Warning Letter: Pragmatic Materials

On June 17, the Food and Drug Administration's Cincinnati officeissued a warningletter to Pragmatic Materials, Inc. (Solon, OH), a company thatrepackages active pharmaceutical ingredients (APIs) for sale topharmacies for compounding.

FDA said the company routinely listed manufacturers' expirationdates on the labels of repackaged products, even though itreplaced the manufacturers' original inert and airtight packages (oftenwith an inert gas overlay) with more porous packages... withoutperforming additional stability or container tests. The products citedwere NADH (nicotinamide-adenine dinucleotide, reduced sodiumsalt), oxytocin, streptomycin sulfate USP, polymyxin Bsulfate, gentamycin sulfate,  and cromolyn sodium.

The agency also criticized Pragmatic Materials for repackagingtechnical grade EDTA Disodium as USP grade for prescriptioncompounding—without performing the additional tests necessary tosupport the higher grade rating.

In its letter, the agency acknowledged the company'scounterarguments and efforts at remediation, but said they fell short.