Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy – FDA Warning Letter, Aug 31, 2016

On August 31, 2016, the FDA issued a Warning Letter to Pensacola Apothecary, Inc. dba Everwell Specialty Pharmacy following an inspection from August 22-31, 2016. The inspection revealed that drug products produced by the firm failed to meet the conditions for exemption under section 503A of the FDCA, specifically regarding the requirement for valid prescriptions for individually-identified patients. This renders the compounded drugs ineligible for exemptions from CGMP (section 501(a)(2)(B)), adequate directions for use labeling (section 502(f)(1)), and FDA approval (section 505).

The ineligible drug products were deemed adulterated under section 501(a)(2)(B) of the FDCA due to significant CGMP violations, including failure to conduct laboratory testing for conformance to specifications prior to release (21 CFR 211.165(a)) and inadequate cleaning and maintenance of equipment (21 CFR 211.67(a)). Additionally, these products were misbranded under section 502(f)(1) of the FDCA because they lacked adequate directions for use for laypersons.

The firm's response, dated September 19, 2016, stated that "Everwell Specialty Pharmacy has ceased compounding any non-sterile medications for office-use as of August 23