New Era Pharmacy, LLC – FDA Warning Letter, Oct 4, 2016

On September 18, 2017, the FDA issued a Warning Letter to Stroheckers Pharmacy, Inc. dba Stroheckers Pharmacy, following an inspection from September 26 to October 4, 2016. The inspection revealed that drug products produced by the pharmacy failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically regarding the requirement for valid prescriptions for individually-identified patients. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

The FDA cited serious deficiencies in sterile drug product practices, leading to adulterated drug products under Section 501(a)(2)(A) of the FDCA. Violations included using non-sterile wipes in the ISO 5 area and failing to demonstrate adequate protection of ISO 5 areas through appropriate studies (e.g., dynamic smoke studies). The firm's response to the Form FDA 483 was deemed deficient, as it did not adequately address the insanitary conditions or the failure to receive individual patient prescriptions.

Consequently, the ineligible drug products are considered unapproved new drugs under Section 505(a) and misbranded under Section 502(f)(1) of the FDCA, as they lack adequate directions for use. The FDA emphasized that CGMP requirements apply regardless of 503A exemption status and recommended a comprehensive assessment