The QMN Weekly Bulletin
Pharmaceuticals / Quality / Postmarket Safety / Commercial Operations

FDA Warns Compounders for Poor Quality and Unapproved Drugs

Aug. 29, 2014

The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities.

Both the Compounding Shop and Zion Rx Formulations Services had been warned for poor responses to prior facility inspections and for making drugs without a prescription, the agency said in warning letters.

The FDA slammed The Compounding Shop for observations that investigators uncovered during a March 2013 inspection and a subsequent August to September 2013 inspection of its St. Petersburg, Fla., facility.

Investigators discovered that the compounder was making drugs containing domperidone, which is sometimes used in anti-vomiting treatments but not approved by the FDA due to health risks. The agency had warned The Compounding Shop before for the violation.

The FDA also found several good manufacturing practice (GMP) violations surrounding aseptic processing. For example, facility-dedicated clothing worn under sterile gowns was stored on an open shelf a few feet from a restroom toilet, the letter said. Personnel also used nonsterile wipes and nonsterile blue mats in a cleanroom hood.

In addition, the compounder doesn’t test intrathecal drug products for endotoxins and assigns extended-beyond use dates to sterile drug products without adequate supporting data, the FDA said.

The Compounding Shop recalled 660 vials last year because it couldn’t assure sterility of the product. In May 2013, it ceased production of sterile drugs. If the pharmacy decides to resume sterile production, management needs to perform a comprehensive assessment of its entire operation, said the Aug. 12 letter. The agency also suggested hiring a third-party expert to help.

Meanwhile, Zion came under fire for a contaminated lot of calcium gluconate 10 percent injection and for poor sterile processing practices.

During a December 2013 to January 2014 inspection of its Mesa, Ariz., facility, investigators found a lot of calcium gluconate containing the bacteria Nocardia, sp.

“FDA also tested and confirmed that environmental samples collected in your facility tested positive for numerous gram-negative bacteria and spore-forming microbes, including fungi,” said the Aug. 15 letter.

In addition, investigators saw facility personnel processing sterile drugs with exposed skin on their faces. Personnel also didn’t use sporicidal agents to clean production areas and didn’t monitor pressure differentials throughout the day, especially during periods of production, the agency said.

The agency acknowledged that in December the compounder recalled all of its sterile products, including the lot of contaminated calcium gluconate.

In its response to a January Form 483, Zion noted that it intends to comply with U.S. Pharmacopeia regulations for compounders. The agency responded that since Zion is making drugs without a prescription then it needs to abide by GMPs.

Zion needs to assess its facility design, procedures, personnel and processes, and hire a third-party consultant to help, the FDA added.

Poor aseptic processing has been a continuous problem as compounding pharmacies have had trouble making the transition from USP regulations to GMPs, quality experts said. The agency has so far warned 24 compounding pharmacies this year for quality violations.

More warning letters are expected to come as the FDA makes full use of new authority over larger pharmacies that was included in the 2013 Drug Quality and Security Act.

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