Drug Shortages 

• Introduction

• FAQs

• Current Drug Shortages   (9/30/2004)

• Resolved Drug Shortages  (9/29/2004)

• Drugs to be Discontinued  (9/17/2004)

• Additional Communications  (5/25/2004)

• Drug Shortage Manual of Policies and Procedures (MaPP)

• Medical Necessity Guidance Document

• How to Report a Drug Shortage  

• Practical Steps for Practitioners Facing Shortage Situations

• More Information on Drug Shortages, Product Recalls and Warnings

• Other Sites

• Comments on this Web Page

Introduction

 It is FDA's policy to help prevent or alleviate shortages primarily of medically necessary drug products, since these can have significant public health consequences. A drug shortage may involve either an actual or a potential shortage of a drug product. 

 A 1997 FDA Consumer article "Inside FDA: When a Drug is in Short Supply" provides background information and an example of how FDA manages drug shortages. The article "FDA's Role in Responding to Drug Shortages” published in the American Journal of Health Systems Pharmacists {2002 Aug 1;59(15):1423-5}, provides additional information.

 Frequently Asked Questions 

Current Drug Shortages

Drug Name	Company Information	Reason for Shortage	Related Information
Amphotericin B injection updated 9/29/2003	X-GEN (formerly Pharma-Tek) and Geneva	Manufacturing delays	X-GEN and Geneva are working to address this shortage
Avonex (interferon Beta 1a) Posted 5/5/2004	Biogen Idec (800) 456-2255	Manufacturing issues	Dear Healthcare Professional Letter
Celestone Soluspan (Betamethasone Injection) updated 9/16/2004	Schering-Plough Corp. 2000 Galloping Hill Rd. Kenilworth, NJ 07033-0530 908-298-4000 800-526-4099 www.sch-plough.com	Manufacturing Issues	Additional Information  (updated 9/16/2004)
Cortrosyn Injection (Cosyntropin) 0.25mg/vial Updated 8/11/2004	Amphastar 1-800-423-4136	Manufacturing delays	Limited quantities of cortrosyn vials are currently available and supplies are expected to return to normal levels. Please call Amphastar Customer Service at 1-800-423-4136 for additional information.
Cytovene (ganciclovir) Powder for Injection updated 1/10/2003	Roche Professional Product Information Department 1-800-526-6367	Previous Production Problems	Roche reports an adequate supply and is continuing to supply Cytovene-IV by drop-shipment. Please see the attached letters   for additional information.
Merrem I.V.(meropenem for injection) Posted 9/30/2004	AstraZeneca Pharmaceuticals LP (Corporate Information Center 1-800-236-9933)	Manufacturing delays due to bulk drug supply shortage.	AstraZeneca is working closely with its Suppliers to address this drug shortage. Please call AstraZeneca for additional information (1-800-236-9933).
Penicillin G Potassium and Penicillin G Sodium Injectables Posted 4/6/2004	Sandoz and Baxter currently have product available	Supply problems	Sandoz currently has Penicillin G Potassium and Penicillin G Sodium injectables available - please call 1- 800-525-8747 for additional information. Baxter continues to have Penicillin G Potassium injectables available - for additional information please call 1-888-229-0001.
Pre-Pen (benzylpenicilloyl polylysine) injection Posted 7/19/2004	Hollister-Stier (800) 992-1120	Requirement for a penicillin manufacturing facility	Pre-Pen is currently not available. There is not an estimated timeline yet for when this product will again be available. Please call Hollister-Stier for additional information.
Solu-Cortef (Hydrocortisone sodium succinate) for injection updated 1/30/2004	Pharmacia Customer Service (800) 821-7000	Capacity Constraints	Please contact Pfizer Customer Service (800) 533-4535 if the product is NOT available through wholesale channels. Limited quantities are available for emergency situations.
TABLOID brand Thioguanine 40 mg Tablets updated 5/6/2003	GlaxoSmithKline	Manufacturing Issues	1-888-527-6933 operational between 8:00 a.m. and 8:00 p.m. ET, Monday through Friday Dear Health Care Professional Letter from GSK
Thiola (tiopronin) 100 mg tablets  updated 1/17/2003	Mission Pharmacal Customer Service 1-800-531-3333	Mission and FDA continuing to work to resolve this shortage	Please see the attached "Outline of Procedures for Filling a Prescription for Thiola" to obtain a limited supply of Thiola at this time
Zemuron (rocuronium bromide) injection, 5 ml and 10 ml vials updated 7/15/2004	Organon Pharmaceuticals USA Inc.	Manufacturing delays	Limited quantities of Zemuron 5 ml vials are available and supplies are returning to normal levels. Supplies of Zemuron 10 ml vials are expected by the end of September 2004. Please call Organon Customer Service at 1-800-241-8812 for additional information

Back to Top

Resolved Drug Shortages

Back to Top

Discontinuations

To locate drugs that have already been discontinued, please consult the following:
Drugs@FDA
Orange Book Query
Orange Book Monthly Additions and Deletions

Drug Name	Company Information	Related Information
Agenerase (amprenavir) 150mg capsule 9/17/2004	GlaxoSmithKline 1-888-825-5249	Letter from GlaxoSmithKline
Calciferol injection in oil (ergocalciferol) 3/19/2004	Schwarz Pharma 6140 W. Executive Drive Mequon, WI 53092 1-800-558-5114	Schwarz has discontinued manufacturing of calciferol
ELAVIL (amitriptyline hydrochloride) Tablets and Injection. 5/15/2003	AstraZeneca Pharmaceuticals LP (AstraZeneca) – Contact Corporate Information Center at  1-800-236-9933	ELAVIL Injection is no longer available at AstraZeneca. The remaining inventory of ELAVIL Tablets will be depleted by December 31, 2003. AstraZeneca has no further plans to manufacture ELAVIL (amitriptyline hydrochloride) Tablets or Injection.
Flovent Rotadisk (fluticasone propionate inhalation powder) 8/31/2004	GlaxoSmithKline 1-888-825-5249	Please see Dear Healthcare Professional letter for additional information.
Inulin in Sodium Chloride Injection, USP 9/26/2003	Questcor Pharmaceuticals, Inc.	Letter
Kefzol (cefazolin) all presentations 2/28/2003	Eli Lilly and Company	Letter
Kefurox (cefuroxime) all presentations 2/28/2003	Eli Lilly and Company	Letter
Mandol (cefamandole) all presentations 2/28/2003	Eli Lilly and Company	Letter
Novolin L, Lente, human insulin zinc suspension [rDNA origin] 7/15/2003	Novo Nordisk Pharmaceuticals, Inc.  Contact: 1-800-727-6500 Customer Service	Letter
ORLAAM (Levomethadyl hydrochloride acetate) Oral Solution, 10 mg/mL 9/2/2003	Roxane Laboratories	Letter
Serevent Inhalation Aerosol 6/10/2003	GlaxoSmithKline 1-800-340-3236	GSK anticipates that SEREVENT Inhalation Aerosol will no longer be available starting in June 2003. Dear Health Care Professional Letter from GlaxoSmithKline
Stelazine (trifluoperazine) oral concentrate 10mg/ml Stelazine (trifluoperazine) tablets (1mg, 2mg, 5mg, 10mg) Stelazine (trifluoperazine) Injection 2mg/ml 12/18/2003	GlaxoSmithKline 1-888-825-5249	Stelazine was discontinued and withdrawn from the market. The final lots were distributed by GSK August 2003 and the final expiry date of all products in the marketplace is no later than January 31, 2004.
Suprax (cefixime) updated 2/25/2004	Lederle/Wyeth Pharmaceuticals	Discontinued July 2002. Stock will be distributed until exhausted or until March 2003, whichever comes first.  For additional information, please call customer service (800) 666-7248 Lupin Pharmaceuticals recently received approval for cefixime 400 mg tablets and cefixime 100 mg/5 ml suspension. For further information, please contact Lupin Pharmaceuticals at 410-576-2000 (2/25/2004)
Valstar (valrubicin) Solution for Intravesical Instillation 1/30/2004	Formerly distributed by Celltech (Celltech Customer Service 1-888-963-3382)	No further availability planned at this time.
Velosulin BR Human, Buffered Regular Human Insulin Injection [rDNA origin] 11/3/2003	Novo Nordisk Pharmaceuticals, Inc. Contact: 1-800-727-6500 Customer Service	Dear Healthcare Professional Letter
Zyflo Filmtab (Zileuton) Tablets 7/9/03	Abbott Laboratories Medical Information department  1-800-633-9110	Discontinued June 2003.  Zyflo 600 mg tablets will remain available through pharmacies and wholesalers for at least 6 months from the date of this letter. After Abbott, pharmacy and wholesaler supplies are exhausted, no additional product will be available. Letter

Back to Top

Additional Communications

Drug Shortage Manual of Policies and Procedures (MaPP)

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.  MaPPs define external activities as well.   All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities, and procedures.

• 4730.1 Drug Shortage Management (11/21/96).    This describes CDER’s Office of Compliance policy and procedures on drug shortage management. A CDER-wide MaPP is under development.

Back to Top

 Medical Necessity

A product is considered to be medically necessary, or a medical necessity, if it is used to treat or prevent a serious disease or medical condition, and there is no other available source of that product or alternative drug or therapy that is judged by medical staff to be an adequate substitute. Patient "inconvenience" alone is an insufficient basis to classify a product as a medical necessity. 

Back to Top

How to Report a Drug Shortage

 To report a CDER product by email

 drugshortages@cder.fda.gov

 To report a CDER product by phone:

CDER Drug Information (888) INFOFDA or (888) 463-6332, or (301) 827-4570

  To report a CBER, CDRH or CFSAN shortage to FDA, see listing under FAQs

 To report a shortage to ASHP you may use the Drug Product Shortages Report form (non-FDA site) available from the American Society of Health-Systems Pharmacists (ASHP) web page. When you use this form, you are reporting a drug shortage to ASHP, not FDA.  CDER partners with ASHP to minimize drug shortages and report rapid accurate drug shortage information.  

 For background information on reporting drug shortages, please see the CDER Handbook, Drug Shortages page.

Back to Top 

Practical Steps for Practitioners Facing Drug Shortage Situations

ASHP Guideline on Managing Drug Shortages.   The American Society of Health-System Pharmacists guideline describes the contributing factors to drug product shortages and recommends a general process for inventory management in preparation for and working through shortage situations. 

   Back to Top

 More Information on Drug Shortages, Product Recalls and Warnings

FDA Product Recalls, Alerts, and Warnings.  FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties.

Cderrecalls@cder.fda.gov  or phone (301) 827-9039

Other Drug Shortage Links

For more detailed information on all drug shortages we refer you to the following sites:

American Society of Health-System Pharmacists [External non-FDA Site]

Back to Top     Back to Drug Information

Last Updated:  October 29, 2004

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research