FDA WARNING_LETTER - ECI Pharmaceuticals, LLC - March 22, 2022

The FDA issued a Warning Letter to John Copanos regarding drug listing deficiencies for "esterified estrogens and methyltestosterone" (NDC 51293-639 and 51293-640). The review of the firm’s electronic Drug Registration and Listing System (eDRLS) submission revealed an incorrect active ingredient selection.

Specifically, the electronic listing file for both products incorrectly listed "conjugated estrogens" as the active ingredient, while the accompanying labeling correctly identified "esterified estrogens." These are distinct and non-equivalent active ingredients. This constitutes a violation of Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires firms to include the correct name and quantity of each active pharmaceutical ingredient in the listing. This is a prohibited act under Section 301(p) of the FD&C Act.

Furthermore, the failure to properly list the drug renders it misbranded under Section 502(o) and in violation of Section 301(a) of the FD&C Act. The FDA had previously notified the firm of these deficiencies on October 26, 2021, and subsequently removed the products from the FDA’s Online NDC Directory on December 10, 2021, due to continued non-compliance.

The FDA emphasizes that accurate registration and listing information is crucial for patient safety, drug establishment inspections