The U.S. Food and Drug Administration has put a Nashville compounding pharmacy on notice to correct multiple safety hazards in a warning letter issued this month to its owner, John W. Hollis.
The letter comes after the FDA last spring cited John Hollis Pharmacy on 11 rule violations, ranging from failing to maintain sterility safeguards to compounding drugs without having legally required individually identified patients. The FDA acknowledged that Hollis had agreed to recall drug products and verbally stated in May that he would cease sterile compounding.
However, the pharmacy continues to fill and compound prescriptions that do not require sterility measures.
“If you decide to resume production of sterile drugs, FDA strongly recommends your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials and systems,” the letter stated. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”
The Sept. 4 letter instructs Hollis to take prompt actions to correct the violations and to submit in writing within 15 days whether the pharmacy has taken specific steps to correct the violations.
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