DEA: Diversion Control

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DEA Form 106 and Loss of Controlled Substances

Jesse C. Vivian, RPh, JD Professor, Department of Pharmacy Practice College of Pharmacy and Health Sciences Wayne State University Detroit, Michigan

US Pharm . 2015;40(12):43-45.

Upon discovery of a theft or significant loss of controlled substances, a pharmacy must report the loss in writing to the area Drug Enforcement Administration (DEA) field office on DEA Form 106 ( FIGURE 1 ) either electronically or manually within one business day. 1,2 This seemingly simple directive is fraught with vagueness, opening it to interpretation and controversy (at least to lawyers), leading many a community and hospital pharmacy astray when it comes to reporting activity.

Reporting Thefts and Losses

Important questions to consider include: what is a “significant loss,” when does “upon discovery” begin, how long does the pharmacy have until the report is required, and what exactly is a “loss”? These and other inquiries were addressed in a 2005 rulemaking discussion. Pharmacists who are responsible for managing controlled substances inventories should be familiar with these regulations. 3

The rule addresses the theft or loss of controlled substances. Obviously, this would apply to any diversion (of a significant nature) irrespective of the source of the loss or theft. Burglary, robbery, and employee theft are probably the most common types of illegal diversion. Inventory shrinkage from unintentionally dropped or otherwise unusable drugs may be another source of loss that a pharmacy may experience. Note also that all thefts, whether significant or not, must be reported. Only a “significant loss” is reportable. 3

As to how long the pharmacy has to make the report, the rule discussion is clear: one business day. This means that the pharmacy has to fill out the DEA Form 106 within 24 hours of the discovery of the loss. The pharmacy may have to provide the DEA with updated information as it uncovers the source or cause of the loss for up to 2 months after the initial report. Updates also have to be in writing and submitted either electronically or manually. 3

One day to make a report may be burdensome for some practitioners, but this reflects the DEA’s expectation that pharmacies will exercise tight controls over controlled substances inventories. As one commentator noted, “Another challenge providers and pharmacies have to face as a result of the short reporting window is that it may not be possible to determine within one business day whether a loss was, in fact, a theft. If the loss was a theft, then under the DEA’s regulations, it is reportable whether significant or not and local authorities generally should be notified to investigate the incident.” 4

As a general operational guide, when a pharmacy is unable to determine whether a loss was a theft in one business day, a report of loss should be filed. Recognizing that the facts and circumstances of apparent thefts and losses can vary a great deal, the DEA has said that when in doubt, registrants should err on the side of notifying the appropriate law enforcement authorities, including the DEA, of thefts and losses of controlled substances. 5 As such, it is a good rule of thumb for providers and pharmacies to be conservative in their approach to reporting in cases where controlled substances are missing and the significance or theft may be unclear.

The “upon discovery” portion of the rule means that the pharmacy needs to make a reportable loss once it has made a good-faith effort to learn that a loss has occurred. The discussion of the discovery requirement states that the “DEA has always viewed ‘upon discovery’ to mean that notification should occur immediately and without delay. The purpose of immediate notification is to provide an opportunity for DEA, state, or local participation in the investigative process when warranted and to create a record that the theft or significant loss was properly reported. It also alerts law enforcement personnel to more broadly based circumstances or patterns of which the individual registrant may be unaware. This notification is considered part of a good-faith effort on the part of the regulated industries to maintain effective controls against the diversion of controlled substances…. Lack of prompt notification could prevent effective investigation and prosecution of individuals involved in the diversion of controlled substances.” 3

What Is Considered a Significant Loss?

The part of the rule that has generated the most controversy is the “significant loss” wording. What is significant to a single local corner drugstore may be very different from that of a major metropolitan healthcare system. “The rule itself provides guidance on how to quantify this mandate. When determining whether a loss is significant, a registrant should consider, among others, the following factors:

1) The actual quantity of controlled substances lost in relation to the type of business; 2) The specific controlled substances lost; 3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances; 4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, 5) Whether the specific controlled substances are likely candidates for diversion; and 6) Local trends and other indicators of the diversion potential of the missing controlled substance.” 1

It should be noted that this list is inclusive, not exclusive, meaning that other factors may be taken into account where appropriate. For example, the DEA has stated that the “loss by a pharmacy of a 100-count bottle of controlled substance tablets would be viewed as significant, whereas the same loss by a full line distributor may be viewed differently.” 4 In another example, the DEA posited, “the repeated loss of small quantities of controlled substances over a period of time may indicate a significant aggregate problem triggering reporting even where the quantity lost in each occurrence, by itself, is not significant.” 4 In other words, the loss of two or three tablets of oxycodone per day in a small pharmacy may go unnoticed or be insubstantial, but if this goes on for 3 or 4 weeks, with a net loss of 50 to 80 tablets, a problem with employee theft may be occurring.

Other factors to consider are the pharmacy’s overall sales history for controlled substances, so as to identify trends. Large increases could signal theft by employees or invalid prescriptions. 4

Take note that all thefts or losses must be reported “in writing.” Telephone calls discussing losses will not protect the pharmacy from sanctions for failing to report. As stated by the DEA, “DEA controlled substance registrants are strongly encouraged to complete and submit the DEA Form 106 online.” 2 Note that only a DEA-registered pharmacy is allowed to utilize Form 106. The National Drug Code (NDC) for each controlled substance drug reported lost or stolen must be used on this form. It is also important to note that state laws may require the pharmacy to make reports to the Board of Pharmacy or other regulatory agency. This is in addition to, and not in lieu of, reporting to the DEA.

Examples of Diversion

As for examples of losses of controlled substances that may not seem significant, consider a very large metropolitan healthcare system where hundreds of thousands, if not millions, of doses of controlled substances medications are dispensed on an individual basis over the course of a year. Is the loss of 16,000 pills significant? This real-life example was discovered only after the death of a 29-year-old nurse and an overdose by a 32-year-old anesthesiology resident occurred in a single day at the University of Michigan Hospital System. 6 Both were found in hospital restrooms. 7 Eight cases of stolen controlled substances drugs were reported in 2014. However, no controlled substances losses were reported in two prior years by this same organization. Another large healthcare system located just a few miles away also failed to report any drug loss or theft during the same period of time when losses did, in fact, occur. 6 The DEA is investigating both healthcare systems.

The Mayo Clinic has been involved in efforts to prevent the controlled substances drug diversion from the workplace and to rapidly identify and respond when such diversion is detected. 8 These efforts have found that diversion of controlled substances is not uncommon and can result in substantial risk not only to the individual who is diverting the drugs but also to patients, coworkers, and employers. The study showed that in the United States, nearly 4 billion retail prescriptions were filled in 2010, with sales totaling $307 billion. The opioid hydrocodone combined with acetaminophen was the drug prescribed most frequently (131.2 million times). Although most of these sales resulted in the legitimate administration of medications to patients, a fraction of the agents prescribed are diverted for illicit purposes. These researchers found that although a relatively small portion of the nation’s drug supply is administered in a healthcare facility such as a hospital or outpatient surgery center, the nature of these practices provides ample opportunity for drug diversion. 8

Outside of the pharmacy, theft can be of unopened vials; syringes or vials that have been tampered with, resulting in either substituted or diluted dosages being administered to the patient; or residual drug left in a syringe or vial after only a fraction of the drug that has been signed out was actually administered to the patient. This theft can also be of discarded syringes or ampules that have been properly disposed of in a sharps safety container. 8

Studies have shown that 10% to 15% of all physicians develop a substance abuse problem in their lifetime, while 6% to 8% of nurses have used controlled substances in a sufficient enough quantity to impair professional performance. 9 The drug abuse rate among pharmacists is twice that of general society. 10 One study reported that 46% of pharmacists and 62% of pharmacy students have used a prescription drug without having obtained a prescription. 11 In addition, 20% of pharmacists surveyed reported they had used a prescription drug without a prescription at least five times or more in their lives. 11

Then there are the pharmacy technicians and other healthcare support personnel. In Maine alone, from 2003-2013, 41 pharmacy technicians lost their licenses for pilfering drugs from pharmacy shelves or even from the patients whose prescriptions they filled. 12 It stands to reason that some of the drugs used to sustain their drug habits come from the theft of controlled substances from pharmacy inventories. One study showed that about 45% of all controlled substances drug losses are from employee theft. 12

The loss of controlled substances from employee theft of small quantities at any one time makes it all the more difficult for pharmacy supervisors to determine not only that a loss has occurred but the source of the loss as well. Unless the pharmacy is doing daily or weekly inventories of controlled substances, it may be nearly impossible to tell whether a loss has occurred or if the loss is significant. In large-scale pharmacies, ongoing daily or weekly counts of controlled substances may be necessary to determine if there are significant losses or patterns of losses that are occurring.

When a pharmacy discovers that controlled substances losses have likely occurred, the best practice is to fill out a DEA Form 106 and send it in electronically or manually. Waiting too long can result in DEA investigations and, perhaps, sanctions for not timely notifying the DEA that a loss or theft has taken place.

1. 21 CFR §1301.76(b). 2. Theft or loss of controlled substances—DEA Form 106. www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html. Accessed November 10, 2015. 3. DEA. Reports by registrants of theft or significant loss of controlled substances. 21 CFR Part 1301. Final rule. August 12, 2005. www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0812.htm. Accessed November 6, 2015. 4. Reporting thefts and losses of controlled substances for providers and pharmacies. Lexology . September 28, 2012. www.lexology.com/library/detail.aspx?g=f3ce9368-7853-481f-a00d-f6ad80505f19. Accessed November 6, 2015. 5. DEA. Reports by registrants of theft or significant loss of controlled substances. 21 CFR Part 1301. Proposed rule. July 8, 2003. www.deadiversion.usdoj.gov/fed_regs/rules/2003/fr0708.htm. Accessed November 6, 2015. 6. Counts J. Drug thefts at U-M hospital: a nurse’s death, a doctor’s overdose and 16,000 missing pills. MLive . October 26, 2014. www.mlive.com/news/ann-arbor/index.ssf/2014/10/drug_thefts_at_u-m_hospital_a.html. Accessed November 10, 2015. 7. Doctor nearly dies of an overdose from drugs stolen at UM hospital. Washtenaw Watchdogs . March 18, 2014. www.washtenawwatchdogs.com/doctor-nearly-dies-of-an-overdose-from-drugs-stolen-at-um-hospital/doctor-nearly-dies-of-an-overdose-from-drugs-stolen-at-um-hospital. Accessed November 8, 2015. 8. Berge KH, Dillon KR, Sikkink KM, et al. Diversion of drugs within health care facilities, a multiple-victim crime: patterns of diversion, scope, consequences, detection, and prevention. Mayo Clin Proc. 2012;87(7):674-682. www.ncbi.nlm.nih.gov/pmc/articles/PMC3538481/. Accessed November 12, 2015. 9. Bittinger A, Abramowitz LH. Health care diversion. American Health Lawyers Association. https://www.healthlawyers.org/Events/Programs/Materials/Documents/PHLI14/t_abramowitz_bittinger.pdf. Accessed November 10, 2015. 10. Sochoka J. Pharmacist drug abuse. Pharmacy Times . January 17, 2013. www.pharmacytimes.com/blogs/piller-of-the-community/0113/pharmacist-drug-abuse. Accessed November 10, 2015. 11. Combs J. Pharmacists get addicted, too. Drug Topics . June 1, 2009. http://drugtopics.modernmedicine.com/drug-topics/news/modernmedicine/modern-medicine-now/pharmacists-get-addicted-too. Accessed November 10, 2015. 12. Schalit N, Christie J. Behind the pharmacy counter: the unseen drug theft problem. Pine Tree Watchdog . September 4, 2013. http://pinetreewatchdog.org/behind-the-pharmacy-counter-the-unseen-drug-theft-problem/. Accessed November 10, 2015.

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DEA Final Rule: Reporting Theft or Significant Loss of Controlled Substances

  • Alyssa Leiva
  • June 26, 2023

Summary:  DEA form 106 used to  report thefts or significant losses of controlled substances can only be submitted electronically. Registrants will have 45 days, after discovery of the theft or loss, to complete and submit an accurate DEA Form 106 through the DEA Diversion Control Division secure network application. This final rule does not change the requirement that registrants preliminarily notify the DEA Field Division Office in their area , in writing, of the theft or significant loss of any controlled substances within one business day of discovering such theft or loss. 

What does this mean to you? Visit our information page for all you need to know.

Diversion, Significant Loss, Spills or Theft

Federal Register Notice

Date June 22, 2023

The Final Rule:   Reporting Theft or Significant Loss of Controlled Substances (DEA574), published on June 22, 2023, in the Federal Register under citation 88 FR 40707. 

This rule amends DEA regulations regarding DEA Form 106, used by DEA registrants to report thefts or significant losses of controlled substances, to require the DEA Form 106 be submitted electronically , and clarifies the timeframe registrants have to complete the necessary documentation.

Effective July 24, 2023, registrants will be required to submit all DEA Forms 106 electronically (online) through DEA’s Diversion Control Division secure network application.  After July 24, 2023, DEA will no longer accept paper submissions of the DEA Form 106.  Thus, eliminating all paper submissions of the DEA Form 106 after July 24, 2023.

This Final Rule also requires a timeframe on the submission of the DEA Form 106.  Registrants will have 45 days, after discovery of the theft or loss, to complete and submit an accurate DEA Form 106 through the DEA Diversion Control Division secure network application. 

This final rule does not change the requirement that registrants preliminarily notify the DEA Field Division Office in their area , in writing, of the theft or significant loss of any controlled substances within one business day of discovering such theft or loss. 

For further information, please contact : 

Scott A Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882; Email: [email protected] .

If you are experiencing an emergency, please call 9-1-1.   EH&S Main Line (Office): (310) 825-5689

Report an incident (EH&S Hotline): (310) 825-9797

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Report a Drug Theft/Drug Loss/Impaired Licensee

Any controlled substance loss (significant or not), must be reported to the California Board of Pharmacy within 14 calendar days from the date of loss for losses due to licensed employee theft (pursuant to Business and Professions Code, §4104), or 30 calendar days (pursuant to California Code of Regulations, Title 16, §1715.6) for any other type of loss.

During its January 2020 Board meeting, the Board approved the following policy statement intended to encourage pharmacies to refer such matters also to local law enforcement of drug diversion cases, in addition to providing the mandatory report to the Board.

In recognition of the ongoing national opioid crisis and in addition the mandatory reporting obligations to the Board included in BPC 4104, the board encourages pharmacies and pharmacists to contact local law enforcement for guidance on matters involving narcotics diversion by its employees.

To report an impaired licensee, file a complaint with the California State Board of Pharmacy within 14 days of discovery.

A copy of the DEA-106 form can be sent to the Board of Pharmacy if one was completed and submitted to the DEA. (You can complete and submit the DEA 106 form on-line to the DEA at https://www.deadiversion.usdoj.gov/webforms/app106Login.jsp ). However, notifications of controlled substance drug losses sent to the Board of Pharmacy may be in any format that includes the following information:

  • Pharmacy Name and Address
  • Date(s) of Loss or Theft
  • Type of Theft or Loss
  • Name of the carrier (if “Lost in Transit”)
  • Name, quantity, and strength of the drug(s) lost or stolen
  • Person submitting the loss notification with contact information
  • Board of Pharmacy license numbers of all parties involved

Optional, but helpful information to include:

  • Previous number of thefts or losses
  • NDC number(s)
  • Any details that may be pertinent to the loss (if applicable)

Notifications can be sent to the Board of Pharmacy in one of three ways:

  • Send us a message ,
  • By fax to (916) 574-8614, or
  • By mail to: 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833
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DEA Fine-Tunes the Theft and Significant Loss Reporting Two-Step

Like the celebrated Texas dance of the same name, reporting controlled substance thefts and significant losses to the Drug Enforcement Administration (“DEA”) requires just that: two steps.  For the first time in eighteen years, DEA has revised its controlled substance theft and significant loss reporting regulations.  Since 1995, at least 28 registrants, primarily hospitals and pharmacies, have paid significant civil penalties ranging from $10,000 to $5,000,000 to settle allegations that they wholly or in part failed to report, or failed to report in a timely manner, controlled substance thefts or significant losses to DEA.  We thought it appropriate to take this opportunity to not only explain DEA’s revised regulations but also how registrants must now report controlled substance thefts and significant losses.

Step 2: DEA-106 Submission

DEA just published a final rule amending its theft and loss reporting regulations to require registrants to submit a “Report of Theft or Loss of Controlled Substances,” DEA Form 106 (“DEA-106”), electronically to the agency within 45 days of discovery of a theft or significant loss.  Reporting Theft or Significant Loss of Controlled Substances, 88 Fed. Reg. 40707, 40708 (June 22, 2023) (to be codified at 21 C.F.R. §§ 1301.74(c) and .76(b)). Attached here .

The rule now requires registrants to first report a theft or significant loss in writing within one business day of discovery (step 1), followed literally by a DEA-106 filed through the agency’s secure network application “within 45 calendar days” (for non-practitioners) and “within 45 days” (for practitioners) after discovery (step 2).  Id . at 40712.  DEA will no longer accept hardcopy DEA-106s as of July 24, 2023.  Id . at 40708.

DEA’s notice of proposed rulemaking would have required registrants to electronically file a DEA-106 within 15 calendar days after discovery, the original intent to align the shorter DEA-106 submission with the time required for submission of a “Report of Theft or Loss of Listed Chemicals,” DEA Form 107, for listed chemicals.  Id .  DEA expanded the proposed rule to allow 45 days, reasoning “that adequate time is needed in order to complete an accurate and thorough investigation” to submit a DEA-106.  Id . at 40709.  The 45-day timeframe within which to complete the second step allows registrants time to adequately investigate and make a final determination about the incident.  Id .  DEA justified requiring electronic submission of DEA-106s rather than a paper copy because it “will allow all report submissions to be received more quickly and stored in a central database, as well as allow for analysis.”  Id . at 40710.

Step 1: Initial Notification

The final rule does not revise the requirement that registrants must initially notify the DEA field division office in their area in writing within one business day of discovery of a theft or significant loss.  21 C.F.R. §§ 1301.74(c) and .76(b).  Notification by email or facsimile work; a telephone call does not.  Written notification eliminates misunderstanding that can arise with oral communication.  It documents what information was provided, when, and to whom.  Registrants should provide as much information about the incident as possible, including controlled substance quantity and the circumstances if known.  Reporting within one day of discovery allows the agency to know promptly about a theft or significant loss and to investigate immediately or undertake other appropriate actions.  88 Fed. Reg. 40707, 40709.

Registrants must report all controlled substance thefts but only those losses that are “significant.”  The agency does not clarify what constitutes a “theft,” an intentional taking or diversion, while non-theft losses can include miscounting, dispensing an incorrect quantity, or misplacing or accidentally disposing of controlled substances.  In addition, registrants should also report thefts to local law enforcement.

Significant Loss

While DEA regulations require registrants to report all thefts, they must report only controlled substance losses that are “significant.”  21 C.F.R. §§ 1301.74(c) and .76(b).  Registrants have long wrestled with whether a particular loss they have experienced is significant and therefore reportable.  Over the years industry has requested DEA to define what constitutes a “significant loss.”  As with its 2005 revision of the regulations, the agency has again punted on defining “significant loss,” reasoning that what constitutes a significant loss for a manufacturer experiencing continuous losses in the manufacturing process may not be deemed significant by that registrant (but would need to be recorded in batch records).  88 Fed. Reg. 40707, 40709.  For non-manufacturer registrants, the loss of small quantities over time “may indicate a significant aggregate significant loss that must be reported to DEA, even though the individual quantity of each occurrence is not significant.”  Id .  DEA concluded once again that registrants are in the best position to determine whether their loss is significant, requiring reporting.

While not defining what constitutes a significant loss, DEA has again provided a list of factors that registrants should consider in determining whether a loss is significant.  Factors include:

  • The actual quantity of controlled substances lost in relation to the type of business;
  • The specific controlled substances lost (schedule IIs as opposed to schedule IIIs, IVs and Vs);
  • Whether the loss can be associated with access by specific individuals or attributed to unique activities that may take place involving the controlled substances;
  • A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;
  • Whether the controlled substances are likely candidates for diversion; and
  • Local trends and other indicators of diversion potential of the missing controlled substances. 21 C.F.R. §§ 1301.74(c) and .76(b).

Because DEA has abdicated defining whether a loss is significant, the agency should only seek enforcement for failure to report a significant loss in the most egregious cases.

Registrants must report a theft or significant loss in writing within one business day of discovery, followed by a DEA-106 filed electronically within 45 days after discovery.  In 2005, DEA acknowledged that discovery can occur incrementally.  Reports by Registrants of Theft or Significant Loss of Controlled Substances , 79 Fed. Reg. 47094, 47095 (Aug. 12, 2005).  The agency has again declined to define discovery in the current final rule, but plans “on addressing the definition of Discovery in a future rulemaking.”  88 Fed. Reg. 40707, 40709.

DEA Field Division Office

The regulations require registrants to notify the DEA field division office in their area of thefts and significant losses.  Field division offices are the largest offices within a DEA field division where diversion program managers, diversion investigators, program analysts, and registration assistants are assigned, while resident and district offices are smaller offices, only some of which may be staffed by diversion investigators.  Strict adherence to the regulation requires reporting to the larger field division office despite geographic proximity or a relationship with a particular diversion group or investigator.

In-Transit Losses

Suppliers must report all in-transit controlled substance losses, not just those that are thefts or significant.  The agency also does not define “in-transit,” but uses the term in connection with use of a common or contract carrier.  21 C.F.R. § 1301.74(c).  So, suppliers must report any controlled substance lost while en route via common or contract carrier.  Purchasers must report any loss after they have signed for and taken custody of controlled substances.  DEA, Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act (Rev. 2022), at 63.

Breaks and Spills

Breaks, spills, and other witnessed controlled substance losses do not require reporting to DEA.  DEA has reasoned that they are not actually lost “because they can be accounted for.”  Reports by Registrants by Registrants of Theft or Significant Loss of Controlled Substances , 70 Fed. Reg. 40576, 40578 (July 8, 2003).

Miscounts and Inventory Adjustments

Neither controlled substance miscounts nor inventory adjustments involving clerical errors should be reported.

ARCOS Reporting

Thefts and losses must be reported to DEA’s Automation of Reports and Consolidated Orders System (“ARCOS”).  Registrants should report thefts via ARCOS as “thefts” using the appropriate transaction code and report losses as “losses.”  Reporting to ARCOS is in addition to initial notification and electronic submission of a DEA-106.

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DEA Makes Changes in the Process for Reporting Theft or Significant Loss of Controlled Substances

Effective July 22, 2023, the U.S. Drug Enforcement Agency (DEA) will no longer accept paper filing from Registrants when reporting the theft or “significant loss” of Controlled Substances.

On June 22, 2023, the DEA published a Final Rule amending the regulations regarding DEA Form 106, which is required for all Registrants to formally report any theft or significant loss of Controlled Substances to the DEA under the Controlled Substances Act (CSA) [1] .  While the current regulation required the submission of the DEA 106, it was silent as to the mechanism and timing for doing so.  In its Final Rule, the DEA indicated that 99.5% of all DEA 106 submissions were through a secure application on the DEA’s Diversion Control Division’s website, and the remaining .5% were submitted on paper.  The Final Rule eliminates paper filing to ensure that the DEA receives legible and timely submission of the DEA Form 106. With the issuance of its Final Rule, the DEA is mandating that all DEA Form 106 be filed with the Administration electronically.  Further, the Final Rule adds a timeframe for submission—within 45 calendar days of discovery of the theft or loss.  

This reporting is the second step in the current 2-step process; the first step being an initial report within one business day .  Notably, despite comments that the one-day reporting requirement should be abolished—claiming it was arbitrary, confusing and redundant—the DEA disagreed and declined to alter the current two-step reporting requirement.  Thus, under the Final Rule, Registrants must report thefts or losses of Controlled Substances as follows:

  • a preliminary report of all thefts and significant losses must be reported to the Registrant’s local DEA Field Office within one (1) business day of discovery;
  • a DEA Form 106 must be submitted online within 45 calendar days.

The DEA also rejected comments that the term “significant loss” should be defined, noting that the decision is one that is best made by the Registrant based on the specific case and circumstances.

Regarding other comments on a definition of “discover” to assist in determining when the reporting obligations commence, the DEA indicated that it would address that issue in future rulemaking.

While the Final Rule does not make a significant change in a Registrant’s reporting obligations, it provides welcome clarification on the procedure for submitting a DEA Form 106 and serves as a reminder that Registrants need to be vigilant in their efforts to secure their Controlled Substances through internal processes ( i.e., accurate inventories/record-keeping, auditing and training on drug diversion, systems for timely reporting and follow-up).  Failure to do so can lead to costly penalties and DEA oversight. [2]

Butzel will continue to monitor the DEA reporting process, however if you have questions or would like to discuss the topic, please contact your Butzel health care attorney.

Debra Geroux  248.258.2603 geroux@butzel.com

Mark Lezotte 313.225.7058 lezotte@butzel.com

Robert Schwartz 248.258.2611                                     schwartzrh@butzel.com

[1] 21 C.F.R. 1301.74(c) and 1301.76(b).

[2] By way of example, in November 2021, the University of Texas Southwestern Medical Center entered into a Settlement Agreement with the DOJ to resolve allegations of violations of the CSA, agreeing to pay $4,500,000 and enter into a 3-year Memorandum of Agreement with the DEA.

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reporting drug loss to dea

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IMAGES

  1. Report Of Loss Of Controlled Substances printable pdf download

    reporting drug loss to dea

  2. Lincoln Co. Sheriff's Office news via FlashAlert.Net

    reporting drug loss to dea

  3. Pin On Drug Test Report Template With Regard To Weekly Test Report Template

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  4. A Pharmacy Technician Should Report Theft Or Loss Of Controlled Substances On What Form

    reporting drug loss to dea

  5. DEA Releases 2020 National Drug Threat Assessment ~ Borderland Beat

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  6. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use

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COMMENTS

  1. How Is It Possible to Look up a DEA Number?

    Drug Enforcement Agency, or DEA, numbers are not accessible to the public. However, other current DEA registrants may look up physicians and pharmacists to verify DEA numbers on the DEA’s Diversion Control Program website.

  2. How Do You Renew Your DEA Registration?

    It is possible to renew a Drug Enforcement Administration registration by submitting a renewal application online through the DEA website, according to the Drug Enforcement Administration Office of Diversion Control.

  3. How Can You Verify a DEA License?

    A Drug Enforcement Administration license number cannot be verified, but requesting to see a copy of the official DEA registration certificate provides satisfactory proof of licensing, according to the DEA’s Office of Diversion Control.

  4. Significant Theft or Loss Reporting of Controlled Substances

    If you have questions regarding the electronic submission, please contact DEA Call Center 1-800-882-9539. Federal regulations require that registrants notify

  5. Chemical and Drug Theft/Loss Reporting Login!

    DO

  6. Reporting Theft or Significant Loss of Controlled Substances

    The Drug Enforcement Administration (DEA) is publishing this final rule amending the regulations regarding DEA Form 106, used by DEA

  7. DEA Form 106 and Loss of Controlled Substances

    Upon discovery of a theft or significant loss of controlled substances, a pharmacy must report the loss in writing to the area Drug Enforcement

  8. DEA Final Rule: Reporting Theft or Significant Loss of Controlled

    Summary: DEA form 106 used to report thefts or significant losses of controlled substances can only be submitted electronically.

  9. Report a Drug Theft/Drug Loss/Impaired Licensee

    Report a Drug Theft/Drug Loss/Impaired Licensee · Send us a message, · By fax to (916) 574-8614, or · By mail to: 2720 Gateway Oaks Drive, Suite 100, Sacramento

  10. DEA and State Controlled Substance Diversion and Loss Reporting

    DEA: The U.S. Drug Enforcement Administration. DEA Form 106: The official DEA Form 106 (Report of Theft or Loss of Controlled Substances), submitted through

  11. DEA Fine-Tunes the Theft and Significant Loss Reporting Two-Step

    Registrants must report a theft or significant loss in writing within one business day of discovery, followed by a DEA-106 filed electronically

  12. Instruction Document: Reporting Theft and Loss on DEA Form 106

    The DEA Form 106 Reporting Theft or Loss of Controlled Substances is an online report form. Follow the instructions found on

  13. #2821, Procedure for Reporting Theft or Loss of Controlled

    Phar 8.02(3)(f) Records: In any instance that a pharmacy, practitioner or other DEA registrant authorized to possess controlled substances is required to

  14. DEA Makes Changes in the Process for Reporting Theft or

    DEA Makes Changes in the Process for Reporting Theft or Significant Loss of Controlled Substances ... Effective July 22, 2023, the U.S. Drug