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  4. CBER-Regulated Products: Current Shortages
  1. Safety & Availability (Biologics)

CBER-Regulated Products: Current Shortages

The following table identifies current shortages of CBER-regulated products. The information contained in this table is generally provided to CBER by the manufacturer of the CBER-regulated product that is in shortage. CBER is committed to ensuring that the information in the table is current, and works closely with the manufacturer to obtain accurate information.

Please refer to the Resources for You box at the bottom of the page for a complete listing of all CBER approved, licensed, and cleared products, as well as CDC's recommended immunization schedules for adult and children.

Additional information regarding possible causes for CBER-regulated product shortages is provided on
CBER-Regulated Products: Possible Causes of Shortages Page.

Product Manufacturer and Manufacturer Contact Information Product Availability and Estimated Shortage Duration (when known) Shortage Reason (per FDASIA)* Additional Information Date
Cholera Vaccine, Live, Oral
Vaxchora®

NDC Number:
70460-0004-01
Emergent Travel Health, Inc.

For questions, please call customer care at:
1-800-533-5899

Or email at: customercare@ebsi.com
Vaxchora® Cholera Vaccine, Live, Oral is currently unavailable. Discontinuation of the manufacture of the drug or biological product Emergent Travel Health, Inc. has informed the FDA that they have decided to temporarily discontinue the manufacture and distribution of Vaxchora® in the United States due to a significant reduction in international travel caused by the COVID-19 pandemic.

Emergent has also informed the FDA that they remain committed to travel health and plan to resume the manufacture and distribution of Vaxchora® in the United States once global travel resumes. The duration of this interruption is estimated to be one year.

Additional information from Emergent may be found here:
https://emergenttravelhealth.com/fda-notice
Onset: May 2021

Ongoing
Typhoid Vaccine Live Oral Ty21a
VIVOTIF®

NDC Number:
69401-000-02

Emergent Travel Health, Inc.

For questions, please call customer care at:
1-800-533-5899

Or email at: customercare@ebsi.com

VIVOTIF® Typhoid Vaccine Live Oral Ty21a is currently unavailable. Discontinuation of the manufacture of the drug or biological product Emergent Travel Health, Inc. has informed the FDA that they have decided to temporarily discontinue the manufacture and distribution of VIVOTIF® in the United States due to a significant reduction of international travel caused by the COVID-19 pandemic.

Emergent has also informed the FDA that they remain committed to travel health and plan to resume the manufacture and distribution of VIVOTIF® in the United States once global travel resumes. The duration of this interruption is estimated to be one year.

Additional information from Emergent may be found here:
https://emergenttravelhealth.com/fda-notice
Onset: January 2021

Updated: May 2021

Ongoing
BCG Live (Intravesical)
TICE® BCG

NDC Number:
00052-0602-02

50 mg lyophilized powder
Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc.

For questions, please call customer service at: 1-800-NSC-MERCK
(1-800-672-6372)
TICE® BCG, BCG Live (Intravesical) is currently available.

In order to help manage inventory and to minimize disruption to patient care when demand exceeds production plans and available inventory product will be placed on allocation.
Demand increase in the drug or biological product Because of increased global demand and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for TICE® BCG for the foreseeable future.

To minimize disruption to patient care and address the current imbalance between supply and increased global demand TICE® BCG will be under allocation when demand exceeds production plans and available inventory.

Please Note: In the past, Merck has provided preservative-free saline with certain orders of TICE® BCG. Merck is no longer able to provide saline with TICE® BCG and has discontinued the distribution of saline with TICE® BCG.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)

Or visit
http://www.merck.com/product/
oncology/home.html
Onset:
January 2019

Updated: July 2020

Ongoing
Venoms, Honey Bee Venom
Venoms, Mixed Vespid Venom Protein
Venoms, Wasp Venom Protein
Venoms, White Faced Hornet Venom Protein
Venoms, Yellow Hornet Venom Protein
Venoms, Yellow Jacket Venom Protein

Pharmalgen®

Venoms, Honey Bee Venom

NDC Number: 52709-0801-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Mixed Vespid Venom Protein

NDC Number: 52709-1201-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Wasp Venom Protein

NDC Number: 52709-1301-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, White Faced Hornet Venom Protein

NDC Number: 52709-1101-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Yellow Hornet Venom Protein

NDC Number: 52709-1001-1
1.2 mL in 1 VIAL, SINGLE-DOSE

Venoms, Yellow Jacket Venom Protein

NDC Number: 52709-0901-1
1.2 mL in 1 VIAL, SINGLE-DOSE
ALK - Abello A/S

Customer Service: 1-512-251-0037

For questions concerning patient treatment options or manufacturer conversions, please contact ALK Scientific Services: 1-800-325-7354
At this time Pharmalgen® (lyophilized allergenic venom extract) products are unavailable. Other For general questions and questions concerning supply, please contact ALK Customer Service at: 1-512-251-0037

For questions concerning patient treatment options or manufacturer conversions, please contact ALK Scientific Services at: 1-800-325-7354
Onset:
November 2016

Updated: November 2019

Ongoing
BCG Vaccine

NDC Number:
00052-0603-02

50 mg lyophilized powder
Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)
BCG Vaccine, for tuberculosis prevention is currently unavailable. Other Merck is developing a control mechanism to ensure that customer orders being placed for BCG Vaccine, are for tuberculosis prevention. BCG vaccine will remain unavailable until a new ordering process is implemented.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)

Or visit https://www.merckorders.com
Onset:
July 2019

Updated: November 2019

Ongoing
Immune Globulin Intravenous (Human)
Gammaplex®

NDC Number:
64208-8234

Gammaplex 5% Liquid

NDC Number:
64208-8235

Gammaplex 10% Liquid
Bio Products Laboratory

For questions, please call BPL customer service at:
1-844-4BPLUSA
(1-844-427-5872)
Gammaplex® Immune Globulin Intravenous (Human) is currently available but due to continued high demand and manufacturing schedule, there is a limited supply of this product, which is presently being allocated to a limited number of customers. Other For questions, please call BPL customer service at:
1-844-4BPLUSA
(1-844-427-5872)
Onset: October 2018

Updated:
August 2019

Ongoing
Anticoagulant Sodium Citrate Solution

NDC Number:
0942-9505-10
250 mL
Fenwal, Inc., a subsidiary of Fresenius Kabi USA, LLC.

For questions, please call customer service at: 1-800-3-FENWAL
(1-800-333-6925)
Fenwal Anticoagulant Sodium Citrate Solution 250 mL is in short supply and is being allocated.

This measure is necessary to responsibly manage the limited supply of Anticoagulant Sodium Citrate Solution until supply once again meets demand.
Other Demand exceeding production and available inventory is causing a short supply situation.

Please check with your wholesaler, or call Fenwal, Inc. directly for product availability.

1-800-3-FENWAL
(1-800-333-6925)
Onset:
May 2017

Ongoing

* FDASIA added several new, drug-shortage related sections to the FD&C Act, including section 506E. Section 506E of the FD&C Act further requires FDA to include on the shortages list the reason for the shortage, choosing from the following categories:

  • Requirements relating to complying with current good manufacturing practices (CGMP);
  • Regulatory delay;
  • Shortage of an active ingredient;
  • Shortage of an inactive ingredient component;
  • Discontinuation of the manufacture of the drug or biological product;
  • Delay in shipping of the drug or biological product;
  • Demand increase in the drug or biological product; or
  • Other.

Resources for You

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