FDAnews Drug Daily Bulletin

Compounder Lost Exemption From Rules, Then Violated Them, FDA Said

Sept. 6, 2017

A Georgia compounding pharmacy ran afoul of the FDA after losing the exemption from agency rules that is extended to compounders that limit their production to filling prescriptions for individual patients, the FDA said in a warning letter.

Because the producer, Carlton’s Dunwoody Pharmacy, in Dunwoody, exceeded the limitation, it fell under FDA rules for quality control and labeling — and it did not meet the FDA standards, the letter said.

The agency said the pharmacy failed to establish a testing program, failed to prepare production records, used inadequate instruments, and violated labeling rules.  

The FDA said Carlton’s responded to the findings of the agency inspection, but did not say in the response that it would stop filling orders without valid prescriptions for individual patients.

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