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: [email protected]	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
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

* 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.