of a meningitis outbreak according to the USA Today report. The meningitis outbreak resulted in illness to approximately 750 people and the tragic death of 58 others. The spread of meningitis was allegedly attributed to tainted vials that originated from the drug compounding pharmacy. Congress is currently considering enacting regulations governing compounding drug pharmacies to reduce the risk of dangers from contaminated or overly potent drugs.
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