The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders.
The warning letter, issued April 30, cited findings from an Oct. 23, 2013, inspection of the pharmacy’s Raleigh, N.C. facility. Investigators found that Blue Ridge doesn’t “use sterile disinfectants, including a sporicidal agent, for disinfection of the glove box, an area where you perform aseptic operations.”
The gloves used in the glove box also weren’t sterile, and the facility didn’t ensure that personnel wore appropriate clothing to protect drugs from contamination, the FDA said. The agency also chided Blue Ridge for not establishing and following written procedures for preventing contamination.
During the October inspection, the pharmacy recalled all of its sterile products and said that in August 2013 it had ceased all sterile compounding operations.
The warning letter outlined the requirements Blue Ridge would need to meet to resume production of sterile drugs.
Management must do a comprehensive assessment of its operations, from aseptic processing to its personnel and facility design. The pharmacy should also hire a third-party consultant to help conduct this assessment, the FDA said.
In an unusual note, the agency also urged Blue Ridge to do its homework on any suppliers or contractors it hires. The agency noted that an unnamed contract testing laboratory hired to perform some of the testing on finished drug products had a poor FDA inspection.
The violation of making drugs without a prescription is a common element in the agency’s warnings to compounders.
The FDA received more authority to oversee large compounders in the 2013 Drug Quality and Security Act (DQSA).
The act included a provision under which large compounders could voluntarily register with the FDA, and agree to be subjected to inspections and follow good manufacturing practices. If a pharmacy doesn’t register and is found to be making large amounts of drugs without a prescription, then it would fall under the agency’s regulations governing drug manufacturers.
Since the DQSA’s passage, nine compounders including Blue Ridge have received warning letters. The agency’s practice of citing DQSA authority in some of these warnings has been criticized by the compounding pharmacy lobby.
“We are very concerned that the FDA appears to be ignoring the word ‘voluntary’ in the DQSA,” David Ball, spokesman for the International Academy of Compounding Pharmacists, said. “This really appears to be rule-making by warning letter and we do not believe it is the best approach.”
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