Today the U. S. Drug Enforcement Administration’s (DEA’s) Final Rule for the Disposal of Controlled Substances, which implements the Secure and Responsible Drug Disposal Act of 2010, was made available online for preview by the Federal Register at https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-20926.pdf. The Act, in an effort to curtail the prescription drug abuse epidemic, authorized DEA to develop and implement regulations that outline methods to transfer unused or unwanted pharmaceutical controlled substances to authorized collectors for the purpose of disposal. The Act also permits long-term-care facilities to do the same on behalf of residents or former residents of their facilities. The Final Rule will be officially published tomorrow and will take effect on October 9.
“These new regulations will expand the public’s options to safely and responsibly dispose of unused or unwanted medications,” said DEA Administrator Leonhart. “The new rules will allow for around-the-clock, simple solutions to this ongoing problem. Now everyone can easily play a part in reducing the availability of these potentially dangerous drugs.”
Prior to the passage of the Act, the Controlled Substances Act made no legal provisions for patients to rid themselves of unwanted pharmaceutical controlled substances except to give them to law enforcement, and banned pharmacies, doctors’ offices, and hospitals from accepting them. Most people flushed their unused drugs down the toilet, threw them in the trash, or kept them in the household medicine cabinet.
Unused medications in homes create a public health and safety concern, because they are highly susceptible to accidental ingestion, theft, misuse, and abuse. Almost twice as many Americans (6.8 million) currently abuse pharmaceutical controlled substances than the number of those using cocaine, hallucinogens, heroin, and inhalants combined, according to the 2012 National Survey on Drug Use and Health. Nearly 110 Americans die every day from drug-related overdoses, and about half of those overdoses are related to opioids, a class of drug that includes prescription painkillers and heroin. More than two-thirds (70 percent) of people who misuse prescription painkillers for the first time report obtaining the drugs from friends or relatives, including from the home medicine cabinet.
As a temporary measure, DEA began hosting National Prescription Drug Take-Back events in September 2010. Since then, the DEA has sponsored eight take-back days. Enormous public participation in those events resulted in the collection of more than 4.1 million pounds (over 2,100 tons) of medication at over 6,000 sites manned by law enforcement partners throughout all 50 states, the District of Columbia, and several U.S. territories.
“Every day, I hear from another parent who has tragically lost a son or daughter to an opioid overdose. No words can lessen their pain,” said Michael Botticelli, Acting Director of National Drug Control Policy. “But we can take decisive action, like the one we’re announcing today, to prevent more lives from being cut short far too soon. We know that if we remove unused painkillers from the home, we can prevent misuse and dependence from ever taking hold. These regulations will create critical new avenues for addictive prescription drugs to leave the home and be disposed of in a safe, environmentally friendly way.”
On September 27, the DEA holds its next Take-Back Day. The public may visit www.dea.govor call 1-800-882-9539 in September to find a nearby collection site. At this time, DEA has no plans to sponsor more nationwide Take-Back Days in order to give authorized collectors the opportunity to provide this valuable service to their communities.
DEA’s goal in implementing the Act is to expand the options available to safely and securely dispose of potentially dangerous prescription medications on a routine basis.
- The Final Rule authorizes certain DEA registrants (manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies, and hospitals/clinics with an on-site pharmacy) to modify their registration with the DEA to become authorized collectors.
- All collectors may operate a collection receptacle at their registered location, and collectors with an on-site means of destruction may operate a mail-back program.
- Retail pharmacies and hospitals/clinics with an on-site pharmacy may operate collection receptacles at long-term care facilities.
- The public may find authorized collectors in their communities by calling the DEA Office of Diversion Control’s Registration Call Center at 1-800-882-9539.
- Law enforcement continues to have autonomy with respect to how they collect pharmaceutical controlled substances from ultimate users, including holding take-back events. Any person or entity—DEA registrant or non-registrant—may partner with law enforcement to conduct take-back events.
- Patients also may continue to utilize the guidelines for the disposal of pharmaceutical controlled substances listed by the Food and Drug Administration on their website at http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/
- Any method of disposal that was valid prior to these new regulations being implemented continues to be valid.