Release Information

CDC dispenses drugs to physicians who request them for patients with medical conditions that are approved for the drug product's use. CDC can only dispense drug to physicians of patients who are within the United States or who are United States citizens. These drugs may not be exported for use in other countries. Physicians requesting drugs for foreign patients will be referred directly to the drug manufacturer, when possible.

FDA Requirements for Release of Drugs and Biologicals

The CDC dispenses immunobiologics or drugs to physicians who request them for patients with medical conditions that are approved for the drug product's use. Physicians requesting an investigational product must adhere to the following FDA requirements:

• The requesting physician is required to complete form FDA-1572 "Statement of Investigator." PDF (495 KB/2 pages)
• The physician must fill out and return a specific "Patient Report Form," with results of therapy and any adverse reactions that the patient experiences. This information is used in IND annual reports required by FDA. Severe reactions must be reported to CDC immediately by phone or FAX.
• A patient "Informed Consent Form", signed by both the clinical investigator and the patient, is required.

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 immunobiologic.

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 immunobiologics 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.