The Origins of the Drug Take Back Laws
It is well recognized that pharmaceutical waste management presents a number of significant health, safety and environmental risks. Expired medications are a leading cause of drug-related deaths and provide a gateway to addiction for family members and friends (often minors) who have access to unused or expired medications.[1] Unused or expired prescriptions in healthcare settings, such as nursing homes and hospitals, are invitations to drug diversion, threatening patients, medical facilities, healthcare workers and the public.[2] In response to these concerns, federal and state governments have enacted drug “take-back” statutes and regulations, which create a complicated and not entirely effective solution to this problem.
Federal Initiatives
In response to the increasingly well-recognized danger to public health represented by drug waste, the Drug Enforcement Administration (DEA) initiated a biannual National Prescription Take-back Day in 2010, which focused on the proper disposal of controlled substance medications.[3] Moreover, the U.S. Congress passed the Secure and Responsible Drug Disposal Act of 2010 (the “Disposal Act”).[4] This legislation amended the Controlled Substances Act to make it easier for states and communities to establish programs or initiatives that allow people to give their unused prescription drugs to an appropriate person, such as law enforcement officials or pharmacists, for disposal purposes, as determined by the Attorney General. The Disposal Act instructed the Attorney General to issue regulations to ensure that drugs do not fall into the wrong hands. Subsequently, the DEA promulgated regulations that explicitly authorized drug manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals and clinics with on-site pharmacies, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles on-site for the disposal of prescription-controlled substances without the need for state authorization. States have also initiated their own drug take-back programs and legislation that provides for the collection of prescription and over-the-counter medication as well.
State Drug Take Back Laws and Manufacturer Responsibility
As of September 2024, forty-five states, Washington, D.C., and Guam, have enacted laws establishing prescription drug repository programs and twenty-nine states have operational programs. Seventeen states and Guam have passed enabling legislation but have not yet implemented active programs. For purposes of these laws, “operational” programs are those with state-approved participating pharmacies, charitable clinics, or hospitals authorized to collect and redistribute donated drugs.[5] Not surprisingly, the characteristics of these programs vary widely from the type of products accepted for disposal, sites identified for collection and disposal, and who may dispose of the product. Most interestingly, responsibility for administering and funding these programs also varies across the various state statutes and regulations. For example, in both Oregon and Washington, “covered manufacturers” are tasked with administering and funding state drug take-back programs.[6],[7] Pursuant to Chapter 120 Laws of 2018, the New York State Drug Take-Back Act mandates that manufacturers establish, fund, and manage a New York State-approved drug take-back program(s) for the safe collection and disposal of unused covered drugs.[8]
The concept of manufacturer responsibility for the lifespan of a product is rooted in the notions of “product stewardship” and “extended producer responsibility.” Specifically, this approach provides that the manufacturer’s responsibility for its product extends to post-consumer management of that product and its packaging. There are two related prongs to the extended producer responsibility policy: (1) shifting financial and management responsibility, with government oversight, upstream to the manufacturer and away from the public sector; and (2) providing incentives to manufacturers to incorporate environmental considerations into the design of their products and packaging.[9] Although a coalition of pharmaceutical manufacturers challenged the concept of pharmaceutical product stewardship, and the laws based thereupon, as an unconstitutional burden on interstate commerce under the Commerce Clause, the Ninth Circuit Court of Appeals in 2014 found that such ordinances, mandating manufacturer responsibility to fund the cost of drug disposal programs, did not control conduct outside of the local county where the ordinance was in effect, nor did it discriminate against interstate commerce.[10] The Court also concluded that the burden imposed by the ordinance was not clearly excessive to the benefits conferred.[11]
A Challenging Compliance Landscape
Navigating compliance with the various state and local take-back programs is a complex challenge for manufacturers, and failure to comply may result in significant fines and penalties. Non-compliance with the Disposal Act may result in severe civil penalties of up to $50,000 for each of the first two convictions of a representative within a ten-year period; up to $1,000,000 for each conviction after the second one within a ten-year period; and up to $100,000 for failure to make a required report, which violates section 331(t) of the Act. While most violations are not criminal, serious ones can lead to criminal prosecution. Manufacturers may also face fines from other agencies for related violations, such as those related to waste disposal under the Resource Conservation and Recovery Act (RCRA) or transportation under the Department of Transportation (DOT). The maximum fine for an RCRA violation is currently approximately $70,000 per day.
State law violations may also result in significant fines and penalties. In New York, for example, failure of manufacturers to comply with the state drug take back law can result, under PBH § 12, in civil penalties of up to $2,000 per violation, and potential referral to the New York State Attorney General who is authorized to bring an injunction for noncompliance, as well as other existing remedies, such as criminal penalties for violations classified as misdemeanors or felonies. Finally, significant reputational harm may also result from non-compliance.
These laws require not only a nuanced understanding of the ordinance or statute at issue but may require manufacturers to coordinate with both political stakeholders, as well as parties along the span of the drug ecosystem, including but not limited to prescribers, reverse distributors, treatment programs, healthcare providers and institutions, and pharmacies. Compliance with state environmental laws as well as requirements to notify local law enforcement of any suspect or known tampering or theft add an additional layer of complexity. Recordkeeping, storage and security requirements will vary, depending on the state and locality involved. The type of medications (prescription, over the counter, veterinary, compounded, controlled, home-generated) subject to state and local drug take-back laws will vary widely. Drug destruction protocols vary from state to state. Finally, manufacturers will have to contract with and monitor vendors in order to accomplish the goals of the particular state or local drug take-back law.
How Frier Levitt Can Help
The continued implementation of drug take-back laws at both the state and local levels represents an ongoing challenge for pharmaceutical manufacturers, as well as an additional economic burden. The complex and inconsistent nature of these ordinances and statutes create compliance risks and require an enterprise-wide focus on achieving results that are both cost-effective and compliant. Just as importantly, manufacturers must remain vigilant as the legal landscape governing these laws evolves.
While implementing and coordinating mandated drug take-back activities can be challenging, Frier Levitt can help. From assessing the legal and compliance risks your company may face across multiple states, to preparing and reviewing your policies and procedures, to engaging the state and local regulators and other stakeholders, the attorneys at Frier Levitt provide the guidance necessary to help ensure that drug-take back laws do not adversely impact your operations. Our extensive network of relationships with state regulatory bodies and participants across the drug ecosystem enables us to communicate your concerns to the right decision-makers at the right time. Contact us today to discuss how we can assist you.
[1] https://www.justice.gov/usao-ndal/pr/dea-holds-national-prescription-drug-take-back-day-turn-tide-against-us-opioid-epidemic
[2] https://www.myamericannurse.com/drug-diversion-in-healthcare/
[3] https://www.justice.gov/archives/opa/pr/dea-heads-first-ever-nationwide-prescription-drug-take-back-day
[4] Secure and Responsible Drug Disposal Act of 2010, PL 111-273, 124 Stat 2858 (West)(2010).
[5] https://www.ncsl.org/health/state-prescription-drug-repository-programs
[6] OR. REV. STAT. ANN. §459a.200; see also H.B. 2078, 81st Legis. Sess. (Or. 2021) H.B. 2078 amends Oregon’s
definition of a “covered manufacturer.
[7] 41 WASH. REV. CODE ANN. §§ 69.48.010– 69.48.200. Washington law provides that “ a covered manufacturer must establish and implement a drug take-back program that complies with the requirements of this chapter”.
[8] N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 60-4.3
[9] https://missouripsc.org/what-is-product-stewardship/#:~:text=There%20are%20two%20related%20features%20of%20EPR%20policy%3A,into%20the%20design%20of%20their%20products%20and%20packaging.
[10] PHARM. RSCH. & MFRS. OF AM. V. CTY. OF ALAMEDA, 768 F.3d 1037 (9th Cir. 2014)
[11] Id. at 1045-1046