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Pharmaceuticals / Inspections and Audits

FDA Warns Florida Compounder for Failing to Meet Quality Conditions

Dec. 26, 2018

The FDA hit Hybrid Pharma with a warning letter, citing the Deerfield Beach, Florida, pharmacy for producing drugs that failed to qualify for exemptions from FDA oversight for compounded drugs.

Specifically, the company compounded products using sildenafil, testosterone cypionate and human chorionic gonadotropin — bulk substances that aren’t on the agency’s “bulks list” for drugs covered under section 503B of the Food, Drug and Cosmetic Act or used to compound a drug on the agency’s drug shortage list.

The FDA also cited the compounder for labeling violations for products lacking the required labeling statements “This is a compounded drug” or “Not for resale.” Some labels did not include storage and handling directions and national drug code numbers — and others failed to include a link to MedWatch for reporting adverse events.

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