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Frequently Asked Questions about the CDC Drug Service
Questions that apply to ALL our products
Is there a charge for these products?
No. At this time, all of our products are supplied free of charge by the CDC. However, CDC does not cover any other costs associated with the use/administration of the drug.
Why are these drugs not available elsewhere in the US?
Due to the limited demand for these products, many of them are not licensed or commercially available for use in the United States. Some drugs and biologic products dispensed by the CDC are licensed by the FDA, but their use is restricted to select groups. These restrictions are outlined under each section of our formulary page.
How do HIPAA Privacy Rules apply to the activities of the CDC Drug Service?
The Privacy Rule expressly permits protected health information (PHI) to be shared for specified public health purposes. For example, covered entities may disclose PHI, without individual authorization, to a public health authority legally authorized to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability. Read more.
Due to the requirements of our IND protocols and our need to collect safety and surveillance data, CDC may need to obtain and store information from the patient’s record, including patient identifiers. Hard copies of patient records will be stored in locked, secure storage areas in the CDC Drug Service.
What if I receive a product from the CDC Drug Service but do not use it?
- If you are the physician/pharmacy/hospital who requested the product but do not use it for the intended patient, it must be returned to the CDC Drug Service.CDC Drug Service
1600 Clifton Rd, MS/H23-6
Atlanta, GA 30329
404-639-3670
drugservice@cdc.gov - If you are the patient who received the drug, please contact your health care provider for instructions on how to return it to their office.
Questions about products distributed under investigational status
Why are these drugs used under “investigational” status?
Many of the products dispensed by the CDC Drug Service have been used extensively in other countries, and in some cases, for decades. Even though the drug is not “new”, we utilize FDA’s Investigational New Drug (IND) status as a mechanism to provide these drugs in the US, where a critical need for them may exist.
What drug information and paperwork should I expect to receive with the IND products?
- The CDC IRB-approved protocol (sometimes referred to as “Information for Physicians”), an Investigator’s Brochure if one is available, and the USP-DI monograph (also, when available): These documents provide information about the indication(s), contraindications, dosage, routes, frequency of administration, reported adverse reactions, toxicity, and other data.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.
- Informed Consent Statement: 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.
- FDA-1572: 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]
- Patient Report Forms: After therapy, the physician must complete and return all patient report forms, documenting details on patient response to therapy and any drug-associated toxicity. This information is reported in the IND annual report required by FDA.
Why are your protocols not accessible from your website?
The protocols distributed from the CDC Drug Service may contain confidential and proprietary information. These documents, and the contents within these documents, must not be further distributed or disclosed to others without written authorization from the CDC.
Is local IRB review necessary?
It depends. All of the products distributed by the Drug Service under an IND protocol have been approved by CDC’s Human Subject Review Board. If you are required to provide evidence of this approval, please contact the CDC Drug Service for more information.
Unless otherwise precluded by local law or institutional policy, each local site that becomes involved in a CDC IRB-approved protocol may rely on the CDC IRB to meet the FDA regulatory requirements of IRB review. CDC does not require local IRB approval or any documentation of local IRB approval. However, the treating physician should check whether the local site requires IRB approval.
Who do I report adverse reactions to?
Unexpected, severe, or life-threatening adverse events must be reported to the CDC Drug Service immediately to assist CDC in following the requirements of 21 CFR 312.32 and in accordance with CDC’s Human Research Protection Office guidance policy on reporting incidents.
Suspected adverse events that may be expected with the use of an IND product (which would be listed in the protocol) may be reported to the CDC Drug Service on the Patient Report Forms previously mentioned, given they are not severe, unexpected, or life-threatening in nature.
Questions about products distributed under licensed (FDA approved) status
What drug information and paperwork should I expect to receive with the licensed products?
Drug Information: CDC Drug Service will supply the package insert, i.e. full prescribing information approved by the FDA, along with any other instructions that enable physicians to use the product safely and effectively.
Accountability Form: In order to maintain responsible accountability for the products we provide, you may be asked to supply information on their individual use and disposal.
Who do I report adverse reactions to?
CDC Drug Service would like to know about all unexpected or severe adverse reactions related to our products, even ones that are approved by the FDA.
Adverse events that result from a licensed (FDA-approved) product should be reported to either the manufacturer or to the FDA, using the applicable mechanism.
Information for Patients
What if I receive a product from the CDC Drug Service but do not use it?
If you are the patient (or caregiver) who received the drug, please contact your health care provider for instructions on how to return it to their office.
Who do I report adverse reactions (side effects) to?
If you feel you have experienced (or are experiencing) an adverse reaction to a product distributed by the CDC Drug Service, please contact the health care provider who is managing your disease/condition.