The Complexities and Application of Drug Takeback Programs
Written-by: Deneen Fumich, RPh
For those Health Care Practitioners and Pharmacies that are not located in any of the jurisdictions with a Producer/Manufacturer Funded Drug Takeback program, you can help prevent diversion and overdose, sharps safety and proper disposal of unwanted household medications by educating your patients using any of the following programs:
- EPA – How to Dispose of Medicines Properly (PDF)
- EPA – Disposal of Medical Sharps
- FDA – How to Dispose of Unused Medicines
- FDA – Disposal of Unused Medicines
- FDA – Safe Opioid Disposal – Remove the Risk Outreach Toolkit
- DEA – Registration for Disposal of Controlled Substances
- DEA – Search for Year Round Pharmaceutical Disposal Locations
- DEA – Participate in the National Prescription Drug Take Back Days
Although the U.S. Food & Drug “FDA”, U.S. Environmental Protection Agency “EPA”, and the U.S. Drug Enforcement Administration Diversion Control Division “DEA” have websites with methods listed for Home Disposal of Unused Medications and Medical Sharps, there is a rising trend of local and state jurisdictions requiring Producer/Manufacturer Funded Drug Takeback programs.
Why More Laws Are Being Enacted
With all the federal guidance, why are we seeing more state and local jurisdictions enacting laws for Producer/Manufacturer funded programs? Simply, it is the growing concern of state and local governments about drug abuse, overdose, drug safety in the home and environmental contamination from improperly disposed of pharmaceutical waste generated by households.
So, what is the state and local jurisdiction’s solution? Mandatory drug takeback programs that target manufacturers and producers of pharmaceutical products in which the manufacturers/producers will bear the cost and burden to implement the programs themselves.
Are the program implementations affordable and easy to manage? Not in the least. All of the separate programs listed above have unique compliance challenges. Below is just a small listing of the requirements:
- Monthly, Quarterly, and Yearly Reporting
- Locate and Manager Participating Pharmacies
- Provide Kiosks, Mail-In or Takeback Community Programs
- Provide Community Education: TV, Radio, Newspaper, Websites
- Provide Pharmacy Training
- Requirements for Controlled Substance & DEA/Pharmacy site licenses
- Compliant Pick Up of Kiosk meds
- Compliant Destruction of Meds
- Call-In Center
- Information in Multiple Languages
- Different requirements for Sharps
Understanding The Drug Takeback Program
Who can establish Drug Takeback Program? Anyone within the pharmaceutical industry such as manufacturers, wholesalers, pharmacies, and reverse distributors; as long as; the program meets federal and state law requirements. However, a Producer/Manufacturer funded program must submit a complete package detailing all required components to the overseeing agency. The agency must approve all components of the plan before a manufacturer is considered a participant in an approved plan.
For example, the state of California’s Pharmaceutical Waste Stewardship Plan is overseen by Cal-Recycle and all documents are public information. To see an example of a plan, compliance, and requirements: Pharmaceutical Waste Stewardship Plan(s)
Alternative Consumer Options
What if my state does not have a Manufacturer Funded program? How can I be a good Steward? There are many options in each state that a consumer may utilize.
1. Pharmaceutical companies that are providing safe disposal of unwanted medications such as select CVS Pharmacies, Hy-Vee’s, Walgreens’, Publix Super Markets, Owens Pharmacy, Meijer’s, and Kinney Drug to name a few.
2. Utilize location finders like:
3. DEA’s Drug Takeback events
National Prescription Drug Take Back Day 2022
In an effort to combat the opioid crisis and drug abuse, the DEA has announced that the Drug Take Back Day for 2022 is on Saturday, April 30th. Please take note of this event if you or someone you know is in possession of prescription drugs that need to be disposed of properly. If you cannot make it on this day, the DEA operates year-round drop off sites. Click here for the full list of locations.
Disclaimer: Pharma Solutions makes every effort to provide accurate information in the content it offers. However, the information provided is “as is” and Pharma Solutions makes no warranties, express or implied, as to the content provided. Pharma Solutions assumes no liability or responsibility for any errors or omissions in the content provided. Laws and regulations that are referenced herein may change over time and as such the content offered is not to be interpreted as advice. Pharma Solutions shall not be liable for any damages whatsoever incurred in connection with the use or performance of this information.