FDA WARNING_LETTER - Hieber's Pharmacy - February 17, 2017

On December 5, 2017, the FDA issued a Warning Letter to Hieber's Pharmacy, Inc. following an inspection from January 23 to February 17, 2017. The inspection revealed that the firm produced drug products that failed to meet the conditions for exemption under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) and exhibited serious deficiencies in sterile drug product production, posing patient risks.

One key violation was compounding drug products using melatonin, which is not eligible for 503A exemptions as it lacks a USP/NF monograph, is not an FDA-approved drug component, and is not on the 503A bulks list. This renders these products unapproved new drugs, misbranded for lacking adequate directions for use, and not exempt from CGMP.

Furthermore, the facility's sterile drug products were deemed adulterated under FDCA section 501(a)(2)(A) due to insanitary conditions. Deficiencies included: a carpeted vestibule as the sole entrance to the sterile compounding room (SCR); an operator conducting handwashing/partial gowning in a bathroom with a toilet before aseptic processing; turning off HEPA filters in the ISO 5 glovebox and SCR daily without sporicidal pre-production cleaning; failure to use sterile wipes for disinfection; and an operator cleaning the ISO 5 area with exposed skin. Media fills