For immediate release:

Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a potential change that would require opioid pain relievers used on an outpatient basis to be dispensed from prepaid envelopes and that pharmacists instruct patients on safe disposal of opioids. This potential modification of the existing opioid analgesic risk assessment and mitigation strategy would provide a convenient and additional disposal option for patients beyond those already available, such as flushing, removal products at home, collection kiosks and trade-in events.

“The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that can reduce unnecessary exposure to opioids and prevent new cases of addiction. Prescribing opioids for durations and doses that do not properly match the clinical needs of the patient not only increases the risk of abuse, misuse, and overdose, but also increases the likelihood of unnecessary exposure to unused medications” said FDA Commissioner Robert M. Califf. , MD “As we explore ways to address this issue more broadly, the envisioned mail-back envelope requirement for these unused medications would complement current disposal programs and provide meaningful and achievable steps to improve safe use and disposal.”

Patients often report having unused opioid painkillers from surgeries, creating unfortunate opportunities for non-medical use, accidental exposure, overdose, and potentially increasing new cases of opioid addiction. Since many Americans are first accessing opioids through friends or relatives who have unused opioids, requiring that a mail-back envelope be provided with each prescription could reduce the amount of unused opioid analgesics in patients’ homes. Data show that educating patients about disposal options may increase the rate of disposal of unused opioids and that providing a disposal option with education may further increase this rate.

Mail-back envelopes have several favorable features. They do not require patients to mix medications with water, chemicals, or other substances or use other common home disposal techniques. Opioid painkillers returned to Drug Enforcement Administration-registered facilities in mail-back envelopes do not enter the water supply and landfills (instead, they are incinerated). The nondescript mail-back envelopes provided would be stamped, providing patients with a free disposal option. Additionally, there have long been regulations and policies in place to ensure that mail-in envelopes are suitable for this purpose and can safely transport unused medication from the patient’s home to where it will be destroyed. .

The change under consideration underscores the agency’s efforts to address the dynamic facets of the opioid crisis and supports HHS’s overdose prevention strategy, which focuses on four priority areas – primary prevention, reduction of harm, evidence-based treatment and recovery assistance.

The FDA is accepting public comments from interested parties, including patients, patient advocates, healthcare professionals, academics, researchers, the pharmaceutical industry, and other government entities through June 21, 2022; however, comments are welcome at any time.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.