As a pharmacy, logic would stand to reason that you have pharmaceutical waste. Shocking leap, I know.... Daniels Health has a long history of providing pharmacies with safe pharmaceutical waste disposal—we also want to make sure you know what to consider when developing a waste plan. A clear plan must be made whether you are a stand-alone pharmacy or a pharmacy located within the walls of a healthcare facility. As experts in healthcare waste management for over 30 years, we at Daniels are here to assist with education on segregation, collection, and disposal.
 

The Environmental Protection Agency (EPA) and Resource Conservation and Recovery Act (RCRA) regulations provide guidelines for pharmaceutical waste disposal but state guidelines and regulations also apply. State guidelines may be even more stringent than federal guidelines. RCRA waste is commonly stored in sealed, disposable black bins.  To easily discuss that waste stream, many facilities simply refer to it as “black bin waste” or “hazardous pharmaceutical” waste. Let’s face, it RCRA (rik-ruh) sounds like an uncomfortable fiber that sweaters were made of in the 80s!!! 

How is pharmaceutical waste defined? 

Pharmaceutical waste is defined as any chemical or biological product medicine that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal. On top of federal regulations, individual states also employ additional regulations regarding chemotherapy waste, infectious waste, and sharps container disposal. Management of pharmaceutical hazardous waste is probably the trickiest waste stream to manage, but we can help with this..

Classifications of Pharmaceutical Waste

Pharmaceutical waste considerations are categorized under a number of categories including:

• RCRA Hazardous Pharmaceuticals

• Non-Regulated Pharmaceuticals

• Non-Hazardous Pharmaceuticals

• DEA Controlled Pharmaceuticals

Before 2015, subtitle C of the RCRA established guidelines regarding hazardous waste disposal and management regulations. These regulations include generation, transportation, storage, treatment, and disposal. However, specific focus on management of hazardous waste from pharmacies, hospitals, and reverse distributors were lacking. But fear not, the EPA recently proposed a new rule: 40 CFR Part 266, subpart P, regarding standards for the management of specific hazardous wastes and hazardous waste disposal that includes pharmacy regulations for any generator producing potentially hazardous pharmaceutical waste. Such facilities will meet requirements for specific classes of hazardous waste generators (found in 40 CFR Part 262).
 

Standards of the EPA guidelines define different types of pharmaceutical waste. For example, a pharmacy may have at its disposal thousands of formulary drugs, some which are deemed hazardous waste when disposed of and others that contain pharmaceutical ingredients defined as "acute" hazardous wastes, (some of which may be regulated even in small amounts).  It is all very specific—but Daniels is here to help.  We have an in-house hazardous waste program manager that assists in the finer details.  Daniels Health can also provide a formulary characterization service to correctly identify disposal, transport and treatment requirements for each medication or pharmaceutical. If this sounds helpful, please don’t hesitate to reach out to us via our quote form here or learn more by accessing our formulary analysis page here. 

EPA regulations implemented for specific management of hazardous waste pharmaceuticals contain certain stipulations such as:

• Currently, non-hazardous / non-regulated pharmaceuticals are not required to be transported as hazardous waste, they can be packaged and treated as non-hazardous pharmaceutical waste . However, as the proposed rule may be inducted, Daniels advises that best practice is that pharmaceutical waste, if you are not 100% confident that it contains non-hazardous pharmaceuticals only, should be transported as hazardous waste;
• A uniform hazardous waste manifest is required to ship hazardous pharmaceuticals and they must be send to a RCRA permitted facility.

Daniels happily meets both of these stipulations. Healthcare facility pharmaceuticals and potentially hazardous waste pharmaceuticals may still be transported to a pharmaceutical reverse distributor for processing credit by the manufacturer, but standards have been improved regarding security and safety in the return of unwanted or expired pharmaceuticals.
 

Is your pharmacy compliant?

FINES AND PENALITIES
…are what can be prevented by maintaining compliance in the face of ever evolving guidelines.  Did I get your attention back yet?

All pharmacies, regardless of location must adhere to often simultaneous multi-regulatory directives from the:

• Drug Enforcement Administration (DEA)
• Environmental Protection Agency EPA)
• The Centers for Medicare and Medicaid Services (CMS)

Regulations and guidance differ for each type of pharmacy and may include rules such as:

• Short-cycle dispensing regulations (CMS)
• Secure and Responsible Drug Disposal Act of 2010 guidelines (DEA)
• Best management practices for unused pharmaceuticals and healthcare facilities (EPA)

Management strategies also differ and include a number of considerations based on type:

• Hazardous waste - required to use a hazardous waste incinerator
• Return to pharmacy stock - applicable when the facility/and or payer contracts mandate credits for unused medications, as long as medications meet return guidelines
• Reverse distribution - typically appropriate for pharmacies or in the case of creditable expired drugs still contained within original manufacturer packaging
• Nonhazardous pharmaceutical –may be incinerated at a medical waste treatment facility or waste to energy processing plant. 
• Trace chemotherapy drugs - to be incinerated at a medical waste treatment facility

It is ultimately the responsibility of the waste generator to determine when such pharmaceuticals are hazardous. Discarded pharmaceuticals may be deemed hazardous waste if they are defined as a product listed under RCRA's P or U listings, or in cases where the pharmaceutical exhibits one or more characteristics of a hazardous waste. Failure to properly identify hazardous pharmaceutical waste may incur fines and penalties.  This is a lot to digest, but Daniels is here to partner with you and properly categorize your waste.

Reduce risk of fines with proper pharmaceutical waste disposal

Fines and penalties have doubled and sometimes even tripled in states around the country. In 2018, California raised maximum daily penalties for improper hazardous waste disposal from $25,000 - which can apply to each separate violation or continuing violations for every day that specific violations continue - up to $70,000.

Criminal provisions found under the RCRA cover a number of infractions such as:

• Treatment, storage, or disposal without a permit or in violation of a permit
• Transporting hazardous waste without a manifest
• Knowing alteration, destruction, or concealment of records
• Knowing endangerment

Under statute 42 U.S.C. 6928 (d) (2) (A) penalties of up to $50,000 per day per violation and/or five years of jail time may be incurred, with penalties are doubled for subsequent violations.

In short, this is serious! Everyone can sympathize with the mismanagement of hazardous pharmaceutical waste, especially with the ongoing opioid epidemic.  Let’s do our part.  Engage with your site to properly segregate and dispose of your pharmaceutical waste.  Daniel Health can assist with pharmaceutical waste categorization, proper RCRA disposal, education, and tamper-proof non-hazardous pharmaceutical sharps containers.

Daniels Health stays up to date with federal and state guidelines and regulations when it comes to different types of medical waste. Don't take chances. Turn to the experts in pharmaceutical waste disposal and avoid non-compliance tags or fines.  It’s okay to ask for help.  Let’s learn together!