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DEA: Diversion Control


Guidance Document Portal

Executive Order 13891 requires agencies to put their guidance documents on easily searchable websites so individuals are able to access them, and Department of Justice policy prohibits using guidance as a substitute for regulation. Guidance may not be used to impose new requirements on persons outside the Executive Branch except as expressly authorized by law or expressly incorporated into a contract, grant, or cooperative agreement. See JM 1-19.000.

Guidance documents are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance not so authorized or incorporated that is not accessible through this guidance portal, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws.

Furthermore, guidance documents may not represent the Department’s authoritative or official position and generally are not intended to receive judicial deference. A guidance document may be considered the Department’s authoritative or official position only if it is issued in a form understood to reflect the Department’s authoritative policy, and only if it emanates from those Department officials whose actions in the relevant context may be said to reflect the considered views of the Department as a whole. See Question 25 of OMB Memorandum M-20-02, Guidance Implementing Executive Order 13891 (October 31, 2019).

Effective February 28, 2020, these documents can also be viewed and commented on at the United States Department of Justice Guidance Portal, the link to which will be posted soon.

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ActionDoc NameDoc Agency IDDoc TopicDoc SummaryIssued DatePosted DateCategory
Subcategory
Significant
COVID to OPIOID Epidemic and Telemedicine - BuprenorphineDEA-DC-64PrescriptionPolicy transfering the audio only flexibility to prescribe buprenorphine products from the COVID-19 public health emergency to the OPIOID public health emergency.11/30/202211/17/2023Controlled Substance PrescriptionsPrescriptionsNo
COVID-19 Flexibility UpdatesDEA-DC-72OtherThis document informs Drug Enforcement Administration (DEA) registrants and others impacted by the flexibilities DEA granted during the COVID-19 Public Health Emergency (PHE), which flexibilities will automatically terminate at the conclusion of the COVID-19 PHE on May 11, 2023, and which flexibilities will remain in effect after May 11, 2023 under the Opioid Crisis PHE. The document also informs DEA registrants of newly published proposed rules intended to make some exceptions related to the COVID-19 PHE permanent.05/10/202305/10/2023OtherOtherNo
COVID-19 Off-Site OTP Delivery MethodDEA-DC-25MethadoneDuring the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of methadone to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA.04/07/202004/07/2020OtherCOVID-19No
COVID-19 Office Site Delivery Buprenorphine)DEA-DC-30BuprenorphineDuring the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of buprenorphine to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA.04/28/202004/29/2020OtherCOVID-19No
COVID-19 QA Administering CS in vehicle during COVID-19DEA-DC-43AdministeringQuestion and answer concerning DEA allowing certified health care providers to administer REMS-designated controlled substances to patients in parking lots at the health care providers DEA registered location.07/28/202007/28/2020OtherCOVID-19No
COVID-19 SAMHSA Telemedicine (Phone)DEA-DC-22TelemedicineIn light of the nationwide public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease (COVID-19), and only for the duration of this public health emergency (unless DEA specifies an earlier date), OTPs should feel free to dispense, and DATA-waived practitioners should feel free to prescribe, buprenorphine to new patients with OUD for maintenance treatment or detoxification treatment following an evaluation via telephone voice calls, without first performing an in-person or telemedicine evaluation. This may only be done, however, if the evaluating practitioner determines that an adequate evaluation of the patient can be accomplished via the use of a telephone. The prescription also must otherwise be consistent with the practitioner’s aforementioned obligation under the CSA and DEA regulations to only prescribe controlled substances for a legitimate medical purpose while acting in the usual course of professional practice.03/31/202003/31/2020OtherCOVID-19No
Changes to a Prescription by a PharmacistDEA-DC-63PrescriptionsThis guidance document provides clarification regarding the changes pharmacists may make to schedule II paper prescriptions. This guidance will remain in effect until the Drug Enforcement Administration (DEA) codifies new regulations, or until this guidance is otherwise modified or withdrawn by DEA.10/18/202210/18/2022Controlled Substance PrescriptionsPrescriptionsNo
Civil Unrest Q&A Destruction of Damaged C/SDEA-DC-40Destruction - Civil UnrestQuestions and answer concerning pharmacys destruction of damaged controlled substances due to the civil unrest.06/12/202006/23/2020Controlled Substance SecurityCivil Unrest/LootingNo
Civil Unrest Q&A Offsite Dosing OptionDEA-DC-36NTP - Civil UnrestQuestion and answer concerning off-site dosing of narcotic treatment program patients during civil unrest.06/09/202006/10/2020OtherNTP - Civil UnrestNo
Civil Unrest Q&A Pharmacy Closure (Pharmacy)DEA-DC-39Destruction - Civil UnrestQuestion and answer addressing what steps must be taken if a pharmacy is closing permanently due to the civil unrest.06/10/202006/23/2020Controlled Substance SecurityCivil Unrest/LootingNo
Civil Unrest Q&A Pharmacy Movement of Controlled Substances without Address ChangeDEA-DC-34Registration - Civil UnrestQuestion and answer concerning moving controlled substances to another address without changing the address of the DEA registered location.06/07/202006/10/2020RegistrationCivil Unrest/LootingNo
Civil Unrest Q&A RE Transfer of PrescriptionsDEA-DC-41Prescriptions - Civil UnrestQuestion and answer concerning a pharmacists ability to dispense controlled substances during civil unrest.06/07/202007/13/2020Controlled Substance PrescriptionsCivil Unrest/LootingNo
Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)DEA-DC-31Registration - Civil UnrestQuestions and answer concerning obtaining a new DEA registration number for a temporary pharmacy that is replacing a damaged pharmacy due to civil unrest/looting at the same physical address.06/04/202006/04/2020RegistrationCivil Unrest/LootingNo
Civil Unrest Q&A Suspicious Order ReportingDEA-DC-35Records and Reports - Civil UnrestQuestion and Answer concerning suspicious order reporting during the civil unrest and looting.06/09/202006/10/2020Records and ReportsCivil Unrest/LootingNo
Civil Unrest Q&A Theft and LossDEA-DC-33Theft/Loss Civil UnrestQuestion and answer concerning reporting of theft and/or loss of controlled substances during civil unrest and looting.06/05/202006/10/2020Records and ReportsCivil Unrest/LootingNo
Civil Unrest Q&A: Moving of Controlled Substances (Practitioners)DEA-DC-37Practitioners - Civil UnrestQuestion and answer concerning practitioners needing to move controlled substances due to civil unrest and looting.06/10/202006/10/2020RegistrationPractitioners - Civil UnrestNo
Civil Unrest QA Pharmacy Prescription TransferDEA-DC-38Prescriptions - Civil UnrestQuestion and answer concerning controlled substance prescription transfers during civil unrest.06/10/202006/23/2020Controlled Substance PrescriptionsCivil Unrest/LootingNo
Civil Unrest QA, Bulk DestructionDEA-DC-42Destruction - Civil UnrestQuestion and answer concerning the bulk destruction of controlled substances during the civil unrest.07/14/202007/28/2020Controlled Substance SecurityCivil Unrest/LootingNo
Clarification of Title 21 CFR 1301.90 - Employee Screening - Non-PractitionersDEA-DC-6Employee ScreeningThis document identified a DEA regulation that may create unintended consequences for a formerly incarcerated individual that is attempting to successfully reenter society. Specifically, 21 CFR 1301.90 has been identified as such because this regulation sets forth specific questions in order for a non-practitioner to comprehensively screen employees. It also states DEA’s position on employee screening by non-practitioners in which “….obtaining information by non-practitioners is vital to fairly assess the likelihood of an employee committing a drug security breach. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are properly subjects for injury.” Although 21 CFR 1301.90 has been identified, DEA would like to clarify that such regulation is only applicable to screening procedures for prospective employees at a non-practitioner DEA registered location where controlled substances are stored, distributed, manufactured, or otherwise handled and not applicable to prospective employees who will be employed at non-registered locations (ie corporate headquarters or sales offices).01/29/2020Controlled Substance SecurityPolicy StatementNo
Communication Between Pharmacists for the Transfer of Electronic Prescriptions for Controlled Substances (EPCS) for Initial DispensingDEA-DC-77PrescriptionThe Drug Enforcement Administration (DEA) amended its regulations to allow the transfer of EPCS between registered retail pharmacies for initial filling, upon request from the patient, on a one-time basis. 1. That final rule requires the transfer to be communicated directly between two licensed pharmacists. 2. This guidance clarifies regulatory requirements regarding the form of communication used between pharmacists when transferring EPCS from one pharmacy to another for initial dispensing.10/06/202310/30/2023Controlled Substance PrescriptionsPrescriptionsNo
Controlled Substances Act Pursuant to the Religious Freedom Restoration ActDEA-DC-5Religious ExemptionGuidance establishing a process for DEA decisions regarding requests for exemptions to handle controlled substances pursuant to the Religious Freedom Restoration Act (RFRA).02/26/201801/29/2020OtherPolicy StatementNo
DEA Chemical Handler's ManualDEA-DC-54ManualsThis manual was prepared by the Drug Enforcement Administration (DEA), Diversion Control Division, to assist those persons who handle scheduled listed chemical products and List I and II chemicals in understanding the Federal Controlled Substances Act and its implementing regulations as they pertain to regulated chemicals.03/01/202203/01/2022OtherManualsNo
DEA's policy concerning Locum TenensDEA-DC-12Locum TenensDEA’s policy concerning Locum Tenens provides an exception to 21 CFR 1301.12(a) requiring separate registration for each place of practice where controlled substances are handled. Separate registrations are not required in locations within the same state where practitioners merely prescribe. If practicing in multiple states, a practitioner at a hospital can use a hospital’s registration, and/or transfer an existing registration from one state to another through DEA’s Registration Section.09/13/201001/29/2020OtherLocum TenensNo
DEA-Practitioner Training or Continuing Education Requirement for Registration (Revision 1)DEA-DC-76OtherThis is a revision of a previously approved and posted Q&A, published on October 5, 2020. (EO-DEA182). This updated Q&A provides information regarding the training requirement included in Division FF of the Consolidated Appropriations Act (CAA) of 2023. All practitioners, who are not solely a veterinarian, must attest to satisfying the training, credentialing, or educational requirements identified in section 1263 of Division FF of the CAA in order to obtain a new or renewal DEA registration. The deadline for attesting to this training requirement is the date of a practitioner's next scheduled DEA registration submission – regardless of whether it is an initial registration or a renewal registration – on or after June 27, 2023. Additional information regarding the training requirement is noted below. This revised Q&A will replace the current Q&A posted on DEA's website (EO-DEA-182) and will be sent via email to all DEA-registered pharmacies and practitioners.09/21/202309/25/2023OtherOtherNo
DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s CustodyDEA-DC-59DestructionThis guidance document addresses whether a Drug Enforcement Administration (DEA) registrant who is an authorized collector has the responsibility to file a Report of Theft or Loss of Controlled Substances (DEA Form 106) if a sealed inner liner is stolen, lost, or missing while in a common or contract carrier’s custody after the DEA authorized collector requests pick-up.09/13/202209/16/2022Records and ReportsDestructionNo
DEA-Registered Manufacturer and Distributor Established Controlled Substance Quantitative Thresholds and the Requirement to Report Suspicious OrdersDEA-DC-65Records and ReportsThis guidance document clarifies that neither the Controlled Substance Act (CSA) nor DEA regulations establish quantitative thresholds or place limits on the volume of controlled substances DEA registrants can order and dispense; and, reminds all DEA registrants of the requirement to establish systems to identify and report suspicious orders of controlled substances to include Medication for Opioid Use Disorder (MOUD).01/20/202301/20/2023Records and ReportsRecords and ReportsNo
Date of Receipt of Sealed Inner Liners by Reverse DistributorsDEA-DC-62DestructionThis guidance document addresses when a Drug Enforcement Administration (DEA)-registered reverse distributor is considered to have received a sealed inner liner from either DEA registrants authorized as collectors or Federal, State, Tribal, or local law enforcement agencies.09/13/202209/16/2022Records and ReportsDestructionNo
Disposal of Controlled Substance Prescription Medications (Schedules II-V) Abandoned by Patients and/or Visitors at the Locations of DEA-Registered PractitionersDEA-DC-73OtherDisposal of Controlled Substance Prescription Medications (Schedules II-V) Abandoned by Patients and Visitors at DEA-registered Hospital/Clinics, Narcotic Treatment Programs, and Practitioners’ and Mid-Level Practitioners’ Registered Locations.06/14/202306/14/2023OtherOtherNo
Drug Addiction in Health Care ProfessionalsDEA-DC-1Drug AddictionThis informational pamphlet is aimed at health care professionals. It is a guide to show how they can recognize drug addiction with co-workers and/or a drug impaired co-workers. The information alerts the reader to certain signs, behaviors or symptoms that the drug impaired co-worker may exhibit. The material discusses things such as absenteeism, frequent disappearances, not meeting deadlines and work performances alternating between low and high periods of productivity. The material also identifies responsibilities and things that can be done to help the co-worker. The guide also provides signs that an individual maybe diverting controlled substances.01/29/2020OtherPamphletNo
Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023DEA-DC-66RegistrationThis guidance document provides information regarding the elimination of limitations on the number of patients with OUD that a practitioner may treat with buprenorphine, as a result of Congress’s enactment of the CAA.03/22/202303/22/2023RegistrationRegistrationNo
Faxing DEA Form 222s - COVID-19DEA-DC-19Records and ReportsIn light of the current public health crisis declared by the Secretary of HHS on January 31, 2020, as a result of Coronavirus Disease 2019 (COVID-19) and the determination by WHO on March 11, 2020 that the global COVID-19 outbreak constitutes a pandemic, DEA will grant an exception to 21 CFR 1305.13 regarding the requirement that a purchaser mail a hard copy version of DEA Form 222 to the original supplier in order to ensure an adequate supply of controlled substances for the duration of this public health emergency. Normally, under the CSA, the distribution of a schedule I or II controlled substance must be pursuant to an order form that complies with the DEA regulations. The DEA regulations provide that either a DEA Form 222 or its electronic equivalent is required for each distribution of a schedule I or II controlled substance. 21 CFR 1305.03. A purchaser of a schedule I or II controlled substance that utilizes a paper copy must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. 21 CFR 1305.13(a). Under this exception, all DEA registrants who order controlled substances are permitted to fax or scan/email a DEA Form 222 to their respective suppliers. This exception is granted from March 20, 2020 through the duration of this public health emergency as declared by the Secretary of HHS.03/25/202003/26/2020Records and ReportsCOVID-19No
List 1 Chemical Importers Dear Registrant LetterDEA-DC-55RegistrationDEA is writing a letter to registrants informing them of the restriction on Chemical Importer registrations. DEA is advising registrants that they are prohibited from ordering chemicals from manufacturers and delivering them directly to their customers. The delivery of the chemicals must be at the registered location of the registrant. Violation of this rule is subject to denial, or revocation of the registration.06/08/202206/10/2022RegistrationRegistrationNo
Narcotic Treatment Program ManualDEA-DC-56ManualsThis manual is intended to summarize and explain the basic requirements for administering and dispensing (but not prescribing) narcotic controlled substances approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment in a DEA registered NTP under subchapter I (Control and Enforcement) of the CSA and DEA regulations, 21 CFR Parts 1300 to End.06/22/202206/23/2022OtherManualsNo
National Health Emergency and Telemedicine - COVID-19DEA-DC-16Telemedicine - COVID-19On January 31, 2020, Department of Health and Human Services Secretary Azar declared a public health emergency due to the COVID-19 virus. This documents answers DEA registrants questions concerning the practice of telemedicine during this national health emergency.03/17/202003/18/2020OtherTelemedicineNo
Pharmacist Guide to Prescription FraudDEA-DC-2Pharmacist GuideThis information alerts the reader to certain signs, behaviors or symptoms that the drug impaired co-worker may exhibit. The material discusses things such as absenteeism, frequent disappearances, not meeting deadlines and work performances alternating between low and high periods of productivity. The material also gives the reader what are his/her responsibilities and things they can do to help to co-worker. The guide also provides signs that an individual maybe diverting controlled substances. 01/29/2020Controlled Substance PrescriptionsGuideNo
Pharmacist ManualDEA-DC-46R1ManualsThe DEA Pharmacist Manual.08/02/202208/02/2022OtherManualsNo
Practitioners ManualDEA-DC-71OtherThis Practitioner's Manual has been prepared by the Drug Enforcement Administration (DEA), Diversion Control Division, as a guide to assist practitioners (i.e., registrants, such as physicians, dentists, veterinarians, scientific investigators, or other persons licensed, registered, or otherwise permitted, who are authorized to prescribe, dispense, and administer controlled substances) in their understanding of the federal Controlled Substances Act and its implementing regulations as they pertain to their profession.06/14/202306/14/2023OtherOtherNo
Prescribing Buprenorphine under the Mainstreaming Addiction Treatment Act (the MAT Act) for Opioid Use Disorder (OUD)DEA-DC-78PrescriptionThis guidance document provides clarification regarding the changes set forth in the Consolidated Appropriations Act (CAA) of 2023, which incorporates the MAT Act and amends the Controlled Substances Act (CSA) by eliminating the “DATA-Waiver requirement,” which had been codified in 21 U.S.C. 823. This document provides information as to when qualified practitioners can begin prescribing buprenorphine for OUD.11/28/202311/28/2023Controlled Substance PrescriptionsPrescriptionsNo
Preventing DiversionDEA-DC-13Preventing DiversionThe document discusses ways for practitioners to be aware of signs that patients are trying to access drugs for diversion, such as giving vague symptoms, exaggerating pain, or avoiding tests and accessing medical history. The document also discusses ways for practitioners to avoid giving out prescriptions that could lead to diversion. Practitioners must assure they conduct medical examinations and tests while also looking out for signs of abuse when dealing with patients. 01/29/2020OtherPamphletNo
Preventing the Retail Diversion of PseudoephedrineDEA-DC-4Pseudoephedrine DiversionSummary of the Combat Methamphetamine Epidemic Act of 2005 (CMEA). Preventing the Retail Diversion of Pseudoephedrine, including CMEA requirements, methamphetamine background information, and DEA’s goals in combating the methamphetamine epidemic. 01/29/2020OtherPamphletNo
Q&A Home as a Registered AddressDEA-DC-52RegistrationThis guidance document addresses issues pertaining to an individual practitioner's use of their home address as a principal place of business or professional practice and the home address becoming controlled premises subject to unannounced inspections and administrative warrants under existing Drug Enforcement Administration (DEA) regulations.07/08/202107/08/2021RegistrationRegistrationNo
Q&A Spilled Methadone ReportingDEA-DC-51Records and ReportsExplanation concerning the reporting of spilled methadone.06/17/202107/08/2021Records and ReportsSpilled MethadoneNo
Q&A: Sending Prescriptions via emailDEA-DC-49PrescriptionsQuestion and Answer concerning E-mailing prescriptions for controlled substances.11/20/202012/29/2020Controlled Substance PrescriptionsPrescriptionsNo
QA Can I Use a PO BoxDEA-DC-50DEA RegistrationThis guidance document answers the question: "If a registrant may use a post office box or private mailbox address as the registered address."12/09/202012/29/2020RegistrationRegistrationNo
QA Double Blind StudyDEA-DC-48Double Blind StudyQuestion and Answer addressing if a Researcher registrant should complete a DEA Form 222 when participating in double-blind studies in which the exact quantity of schedule I or II controlled substances received is unknown.10/13/202010/20/2020OtherDouble Blind StudyNo
QA Pharmacy Delivery of Buprenorphine Prescription under SUPPORT ActDEA-DC-45BuprenorphineQ&A asking if a pharmacy may deliver a prescribed buprenorphine product to a practitioner for direct administration to the patient. This Q&A further explains that a pharmacy may deliver controlled substance (CS) to the registered location of either the prescribing practitioner or the administering practitioner, and must be administered by injection or implantation only to the patient named on the prescription within 14 days after the date of receipt of the CS by the practitioner.09/18/202009/21/2020OtherBuprenorphineNo
QA Telemedicine - DEA Registration in other statesDEA-DC-44Telemedicine - DEA RegistrationQuestion and Answer concerning registering with DEA and prescribing controlled substances in more than one state.07/28/202007/30/2020Controlled Substance PrescriptionsTelemedicineNo
QA re Black Bag ExceptionDEA-DC-47AdministeringQ&A answering whether a physician transport controlled substances and administer controlled substances at the patient’s home residence (the so-called "black bag exception").10/08/202010/20/2020OtherBlack BagNo
Questions and Answers for Pharmacies (EPCS)DEA-DC-10Pharmacies and EPCSQuestions and answers for pharmacies intended to summarize and provide general information regarding DEA’s Interim Final Rule for ECPS with request for comment.  The topics discussed include, but are not limited to: Audits and Certification of Applications, Reporting Security Incidents, Records, and Transmission of Prescriptions to Pharmacies.03/31/201001/29/2020Controlled Substance PrescriptionsEPCSNo
Questions and Answers for Prescribing Practitioners (EPCS)DEA-DC-9R1Records and ReportsAll records for prescribing of an FDA-approved narcotic for the treatment of opioid addiction need to be kept in accordance with 21 CFR 1304.03(c), 21 CFR 1304.21(b).03/31/202007/24/2023Records and ReportsPrescriptionsNo
Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and IntermediariesDEA-DC-11EPCSQuestions and answers summarizing and providing information for electronic prescription application providers (including electronic health record application providers), pharmacy application providers, and intermediaries regarding the Drug Enforcement Administration Interim Final Rule with Request for Comment “Electronic Prescriptions for Controlled Substances” (75 FR 16236, March 31, 2010).03/31/201001/29/2020Controlled Substance PrescriptionsEPCSNo
Recognize the AbuserDEA-DC-3Public InformationThis pamphlet is directed to medical practitioners to assist them in recognizing a drug abuser, give them actions to take when confronted by a suspected drug abuser, and responsibilities regarding proper prescribing to prevent diversion. This includes common characteristics of the drug abuser and modus operandi often used by a drug-abusing patient.01/29/2020OtherPamphletNo
Registrant Email - Disposal of Controlled SubstancesDEA-DC-68OtherThis guidance document provides clarification concerning disposal.04/14/202304/14/2023OtherOtherNo
Reporting Regulated Transactions Involving Listed ChemicalsDEA-DC-74Records and ReportsThis guidance document provides clarification regarding the regulatory requirement for persons engaging in regulated transactions in listed chemicals to report transactions involving an extraordinary quantity, an uncommon method of payment or delivery, or other circumstances indicating a potential use of listed chemicals in violation of the law. This guidance is being sent via email to all Drug Enforcement Administration (DEA) listed chemical registrants and regulated persons.08/30/202308/30/2023Records and ReportsRecords and ReportsNo
Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized Collector LocationsDEA-DC-58DestructionThis guidance document addresses whether a Drug Enforcement Administration (DEA) registrant who is an authorized collector has the responsibility to file a Report of Theft or Loss of Controlled Substances (DEA Form 106) if a sealed inner liner is stolen, lost, or missing from the collector’s registered location (or authorized long-term care facility) before the sealed inner liner is picked up for destruction or destroyed on-site.09/13/202209/16/2022Records and ReportsDestructionNo
Reporting Theft, Loss, or Missing Sealed Inner Liners from Federal, State, Tribal, or Local Law Enforcement AgenciesDEA-DC-60DestructionThis guidance document explains that Federal, State, Tribal, or local law enforcement agencies have autonomy regarding the collection and disposal of controlled substances, and therefore, would not file a Report of Theft or Loss of Controlled Substances (DEA Form 106) with the Drug Enforcement Administration (DEA) if a sealed inner liner is stolen, lost, or missing from a Federal, State, Tribal, or local law enforcement agency.09/13/202209/16/2022Records and ReportsDestructionNo
Required Training with Respect to Opioid Use Disorder (OUD) for DEA-Registered PractitionersDEA-DC-75OtherThis guidance document provides information regarding a Drug Enforcement Administration (DEA)-registered practitioner's attestation of the training requirement in the recently enacted Consolidated Appropriations Act of 2023 (CAA). While specifically targeted to the treatment of or screening for OUD, this training is required for all qualified practitioners applying for or renewing a registration to dispense controlled substances in schedules II-V.08/31/202308/31/2023OtherOtherNo
Requirement to Use Multiple Single-Sheet DEA Form 222s (Order Forms) When Transferring Schedule I or II Controlled Substances Upon Termination or Transfer of a DEA Registration, or Discontinuing Business AltogetherDEA-DC-70Records and ReportsThis guidance document clarifies the requirement for Drug Enforcement Administration (DEA) registrant-transferors to use multiple single-sheet DEA Form 222s (order forms) when transferring schedule I or II controlled substances to a DEA registrant-transferee when the number of items being transferred exceeds the number of lines available on the order form.04/26/202304/26/2023Records and ReportsRecords and ReportsNo
Researchers ManualDEA-DC-57ManualsThe DEA Researchers Manual is a guide for registrants and the public as to the rights and obligations of registrants under the CSA and its implementing regulations.06/22/202206/23/2022OtherManualsNo
SAMHSA NTP Deliveries ExceptionDEA-DC-15NTP - COVID-19On January 31, 2020 the Secretary of HHS declared a public health emergency, and asked for DEA-registered narcotic treatment programs (NTPs) to have an exception to 21 CFR 1301.74(i) in order to provide consistent dosing to patients enrolled in NTPs. The Secretary of HHS also asked that in the event a patient is quarantined due to the coronavirus, that an alternative delivery method using the NTP's established chain of custody protocol for take-home medications be allowed. Specifically, it was asked that the NTP make a “doorstep” deliver of take-home medication in an approved lock-box, by an authorized NTP staff member, law enforcement officer, or national guard personnel instead of limiting the person who are allowed to deliver specified in 21 CFR 1301.74(i). DEA reviewed the request for an exception to 21 CFR 1301.74(i), and took into account the safeguards against diversion incorporated into the guidance for Opioid Treatment Programs, and granted the exception to 21 CFR 11301.74(i), but only to the extent that such activities will take place during the HHS-declared public health emergency.03/16/202003/16/2020OtherNTPNo
Separate Registration In Each State (Reciprocity)DEA-DC-18Registration - COVID-19On account of the COVID-19 public health emergency declared by the Department of Health and Human Services on January 31, 2020, the DEA is granting a temporary exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. Dispensing traditionally refers to both the state of practitioner’s licensing/practice, and the state in which the patient is located. However, under this temporary exception, practitioners may dispense controlled substances (including dispensing via telemedicine) in states where they do not hold a registration - provided that they still hold at least one registration, and comply with all applicable state laws.03/25/202003/25/2020RegistrationCOVID-19No
Transportation of Sealed Inner Liners by DEA-Registered Authorized Collectors or Common Courier DriversDEA-DC-61DestructionThis guidance document addresses whether a sealed inner liner may be transported by employees of a Drug Enforcement Administration (DEA) registrant authorized as a collector, or after pick-up by a common courier driver, to a common carrier storefront or franchise prior to the common carrier transporting the sealed inner liner to a reverse distributor for destruction.09/13/202209/16/2022Records and ReportsDestructionNo
Updated DEA Registration Certificate after Removal of X-WaiverDEA-DC-67RegistrationThis guidance document provides information regarding issuance of updated Drug Enforcement Administration (DEA) registration certificates to reflect Congress’s elimination of the X-waiver (DATA-Waiver) in the Consolidated Appropriations Act (CAA) of 2023.03/23/202303/23/2023RegistrationRegistrationNo
Use of Existing DEA-Form 222s (U.S. Official Order Forms – Schedules I & II) after Removal of X-WaiverDEA-DC-69Records and ReportsThis guidance document provides information regarding a practitioner’s use of existing Drug Enforcement Administration (DEA)-Form 222s after Congress’s elimination of the X-waiver (DATA-Waiver) in the Consolidated Appropriations Act (CAA) of 2023.04/02/202304/04/2023Records and ReportsRecords and ReportsNo
Use of Mobile Devices in the Issuance of EPCSDEA-DC-8Mobile Devices and EPCSThe remote practitioner engaged in the practice of telemedicine must be registered with DEA in the State where they are physically located and in every State where their patient(s) is (are) physically located.08/16/201801/29/2020Controlled Substance PrescriptionsEPCSNo
Use of Telemedicine While Providing Medication Assisted Treatment (MAT)DEA-DC-7Telemedicine and Medication Assisted TreatmentThe Ryan Haight Act requires that practitioners prescribing by means of the Internet conduct at least one in-person medical evaluation of their patient. (21 USC. 829(e)). However, there is an exception to this requirement; if the practitioner is DEA-registered and acting within the U.S, they can be exempt from the in-person medical evaluation if the practitioner is engaged in the practice of telemedicine and in accordance with 21 USC 802(54). The remote practitioner engaged in the practice of telemedicine must be registered with DEA in the State where they are physically located and in every State where their patient(s) is (are) physically located. All records for prescribing of an FDA-approved narcotic for the treatment of opioid addiction need to be kept in accordance with 21 CFR 1304.03(c), 21 CFR 1304.21(b).05/05/201801/29/2020OtherTelemedicineNo
Veterinary Medicine Mobility Act of 2014DEA-DC-14Veterinary Medicine Mobility Act of 2014The DEA policy letter from Louis J. Milione to registrant explaining that the Veterinary Mobility Act of 2014 should be interpreted exactly as written, and outlines the situations that vets can transport and dispense CS a site other than their principle place of business without a separate registration according to the new law. “House calls” are used as the prime example in which the vet does not need a separate registration to dispense CS.02/25/201601/29/2020OtherPolicy StatementNo

Guidance Document Histories

Doc Agency IDDoc NameEffective DateStatusRemarks
DEA-DC-1Drug Addiction in Health Care Professionals01/29/2020NEW
DEA-DC-2Pharmacist Guide to Prescription Fraud01/29/2020NEW
DEA-DC-14Veterinary Medicine Mobility Act of 201401/29/2020NEW
DEA-DC-13Preventing Diversion01/29/2020NEW
DEA-DC-12DEA's policy concerning Locum Tenens01/29/2020NEW
DEA-DC-11Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and Intermediaries01/29/2020NEW
DEA-DC-10Questions and Answers for Pharmacies (EPCS)01/29/2020NEW
DEA-DC-9Questions and Answers for Prescribing Practitioners (EPCS)01/29/2020NEW
DEA-DC-8Use of Mobile Devices in the Issuance of EPCS01/29/2020NEW
DEA-DC-7Use of Telemedicine While Providing Medication Assisted Treatment (MAT)01/29/2020NEW
DEA-DC-3Recognize the Abuser01/29/2020NEW
DEA-DC-4Preventing the Retail Diversion of Pseudoephedrine01/29/2020NEW
DEA-DC-5Controlled Substances Act Pursuant to the Religious Freedom Restoration Act01/29/2020NEW
DEA-DC-6Clarification of Title 21 CFR 1301.90 - Employee Screening - Non-Practitioners01/29/2020NEW
DEA-DC-15SAMHSA NTP Deliveries Exception03/16/2020NEW
DEA-DC-16National Health Emergency and Telemedicine - COVID-1903/18/2020NEW
DEA-DC-17Prescription Refills - COVID-1903/21/2020NEW
DEA-DC-18Separate Registration In Each State (Reciprocity)03/25/2020NEW
DEA-DC-19Faxing DEA Form 222s - COVID-1903/26/2020NEW
DEA-DC-2065% Bulk Manufacture Exception03/26/2020NEW
DEA-DC-21Emergency CII Call In Exception03/30/2020NEW
DEA-DC-22COVID-19 SAMHSA Telemedicine (Phone)03/31/2020NEW
DEA-DC-23COVID-19 Prescribing Chart04/01/2020NEW
DEA-DC-24COVID-19 Q&A Mail Methadone04/07/2020NEW
DEA-DC-25COVID-19 Off-Site OTP Delivery Method04/07/2020NEW
DEA-DC-26COVID-19 QA EPCS Hospitals & Remote ID Proofing04/13/2020NEW
DEA-DC-27COVID-19 OTP Signed Delivery Exception to Regs04/13/2020NEW
DEA-DC-28COVID-19 Exception (Campus Registration)04/13/2020NEW
DEA-DC-29COVID-19 Exception (5% Rule)04/13/2020NEW
DEA-DC-30COVID-19 Office Site Delivery Buprenorphine)04/29/2020NEW
DEA-DC-31Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)06/04/2020NEW
DEA-DC-32COVID-19 H.D.A. Question and Responses06/04/2020NEW
DEA-DC-33Civil Unrest Q&A Theft and Loss06/10/2020NEW
DEA-DC-34Civil Unrest Q&A Pharmacy Movement of Controlled Substances without Address Change06/10/2020NEW
DEA-DC-35Civil Unrest Q&A Suspicious Order Reporting06/10/2020NEW
DEA-DC-36Civil Unrest Q&A Offsite Dosing Option06/10/2020NEW
DEA-DC-37Civil Unrest Q&A: Moving of Controlled Substances (Practitioners)06/10/2020NEW
DEA-DC-38Civil Unrest QA Pharmacy Prescription Transfer06/23/2020NEW
DEA-DC-40Civil Unrest Q&A Destruction of Damaged C/S06/23/2020NEW
DEA-DC-39Civil Unrest Q&A Pharmacy Closure (Pharmacy)06/23/2020NEW
DEA-DC-41Civil Unrest Q&A RE Transfer of Prescriptions07/13/2020NEW
DEA-DC-42Civil Unrest QA, Bulk Destruction07/28/2020NEW
DEA-DC-43COVID-19 QA Administering CS in vehicle during COVID-1907/28/2020NEW
DEA-DC-44QA Telemedicine - DEA Registration in other states07/30/2020NEW
DEA-DC-45QA Pharmacy Delivery of Buprenorphine Prescription under SUPPORT Act09/21/2020NEW
DEA-DC-46Pharmacist Manual10/08/2020NEW
DEA-DC-47QA re Black Bag Exception10/20/2020NEW
DEA-DC-48QA Double Blind Study10/20/2020NEW
DEA-DC-49Q&A: Sending Prescriptions via email12/29/2020NEW
DEA-DC-50QA Can I Use a PO Box12/29/2020NEW
DEA-DC-51Q&A Spilled Methadone Reporting07/08/2021NEW
DEA-DC-52Q&A Home as a Registered Address07/08/2021NEW
DEA-DC-53Q&A How to Terminate an X number12/01/2021NEW
DEA-DC-54DEA Chemical Handler's Manual03/01/2022NEW
DEA-DC-55List 1 Chemical Importers Dear Registrant Letter06/10/2022NEW
DEA-DC-56Narcotic Treatment Program Manual06/23/2022NEW
DEA-DC-57Researchers Manual06/23/2022NEW
DEA-DC-46R1Pharmacist Manual08/02/2022REVISED
DEA-DC-58Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized Collector Locations09/16/2022NEW
DEA-DC-59DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s Custody09/16/2022NEW
DEA-DC-60Reporting Theft, Loss, or Missing Sealed Inner Liners from Federal, State, Tribal, or Local Law Enforcement Agencies09/16/2022NEW
DEA-DC-61Transportation of Sealed Inner Liners by DEA-Registered Authorized Collectors or Common Courier Drivers09/16/2022NEW
DEA-DC-62Date of Receipt of Sealed Inner Liners by Reverse Distributors09/16/2022NEW
DEA-DC-63Changes to a Prescription by a Pharmacist10/18/2022NEW
DEA-DC-65DEA-Registered Manufacturer and Distributor Established Controlled Substance Quantitative Thresholds and the Requirement to Report Suspicious Orders01/20/2023NEW
DEA-DC-53Q&A How to Terminate an X number02/01/2023RESCINDED
DEA-DC-66Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 202303/22/2023NEW
DEA-DC-67Updated DEA Registration Certificate after Removal of X-Waiver 03/23/2023NEW
DEA-DC-69Use of Existing DEA-Form 222s (U.S. Official Order Forms – Schedules I & II) after Removal of X-Waiver04/04/2023NEW
DEA-DC-68Registrant Email - Disposal of Controlled Substances04/14/2023NEW
DEA-DC-70Requirement to Use Multiple Single-Sheet DEA Form 222s (Order Forms) When Transferring Schedule I or II Controlled Substances Upon Termination or Transfer of a DEA Registration, or Discontinuing Business Altogether04/26/2023NEW
DEA-DC-72COVID-19 Flexibility Updates05/10/2023NEW
DEA-DC-2065% Bulk Manufacture Exception05/11/2023RESCINDED
DEA-DC-21Emergency CII Call In Exception05/11/2023RESCINDED
DEA-DC-23COVID-19 Prescribing Chart05/11/2023RESCINDED
DEA-DC-32COVID-19 H.D.A. Question and Responses05/11/2023RESCINDED
DEA-DC-24COVID-19 Q&A Mail Methadone05/11/2023RESCINDED
DEA-DC-26COVID-19 QA EPCS Hospitals & Remote ID Proofing05/11/2023RESCINDED
DEA-DC-27COVID-19 OTP Signed Delivery Exception to Regs05/11/2023RESCINDED
DEA-DC-28COVID-19 Exception (Campus Registration)05/11/2023RESCINDED
DEA-DC-29COVID-19 Exception (5% Rule)05/11/2023RESCINDED
DEA-DC-17Prescription Refills - COVID-1905/11/2023RESCINDED
DEA-DC-73Disposal of Controlled Substance Prescription Medications (Schedules II-V) Abandoned by Patients and/or Visitors at the Locations of DEA-Registered Practitioners06/14/2023NEW
DEA-DC-71Practitioners Manual06/14/2023NEW
DEA-DC-9R1Questions and Answers for Prescribing Practitioners (EPCS)07/25/2023REVISED
DEA-DC-74Reporting Regulated Transactions Involving Listed Chemicals08/30/2023NEW
DEA-DC-75Required Training with Respect to Opioid Use Disorder (OUD) for DEA-Registered Practitioners08/30/2023NEW
DEA-DC-76DEA-Practitioner Training or Continuing Education Requirement for Registration (Revision 1)09/24/2023NEW
DEA-DC-77Communication Between Pharmacists for the Transfer of Electronic Prescriptions for Controlled Substances (EPCS) for Initial Dispensing10/30/2023NEW
DEA-DC-64COVID to OPIOID Epidemic and Telemedicine - Buprenorphine11/17/2023NEW
DEA-DC-78Prescribing Buprenorphine under the Mainstreaming Addiction Treatment Act (the MAT Act) for Opioid Use Disorder (OUD)11/28/2023NEW

Guidance Document History

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