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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
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.

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: December 2019

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
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Pediatric/Adolescent formulation (5 mcg/0.5mL),
vials and syringes

NDC Number:
0006-4981-00
10 Vials, Single-use in 1 Carton

NDC Number:
0006-4093-02
10 Syringes, Single-use in 1 Carton

NDC Number:
0006-4093-09
6 Syringes, Single-use in 1 Carton
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)
Currently, RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)] Pediatric/Adolescent formulation is available but will be in limited supply through mid-2020.

Merck’s limited supply will be allocated to the Centers for Disease Control and Prevention (CDC) to ensure utilization consistent with their clinical guidance. For additional information please reference the CDC website.

CDC's Current Vaccine Shortages and Delays web page

2019 Pediatric Hepatitis B Vaccine Supply Update and Guidance Table
Demand increase in the drug or biological product There is an increased global demand for this product.

Please check with your physician, wholesaler, or call Merck directly for product availability.

1-800-NSC-MERCK
(1-800-672-6372)

Additional information may be found here:

www.merckvaccines.com

CDC's Current Vaccine Shortages and Delays web page
Onset:
August 2017

Updated:
September 2019

Ongoing
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Dialysis formulation (40 mcg/mL), vials

NDC Number:
0006-4992-00
1 vial, Single-use in 1 Carton

Suspension for intramuscular injection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)
Currently, RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)] dialysis formulation is unavailable.

Dialysis formulation is not anticipated to be available throughout 2020.
Demand increase in the drug or biological product There is an increased global demand for this product.

Please check with your physician, wholesaler, or call Merck directly for product availability.

1-800-NSC-MERCK
(1-800-672-6372)

Additional information may be found here:

www.merckvaccines.com

CDC's Current Vaccine Shortages and Delays web page
Onset:
April 2018

Updated:
September 2019

Ongoing
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Adult formulation (10 mcg/1mL), vials and syringes

NDC Number:
0006-4995-00
1 Vial, Single-use in 1 Carton

NDC Number:
0006-4995-41
10 Vials, Single-use in 1 Carton

NDC Number:
0006-4094-02
10 Syringes, Single-use in 1 Carton

NDC Number:
0006-4094-09
6 Syringes, Single-use in 1 Carton

Suspension for intramuscular injection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)
Currently, RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)] adult formulation is unavailable.

Adult formulation is not anticipated to be available throughout 2020.
Demand increase in the drug or biological product There is an increased global demand for this product.

Please check with your physician, wholesaler, or call Merck directly for product availability.

1-800-NSC-MERCK
(1-800-672-6372)

Additional information may be found here:

www.merckvaccines.com

CDC's Current Vaccine Shortages and Delays web page
Onset:
May 2017

Updated:
September 2019

Ongoing
Rabies Immune Globulin (Human)
Imogam®

NDC Number:
49281-0190-20

2 mL vial

NDC Number:
49281-0190-10

10 mL vial
Sanofi Pasteur SA

For questions, please call Sanofi Pasteur customer service at:

1-800-VACCINE
(1-800-822-2463)
Sanofi Pasteur SA currently has a limited supply of Rabies Immune Globulin (Human) Imogam®

Because of this supply shortage, Imogam® will only be shipped directly to customers who have a patient with current suspected rabies exposure requiring immediate post-exposure prophylaxis.

This measure is necessary to responsibly manage the limited supply of rabies immune globulin in the United States.
Other How to obtain products for patients with immediate need:

Access post-exposure information via link on the VACCINESHOPPE home page found here.
https://www.vaccineshoppe.com/

Please fill out a Rabies Post-Exposure Form in its entirety and fax completed form to Sanofi Pasteur at 1-877-287-9391
(Attn: Sanofi Pasteur Customer Service).

For questions, please call Sanofi Pasteur customer service at: 1-800-VACCINE
(1-800-822-2463)
Onset: August 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
Immune Globulin Infusion (Human)
GAMMAGARD LIQUID®

NDC Number:
0944-2700-02 10mL, 1.0 Grams Protein


NDC Number: 0944-2700-03 25mL, 2.5 Grams Protein


NDC Number: 0944-2700-04 50mL, 5.0 Grams Protein


NDC Number: 0944-2700-05 100mL, 10.0 Grams Protein


NDC Number: 0944-2700-06 200mL, 20.0 Grams Protein


NDC Number: 0944-2700-07 300mL, 30.0 Grams Protein
Baxalta US Inc., a subsidiary of Shire Pharmaceuticals.

For questions, please call Shire customer service at: 1-866-888-0660
GAMMAGARD LIQUID® Immune Globulin Infusion (Human) is currently available, though patient shipping schedules may be impacted as continued high demand exceeds production plans and available inventory. Demand increase in the drug or biological product Please check with your physician, pharmacy, or call Shire Pharmaceuticals directly at 1-866-888-0660, for product availability Onset: April 2019

Ongoing
Zoster Vaccine Recombinant, Adjuvanted
SHINGRIX®

NDC Number:
58160-819-12

1 dose

NDC Number: 58160-823-11

10 doses
GlaxoSmithKline Biologicals

For questions, please call GSK customer service at: 1-800-772-9292
SHINGRIX® Zoster Vaccine Recombinant, Adjuvanted is currently available.

Customers may experience shipping delays and back-orders when demand exceeds production plans and available inventory throughout 2019. Resupply is expected to be continuous and expedited throughout 2019 in response to demand.
Demand increase in the drug or biological product Please check with your physician, pharmacy, or call GlaxoSmithKline Biologicals directly at 1-800-772-9292 for product availability.

Additional information may be found here:

https://www.gskdirect.com/

CDC's Current Vaccine Shortages and Delays web page
Onset:
May 2018

Updated:
January 2019

Ongoing
Yellow Fever Vaccine
YF-VAX®

NDC Number: 49281-915-01

Vial, 1 Dose (5 per package)

NDC Number:
49281-915-05

Vial, 5 Dose with 3mL vial of diluent
Sanofi Pasteur Inc.
For questions, please call Sanofi Pasteur customer service at: 1-800-VACCINE (1-800-822-2463)
Yellow Fever Vaccine YF-VAX® is currently unavailable to order.

In April 2016 Sanofi Pasteur Inc. reported there was a limited supply of YF-VAX®. As of July 2017 Sanofi Pasteur Inc. reports that YF-VAX® is currently unavailable to order.
Other How to obtain another yellow fever vaccine for patients:

Sanofi Pasteur has worked with FDA to make another yellow fever vaccine available in the US. Clinics providing access to the vaccine can be found at:
http://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search.

Information from Sanofi Pasteur can be found at:
https://www.sanofi.us/en/products-and-resources/vaccines/yellow-fever-vaccine-information/
and
https://www.vaccineshoppe.com.

You may also contact Sanofi Pasteur directly at: 1-800-VACCINE or (1-800-822-2463).

Onset: April 2016

Updated:
August 2018

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