CHA has submitted the attached comments on the Drug Enforcement Administration’s (DEA) notice of proposed rulemaking on aggregate production quotas for Schedule I and II controlled substances.
The DEA’s proposed aggregate production quotas would reduce manufacturing quotas for six frequently used opioids by an average of 10 percent. In the letter, CHA requests that the DEA reconsider this reduction to mitigate the ongoing drug shortages in California’s hospitals. Further, CHA urges the agency to reconsider its proposal to reduce manufacturing quotas specific to injectable medications used in hospitals rather than other dosage forms or opioid products.
While setting production quotas for opioid medications can be an effective step in preventing these controlled substances from accumulating in amounts that exceed legitimate need, CHA raises concerns that the limited information the DEA considered when developing these quotas does not reflect hospital patients’ legitimate need for essential medication.
CHA will continue to work with stakeholders, as California continues to be in a critical shortage situation.