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Our Formulary
The following information is provided as an informational resource for guidance only. It is not intended as a substitute for professional judgment. These highlights and any hyperlinks may not include all the information needed to use each respective drug or biologic safely and effectively. See full prescribing information (package insert) or IND protocol for each respective drug or biologic, which accompany the product when it is delivered to the treating physician and/or pharmacist.
The Drug Service formulary is subject to change based on current public health needs, updates to treatment guidelines, and/or drug availability. For historical reference, we have included products no longer supplied by the Drug Service.
| Product & Supplier | Indication & Eligibility | How Supplied |
|---|---|---|
| ACAM2000® (Also known as the “Vaccinia Vaccine”); Manufactured by Sanofi Aventis | For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection | Lyophilized powder reconstituted with diluent (provided) Contains 100 doses per vial |
| Anthrax Vaccine Adsorbed (Also known as “AVA”; BioThrax®, Emergent BioSolutions) | For the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure
Because the risk for anthrax infection in the general population is low, routine immunization is not recommended The safety and efficacy of BioThrax® in a post-exposure setting have not been established. |
Suspension for injection in 5 mL multidose vials, each containing 10 doses |
| Botulism Antitoxin Heptavalent (Equine), Types A-G (Also known as “HBAT”; Manufactured by Cangene Corp. – BAT™) | For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin | 20 mL or 50 mL single-use glass vial
May be received frozen or thawed |
| Diethylcarbamazine (Also known as “DEC”; Supplied to CDC by the World Health Organization; Manufactured by E.I.P.I.C.O.) | For the treatment of certain filarial diseases, including lymphatic filariasis caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori; tropical pulmonary eosinophilia; and loiasis
For prophylactic use in persons determined to be at increased risk for Loa loa infection Patient must meet the eligibility criteria in the IND protocol |
100 mg tablet |
| Diphtheria Antitoxin (Equine) (Also known as “DAT”; Manufactured by Instituto Butantan) | For prevention or treatment of actual or suspected cases of diphtheria
Patient must meet the eligibility criteria in the IND protocol |
1 mL single-use ampule containing 10,000 units |
| Eflornithine (Also known as “DFMO”; Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Ornidyl®) | For the treatment of second-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense, with involvement of the central nervous system | 20 g/100 mL hypertonic solution for IV infusion
Must be diluted with Sterile Water for Injection before use |
| JYNNEOS™; Manufactured by Bavarian Nordic | JYNNEOS™ is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at risk for smallpox or monkeypox virus infection. | JYNNEOS™ is a suspension for injection. Each dose (0.5 mL) is supplied in a single-dose vial |
| Melarsoprol (Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Arsobal®) | For the treatment of second-stage African trypanosomiasis (sleeping sickness), with involvement of the central nervous system
Patient must meet the eligibility criteria in the IND protocol |
5 mL glass ampule containing 180 mg/5 mL (36 mg/mL) |
| Suramin (Supplied to CDC by the World Health Organization; Manufactured by Bayer – Germanin) | For the treatment of first-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei rhodesiense, without involvement of the central nervous system
Patient must meet the eligibility criteria in the IND protocol |
1 gram of suramin for injection in a 10 mL vial (100 mg/mL solution of suramin sodium)
Must be reconstituted with 10 mL Sterile Water for Injection before use |
ACAM2000®, “Vaccinia Vaccine”
Vaccinia vaccine is made of live vaccinia virus derived from plaque purification cloning of Dryvax® (calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents. It contains approximately 2.5 – 12.5 x 105 plaque-forming units per dose.
Smallpox was declared globally eradicated in 1980. In 1982, Wyeth Laboratories, the only active manufacturer of licensed vaccinia vaccine in the United States, discontinued production; and, in 1983, distribution to the civilian population was discontinued. Since January 1982, smallpox vaccination has not been required for international travelers, and International Certificates of Vaccination no longer include smallpox vaccination. ACAM2000® is a new-generation smallpox vaccine that was licensed in 2007 for use as a medical countermeasure held by the Strategic National Stockpile.
CDC recommends vaccinia vaccine for laboratory workers who directly handle a) cultures or b) animals contaminated or infected with non-highly attenuated vaccinia virus, recombinant vaccinia viruses derived from non-highly attenuated vaccinia strains, or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, vaccinia, and variola). Other health-care workers (e.g., physicians and nurses) whose contact with non-highly attenuated vaccinia viruses is limited to contaminated materials (e.g., dressings) and who adhere to appropriate infection control measures are at lower risk for inadvertent infection than laboratory workers. However, because a theoretical risk for infection exists, vaccination can be offered to this group. Read more [PDF – 930KB].
More Information for Clinicians
Full Prescribing Information for ACAM2000® [PDF – 11 pages]
ACAM2000® Medication Guide [PDF – 6 pages]
MMWR Notice to Readers: Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine
CDC’s Vaccine-Related Topics: Smallpox Vaccine
How to Request
Smallpox vaccine must be administered by or under the supervision of the physician who registers with CDC.
Ancillary supplies, such as bifurcated needles (for administration) and 1 mL tuberculin syringes with 25 gauge x 5/8″ needles (for reconstitution), are supplied with the vaccine.
Contact the CDC Drug Service for more information.
Requests for unapproved uses cannot be granted.
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Anthrax Vaccine Adsorbed
Anthrax Vaccine Adsorbed (AVA) is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure. The safety and efficacy of AVA in a post-exposure setting have not been established.
CDC provides anthrax vaccine for laboratory workers conducting research under federally funded projects who require preexposure vaccination based on their occupational risk.
Preexposure vaccination is recommended for laboratorians at risk for repeated exposure to fully virulent B. anthracis spores, such as those who 1) work with high concentrations of spores with potential for aerosol production; 2) handle environmental samples that might contain powders and are associated with anthrax investigations; 3) routinely work with pure cultures of B. anthracis; 4) frequently work in spore-contaminated areas after a bioterrorism attack; or 5) work in other settings where repeated exposures to B. anthracis aerosols may occur. Read more [PDF – 36 pages].
More Information for Clinicians
CDC’s Anthrax Vaccination Website
Educational Toolkit for Clinicians (from Department of Defense Anthrax Immunization Program)
Vaccine Information Statement (VIS) for Anthrax Vaccine [PDF – 2 pages]
Full Prescribing Information for BioThrax®
How to Request
Anthrax vaccine must be administered by or under the supervision of the physician who registers with CDC.
Contact the CDC Drug Service for more information.
Botulism Antitoxin Heptavalent (Equine), Types A-G
Botulism Antitoxin Heptavalent (HBAT) contains equine-derived antibody to the seven known botulinum toxin types (A-G). HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab’)2 immunoglobulin fragments. These fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. HBAT is supplied on an emergency basis for the treatment of persons thought to be suffering from botulism and works by neutralizing unbound toxin molecules. In 2010, HBAT became the only botulism antitoxin available in the United States for naturally occurring non-infant botulism.
It is available only from CDC because of its limited use and its relatively short expiration date. The antitoxin is stored at CDC Port Health Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.
BabyBIG® (botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program.
More Information for Clinicians
How to Request
Clinicians who suspect a diagnosis of botulism in a patient should immediately call their state health department’s 24-hour telephone number to maintain effective botulism surveillance and to facilitate rapid detection of outbreaks. The state health department will contact CDC to arrange for a clinical consultation by telephone and, if indicated, release of botulism antitoxin. State health departments requesting botulism antitoxin should contact the CDC Emergency Operations Center (EOC) at 770-488-7100. Read more.
For non-emergency questions concerning botulism antitoxin, contact the CDC Drug Service.
Diethylcarbamazine (DEC)
DEC is an antihelminthic agent used for treatment of lymphatic filariasis (caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori), tropical pulmonary eosinophilia, and loiasis; DEC also has prophylactic benefit for Loa loa infection. DEC has been used worldwide for more than 50 years. In the past, Wyeth-Ayerst Laboratories made DEC available as a licensed drug; in the late 1990s, because of unavailability of a bulk chemical supplier, Wyeth-Ayerst discontinued distribution of DEC in the United States.
More Information for Clinicians
Diagnostic assistance for filarial diseases is available through DPDx.
How to Request
Contact the CDC Drug Service for more information.
Questions regarding treatment of filarial diseases should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.
After-hours emergencies: 1-770-488-7100
Diphtheria Antitoxin (Equine)
Diphtheria antitoxin (DAT) is used to prevent or treat diphtheria by neutralizing the toxins produced by Corynebacterium diphtheriae. DAT is a sterile, aqueous solution of the refined and concentrated proteins, chiefly globulins, containing antibodies obtained from the serum of horses that have been immunized against diphtheria toxin. DAT is available under an IND protocol sponsored by CDC and is released only for actual or suspected cases of diphtheria. The antitoxin is stored at CDC Port Health Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.
More Information for Clinicians
CDC’s Vaccine-Related Topics: Diphtheria Antitoxin
How to Request
Clinicians who suspect a diagnosis of respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. They will be connected with the diphtheria duty officer, who will provide clinical consultation and, if indicated, initiate the release of diphtheria antitoxin.
For non-emergency questions concerning diphtheria antitoxin, contact the CDC Drug Service.
Eflornithine
Eflornithine is an antitrypanosomal agent that inhibits the enzyme ornithine decarboxylase. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Eflornithine is considered the drug of choice for the treatment of second-stage Trypanosoma brucei gambiense (West African) infection, with involvement of the central nervous system. It is not effective against T. b. rhodesiense (East African) infection (see melarsoprol). Although the manufacturer, Aventis, maintains its US licensure, eflornithine is not commercially available in the United States.
More Information for Clinicians
Human African trypanosomiasis, WHO
Diagnostic assistance for African trypanosomiasis is available through DPDx.
How to Request
Contact the CDC Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
JYNNEOS™
JYNNEOS™ is a non-replicating vaccine indicated for smallpox and mpox disease prevention in adults aged 18 years and older. JYNNEOS™ contains a live, attenuated form of the vaccinia virus called Modified Vaccinia Ankara (MVA), which is like variola or Monkeypox viruses but is less harmful. It is non-replicating and capable of generating humoral and cellular immune responses to orthopoxviruses. The MVA is cultured in Chicken Embryo Fibroblast (CEF) cells placed in a serum-free medium. It is purified and filtered from the cells using various methods, including benzonase digestion.
JYNNEOS™ was developed by Bavarian Nordic, a Denmark-based biotechnology company, in partnership with the US Government to protect adults from smallpox infection, including those with weak immune systems and those at high risk of reactions to existing replicating vaccines. JYNNEOS™ was approved by the US Food and Drug Administration (FDA) in September 2019 for the prevention of smallpox and mpox in adults. It is the only FDA-approved non-replicating smallpox and mpox vaccine and the only approved mpox vaccine in the world. JYNNEOS™ involves 2 vaccine doses 28 days apart and vaccine protection is not conferred until 2 weeks after receipt of the second dose. It is available as a pale yellow to white sterile suspension for subcutaneous administration in 0.5mL single-dose vials.
In 2021, ACIP voted to recommend JYNNEOS™ as an alternative PrEP to ACAM2000 for certain personnel at risk for exposure to orthopoxviruses. During the global mpox outbreak that started in 2022, JYNNEOS was the predominant vaccine used. In 2023, ACIP recommended the use of JYNNEOS in people 18 years and older during an mpox outbreak and for people 18 years and older who are at risk for mpox. JYNNEOS became commercially available in the U.S. in April 2024.
Research laboratory personnel, clinical laboratory personnel performing diagnostic testing for orthopoxviruses, designated response team members, and health care personnel who administer ACAM2000 (Smallpox [Vaccinia] Vaccine, Live) or care for patients infected with orthopoxviruses are the persons to whom these recommendations apply. Research laboratory personnel are those who directly handle cultures or animals contaminated or infected with monkeypox virus (MPXV). Vaccination is not routinely recommended for clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis testing, including for patients with suspected or confirmed MPXV infection, healthcare personnel who care for patients with mpox or administer ACAM2000. Recommended infection prevention and control practices are effective in minimizing transmission. Vaccination can be offered based on site- and activity- specific biosafety risk assessments (e.g., identification of laboratory procedures with a high likelihood of generating aerosols or inadequate PPE availability). For laboratory personnel and designated response team members, ACIP recommends use of JYNNEOS™ for primary vaccination as an alternative to ACAM2000. For health care personnel who administer ACAM2000 or care for patients infected with orthopoxviruses, ACIP recommends use of JYNNEOS™ (as an alternative to ACAM2000), based on shared clinical decision-making. In addition, persons who received the 2-dose JYNNEOS™ primary series and who are at ongoing risk for occupational exposure to more virulent orthopoxvirus (e.g., Variola virus and Monkeypox virus), should receive a booster dose of JYNNEOS™ every 2 years after the primary JYNNEOS™ series; persons who receive the 2-dose JYNNEOS™ primary series and who are at ongoing risk for occupational exposure to less virulent orthopoxviruses, (e.g., Vaccinia virus or Cowpox virus), should receive booster doses of JYNNEOS™ at least every 10 years after the primary JYNNEOS™ series. ACIP also recommends that persons who received an ACAM2000 primary vaccination and who are at ongoing risk for occupational exposure to orthopoxviruses may receive a booster dose of JYNNEOS™ as an alternative to a booster dose of ACAM2000.
More Information for Clinicians
JYNNEOS Vaccine | Mpox | Poxvirus | CDC
Package Insert – JYNNEOS (fda.gov)
How to request
Poxvirus vaccine must be administered by or under the supervision of the physician who registers with CDC.
Contact the CDC Drug Service for more information.
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Melarsoprol
Melarsoprol is an organoarsenic compound with trypanocidal effects that has been used outside the United States since 1949. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Melarsoprol is used for the treatment of second-stage infection (involving the central nervous system). It is the only available therapy for second-stage Trypanosoma brucei rhodesiense (East African) infection, whereas eflornithine typically is used for second-stage T. b. gambiense (West African) infection.
More Information for Clinicians
Human African trypanosomiasis, WHO
Diagnostic assistance for African trypanosomiasis is available through DPDx.
How to Request
Contact the CDC Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
Suramin
Suramin is a negatively charged, high-molecular-weight sulfated naphthylamine. It was introduced in the 1920s for the treatment of African trypanosomiasis (sleeping sickness). Suramin generally is considered the drug of choice for first-stage Trypanosoma brucei rhodesiense (East African) infection, without involvement of the central nervous system. Pentamidine typically is used for first-stage T. b. gambiense (West African) infection.
More Information for Clinicians
Human African trypanosomiasis, WHO
Diagnostic assistance for African trypanosomiasis is available through DPDx.
How to Request
Contact the CDC Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
Products No Longer Supplied by Drug Service*
Artesunate, Intravenous
In May 2020, FDA-approved artesunate became commercially available. Artesunate is in the class of medications known as artemesinins, which are derivatives from the “qinghaosu” or sweet wormwood plant (Artemisia annua). Intravenous artesunate is the only injectable medication available in the US for severe malaria. Read more.
Benznidazole
In May 2018, FDA-approved benznidazole became commercially available. Benznidazole is a 2-nitroimidazole trypanocidal agent that was introduced in 1971 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis. Benznidazole is one of two drugs available for the treatment of Chagas disease (the other is nifurtimox). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.
Botulinum Antitoxin Types AB & E
In March 2010, CDC announced the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation). HBAT replaced the licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur), becoming the only botulinum antitoxin available in the United States for naturally occurring non-infant botulism. Read more.
Botulinum Toxoid
Pentavalent (ABCDE) botulinum toxoid is a combination of aluminum phosphate-adsorbed toxoid derived from formalin-inactivated types A, B, C, D, and E botulinum toxins, with formaldehyde and thimerosal used as preservatives. Botulinum toxoid was distributed by CDC under an IND protocol for at-risk persons who were actively working or expected to be working with cultures of Clostridium botulinum or the toxins; in 2011, CDC discontinued its program to supply this vaccine. Read more.
(Sodium Stibogluconate) Pentostam®
In 2020, the worldwide manufacturer of Pentostam®, GSK, notified CDC that due to inability to source the necessary raw materials, they would no longer be able to manufacturer the product and it would be discontinued. Following expiration of the last lot in use, CDC closed the IND treatment protocol due to lack of product availability.
Vaccinia Immune Globulin (VIG)
Vaccinia immune globulin (VIG) is released from the CDC Strategic National Stockpile, if indicated, for the treatment of complications associated with vaccinia vaccination or severe orthopoxvirus infection. Clinicians wishing to obtain VIG should contact the Emergency Operations Center (EOC) at 770-488-7100. They will be connected with CDC medical staff who can assist them in the diagnosis and management of patients with suspected complications of vaccinia vaccination or severe orthopoxvirus infection.
*this list is not all-inclusive
Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.