Management Of Hazardous Waste Pharmaceuticals
Hazardous Waste Pharmaceuticals
EPA's nationwide ban on the sewering of hazardous waste pharmaceuticals begins on August 21, 2019.
DEC is utilizing enforcement discretion to allow the use of the amended the P075 nicotine and salts hazardous waste listing that exempts FDA-approved over-the-counter nicotine replacement therapies in New York State, effective August 21, 2019. Please see the RCRA interpretations section below for more information.
Low levels of drugs are being found in our surface waters, adversely affecting fish and other aquatic wildlife. To minimize the amount of waste pharmaceuticals that end up in our waterways, DEC encourages retail and healthcare facilities to have pharmaceuticals thermally destroyed. Managing these waste pharmaceuticals can be a challenge, since they are governed by a series of overlapping and, at times, conflicting regulations from the New York State Department of Health, the US Drug Enforcement Agency, the USEPA, and DEC. This page addresses those pharmaceuticals that, when disposed, are a hazardous waste under USEPA's Resource Conservation and Recovery (RCRA) Rules, as adopted by DEC.
If hazardous waste pharmaceuticals are disposed of by the consumer (referred to as the "ultimate user" in DEA regulations), then they are not considered a hazardous waste, since they qualify for the household hazardous waste exemption. However, expired or otherwise unwanted hazardous waste pharmaceuticals at pharmacies, medical centers, or other places of business would need to be managed as hazardous waste. This page clarifies some New York State-specific rules and interpretations relative to how these drugs must be managed.
Nationwide Sewering Ban for Hazardous Waste Pharmaceuticals
Beginning on August 21, 2019, Healthcare Facilities, as defined in 40 CFR 266.500 (link leaves DEC's website) will no longer be allowed to sewer (i.e., flush) hazardous waste pharmaceuticals. This ban applies to all Healthcare Facilities, regardless of hazardous waste generator status.
NYS RCRA Interpretations for Some Specific Drugs
Epinephrine salts - USEPA Guidance RO# 14778 (link leaves DEC's website) concludes that the P042 hazardous waste listing does not include epinephrine salts. It is DEC's understanding that commercially available pharmaceutical uses of epinephrine are epinephrine salts, and thus are not subject to regulation as a hazardous waste. Wastes from the manufacturing of epinephrine may still be subject to this listing.
Nicotine - DEC is utilizing enforcement discretion to exempt US Food and Drug Administration-approved over-the-counter nicotine replacement therapies ("FDA-approved OTC NRTs") from the P075 nicotine and salts hazardous waste listing. FDA-approved OTC NRTs include nicotine gums, patches, and lozenges. These wastes may be managed and disposed of as regular solid waste in New York State. Other states may still regulate these wastes as hazardous waste, so facilities sending these wastes for out-of-state disposal should also be aware of the regulatory requirements for these wastes in their disposal facility's state. It should also be noted that other nicotine-contain wastes (e-juice, manufacturing grade formulations of nicotine, etc.) are not exempt from the P075 listing. Please see DEC's Amendment to the Listing of Nicotine and Salts Enforcement Discretion Letter (PDF) for more information.
Nitroglycerin - Nitroglycerin is listed as a hazardous waste only because it is reactive. It is DEC's understanding that current on-specification formulations of pharmaceutical nitroglycerine are unlikely to exhibit the reactivity characteristic, and thus would not be hazardous waste (see 6 NYCRR 371.1(d)(6)) (link leaves DEC's website).
Phentermine HCl - USEPA Guidance RO# 14831 (link leaves DEC's website) concludes that a formulation where phentermine HCl is the sole active ingredient is not a P046 listed hazardous waste. Wastes from the manufacturing of phentermine may still be subject to this listing.
Generator Status and Counting Rules
Containers Holding Acute Hazardous Wastes
Containers of listed hazardous wastes can become subject to regulation under RCRA because of the mixture rule (waste mixed with a listed hazardous waste becomes a hazardous waste; 6 NYCRR 371.1(d)(1)(ii)) (link leaves DEC's website). However, containers can stop being a hazardous waste if they become "empty" according to RCRA regulations. For acute hazardous wastes, containers are not considered empty unless they are triple rinsed (or some other process demonstrated to be as effective). If containers are triple rinsed, then the rinsate becomes a hazardous waste, so rinsing does not generally reduce the amount of waste generated.
However, if a jar or bottle is still functioning as a container, DEC does not consider it a waste, and generators do not need to include the weight of still functioning containers and packaging when calculating the quantities of hazardous waste generated, provided that the generator provides sufficient documentation. These containers become fully regulated hazardous waste when they stop functioning as effective containers of the acute hazardous waste held inside (unless triple rinsed).
Policy DSH-HW-03-17 "Counting of Container and Packaging Weights" establishes the uniform policy of allowing container and packaging weights to be excluded when determining the quantity of hazardous waste generated for the purpose of reporting on the Annual Report and Hazardous Waste Reduction Plan, and for assessing generator fees, special assessments, and generator size categories. Generators do not need to include or report the weight of containers and packaging when determining their hazardous waste generator category, or on manifests or annual reports. However, for shipments in containers, generators must clearly note on the relevant documents whether the weight of the container and packaging is or is not included in the weight of the waste.
Counting Pharmaceuticals Sent for Reverse Distribution
It is obvious that hazardous materials being sold by a store are not a hazardous waste while they are on the shelves. Less obvious, perhaps, is the exact point at which they do become a waste. If something spills or breaks, it can become clearly waste-like on its own. But in most cases, the generator has to consciously decide that the material is a waste. As described in DEC's guidance on reverse distributors, material that is clearly a waste should not be sent to a reverse distributor. The materials that can be sent to a reverse distributor must still be managed as a product. Until the reverse distributor decides to dispose of the item, it is still considered a product. As such, products sent for reverse distribution which are not clearly waste-like are not hazardous waste when they leave the store, and they are not counted in determining the store's generator status. If they are clearly waste-like, such as loose pills, partial packages without all of the information on them, etc. they are counted and must be properly handled by the generator. If products meet the definition of a hazardous waste, the handling, transportation, and disposal of the waste pharmaceuticals must meet all of the RCRA rules.