The Centers for Disease Control and Prevention (CDC) distributes special biologic agents and drugs through the Drug Service, Division of Scientific Resources, and the Division of Global Migration and Quarantine.
Why CDC distributes certain biologics and drugs
These special biologic agents and drugs are managed and distributed by the CDC because they meet important medical needs and provide public health surveillance, but due to limited demand in this country, commercial use and/or licensure is neither practical nor profitable for many pharmaceutical companies.
In the United States, federal law prohibits the distribution and transportation of drug products not approved by the Food and Drug Administration (FDA). To allow treatment of patients with an unlicensed drug product, FDA may permit the use of a drug or biological product under an Investigational New Drug (IND) application. The IND application is not a request for approval, but a request for exemption from federal law. An IND application includes a protocol for the clinical use of the unlicensed drug or biological and must be submitted for review to FDA and permitted to proceed before any agents are released under IND status [21CFR312.20].
Many of the drug products carried by the Drug Service at CDC have expanded access IND status. These products are intended as therapy for serious or immediately life-threatening conditions, when no comparable or satisfactory alternative drug or therapy is available [21CFR312.305]. Most are manufactured by foreign drug companies and are commercially available in countries outside the U.S. IND status is maintained by the CDC so that these products are available in the United States if needed.
CDC Drug Service
1600 Clifton Road, MS/D09
Atlanta, GA 30333
Telephone: (404) 639-3670
Fax: (404) 639-3717
- Page last reviewed: November 30, 2015
- Page last updated: February 29, 2016
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