mail back envelopes

May 24, 2023

FDA Now Requires Mail-Back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

Increasing the safe disposal of unused opioid analgesics is one of the priorities of the U.S. Food and Drug Administration (FDA). In April, the FDA announced a new requirement for manufacturers of opioid analgesics dispensed in outpatient settings, stating that prepaid mail-back envelopes must be made available to outpatient pharmacies and other dispensers as an additional disposal option.

This announcement is critical, considering that the United States makes up 4.4% of the global population and consumes over 80% of the global opioids. This move will increase convenient disposal options for people in the U.S. and will help reduce unfortunate opportunities for non-medical use, accidental exposure, overdose, and other potential cases of opioid use disorder. According to the Centers for Disease Control and Prevention, overdose is one of the leading causes of injury-related deaths in the country and most cases are related to opioid misuse.

The agency states in its announcement that “these collective efforts are part of the implementation of the FDA Overdose Prevention Framework that aims to prevent drug overdoses and reduce deaths through impactful and creative actions. The FDA remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S.”

Actions and Timeline for Manufacturers

Based on the information released by the FDA, all manufacturers of opioid analgesics must submit their proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days (6 months) of the date of the FDA notification letter. This action follows a Federal Register notice previously issued in April 2022 that sought public comment on this potential modification of the OA REMS.

Once the amended REMS is approved, outpatient pharmacies and other dispensers can work with manufacturers to obtain and provide mail back envelopes to patients who use prescription opioid analgesics. Manufacturers will also be required to develop patient education materials on the safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers can provide to patients.

How Stericycle Can Help Support Opioid Analgesics Manufacturers

Stericycle offers Seal&Send™ Consumer Medication Mail Envelopes, which can help manufacturers of analgesic opioids comply with the recent FDA announcement. These mail-back envelopes are anonymous and convenient, allowing consumers to send their medications for disposal from home. Sending unused or unwanted prescription drugs for incineration with Stericycle rather than holding on to them, or discarding them down the drain, helps to keep opioids and other drugs out of the wrong hands and out of waterways. Benefits of this program include:

  • Any organization can distribute the envelopes, offering convenience.
  • Consumers package and mail their unwanted or expired medications to Stericycle in anonymous and prepaid envelopes via the United States Postal Service (USPS).
  • Envelopes are sent to a Drug Enforcement Administration (DEA)-registered incinerator for pre-disposal treatment to destroy the active pharmaceutical ingredients.
  • Each envelope has a unique ID (data/tracking available).
  • Envelopes can accept DEA-controlled Schedules II-V (up to 8 ounces per each).

Stericycle is committed to helping individuals responsibly dispose of unused medications. We strongly support drug take-back activities year-round with Seal&Send™ and MedDrop™ Medication Collection Kiosk solutions. In April 2023, as part of our Earth Month celebrations, we distributed Seal&Send™ Consumer Medication Mail Envelopes to our team members in certain offices in the U.S. to take home or give to others.

Learn more about Stericycle’s from-home pharmaceutical waste disposal solutions, including Seal&Send™ Consumer Medication Mail Envelopes, by contacting us at RxTakeBack@stericycle.com.

Frequently Asked Questions

What is Drug Diversion?

Drug diversion is the illegal distribution or use of prescription drugs.

What are The Dangers of Opioid Drug Diversion in At-Home Settings? 

Stericycle’s 2022 Healthcare Workplace Safety Trend Report (HWSTR) found that providers and administrators agree that the rise in at-home care makes proper medical and pharmaceutical waste disposal more challenging and that increased drug diversion risk, and its impact on the opioid epidemic, is a related concern. The report also found that eight in ten of the providers and administrators surveyed are concerned about increased drug diversion in their communities and agree that drug diversion puts the health of their communities at risk.

Why is Proper Pharmaceutical Waste Disposal At-Home Essential in Combating the Opioid Crisis? 

According to the HWSTR, most healthcare providers (82%) and administrators (87%) agree that improper disposal of pharmaceutical waste is one of the most significant contributors to the opioid epidemic and feel that opioid diversions from improper disposals, such as through a drain or regular trash, puts the health of their communities at risk. This improper disposal of pharmaceutical waste substantially impacts the environment. If disposed of without pre-treatment (such as by incineration), waste can leach into surrounding waterways and land areas. Healthcare providers and administrators agree that sustainable environmental practices benefit the health of an overall community and can be linked to positive patient outcomes.

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