Navigating DEA Regulations: A Guide to Registrars, Coordinators, and Power of Attorneys | R.J. Hedges Podcast
This podcast discusses DEA registrants, coordinators, and power of attorneys. Join Becky Templeton and Jeff Hedges from R.J. Hedges & Associates as they discuss the needed to have your pharmacy in compliance with DEA regulations for receiving schedule II’s. Learn what a registrant is, why you should have certificant or coordinator, the 2 types of power of attorneys your pharmacy should have, and what forms you’ll need to complete to get these items in place. Jeff will also discuss the impact and ramifications of not following up on MME’s (Morphine Measurement Equivalents) with prescribing doctors of patients taking 50 or more MME’s per day and on benzodiazepine or patients taking over 90 MMR’s per day.
Hey everyone. Welcome to another podcast here at R.J. Hedges & Associates. We are super excited to bring you some clarification on sometimes a very tricky and very costly area if we don't get it right. I'm Becky Templeton. I am kind of the voice behind some of these things and I'll give myself the tech guru award of the day and I'm joined today by Jeff Hedges, compliance expert and compliance guru himself. Our compliance guide that leads us through all the murky waters of regulatory compliance. And today we've got the fun topic of DEA. Hey Jeff.
Hey, how you doing?
I am good. I am fine. I am dandy. So we've got kind of an area that I'm not very good at, so I'm really glad that you're giving some clarification to our listeners and our clients. So today we're going to be talking about the DEA registrars coordinators, power of attorneys, how everything rolls together. And I know looking through our notes for today, we're going to be talking about the sequencing between obtaining my pharmacy license, getting my DEA license, when I need to register with my 251s, getting the coordinators with the 252s, I'm sorry, getting the registrant established with the 251, getting the coordinator established with 252. And then lastly, delegating things out with that power of attorney for the DEA form 222s. So I think that's what we're going to talk about today, right?
Yes, that is correct.
Fabulous. And I understand there's been some changes within DEA, so I'm sure we'll tuck that in as well. So let's lay the groundwork a little bit first on all of these things because DEA, they love their forum numbers. We've got a whole bunch of them that we're working through today. So can you tell us a little bit about some of the lingo that we might need to know, like what's a registrant? What's a certificate holder and what are those terms that we need to be a little bit familiar about before we really dive in today?
The registrant is someone in the pharmacy, whether it's a pharmacy owner or the pharmacist in charge, but someone who has the authority to make decisions about ordering narcotics, about receiving and handling narcotics. It's one person.
And then how about the certificant? I know I've heard you talking about that before. What exactly is a certificant? I know I've heard of certificates. I've got lots of certificates, but what's a certificant with a NT at the end?
Okay. A certificant or coordinator, depending on which way you call it, both are correct. They are the people that oversee everything and the pharmacy with controlled substances, especially when the registrant is not there. They have all the authority except for delegation down to additional personnel.
I understand there's some changes with DEA that we're going to talk about today. Can you give us a little bit of an update on some of the things that people need to know right off the top before we really dive deep into things?
Well, the biggest change is DEA as well as all the other state and federal agencies have come out of hibernation with the pandemic being over and everybody's being inspected by multiple different entities. We're going to talk about the forms, the 251s, the 252s, the 253s, the 254s and a power of attorney. If you have a DEA license already or you're applying for a new one, the first thing you need is your state pharmacy license. Once you have that, you can apply online for your DEA license. We can put in a request for licensure and we'll have it within 48 to 72 hours.
As long as everything's hunky-dory and fine and there's no abnormal things on the application,
Correct. All right. There's the caveat.
Yeah. But it's no longer eight weeks like it used to be before the pandemic. So once you put your application, the key item is you want your DEA license name to be exactly the same as your pharmacy license. So if you have incorporated on your pharmacy license or LLC, you need to put that on your DEA license as well. But there's no requirement for the legal business name. You may use the doing business name as your customers and everybody knows you by.
And I'm just going to interject there. It's amazing to see how many businesses out there don't actually know their name. That they may have, so I'll make a business up for you that you might have Hedges Pharmacy, but then you might have Hedges Pharmacy Inc. And you might have Hedges Pharmacy Services, you might have Hedges Drugs or Hedges Drug and that actually, none of those names might actually be the real name. That's just what you're using and your bags and your license and your sign out front and your receipt and how you're registering for things might all be different, but at the end of the day, it's always based off of what document first? The IRS document is always going to be the one that drives your LBN, so your legal business name and your state pharmacy license is always going to be the document that drives your DBA, your doing business as name, correct?
So what's the next step with a pharmacy once they receive their DEA license?
Once they receive a new DEA license or if they want to make some changes, we start with the registrant. The registrant, we fill out a DEA form 251. This establishes who can regulate or run the controlled substances within the pharmacy. They're solely responsible for it. This can be the pharmacy owner or the pharmacist in charge. There's some other pharmacies out there that use other folks, but the owner and the pharmacist in charge need to have the responsibility to make decisions on controlled substances coming in and out of their pharmacy. So those are what I recommend.
With the DEA 251 and it's called the CSOS DEA Registrant Certificate Application. Actually, the wording of the name is almost as long as the application. It's a simple application. You fill it out for whomever's going to be to registrant. The big thing is, is that the end of it is a simple document, but at the end it must be notarized and pharmacies will forget to get these documents notarized and they come back from DEA pretty quick and you have to start again. You also need to do a power of attorney, and this power of attorney is for the certificant or the coordinator. And that is done with these applications. So this is different from a different power of attorney we'll talk about a little bit later. If the pharmacy owner owns multiple pharmacies, he or she will still need to fill out the DEA form 254. And with this document, you list all the pharmacies that you have under your ownership listing by the registration number and the name on those permits.
Two people who own this pharmacy and my pharmacist in charges a different person. So I've got three individuals. Do I have three separate registrant applications or can I put all three people on the same application?
No, you can only have one registrant per facility or pharmacy.
So that's going to be the primary owner. Highest share. Which one? What's the best scenario? So I'm the owner and the PIC. That makes it really easy-peasy, right?
So now I'm a co-owner and I'm 51% and you're 49%. So I got the leg up on you on this one. Who gets listed? Is it whoever has the hire or whoever loses at the rock, paper, scissors?
There's no requirement for that decision. Between the owners, they would decide who will be the registrant, which could be one of them or in those type of scenarios, this is normally the pharmacist charges the only one that's in the pharmacy and they're the best one to be the registrant.
Okay, perfect. So let's say I've got the scenario of a non, well outside of the state of California. I have a non pharmacist pharmacy owner. So obviously they're not going to be on this. It has to be the pharmacist in charge.
Not necessarily. We have a couple clients that are owned by regular individuals who are not pharmacists by trade, but they own the pharmacy. They have put in that they're going to control their controlled substances and they become the registrant and that's the owner's decision.
All right. So jumping ahead, should the pharmacy have a coordinator or a certificant? And what's the difference between the two?
It's apples and apples or potatoes and potatoes between a coordinator and a certificant. The certificant comes from a long time ago. It's still the name stuck, but the new term is a coordinator. And yes, the pharmacy needs to have at least one certificant holder. The reason is, is when DEA comes in for their on-site inspections, they will pull your 222s, your documents, they're going to look into your CSOS software, and they're going to see only the registrant signing that six days a week, every day of the month, all through the year.
So the DEA inspector will then walk out to one of the techs and pull them off to the side and they'll say, when the pharmacist is not here, they're on vacation, they're at a conference or it's day off, controlled substances come in. Do you ever handle? A lot of times the person was going to say no, they're set off to the side until they come back in. The next question is, well, if you have to fill a prescription that's important to the patient, it has to be dispensed right away. Does that ever happen? Do you go into that tote and pull it out? And just being very truthful, they'll say, no, I'll go in and I'll pull that item out, dispense the product, and then put it back in the tote. At that point, your fine has now gone well beyond $14,000 because the person who opened the tote had no authority, unless the document we're going to talk about shortly is completed.
Okay. So do we print out a different document concerning the power of attorneys or the, we'll just call it POAs?
Yes, there is. DEA in the new pharmacy manual as well as in past manuals have always required a document called power of attorney for DEA forms 222 and electronic orders. This document is an internal document completed by the registrant. It assigns authority to a pharmacist, a pharmacy technician, or even a clerk to be able to open a tote with C2 narcotics in it, inventory it and put it on the shelf. With this form, the Pharmacist Manual
As a point of clarity, this form now permits the user to also submit the receipt through CSOC.
The power of attorney is given to what's called an attorney in fact, which permits them to handle C2 narcotics and all electronic orders. This is signed by the person and then it has to have two witnesses. This document is a one time document. It does not need to be submitted to anyone other than kept with your DEA documents. If an employee leaves or you want to revoke that at the bottom of the form, there's a revocation notice and you complete the bottom. And then at that point, that individual is no longer allowed to touch a C2 that's coming into the pharmacy.
Now there's some misconceptions, I think in what you just explained with some of our pharmacists. Can you kind of tell me where some of their confusion comes from?
Yes. It all revolves around the power of attorney. So the registrant and coordinator have to fill out a power of attorney. That's for the CSOC application. But the power of attorney for DEA forms 222s and electronic orders is a separate document that's kept internally in the pharmacy with the DEA documentation. This delegate the authority to handle C2 narcotics in place of the registrant or the coordinator. It doesn't take the authority away, but they're able to handle it, do the inventory and get everything together so it's ready for review by the certificant holder or the registrant.
I feel like we've missed something. Wasn't there a process before we had to have triplicates of everything in those 222s? Do you have any other updates for us on that? And why didn't we talk about it yet?
We just haven't got to it.
Oh, okay, perfect.
So as of October 30th, 2021, the old form, the triplicates of the 222s can no longer be used. Only the single page 222 that is printed out of a CSOS system is to be used. Now pharmacies have and still have these triplicate DEA 222s with them. So what are you supposed to do with them? You pack them up and you send them back to DEA to the address in Springfield, Virginia.
These are the blank forms.
The blank ones, yes.
So don't shred them, send them back.
They are serial numbered, so they have to be returned.
So they want all of them sent back. Now is the DEA going to pay the postage and the freight?
I have a whole slew of them. Rat farts. Okay, so now I have to ship all these back to DEA because of that serial number. What about the ones that I've already completed?
Well, you maintain them. So there's been some changes there too. In the past, we had to keep the DEA 222 with the inventory or the receipt, and you had to maintain the hard copy for two years plus enter everything into the CSOS system, which is really dumb because you were doing double work and it was a good trip wire for a pharmacy to get in trouble. However, with the updated pharmacist manual, you only need to keep the invoice or the receipt for all drugs C2s through C5s. They do not need to be matched up. It's just keep them in date sequence so you go back and find them. That's it. You do not need to have any 222 hard copies filed anymore. And these documents are maintained for 24 months or two years.
Now, correct me if I'm wrong, wasn't there something that changed back on July 1st that I saw come through one of our newsletters bulletin's, [inaudible 00:15:06] something around that July date?
Yes. On July 1st, DEA implemented a new rule, which is actually a collection of a lot of rules all put into one, and it all revolves around corresponding responsibilities. This affects C2s only and what happens is everything's being broke down into MMEs, which is, MME is a tough word to say. It is,
Yep. Can't even get it out.
Morphine measurement equivalent.
Morphine measurement equivalent. Okay. Morphine measurement equivalent.
All C2s have a morphine equivalent or MME. Most of the time you don't know what it is because it's in your pharmacy software. When you put it in, the narcotic it's going to give you what the MME per day is. Now what's important is if the patient is receiving up to and including 49 MMEs, nothing needs to be done. However, when a patient hits 50 MMEs and is on benzodiazepine, you have to have a conversation with the physician who actually wrote the prescription and talk to them and make sure that they are giving the patient the correct medication and the correct dosage, so. But the physician has a whole bunch of other things that they have to do, plan of care, other documentation they maintain in their medical record.
So the next threshold is when you hit 90 MMEs. When you hit that threshold, you cannot dispense it until the physician who wrote the prescription provides the pharmacy with the plan of care. That is a very important document. And if the pharmacy dispenses that narcotic without the plan of care, that's a world of hurt. And that's where DEA really comes in. And they do monitor what's happening through your CSOS submissions as well as through the state PMP.
These MMEs, they're collective. So if they're on multiple narcotics,
It's not just up to 49 per medication A, up to 49 for medication B. It's collectively. So I got to add A and B together.
That is correct.
Okay. So we're doing MME math?
The problem is and where this is all coming from with the nation's narcotic problem, that is not talking about anything that's being illegally made in the United States or even being imported illegally into the states. That's where most of the drugs are coming from. They're causing a narcotic epidemic throughout our country. The only thing the DEA can control is the registered legal prescription C2s.
All right. So far we've gone over, let me get my little cheat sheet out here. So we've had a pretty good conversation on things. We've gone over some of our terms that we need to know. We've talked about getting everybody set up, the hierarchy of pharmacy license, DEA license, registrant coordinator, POA, some of the changes that have happened, workflow a little bit within the pharmacy to make sure that we're all in compliance. And I'm going to just throw out that question of what's the worst case scenario?
You go to jail. Yes, go to jail.
So if I'm kind of being an ostrich head in the sand because I've got so much other stuff doing and I'm like, I'm not going to worry about these updates that have happened, I'm still going to use my triplicate forms, I'm not updating anything. What's going to happen?
Well, initially you're going to get a DEA inspection, which you'll probably fail. And then the attorney general, either the US Attorney General or the State Attorney General, they fight over who's going to have jurisdiction and then they go through a legal investigation. In that investigation, depending on what they find and other things that they find in the investigation, it's a Pandora's box and all of a sudden they're providing all the information to DEA when they're asking for it, doing everything you're supposed to, then there's a knock on your door at 6:00 AM and literally this is what happens. You open the door in your pajamas and there are DEA agents in SWAT gear with guns to arrest you because you didn't document your C2s and it's going to be looking like they're coming to arrest a terrorist. But all they're doing is coming in to arrest and indict the pharmacy owner or the registrant and take them to a federal judge or a state judge for the indictment and the reading.
At this point during the investigation, they still continue to find more and more things and it's just piling on. The indictment keeps on increasing and you have to get an attorney and the attorneys that are working on this, we're talking six to $800 an hour. So it's very, very expensive. The best thing to do is to be careful on what you do. We have updated our policy and procedure for DEA diversion. Everything here, what we've talked about is in that policy and procedure. We really worked hard to get this right. There was a number of pharmacies we talked to make sure that we worded it correctly because we didn't want any misunderstanding of what we wrote.
So at the end of the day, for the folks that are going, I don't know if I have time to do this, really, you have to make the time to go back, make sure that you send in your old triplicates, you're using the new DEA 222, you're revisiting any of your POAs that you have set up for people to be handling all of our C2s that are coming through, getting them all checked in to make sure that their current employees. If they're no longer an employee, we've got to redact them, fill out the paperwork, keep it in a secure folder. So if ever we need to provide it to somebody, the proof is right there. We have all of our people that have that POA, any documentation to the people that no longer have it. And then of course, working backwards from the beginning, we need to have all of our other documentation in line for the registrants and the coordinators.
Okay, perfect. So we've got a lot going on folks with our DEA program. If it's something that you're a current client of ours, good news. If you're enrolled in our pharmacy or compounding programs, it's already tucked into that. It's included in that package. If it's something that you're interested in getting a little extra help with DEA, we do have a DEA compliance program that we can sell you a la carte. You can get more information. I've got some information. I'll tag below in the blog that accompanies this podcast. And as always, if you guys have any questions or need any help, we're always here to keep you stress-free and in compliance. So Jeff, thanks so much for your time today.
Okay. Thank you for the time and talking about this important topic.
Good deal. You folks have a great rest of your day.