Commonly Ignored Controlled Substance Regulations That Can Increase Your Risk and Cost You Money When Audited by the DEA

by Zimbis | Nov 1, 2021 | News

Jan Woods, Zimbis Regulatory Consultant

Written By Jan Woods

It’s been said and sadly realized all too late that once the DEA (Drug Enforcement Administration) gets into your practice, it can be difficult getting them out! Here’s a real eye opener, did you know that the average DEA fine is $15,040, per citation? Unfortunately, only one citation is rarely given by the DEA to a Practitioner. Yikes! So, what’s the best way to minimize your biggest risk and keep the DEA out of your practice? Should you just memorize and follow all state and federal Practitioner controlled substance regulations? Nope, the regulations are often confusing, contradictory, and constantly changing! 

Did you know that the under the “Controlled Substance Act, the term “practitioner” is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer,        or use in teaching or chemical analysis,  a controlled substance in the professional practice or research. Every person or entity that handles controlled substances must be registered with the DEA or be exempt by regulation from registration.”  Source: Page 7 of the DEA Practitioner’s Manual.

Question: Do you know which controlled substance regulations take precedence in your practice?  Is it the federal government (DEA), the state government, the state pharmacy board or the state dental board? 

Answer: Whichever regulation is the most stringent! 

That means you must know all the federal DEA regulations found in Title 21 CFR, 1300 to End, plus know all your state’s controlled substance regulations and then follow the most stringent regulation! One can get headache just trying to figure out where to start! 

Even the simplest controlled substance regulations can be confusing. For example, knowing the difference between controlled substance medical waste destruction and expired and unwanted controlled substances destruction is often confusing. This leads to two of the most common violations cited by the DEA and state agencies. Read on to learn more.

Controlled Substance Medical Waste

How do you destroy your controlled substance medical waste? How do you destroy your expired or unwanted controlled substances? Let’s look at their definitions first and then the correct destruction methods per the DEA. Remember that your state’s destruction regs may differ from Federal DEA destruction regs, so always follow the most stringent regulations. 

Controlled Substance Medical Waste is defined as “a controlled substance dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized)”. Source: Title 21 Code of Federal Regulations PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General Requirements. 

Controlled Substance Medical Waste destruction is defined as “Destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with §1304.22(c), and such record need not be maintained on a DEA Form 41. Source: Title 21 Code of Federal Regulations PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General Requirements, Excerpted: Unfortunately, this regulation leaves us in a slightly confused state, doesn’t it? But further research provides us with a clearer solution.  

US Bio Clean States: “Although the DEA states that it seeks to determine a variety of destruction methods, the only acceptable method of destruction for pharmaceutical wastage (i.e., drugs dispensed to a patient and not fully used, such as a single syringe with remaining controlled substance) at this time is incineration”. 

“Therefore, the only method that currently meets the DEA requirement for both the non-retrievable and destruction standards involves a two-part process:

1. Wasting the medication into a suitable neutralizing media, such as a Cactus Smart Sink or an Rx Destroyer. A solidifier can also be used for liquid only waste.
2. Placing the neutralized container into a non-hazardous pharmaceutical waste container that will be sent out for incineration”.

Expired and Unwanted Controlled Substances

The Definition of Expired and Unwanted Controlled Substances is defined as a controlled substance that has expired or is no longer wanted by the Practitioner.

The Destruction of Expired and Unwanted Controlled Substances can be found in “Regulations for the Destruction of Expired or Unwanted Controlled Substances: Title 21 CFR §1317.05, Registrant Disposal’ Acceptable method are shown below:

(a) “Practitioner inventory. Any registered practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways:

(1) Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction.

(2) Promptly deliver that controlled substance to a reverse distributor’s registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant’s registered location;

(3) For the purpose of return or recall, promptly deliver that controlled substance by common or contract carrier pick-up or pick-up by other registrants at the registrant’s registered location to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf; or

(4) Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located.

(i) The request shall be made by submitting one copy of the DEA Form 41 to the Special Agent in Charge in the practitioner’s area. The DEA Form 41 shall list the controlled substance or substances which the registrant desires to dispose.

(ii) The Special Agent in Charge shall instruct the registrant to dispose of the controlled substance in one of the following manners:

(A) By transfer to a registrant authorized to transport or destroy the substance;

(B) By delivery to an agent of the Administration or to the nearest office of the Administration; or

(C) By destruction in the presence of an agent of the Administration or other authorized person.

(5) In the event that a practitioner is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the practitioner to dispose of such substances, in accordance with subparagraph (a)(4) of this section, without prior application in each instance, on the condition that the practitioner keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals. The Special Agent in Charge may place such conditions as he/she deems proper on practitioner procedures regarding the disposal of controlled substances.”

Please note Section (a)(2) is the DEA’s preferred method for destroying unwanted or expired controlled substances. Additionally, the other destruction methods listed above require DEA written approval with destruction in the presence of a DEA Agent or other authorized person. Well, I don’t know about you, but I don’t want to invite the DEA into any practice, do you? 

A DEA Form 41 must be used when destroying expired or unwanted controlled substances. It’s imperative that you select a DEA-registered reverse distributor for the destruction of your expired or unwanted controlled substances.   

Again, keep in mind that the only exception to the federal regulation cited here, would be more stringent state regulations. Additionally, it’s also important to remember regulations change frequently, so doctors (aka practitioners), managers and licensed staff members should access them frequently to ensure complete compliance.

To add further insult to injury, in addition to a DEA citation, the EPA can also fine a Practitioner a minimum of $37,500 per violation, for disposing of your pharmaceutical waste incorrectly! 

Unfortunately, the regulations discussed in this blog represent only a fraction of the basic regulations you need to stay current, complete, and accurate with the DEA and state controlled substance regulations daily! But I hope that you are less confused than when we started. Please stay tuned for more blogs on DEA compliance soon.  

Here are two important takeaways from this blog to help you reduce your risk and improve compliance.   1.) Know the difference between controlled substance medical waste and expired and unwanted controlled substances and follow the correct destruction method for each one.

2.) Familiarize yourself with all state and federal controlled substance regulations and follow the most stringent regulation.

If you would like an easy way to improve your controlled substance compliance and reduce your risk, consider buying an automated dispensing cabinet. Zimbis has all sizes of automatic dispensing cabinets to fit your practice size. Contact a Zimbis representative at 480.399.3436 for further information.

  Jan Woods is a previous practice owner, seasoned regulatory compliance expert, consultant, author, and frequent speaker at national conferences. She is available to help you and your practice to achieve regulatory compliance with your controlled substances, improve your logs and recordkeeping and perform a mock DEA audit, etc. Contact Ms. Woods today at jan@askjanforhelp.com or via telephone at 913-302-4999.

REFERENCES:

1. Title 21 of the Code of Federal Regulations (CFR), Sections 1300 to end.
2. DEA’s Practitioner Manual is available online, but at the time of this writing it is being updated. 
3. Pharmacist’s Manual: An informational outline of the Controlled Substances Act. US Department of Justice Drug Enforcement Administration Diversion Control Division. 2020. 

DISCLAIMER: The government creates changes and updates regulations frequently. As of August 2021, the information contained in this blog is current. Remember to check with the various governmental agencies or your attorney for changes that may affect your practice.

CUBEX LLC appoints inventory automation pioneer Chris Hayden as Chief Revenue Officer (CRO)

by Zimbis | Sep 21, 2021 | News

PHOENIX, Sept. 21, 2021 /PRNewswire/ — CUBEX LLC, the leading provider of pharmacy and supply management technology to the animal health market and dental markets, announced the appointment of Chris Hayden as Chief Revenue Officer. As CRO, overseeing both CUBEX and ZIMBIS, Chris will focus on all aspects of go-to-market plans, from strategy to sales and marketing execution.

Chris brings over 25 years of sales and executive leadership to this new role. With a primary focus in capital medical device and software sales, his particular focus has been in diagnostics and inventory automation. Chris has spent the last 15 years in senior roles with Pyxis, Cardinal Health / Carefusion and BD, while leading the national sales for Pyxis with revenue accountability of $1B. Since 2017, he has overseen BD’s Life Sciences and Diagnostics business for the East Coast accountable for over $600M in Revenue. Prior to that, he spent 4 years at Cerner Corporation overseeing their pharmacy enterprise by managing national sales in the US and Canada, driving a 70% increase in sales during that period through both organic growth and the acquisition of Bridge medical as a tuck in to the product portfolio.

Earlier in Chris’s career, when automated dispensing was still in its relative infancy in the human acute care space, he was hired by Pyxis to help launch the new markets division and drive significant growth in the alternate care marketplace. That experience, and all that has followed, has brought him full circle to CUBEX LLC. “My entire career has been leading up to this moment,” said Chris. “I’ve learned so much about what it takes for leading-edge inventory technology like CUBEX and ZIMBIS to become a standard of care that the majority of the market considers essential. I can’t wait to get started.”

Enhanced Efficiency Through Inventory Automation

by Zimbis | Aug 16, 2021 | News

Nicole Follert, Purchasing Manager

Introduction
Knight Dental Group, a Leixir Group Company, is passionate about providing best-in-class restorations to their clients. As a member of Leixir’s network of dental labs, a prominent focus on advanced technology and digital solutions is at the forefront of delivering highly advanced and quality products.

As dental implant restorations have become more of the norm in recent years, the management of implant inventory has become a priority for dental labs. Knight was determined to find the right solution to their growing implant inventory to securely store, track, and accurately forecast purchasing for these components.

Zimbis proved to be both efficient in the automation of purchasing forecasts and of FDA lot number tracing, as well as providing the ability to securely house materials and ensure they are accurately accounted for and allocated to the correct cases.

Inventory management goals included:
– Reduce excess inventory on-hand
– Reduce labor associated with inventory management
– Improve the efficiency of FDA lot # tracking

The evidence
The Zimbis LabPlus was installed in the implant department in August 2020 to manage these very needs. This case study examines a six-month period ending in March 2021.

Less on-hand inventory equals enhanced cash flow
For the parts managed through Zimbis, the on-hand inventory
decreased by $7,088 or 32%, from $22,000 to $14,912 for the 6-months ending March
2021. These savings directly impacting cash flow in a positive manner.

Material Usage
Nicole Follert, Purchasing Manager at Knight Dental Lab, stated, “We experienced great success in the reporting of used materials and identifying slow moving components allowing us to more accurately forecast purchasing requirements in turn decreasing our spend. We believe the accountability that Zimbis adds to our process plays a big role in that everything is accounted for with steady turnover and less waste and inventory of the slower moving parts.”

Labor savings by time reallocation
As labs are tracking what they use manually, it puts a drain on resources. As a result of Zimbis’ automated processes, Knight Dental Group
eliminated 1-2 hours per day of manual documenting by highly paid technicians. This allowed these technicians to reallocate their focus on essential job duties; completing more complex cases that positively impact revenue.

Automated reporting available from Zimbis also made a significant impact on management’s time as it provides an accurate purchasing forecast based on usage.

FDA compliance improvements
It can be difficult to measure or quantify everything that matters. For example, an extraordinarily positive byproduct of Zimbis solutions is increased efficiency in regulatory compliance.

The automated lot number tracking that the Zimbis plus incorporates not only helps ensure components with lot numbers are accurately logged to each case, it eliminates the need for manual entry of these details into each case. In addition to providing this increase efficiency in lot number tracing, The Zimbis cloud-based software allows for easy reporting on lot numbers both by case and individual lot number, ensuring compliance and accountability.

Does it cost, or does it pay?
Almost immediately, productivity and efficiency improved, and Knight Dental Group saw a significant reduction in on-hand inventory and time spent managing inventory and compliance. Looking purely at labor reallocation savings, the system pays for itself in 3 years.

This study clearly demonstrates the investment in Zimbis led to increased profitability. Additionally, security, accountability, and regulatory compliance proved to be excellent ancillary benefits.

Click the link download the complete case study: Knight Dental Group – Case Study

R-Dent Lab Early Impressions

by Zimbis | Dec 7, 2020 | News

“I wish I had this three years ago!” Cole Coughlin, Implant CAD/CAM Administrator at R-Dent and Zimbis System Administrator, speaks candidly about his first impressions of the Zimbis system recently installed in the dental lab and the efficiencies it has already created.

What challenges were you trying to solve when looking for a solution?  We wanted to locate and quantify our total inventory, make it easily accessible, yet secure, reduce the amount of emergency overnight orders that were occurring and reduce the number of personnel hours being devoted to ordering and stocking of inventory.

READ THE FULL ARTICLE