Florida Compounding Pharmacy Broke GMP Rules, FDA Says

October 27, 2017

A Florida compounding pharmacy did not meet the criteria for exemption from FDA rules on good management practices, and it violated those rules, the FDA said in a warning letter.

In addition, the compounder, Home Care Pharmacy of Palm Coast, violated regulations for sterile processing that apply in any case, the letter said.

During an inspection in May 2016, the letter said, Home Care produced drugs that weren’t designated to fill prescriptions for individually identified patients, a practice that renders the pharmacy ineligible for the exemption.

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