WMSN-TV Fox 47 of Madison, Wisconsin, recently reported that pharmacies are experiencing difficulty obtaining oxycodone to fill their patients prescriptions. Oxycodone, a schedule II opioid painkiller, is indicated for patients suffering from moderate to severe pain. The report stated that “[a] DEA spokesperson in Chicago says this is not a nationwide shortage, and if pharmacies can’t get supply, it’s likely their manufacturer has reached its quota.”
While there may not be a nationwide oxycodone shortage, pharmacies and hospitals outside Wisconsin have also been unable to obtain the drug. Oxycodone has been reported in short supply in Oregon and Washington, as well as in parts of California, Colorado and Maine.
The shortages have been attributed to several factors. Some have blamed DEA for delaying the annual quota, giving manufacturers a late start. Others have said that manufacturers have already hit their quota and were forced to cease production. A recall by manufacturer Mallinckrodt and cutbacks by Ethex have also purportedly contributed to the problem. One pharmacy expert observed that a few years ago five companies manufactured extended-release oxycodone and that four of the companies no longer manufacture the drug.
Other than the statement by the DEA spokesperson in Chicago, there has been no mention of the shortage by the agency. The Controlled Substances Act (“CSA”) requires DEA to establish quotas that control the quantity of schedule I and II controlled substances that may be manufactured in the United States in a calendar year. 21 U.S.C. § 826. DEA establishes an annual aggregate quota for each schedule I or II substance. 21 U.S.C. § 826(a). The agency assigns individual manufacturing quotas to manufacturers of controlled substances such as oxycodone in bulk. 21 U.S.C. § 826(b). DEA issues procurement quotas that authorize manufacturers to procure a basic class of schedule I or II substances to make dosage forms. Manufacturers can only manufacture quantities within their assigned manufacturing quota and they may only procure source materials or manufacture dosage forms within their procurement quota. Manufacturers apply for quotas in April of the year prior to the year of the quota request.
DEA regulations require the agency to publish aggregate production quotas on or before May 1 of each year, and individual procurement quotas and individual manufacturing quotas on or before July 1, 21 C.F.R. §§ 1303.11(c), 1303.12(c), 1303.21(a). The CSA requires DEA to establish individual manufacturing quantities on or before October 1. 21 U.S.C. § 826(c). DEA published the proposed aggregate production quotas for 2009 on November 7, 2008 and “established initial aggregate production quotas” for 2009 on December 29, 2008.