International Inquiries

International requests for BabyBIG®:

• Access to BabyBIG^® is authorized only by one of the IBTPP on-call physicians, who must be contacted by the patient's attending physician to discuss the patient's history and clinical findings before BabyBIG^® can be shipped.

  

• An IBTPP on-call physician can be reached 24 hours a day, 7 days a week at exit calling code -1-510-231-7600.

• Please be advised that the attending physician or hospital must obtain approval from their country's Medicines Regulatory Authority to import BabyBIG^® because BabyBIG^® is licensed only in the US.

Please be advised that the following steps are required for shipment and importation of BabyBIG®:

• A letter of authorization from the requesting country's Medicines Regulatory Authority or Agency to import BabyBIG® must be provided to the Infant Botulism Treatment and Prevention Program (IBTPP) before BabyBIG® can be shipped. The letter should specify the number of vials of BabyBIG® to be imported and the name of the requesting hospital.      

• The receiving hospital/purchasing institution must pay: 1) the costs for expedited shipping of BabyBIG® via the hospital’s international courier service, 2) any customs charges, and 3) the statutorily-required CDPH fee for BabyBIG®.
  

• BabyBIG® must clear customs after arrival in the importing country. As soon as BabyBIG® is shipped, arrangements to expedite customs clearance should be initiated by hospital personnel. Use of a commercial customs brokerage service for this purpose should be considered.
  

• Once BabyBIG® has been ordered, contact the customs office at the receiving airport to arrange for expedited clearance of the package. Use the shipping information that IBTPP will send to your hospital for this purpose.
  

• NOTE: your hospital/facility must have its own active international courier account in order to have BabyBIG® exported to your country. (World Courier and FedEx have locations close to the U.S. distribution facilities for BabyBIG® . DHL locations are more distant.)

  • This account should be in good standing and have permissions in place for CDPH/IBTPP and its distributor, FFF Enterprises, to use it on short notice.
    

  • Attending physicians should immediately notify their hospital administration of this requirement if they are considering ordering BabyBIG® for their patient.
    

  • As of 1 January 2022, CDPH/IBTPP will not use its own courier accounts to ship BabyBIG® to your facility.
    

• BabyBIG® must be shipped expedited because hospital stay is shortened more the sooner after hospital admission the medicine is administered.  The medicine is shipped in validated packaging that will maintain the required temperature for about 96 hours (4 days).
  

• Before BabyBIG® is released for shipment, IBTPP must receive:

1. the signed International Invoice and Purchase Agreement (IPA) document, which is available here, International Invoice and Purchase Agreement (PDF);

2. medical records submitted either electronically or by fax that include documentation of the patient's weight;

3. the import permit authorization letter from the requesting country's Medicines Regulatory Agency; and
   

4. written permission to utilize the hospital’s international courier account, and the contact information for someone at the hospital who can facilitate the shipment, if needed.
   

International use of BabyBIG®:

• As of February 2021, BabyBIG® has been used to treat infants in 16 countries ¹, spanning 5 continents. If used, BabyBIG® should be given as soon as possible in the patient's illness. Treatment should not be delayed while waiting for laboratory confirmation of the diagnosis. Treatment within the first 3 days of hospitalization shortens the hospital stay the most. Treatment between hospital days 4 through 7 also significantly shortens hospital stay when compared to placebo ^2,3 (N Engl J Med 2006;354:462-71) (J Pediatr 2018;193:172-7).