Preparation and distribution of research drug products

The National Institute on Drug Abuse seeks capability statements from other than small businesses for the preparation and distribution of research drug products in support of its Drug Supply Program. Vendors must have experience obtaining DEA registration for controlled substances, managing a secure DEA-approved storage facility, analytical chemistry and drug formulation experience, and FDA registration as a pharmaceutical manufacturer. Capability statements must demonstrate the ability to complete project requirements such as acquiring, importing, and exporting drugs; determining purity and stability; developing and analyzing drug dosage forms; maintaining inventories; and manufacturing, analyzing, storing, and shipping marijuana and nicotine research cigarettes. Capability statements are due no later than November 16, 2023.

There is no set-aside designated for this procurement. The NAICS code is 541715 for Research and Development in the Physical, Engineering, and Life Sciences, with a size standard of 1,000 employees or less. Current contractors were not named. The notice seeks capability statements only and does not include award values or budget ranges. Vendors must address each requirement in their capability statements.