How does CBER Learn about the Discontinuation of the Products It Regulates?
FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products.
Manufacturers of CBER-regulated products often voluntarily notify CBER of the discontinuation of a product that they manufacture when the product does not meet the requirements for notification under FDASIA. In addition, manufacturers of CBER-regulated drug products approved under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition.
In certain circumstances, CBER-regulated products may also be discontinued from marketing by the manufacturer, but are still licensed without being assessed product user fees. These products are identified on CBER's User Fee Billable Biologic Products / Discontinued List. After clicking on this link, you must scroll to bottom of that webpage to view a second table containing the list of CBER discontinued products that are no longer being assessed product user fees.
The table below lists only those CBER-regulated products which the manufacturer has permanently discontinued and, as a result of, CBER has determined may likely lead to a meaningful disruption in the supply of that product in the United States. This table is for informational purposes only.
Tabular Listing of Discontinued CBER-Regulated Products
|Product||Manufacturer||Manufacturer Contact Information||Additional Information||Discontinued Date|
|BCG Live (Intravesical)|
81 mg lyophilized powder
|Sanofi Pasteur, Ltd.||1-800-VACCINE |
|BCG Live (Intravesical) TheraCys®, indicated for the treatment of non-muscle invasive bladder cancer, has been discontinued.||Discontinued:|
|Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA)|
Product Code: 930600
|Manufactured by: |
Ortho-Clinical Diagnostics, Inc.
|Ortho-Clinical Diagnostics, Inc. – Customer Technical Services|
|Novartis Diagnostics, the legal manufacturer of this immunoblot assay, has informed the FDA that the production of the CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA) has been discontinued. |
FDA regulations provide procedures for licensed and unlicensed blood establishments wishing to obtain an exception or alternative procedure to the requirements in Parts 600-680.
Additional information concerning this product and instructions for obtaining an exception or alternative procedure can be found at:
CBER Safety and Availability webpage
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001)
February 18, 2013
|Rubella Virus Vaccine Live|
0.5 mL 10 dose vials
|Merck & Co., Inc.||1-800-NSC-MERCK |
|MERUVAX® II (Rubella Virus Vaccine Live) has been discontinued. |
The Advisory Committee on Immunization Practices (ACIP) has recommended the use of combined measles-mumps-rubella vaccine (M-M-R® II - Measles, Mumps, and Rubella Virus Vaccine Live) for appropriate individuals to help protect against measles, mumps, and rubella.
May 24, 2011
|Varicella Zoster Immune Globulin (Human)|
Massachusetts Public Health Biologic Laboratories (MPHBL)
|MPHBL has discontinued manufacture of VZIG and a limited supply of VZIG remains. |
FFF Enterprises (Temecula, CA) the sole authorized distributor of the product, will assist in determining patient eligibility and in shipping investigational VZIG.
February 10, 2006