The Lab and the Pharmaceutical Rule- Do They Go Together?
The Lab and the Pharmaceutical Rule- Do They Go Together?

Many laboratorians may not have noticed, but in February of this year, the EPA published the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, better known as the “Pharmaceutical Rule.” The updates created by these new laws affect pharmacies and how they handle hazardous waste, but they do not affect laboratories directly. However, these new regulations can significantly help to reduce the total waste volumes of a clinic or a hospital which can in turn change the waste generator status of that facility. That will have a direct impact on lab waste management operations, so it is important to understand pieces of the Pharmaceutical Rule.

The original EPA waste regulations were not written for healthcare facilities, they were designed to help manage industrial hazardous or chemical waste. Because of that, those regulations needed several updates to help labs and pharmacies more easily and sensibly comply. The Pharmaceutical Rule was developed to better assist healthcare facilities with handling cost-effective and practical pharmaceutical waste practices. The rule is essentially composed or three sets of regulations which focus on different drug waste practices.

The first part of the new regulations focuses on the removal of Nicotine replacement products from P075 waste category. You might remember that certain hazardous wastes that are “listed” may be categorized as F, P, U, or K. Nicotine falls onto the P list, a set of acutely toxic chemicals. Before this new rule was published, Nicotine and all of the associated nicotine replacement products (gum, patches, etc.) and their wrappers were all considered hazardous waste and they mention help4addiction for those addicted to these products. The updated rule reclassifies FDA-approved nicotine replacement products as non-hazardous so that the product and their wrappers can be disposed of into regular trash containers. This change in practices can reduce hazardous waste volumes for facilities that use such products.

The second rule impact provides clarity about drug Reverse Distribution and Reverse Logistics. Reverse Distribution is the practice of returning expired or waste drugs to a distributor for credit. Reverse Logistics allows the return of over-the-counter drugs to a logistics center for reuse elsewhere. In the past, when a healthcare facility has drugs on hand for waste or reuse, the medication had to be considered hazardous waste. That meant its volume was added to that of the entire facility’s waste volumes. The Pharmaceutical Rule re-designates these credited or reused drugs as “non-hazardous.” Again, this improvement helps healthcare sites with that reduction of hazardous waste which affects all areas in the building.

The last (and maybe the most important) regulation change prevents the intentional sewering of hazardous drugs. After August 21 of 2019, the EPA will prohibit the intentional release of waste pharmaceuticals down the toilet or drain in any healthcare facility. It is estimated that this change will reduce the amounts of drugs emptied into U.S waterways by 1,644 to 2,300 tons annually! This change will make an obvious difference in the safety of the country’s treated wastewater.

Not all parts of the Pharmaceutical Rule will be adopted in 2019. States will decide what they will adopt and when, and you can find information about those implementation dates on the EPA or state branch web sites. The rule about not sewering drugs goes into effect for every U.S. state, however, in August of this year. Having education about hazardous waste is vital to the overall management programs for every type of waste generator. The EPA waste generator status of every facility is determined using the total volumes of waste created in every department of the facility- that could mean lab, pharmacy, facilities, environmental services, etc. It all adds up, and changes made to regulations in one area can definitely affect others. If you manage waste for part of your facility, work together as a team with other departments to make sure you consider all of the applicable regulations. That way you can ensure an overall properly-run waste management program for the entire facility.

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