The Centers for Disease Control and Prevention (CDC) distributes 14 special biologic agents and drugs through the Drug Service, Division of Scientific Resources, and the Division of Global Migration and Quarantine. The Drug Service web pages review these agents, describing their sources, licensure, Investigational New Drug (IND) application and status, distribution and storage. An updated listing of products can be obtained from the CDC Drug Service staff,* and from the publications of "Drug Facts and Comparisons" and "American Hospital Formulary Service Drug Information."
*CDC Drug Service
1600 Clifton Road, MS/D09
Atlanta, GA 30333
Telephone (404) 639-3670 Fax (404) 639-3717
In the United States, federal law prohibits the distribution and transportation of drug products not approved by the Food and Drug Administration (FDA). Therefore, to allow treatment of patients with an unlicensed drug product, the FDA may approve a drug or biological product as an IND (Investigational New Drug). An application, including a protocol for the clinical use of the unlicensed drug or biological, must be submitted to and approved by the FDA before any agents are released under IND status [21CFR312.20].
There are two main types of INDs: research and treatment. A research IND is used mainly by manufacturers as part of the process for the development of new licensed drugs. The FDA can permit treatment use of an investigational drug under a treatment IND when the drug is intended as therapy for a serious or immediately life-threatening condition and when no comparable or satisfactory alternative drug or therapy is available [21CFR312.34].
Many of the drug products carried by the Drug Service at the CDC have treatment IND status. Most are manufactured by foreign drug companies and are commercially available in countries outside the U.S. Their demand in this country is so limited that commercial licensure is neither practical nor profitable. IND status is maintained by the CDC so that these products are available in the United States if needed.