Release Information

CDC dispenses drugs and biologicals to physicians licensed in the US who intend to use them according to their FDA approved use, or according to an Investigational New Drug (IND) protocol that CDC maintains for certain diseases. CDC can only dispense drugs to physicians for patients residing in the United States. Physicians requesting drugs for patients residing outside the United States will be referred directly to the drug manufacturer.

FDA Requirements for Release of Drugs and Biologicals

Physicians requesting an investigational product must adhere to the following requirements:

• The requesting physician is required to register as a clinical sub-investigator of the IND protocol by completing form FDA-1572 "Statement of Investigator."[PDF - 2 pages]
• Severe adverse events must be reported to the CDC Drug Service immediately to assist CDC in following  21 CFR 312.32 and in accordance with CDC’s Human Research Protection Office guidance policy on reporting incidents.   [PDF - 17 pages]
• A statement of consent must be obtained before therapy is initiated.  A consent form, approved by CDC’s Institutional Review Board (IRB), is provided with the drug.  A copy of this form must be given to the patient, a copy should be maintained in the patient's file and a third copy should be returned to CDC upon completion of therapy. 
• Each IND protocol that governs the use of these agents is reviewed and approved by CDC’s IRB.  Local IRB review may or may not be required, dependent upon each facility’s regulations.  It is the responsibility of the treating physician to follow their local IRB’s rules regarding any additional approval(s) required.
• After therapy, the physician must complete and return all patient report forms, received with the drug, documenting details on patient response to therapy and any drug-associated toxicity. This information is reported in the IND annual report required by FDA.

Information about indication, contraindication, dosage, routes and frequency of administration, reported adverse reactions, toxicity, and other data are sent to the physician along with the investigational drug or biological product.

Physicians who wish to use these products in clinical situations that are not approved under the IND protocol must submit a separate IND application to the FDA directly. Any alterations in dosing schedule or dosage form also require approval under a separate IND.

Some drugs and biologics dispensed by the CDC are licensed by the FDA, but their use is restricted. Restrictions are outlined under each section in this document.

Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.