July 26, 2018

Lawmakers Urge DEA to Update “Partial Filling” Regulations for Controlled Substances

Letter highlights importance of regulatory consistency in combatting opioid epidemic

Text of letter (PDF)

Washington, DC – Today, United States Senators Elizabeth Warren (D-Mass.), Shelley Moore Capito (R-W.Va.), Chuck Grassley (R-Iowa), Dianne Feinstein (D-Calif.), and Representatives  Katherine Clark (D-Mass.) and Steve Stivers (R-Ohio) pressed the Drug Enforcement Administration (DEA) to update outdated regulations on partial filling of Schedule II controlled substances. In a letter sent to DEA Acting Administrator Uttam Dhillon, the lawmakers explained the importance of reducing the number of unused prescription medications in order to address the nation’s opioid crisis.

In 2016, an estimated 42,000 individuals in the United States died from opioid overdoses. Over 70 percent of people who misuse prescription painkillers got them from a friend, relative, or doctor. Section 702 of the 2016 Comprehensive Addiction and Recovery Act (CARA), which was based on a bill originally introduced by Senators Warren and Capito and Representatives Clark and Stivers, helps reduce the number of unused opioids in circulation by allowing “partial filling” of certain prescriptions, letting patients take home a portion of their opioid prescription and return to the pharmacy for the remainder of the same prescription if necessary. However, outdated DEA regulations currently only address “partial filling” in circumstances when a pharmacist does not have enough medication on hand to fill a full prescription. This outdated definition poses a barrier to the complete implementation of the partial filling policies allowed under federal law.

“Section 702 of CARA will help reduce the number of opioids that could be misused in homes across the country. However, this can only be fully implemented once DEA takes the necessary steps to amend its outdated guidance,” wrote the lawmakers. “This discrepancy between federal law and DEA regulations has created confusion and concern on the part of prescribers and pharmacists that they may be violating DEA regulations if they partially fill a Schedule II prescription.”

The letter follows a similar request from the lawmakers in December 2017 in which they urged the DEA to issue updated regulations and guidance regarding partial filling of Schedule II controlled substances.

In April, Senators Warren and Capito introduced the Unused Medication Awareness Act, which was included as part of the Senate Health, Education, Labor and Pensions (HELP) Committee’s bipartisan package of opioid crisis response bills. The legislation requires the Centers for Disease Control and Prevention (CDC) to educate patients and health care providers about the option to partially fill their prescriptions.