Drug Formulation and Manufacturing Contract (DFMC) Program

The Drug Formulation and Manufacturing Contracts (DFMC) allow NIH ICs to hire contractors to conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The goal of the contracts is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug compounds. Throughout the period of performance of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. Additionally, unless otherwise requested any assigned research must be performed in compliance with, all current FDA, World Health Organization (WHO), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable.

The NIH Clinical Center (CC), Pharmacy Department, Investigational Drug Management and Research Service (IDMRS); the Office of Research Support and Compliance (ORSC); and the Office of Logistics and Acquisition Operations (OLAO) are partnering to establish the Drug Formulation and Manufacturing Contracts (DFMC).