DEA Pharmaceutical Waste Q&A with Expert Mike Albert

For medications being wasted in the inpatient setting, what type of container should be used to physically render the product non-retrievable?

Can you give some examples of specific containers that meet the definition of non-retrievable?

The case study you spoke of - how did they render the controlled substances non-retrievable?  Also define and give examples of making a controlled substance "physically" non-retrievable. 

Can you specifically go over the procedure for DISPOSING of partially used controlled medications within a hospital? IE: 1/2 tablet of oxycodone not used by patient or 0.5ml of morphine iv. Without using a sink/Toilet how can these be disposed of?

In the case study mentioned, please explain how the controls were made non-retrievable.

It is not just the container itself that should add a security to unauthorized access but there are different types of materials out there to do this. The container itself does not physically or chemically change the controlled substance to meet the new definition. But what is in the container is critical. Many different style containers can be used; all are reliant on your specific needs, space and requirements.

Some chemical waste, already being generated at your institution could be used; some non-hazardous material and some that are hazardous. There are several different methods to have these containers set up around site, have them secured and denaturing drugs while they are being used. But if there is nothing in the container that meets the new definition, the container would simply be a collection point for all controlled substances onsite, leaving it a very non-compliant and unsafe situation. (Highly enforceable) 

Depending on material and container being used, to meet he definition, there can be multiple ways of handling the material. We have had a client that set up a ‘DEA compliant’ program. A letter was even sent to the SAC for approval (Done before the new regulation) and then also referenced after the new regulation went into effect, that there are compliant, cheap and easy ways to meet the new definition. It depends on how you would like to ultimately track it out of your institution and how each unique program is set up to complete your tasks compliantly.

Physically changing the substances are harder but when mixed together in a container and with a solidifier added, it can be physically altered so it can meet the definition. There are several options to complete this task.

Are sharps containers by definition considered irretrievable?

No. They do not physically or chemically change the controlled substance to meet non-retrievable. 

Do I need a form 41 for wasting controlled substances at a long term facility if we make them non retrievable?

No you do not. As long as you are keeping track of when and how much are getting destroyed, per normal protocol, Form 41 is not needed for your records. (Under Pharmaceutical Wastage Guidelines)

Can you please provide the title of the case study mentioned?

The title of the case study is a client name, who would not like their name given out this publicly. I can reach out separately, specifically for them to contact you if you would like. Please contact back to Triumvirate for more information.

I was under the impression that sewering was specifically addressed in the new rule as not meeting the non-retrievable standard?  This presentation implied to me that sewering is still a viable, although not advisable method. 

In the regulation, there is no mention of sewering specifically. However, on page 53548 (Q&A), it does state that sewering does not meet the definition of non-retrievable alone and will not have such a broad prohibition in the regulation. So yes I would agree with this question/concern. sewering alone does not meet the definition, but if there was a process in conjunction and still meets other regulation approval for sewering, not a regulated material, it could meet the new definition. 

For disposal on site, are you talking about mixing into a flammable waste drum or something similar?

Potentially. You have to prove that is chemically alters the controlled substance to render it non-retrievable. Flammables do not necessarily meet this definition alone. Many flammables can be evaporated off the controlled substance and only the controlled substance is left behind.

Fentanyl Patches - are cutting and disposing in sharps containers meet regulations since they are physically altered?

Unfortunately not; the back of the patch, no matter how small, still contains the active controlled substance. The patch needs to be put into a solution to chemically change it. The sharps container does not change the physical or chemical portion of the substance.

If a reverse distributor takes outdated/expired medications from facility does is a DEA 41 form required to be completed for what they completed the DEA222 for?

If the medications are controlled substances then a Form 222 is used. Section 1317.15 will also help to decipher more reverse distribution requirements per the generator. 

Do you have an opinion about the Cactus Sinks for controlled substance collection? 

Please reference the complete list of requirements for meeting the non-retrievable definition and also think security measures in place when the controlled substances are placed into the sink. Also of this short list of the following questions while evaluating the Cactus Sink: 1) Are they secured to the wall/floor by an outer container? 2) How are they physically or chemically altering the controlled substances? 3) Can contents be removed from the openings? 4) How do they meet the non-retrievable definition?

Take back days are for consumers or end users only correct...not businesses?

Yes you are correct. Only Ultimate End Users and persons lawfully entitled to dispose of an ultimate user's property, not businesses or registrants. 

Is incineration considered a viable means once collected?  If so, can this waste once separated and documented be placed in a chemo waste or pathological box marked for incineration?

Incineration is considered a viable means of destruction, however, when the controlled substances are collected, they are still not destroyed onsite and require specific escorts and witness from facility to end disposal. Potentially putting them in the chemo/pathological box marked for incineration before they are demanded non-retrievable onsite, does not meet the definition.

We are looking for information regarding what companies provide disposal services for the collected drugs. Advice?

Reverse distributors should take it back. There is also a way to send it directly to an incinerator and would require witness accompaniment. According to the new regulations, more reverse distributors should take that collected material. Triumvirate could help out in this case as well by providing services. Please let us know if you would like to talk to one of our Account Managers for more information.

Many reverse distributors do not accept the collector - items just for disposal

This is an interesting point to note because some reverse distributors will not take drugs back if they were tampered with or proven they were not tampered with. I would continue to search for reverse distributors that would take it back. According to the new regulations, more reverse distributors should take that collected material. Triumvirate could help out in this case as well by providing services. Please let us know if you would like to talk to one of our Account Managers for more information.

Where do we get the inner liner?

There is not specific inner liner that can be purchased. They are unique to each setting and specifications can be found under the regulation on page 53567, under 1317.60

Can we ask to remove the drugs out of the plastic bottles before placing into the collection box?

The regulation does not state that you cannot do this. However, an employee of the institution is to not help with this scenario. (53533, Q&A) If there are bags next to the container or suggestion tips on how to get a larger container into the small hole, they can be used. 

What needs to be documented for institutional waste, and any recommendations on record keeping?

Form 41 needs to be completed when completing virgin material destruction and collector disposal. The documentation needs to include the sign off of the staff, 2 witnesses that take the controlled substance for destruction.

If witness wasted pharmaceutical waste, usually they are logged into a Pyxis or Omni Cell Machine that can prove as the documentation. The records go back all the way until when it was installed. No form 41 would need to be filled out for pharmaceutical wastage collected on the floors. IT would be wise to document and have a procedure in place to complete this process and where the containers will go for disposal after collection.

When do you anticipate a ruling to officially not allow waste through sewering?

I would suggest that sooner rather than later. Many waste water commission, Environmental Protection Agencies and per the new regulation, sewering alone does not meet the definition of non-retrievable. Therefore, when the agencies want to start pushing this fact, it will be enforceable to get the controlled substances out of the sewer. Most likely it will be a different agency that will control this ruling. As stated above about sewering, it is not in the final rule specifically.

When do you anticipate a ruling to officially not allow waste through sewering in the hospital setting?

Similar to the previous question's answer but we are going to look into this question with our contacts through the DEA. Also refer to the question above on sewing being mentioned as not the sole method to meet the new definition of non-retrievable. Until another agency regulates the wastewater out of the hospital to regulate what is going down further, the DEA can only work to collaboratively attempt to get away from sewering.

Does hospital have to fill out DEA form 41 for onsite destruction of outdated compounded control substances like PCAs etc.?

If the compounds are made by the registrant and cannot be returned, then yes there should be a form 41 filled out and complete destruction on site can be completed. 

Do you believe this will enable MADEP to potentially enforce a regulatory fine in regard to inappropriate disposal of hazardous waste? Specifically in regard to drugs with a waste code such as chloral hydrate

Yes, it could potentially open the door for them to enforce. If there is a specific collection point for this controlled substance that is both DEA/RCRA regulated then there is less likely a chance of enforcement (negatively). Many institutions send it back to the pharmacy for destruction/disposal. EPA and DEA are continually working with each other to manage the substances that are regulated by both. (References on page 53554 of the Q&A)  DEA cannot advise on the EPA side of the house, they are in a different group in the chain to follow before the DEA regulations. There is an abstract on www.reginfo.gov on "Management Standards for Hazardous Waste Pharmaceuticals" that could also help to answer and clarify this question.

Also, specifically to Chloral Hydrate, if an ultimate end user were to bring it back to the collector point for drop off, it would fall out of the EPA regulation under the RCRA Household's Hazardous Waste Exemption.

If one is using a California smart sink, should they complete a form 41? Would this device allow a hospital or other business to hold take back days?

A form 41 would not be needed if the controlled substances were from "pharmaceutical wastage". The device needs to meet similar criteria as the collector requirements, including an removable inner liner, outer container, small opening for contents to be put in but not taken out. (See above on Cactus Smart Sink Opinion)

However, on page 53565 and 53566 both talk about destruction methods, with-out directly addressing Take Back Days, when on-site destruction can occur. It is up for interpretation and also what the Law-Enforcement agency would like to do as well. No matter how Take Back Days are completed, they must be in conjunction or run by Law enforcement. The majority of the time they are done by removing the controlled substances by law enforcement for destruction, not destruction on-site. However it does not specifically say that you cannot do it.

Are there any signatures, approvals required from DEA prior to on-site destruction? 

Not according to the new Regulation. The Special Agent in Charge (SAC) does not need to approve a process/procedure or method before completing this task. They can however, be sent a letter for guidance on the new process. Proper use of the new form 41, having a procedure in place and following it strongly recommended. 

Is following DEA regulations for "sewering" in violation of EPA or other agency regulations?

Please see above on sewering not specifically called out in the new regulation. Also note question on MADEP regulation of coded DEA substances. There are only a few that would fall under the EPA or other agency regulations at this point in time.