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Management of Hazardous Waste Pharmaceuticals

Hazardous Waste Pharmaceuticals

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, the NYSDEC encourages retail and healthcare facilities to get 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 the NYSDEC. This page addresses those pharmaceuticals that, when disposed, are a hazardous waste under USEPA's Resource Conservation and Recovery (RCRA) Rules, as adopted by the NYSDEC.

If these drugs 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 pharmaceuticals at pharmacies, medical centers, or other places of business would need to be managed as hazardous waste. Information on EPA regulations can be found under the "Links Leaving DEC's Website" section to the right. This page will clarify some New York State-specific rules and interpretations relative to how these drugs must be managed.

NYS RCRA Interpretations for Some Specific Drugs

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)).

USEPA Guidance RO# 14831 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.

USEPA Guidance RO# 14778 concludes that the P042 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 RCRA-C regulation as a hazardous waste. Wastes from the manufacturing of epinephrine may still be subject to this listing.

Generator Status and Counting Rules

Containers for 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)). 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 establishing generator fees, special assessments, and generator size categories. Generators need not include or report the weight of containers and packaging in making their hazardous waste generator classification determination or in manifests or annual reports; however, for shipments in containers, they must clearly note on the relevant documents whether the weight of the container and packaging is, or is not, included in the weight.

Counting products 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.