Drugs and Biologics

The Federal Food Drug and Cosmetic Act (FDCA) and FDA regulations define the term drug, in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), is claimed to be beneficial for such uses will be regulated by FDA as a drug.

All drugs must be manufactured, processed, packed, and labeled in facilities that are registered under FDA drug establishment registration regulations. Facilities that manufacture, process, pack, and label drugs must also submit drug listings to FDA for every drug they distribute in or introduce into the United States. This applies to domestic as well as foreign drug manufacturers, processors, packers, labelers. Foreign drug manufacturers must also appoint a U.S. Agent for FDA purposes when they register their facilities.

Let me help you navigate the FDA requirements surrounding drug products, vaccines, blood products and biologic products.

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.