PharmE^® News Alert

PharmEcology® Revises Status of EPI and Nitro in the PharmE® Waste Wizard

On October 15th, 2007, USEPA issued a memo declaring that epinephrine salts are not P042 and therefore are not a hazardous waste, unless the waste exhibits a characteristic of hazardous waste, such as ignitability. PharmEcology has reviewed all epinephrine products in its database and has determined that all formulated items are either hydrochloride, bitartrate, or borate salts of epinephrine. As of October 23rd, 2007, therefore, the PharmE® Waste Wizard and underlying database reflect the change in status of all formulated epinephrine products in which epinephrine is the sole active ingredient from P042 to Non-hazardous waste, except for ignitable and pressurized aerosols. All epinephrine combination products have been re-classified from PharmE Hazardous® to Non-hazardous. All bulk epinephrine salts (powders, granules, etc.) will be re-categorized from P042 to PharmE Hazardous® due to their bulk nature. Please check with your state regulatory agency to determine if they have accepted USEPA’s position on epinephrine salts. We will post state-specific guidance on the PharmE® Waste Wizard search results under the Additional Information tab as it becomes available.

We are taking this opportunity to also re-classify all nitroglycerin products that are not ignitable from P081 to Non-hazardous, based on the continued adoption by state regulatory agencies of the 2001 change in the federal regulations under 40 CFR 261.3(g). This change enabled an exclusion of weak medicinal nitroglycerin from P081 listing since it never exhibits the characteristic of reactivity. Some states have not yet adopted this rule change and some have decided not to, so it is important you check with your state regulatory agency. We have already posted many of these decisions in the PharmE® Waste Wizard search results under the Additional Information tab and will continue to do so.

You can review the information released by EPA and access the EPA's memo on epinephrine salts at our PharmEcology New Alert: EPA Declares Epinephrine Salts not P042.

PharmEcology® Associates, LLC of Brookfield, WI was founded in 2000 and provides pharmaceutical waste management consulting services to the healthcare industry through seminars, on-site risk assessments, and other custom consulting services, in addition to the PharmE® Waste Wizard and PharmE® Inventory Analysis. Contact us at 262-814-2635 or email us at info@pharmecology.com.

• Posted: October 23, 2007