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. was recently approved and will fully implement their program by early November 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). Wholesalers should use the department wholesaler reporting form (XLS) to provide this list to the department. Include manufacturer email addresses when possible.
See the description of covered and excluded drugs below and the definition of drug wholesalers in RCW 69.48.020(11).
- 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 covered 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.
- brand name and generic drugs.
- drugs for veterinary use for household pets.
- drugs in medical devices and combination products.
- Covered drugs do not include
- 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.
- drugs that are administered in a clinical setting.
- drugs and biological drug products for which manufacturers provide pharmaceutical product stewardship or drug take-back programs as specified in RCW 69.48.020(4)(b)(v and vi).
- emptied injector products or emptied medical devices; exposed needles or sharps, or used drug products that are medical wastes.
- pet pesticide products.
Second Substitute House Bill 1161 (2SHB 1161) modified chapter 69.48 RCW. The department is considering rulemaking to align existing rules with 2SHB 1161 and adopting other amendments necessary to regulate Safe Medication Return. Amendments may include clarifying how multiple program operators participate in the drug take-back program, setting fees, and other changes as appropriate.
The department filed a preproposal statement of inquiry with the Washington State Office of the Code Reviser on December 17, 2021 (WSR 22-01-170).
The department relies on stakeholder assistance to develop rules. We held virtual workshops on April 27 and May 31, 2022 to gather information about draft conceptual language (PDF). We welcome your comments and suggestions. Email them to firstname.lastname@example.org.