
Significant deviations from good manufacturing processes in repackaging and relabeling active pharmaceutical ingredients are what the Food & Drug Administration cited in a letter sent to Pragmatic Materials Inc. in June. During site visits in February, the agency found that the company, which repackages ingredients for use by pharmacies for compounding drug products, had not performed the appropriate tests to support the expiration dates assigned to at least six ingredients. Violations such as these can ignite fear and concern in hospital pharmacists and administrators who are outsourcing their sterile or nonsterile products to compounders to save staff time, cut hospital costs, and comply with new regulations.



