On March 22, 2018, the State of Washington officially enacted the first statewide drug take-back program in the country. Washington Governor Jay Inslee signed HB 1047 into law, which establishes a single, uniform, statewide system of regulation for safe and secure collection and disposal of medicines through a uniform drug “take-back” program operated and funded by drug manufacturers.
The Act goes into effect on June 7, 2018, and requires “covered manufacturers” to submit their proposed programs by July 1, 2019. Also by July 2, 2019, Washington’s Department of Health (DOH) must determine its own costs for administration, oversight, and enforcement, as well as set fees and adopt rules establishing program proposal requirements. The estimated costs to pharmaceutical companies is less than one percent of the annual sales made in Washington markets, though time will tell.
Covered Drugs
Under the Act, only “covered drugs” are part of the take-back program. The Act further defines “covered drugs” as those that are both prescription and non-prescription, brand name and generic, drugs for veterinary use, and drugs in medical device and combination products. Included in that broad definition are drugs administered via ingestion, injection, and inhalation. Excluded from the Act are “exposed” needles and sharps, as well as “used drug products that are medical wastes.”
Further, “covered drugs” are those that “covered entities” no longer want and that the covered entities either have already abandoned or discarded or plan to abandon or discard.
Exempt Products
The follow products are exempt from any requirements under the Act: (1) Vitamins, minerals, or supplements; (2) Herbal-based remedies and homeopathic drugs, products, or remedies; (3) Schedule I controlled substances; (4) Cosmetics, shampoos, sunscreens, lip balm, toothpaste, antiperspirants, or other personal care products that are regulated as both cosmetics and nonprescription drugs under the Federal Food, Drug, and Cosmetic Act; (5) Drugs for which manufacturers provide a pharmaceutical product stewardship or drug take-back program as part of a FDA REMS; (6) Biological drug products; (7) Drugs that are administered in a clinical setting; or (8) Pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms.
Covered Entity
The Act also defines “Covered entity” as any state resident or other non-business entity. This therefore excludes any hospitals, clinics, healthcare providers offices, veterinary clinics, pharmacies, law enforcement agencies, and any other businesses.
Covered Manufacturer
“Covered manufacturers” are those that are engage in the manufacture of covered drugs that are sold in or into Washington. Under this definition, any manufacturers relating to the production, preparation, propagation, compounding, or processing of the drug, substance, or device, will be considered a covered manufacturer. The packager or labeler of the drug is also included.
Not included in this definition are any private label distributors, retail pharmacies selling the drug under the pharmacy’s store label, repackagers, or nonprofit health care corporations that repackages drugs solely to supply them to facilities or retail pharmacies operated by the same corporation or an affiliate.
Obligations of Wholesalers and Other Covered Manufacturers
A drug wholesaler that sells a drug in or into Washington must provide a list of drug manufacturers to the DOH (DOH will create a standardized form). Additionally, a retail pharmacy, private label distributor, or repackager must provide written notification to the DOH identifying the drug manufacturer from which the retail pharmacy, private label distributor, or repackager obtains a drug that it sells under its own label. The law provides that no later than 90-days following the effective date (i.e., July 7, 2018), companies must submit the list to the DOH.
What happens to county disposal ordinances?
Depending on how soon regulations are developed, county programs may continue to operate an existing ordinance for 12 months after a state-approved program begins operating. At the end of the 12-month period, all existing and future local laws regarding drug take-back programs are preempted.
Penalties
As is perhaps expected, there are penalties that come with running afoul of the new law. Such penalties include:
- An informal administrative conference
- A restriction on ability to engage in certain activities; or
- A civil fine of up to $2,000.00 per day.
Interestingly, one penalty excluded from the list of possibilities is that of the DOH prohibiting a manufacturer from selling a drug in or into the state of Washington.