Chapter 69.48 RCW established Washington’s Safe Medication Return. Chapter 246-480 WAC describes the related administrative rules. Safe Medication Return is a statewide system that gives Washington residents free, convenient, and environmentally responsible options to dispose of unwanted medication.
Drug manufacturers fund the program. They pay for Department of Health and program operator expenses. There is no cost to taxpayers. See covered manufacturer section below.
The Department of Health oversees the program. This includes monitoring operations, enforcing compliance, and evaluating program effectiveness. The department also reviews potential program operators’ proposed plans and approves or rejects those plans based on statutory and rule requirements.
The department reviews program operator proposals and updated plans on a four-year cycle. Organizations that would like to become program operators must submit proposed program plans by July 1, 2024. Current program operators must submit updated plans by July 1, 2024 also.
Program operators implement the program according to plans approved by the department. Washington has two approved program operators. MED-Project has been operating in Washington since 2020. Inmar Intelligence, Inc. has operated since 2022.
Drug wholesalers are required to provide the department a list of manufacturers of drugs they sell in or into the State of Washington by January 15 each year.
The Department of Health sends letters to entities that have an active Washington State Pharmaceutical Wholesaler License reminding them of this requirement of RCW 69.48.040(1). Licensees should use the department wholesaler reporting form (XLS) to provide this list to the department. Include manufacturer email addresses when possible.
- Companies engaged in the manufacture of covered drugs
Companies engaged in the manufacture of covered drugs that are ultimately sold in or into Washington state, even if sold by a third party, (covered manufacturers) must participate in Safe Medication Return through an approved program operator.
If you are a covered manufacturer not currently participating through an approved program operator, contact MED-Project or Inmar by email or by phone at 202-495-3131 or 844-492-2382 to inquire about participating in the Washington State program.
- If the department notifies you that you are a potential covered manufacturer you must respond to the department within 60 days.
The department receives a list of potential covered manufacturers from wholesalers that sell drugs in or into Washington state. We compile this information and use it to notify potential covered manufacturers. RCW 69.48.040(3) requires recipients to respond to this inquiry.
- If you don't believe you are a covered manufacturer, RCW 69.48.040 requires you to provide all of the following:
- A statement of the basis for the belief that you are not a covered manufacturer for the purposes of chapter 69.48 RCW. (Cite the specific exception you believe applies to you.)
- A list of any drugs your company sells, distributes, repackages, or otherwise offers for sale within Washington state.
- The name and contact information of the manufacturer of the drugs you listed. (Include emails if possible.)
- If you are a covered manufacturer with your own drug take-back program, it is likely that you must also participate in the Washington state program through an approved program operator.
There are exceptions for:
- Drugs for which manufacturers provide a take-back program, but this exemption only applies if the take-back program is a part of a federal food and drug administration managed risk evaluation and mitigation strategy (REMS) under 21 USC section 355-1.
- Biological drug products, as defined by 21 cfr 600.3 (h) as it exists on June 7, 2018, but this exemption only applies if the manufacturer BOTH:
- Provides a pharmaceutical product stewardship or drug take-back program.
- Provides the department with a report describing the program, including how the drug product is collected and safely disposed and how patients are made aware of the drug take-back program, and who will update the department on changes that substantially alter the drug take-back program.
- Covered drugs include
- prescription and over-the-counter drugs, including schedule II-V controlled substances such as opioids and medication for attention deficit disorder.
- brand name and generic drugs.
- drugs for veterinary use for household pets.
- drugs in medical devices (EpiPens, inhalers, etc.)
- drugs in any form (pill, liquid, gel, ointment, powder, etc.)
- Covered drugs do not include
- business generated pharmaceutical waste, including drugs administered in a clinical setting.
- vitamins, minerals, or supplements.
- herbal-based remedies and homeopathic products.
- personal care products such as cosmetics, shampoos, sunscreens, lip balm, toothpaste, and antiperspirants.
- controlled substances contained in schedule I of the uniform controlled substances act (illegal drugs and cannabis).
- medical devices that do not include drugs and exposed needles or sharps.
- pet pesticide products.
Second Substitute House Bill 1161 (2SHB 1161) modified chapter 69.48 RCW. The department filed a CR102 with the Office of the Code Reviser on July 18, 2023, under WSR 23-15-102 (PDF) to notify the public of proposed new rules that will amend administrative regulations to ensure consistent operation and oversight of a statewide Safe Medication Return system that includes multiple programs.
The public comment period has ended for this proposed rule. For more information, email firstname.lastname@example.org.