- Name and address of the person;
- Name and quantity of each controlled substance to be disposed of;
- Explanation of how the applicant obtained the controlled substance, if known; and
- Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.
Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.
State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.
The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:
- Taking the prescription drugs out of their original containers;
- Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
- Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
- Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
- Placing the sealed container with the mixture, and the empty drug containers, in the trash.
Unused Medication Donation
The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.
Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.
Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.
The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH
Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.