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Albuterol Inhalers - availability status

Posted on Feb 13, 2006

Several members have called with questions on the availability of albuterol inhalers. In March 2005, the FDA issued its final rule for the removal of the essential use exemption for albuterol, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Under the rule, all production and sales of albuterol CFC metered dose inhalers (MDIs) in the U.S. are required to cease on December 31, 2008. Please visit MMCAP’s website (www.mmcap.org under Member News) for more information on this decision.

MMCAP currently has four albuterol inhalers on contract (two CFC products and two HFA products). However, most (if not all) of these products are on backorder or are being allocated. (Section 2.4 – Failure to Supply clause – was suspended for the CFC inhaler manufacturers – these manufacturers are NOT responsible for the difference in cost for the purchase of alternative products.) The following information appeared on the American Society of Health System Pharmacists' website under Drug Products with Limited Availability as of 2/8/06:

Albuterol Metered Dose Inhalers
Strength: Various
Several albuterol metered dose inhalers (MDIs) are in short supply. Schering has available both Proventil (NDC 00085-0614-02) and Proventil-HFA (NDC 00085-1132-01). Warrick expects supplies of the albuterol MDI (NDC 59930-1560-01) and albuterol refill (NDC 59930-1560-02) by mid-February, 2006. Andrx has limited supplies of product available (NDC 62037-0794-44). GlaxoSmithKline has discontinued its Ventolin products. Ventolin-HFA from GlaxoSmithKline is on back order and is not expected until June 2006. IVAX is shipping Albuterol-HFA (NDC 00172-4390-18) as it becomes available. Armstrong Pharmaceuticals has limited supplies available (NDC 17270-0721-01) but anticipates routine supplies will be available by the end of March, 2006. Pliva (formerly Sidmak) discontinued its albuterol MDI in June 2004. (02/03/06, University of Utah, Drug Information Service)

MMCAP will continue to pursue contracts for additional albuterol inhaler products. Some CFC/HFA albuterol products may still be available from your distributor or will be released soon. The distributors will be filling orders as soon as they have supply available to do so.

We are aware that several members have been approached by non-MMCAP vendors that have albuterol inhalers available. Given the limited supply, MMCAP members may want to consider buying from these vendors. MMCAP cautions its members to be wary when purchasing from unknown vendors. Some vendors may be selling short-dated products or products whose integrity and/or pedigree may be in question. MMCAP is not responsible for any purchases that are made outside its contracts.

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