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TROU ER <br /> SAND <br /> Mr. Jonathan Blazo <br /> March 13 , 2017 <br /> Page 2 <br /> Agency also understands that there are instances where it is well known <br /> that a pharmaceutical will not be creditable. Examples of these instances <br /> include the following.0 if the pharmaceutical has been removed from the <br /> original container and re-packaged for dispensing purposes; if an <br /> attempt was made to administer a pharmaceutical, but the patient <br /> refused to take it; if the hazardous waste pharmaceutical was generated <br /> during patient care; if the pharmacy receives a return of a dispensed <br /> pharmaceutical for which they had already received compensation by a <br /> third-party payer; or if the pharmaceutical is more than one year past its <br /> expiration date . In these instances, as well as others, the healthcare <br /> facility knows that it will not receive manufacturer' s credit. It is the <br /> Agency' s intent for the proposed definition of potentially creditable <br /> hazardous waste pharmaceuticals to allow the return of hazardous waste <br /> pharmaceuticals to reverse distributors for the determination of credit. It <br /> is not the Agency' s intent, however, for reverse distributors to serve in <br /> the capacity as TSDFs when it is well known that the manufacturer will <br /> not give credit for those hazardous waste pharmaceuticals. <br /> Also, based on communication with stakeholders and the public <br /> comments received on the 2008 Universal Pharmaceutical Waste <br /> proposal, EPA understands that pharmaceutical manufacturers ' policies <br /> often allow for credit to be received on the return of `partials . ' Partials is <br /> a term used in the industry to refer to opened containers that have had <br /> some contents removed. Under the proposed definition, the Agency <br /> would consider partials to be potentially creditable hazardous waste <br /> pharmaceuticals . 80 Fed. Reg. 58022-23 <br /> Rather than risk inconsistent or ad hoc communication on an issue of such critical <br /> importance to our companies, we would like to meet with the appropriate Agency leadership and <br /> inspectors to review our processes and discuss how relevant data is maintained. We want to <br /> assure the County that we operate in full compliance with California laws that in fact authorize <br /> reverse distribution under Section 117690 (b)(3 ) of the Health and Safety Code, as well as U . S . <br /> EPA guidance regarding this process . <br /> Further, our companies maintain hazardous waste management programs in our <br /> pharmacies . These programs manage non-dispensable pharmaceuticals that do not qualify for <br /> reverse distribution and are waste at the stores. As you know, many of the hazardous waste <br /> Consent Judgments entered between the County and our companies provide that so long as our <br /> companies are working on federal regulatory reform regarding the proper management of non" <br /> dispensable pharmaceuticals through reverse distribution, no enforcement action or notice of <br /> violation would be pursued regarding reverse distribution unless and until the company had <br /> failed to demonstrate reasonable diligence with such reform efforts and a ninety-day advance <br />