 | Applicability of the 8-hour Training Requirement to Medical, Surgical, and other Specialty Residents or Other Individual Practitioners Working Solely under a DEA-Registered Hospital/Clinic Registration | DEA-DC-80 | DEA Registration | This guidance document provides information regarding the applicability of the training requirement included in the Consolidated Appropriations Act (CAA) of 2023 to medical residents, surgical residents and other subspecialty trainees, or other individual practitioners, who solely work under a Drug Enforcement Administration (DEA)-registered hospital/clinic registration under 21 CFR 1301.22(c) as an agent or employee of the hospital. | 02/22/2024 | 02/22/2024 | Registration | Buprenorphine | No |
| COVID to OPIOID Epidemic and Telemedicine - Buprenorphine | DEA-DC-64 | Prescription | Policy transfering the audio only flexibility to prescribe buprenorphine products from the COVID-19 public health emergency to the OPIOID public health emergency. | 11/30/2022 | 11/17/2023 | Controlled Substance Prescriptions | Prescriptions | No |
| COVID-19 Flexibility Updates | DEA-DC-72 | Other | This 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. | 05/10/2023 | 05/10/2023 | Other | Other | No |
| COVID-19 Off-Site OTP Delivery Method | DEA-DC-25 | Methadone | During 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. | 04/07/2020 | 04/07/2020 | Other | COVID-19 | No |
| COVID-19 Office Site Delivery Buprenorphine) | DEA-DC-30 | Buprenorphine | During 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. | 04/28/2020 | 04/29/2020 | Other | COVID-19 | No |
| COVID-19 QA Administering CS in vehicle during COVID-19 | DEA-DC-43 | Administering | Question 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. | 07/28/2020 | 07/28/2020 | Other | COVID-19 | No |
| COVID-19 SAMHSA Telemedicine (Phone) | DEA-DC-22 | Telemedicine | In 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. | 03/31/2020 | 03/31/2020 | Other | COVID-19 | No |
| Changes to a Prescription by a Pharmacist | DEA-DC-63 | Prescriptions | This 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. | 10/18/2022 | 10/18/2022 | Controlled Substance Prescriptions | Prescriptions | No |
| Civil Unrest Q&A Destruction of Damaged C/S | DEA-DC-40 | Destruction - Civil Unrest | Questions and answer concerning pharmacys destruction of damaged controlled substances due to the civil unrest. | 06/12/2020 | 06/23/2020 | Controlled Substance Security | Civil Unrest/Looting | No |
| Civil Unrest Q&A Offsite Dosing Option | DEA-DC-36 | NTP - Civil Unrest | Question and answer concerning off-site dosing of narcotic treatment program patients during civil unrest. | 06/09/2020 | 06/10/2020 | Other | NTP - Civil Unrest | No |
| Civil Unrest Q&A Pharmacy Closure (Pharmacy) | DEA-DC-39 | Destruction - Civil Unrest | Question and answer addressing what steps must be taken if a pharmacy is closing permanently due to the civil unrest. | 06/10/2020 | 06/23/2020 | Controlled Substance Security | Civil Unrest/Looting | No |
| Civil Unrest Q&A Pharmacy Movement of Controlled Substances without Address Change | DEA-DC-34 | Registration - Civil Unrest | Question and answer concerning moving controlled substances to another address without changing the address of the DEA registered location. | 06/07/2020 | 06/10/2020 | Registration | Civil Unrest/Looting | No |
| Civil Unrest Q&A RE Transfer of Prescriptions | DEA-DC-41 | Prescriptions - Civil Unrest | Question and answer concerning a pharmacists ability to dispense controlled substances during civil unrest. | 06/07/2020 | 07/13/2020 | Controlled Substance Prescriptions | Civil Unrest/Looting | No |
| Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy) | DEA-DC-31 | Registration - Civil Unrest | Questions 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. | 06/04/2020 | 06/04/2020 | Registration | Civil Unrest/Looting | No |
| Civil Unrest Q&A Suspicious Order Reporting | DEA-DC-35 | Records and Reports - Civil Unrest | Question and Answer concerning suspicious order reporting during the civil unrest and looting. | 06/09/2020 | 06/10/2020 | Records and Reports | Civil Unrest/Looting | No |
| Civil Unrest Q&A Theft and Loss | DEA-DC-33R1 | Theft/Loss Civil Unrest | Question and answer concerning reporting of theft and/or loss of controlled substances during civil unrest and looting. | 06/05/2020 | 02/22/2024 | Records and Reports | Civil Unrest/Looting | No |
| Civil Unrest Q&A: Moving of Controlled Substances (Practitioners) | DEA-DC-37 | Practitioners - Civil Unrest | Question and answer concerning practitioners needing to move controlled substances due to civil unrest and looting. | 06/10/2020 | 06/10/2020 | Registration | Practitioners - Civil Unrest | No |
| Civil Unrest QA Pharmacy Prescription Transfer | DEA-DC-38 | Prescriptions - Civil Unrest | Question and answer concerning controlled substance prescription transfers during civil unrest. | 06/10/2020 | 06/23/2020 | Controlled Substance Prescriptions | Civil Unrest/Looting | No |
| Civil Unrest QA, Bulk Destruction | DEA-DC-42 | Destruction - Civil Unrest | Question and answer concerning the bulk destruction of controlled substances during the civil unrest. | 07/14/2020 | 07/28/2020 | Controlled Substance Security | Civil Unrest/Looting | No |
| Clarification of Title 21 CFR 1301.90 - Employee Screening - Non-Practitioners | DEA-DC-6 | Employee Screening | This 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). | | 01/29/2020 | Controlled Substance Security | Policy Statement | No |
| Communication Between Pharmacists for the Transfer of Electronic Prescriptions for Controlled Substances (EPCS) for Initial Dispensing | DEA-DC-77 | Prescription | The 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. | 10/06/2023 | 10/30/2023 | Controlled Substance Prescriptions | Prescriptions | No |
| Controlled Substances Act Pursuant to the Religious Freedom Restoration Act | DEA-DC-5 | Religious Exemption | Guidance establishing a process for DEA decisions regarding requests for exemptions to handle controlled substances pursuant to the Religious Freedom Restoration Act (RFRA). | 02/26/2018 | 01/29/2020 | Other | Policy Statement | No |
| DEA Chemical Handler's Manual | DEA-DC-54 | Manuals | This 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. | 03/01/2022 | 03/01/2022 | Other | Manuals | No |
| DEA's policy concerning Locum Tenens | DEA-DC-12 | Locum Tenens | DEA’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. | 09/13/2010 | 01/29/2020 | Other | Locum Tenens | No |
| DEA-Practitioner Training or Continuing Education Requirement for Registration (Revision 1) | DEA-DC-76 | Other | This 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. | 09/21/2023 | 09/25/2023 | Other | Other | No |
| DEA-Registered Authorized Collector Reporting of Theft, Loss, or Missing Sealed Inner Liners that Occurs While in a Common or Contract Carrier’s Custody | DEA-DC-59 | Destruction | This 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. | 09/13/2022 | 09/16/2022 | Records and Reports | Destruction | No |
| DEA-Registered Manufacturer and Distributor Established Controlled Substance Quantitative Thresholds and the Requirement to Report Suspicious Orders | DEA-DC-65 | Records and Reports | This 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). | 01/20/2023 | 01/20/2023 | Records and Reports | Records and Reports | No |
| Date of Receipt of Sealed Inner Liners by Reverse Distributors | DEA-DC-62 | Destruction | This 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. | 09/13/2022 | 09/16/2022 | Records and Reports | Destruction | No |
| Disposal of Controlled Substance Prescription Medications (Schedules II-V) Abandoned by Patients and/or Visitors at the Locations of DEA-Registered Practitioners | DEA-DC-73 | Other | Disposal 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. | 06/14/2023 | 06/14/2023 | Other | Other | No |
| Drug Addiction in Health Care Professionals | DEA-DC-1 | Drug Addiction | This 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. | | 01/29/2020 | Other | Pamphlet | No |
| Drug Enforcement Administration (DEA) Registration Requirements for Practitioners Who Receive Schedule III-V Controlled Substances, Dispensed by a DEA-Registered Pharmacy Pursuant to a Prescription, and Delivered to the Practitioner by the Pharmacy in Accordance with 21 U.S.C. 829a(a). | DEA-DC-82 | Precriptions | The Controlled Substances Act (CSA) allows a pharmacy to deliver a schedule III, IV, or V opioid to be administered for maintenance or detoxification treatment of an opioid use disorder, dispensed by the pharmacy pursuant to a prescription, to the prescribing practitioner or the practitioner administering the controlled substance. (21 U.S.C. 829a(a)). One of the requirements imposed by the CSA is that “the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration” issued under the CSA. See 21 U.S.C. 829a(a)(1), 21 CFR 1306.07(f)(1). | 02/21/2024 | 02/22/2024 | Controlled Substance Prescriptions | Prescriptions | No |
| E-Commerce Letter | DEA-DC-81 | Records and Reports | This guidance document provides information regarding the recordkeeping and reporting requirements for e-commerce entities selling pill press machines. E-commerce entities are generally “regulated persons” under the Controlled Substances Act, 21 U.S.C. § 802(38) and are required to comply with CSA recordkeeping and reporting requirements of 21 U.S.C. § 830 for transactions involving the distribution, importation and exportation of pill press machines. | 02/26/2024 | 02/26/2024 | Records and Reports | Enc/Tab Machines | No |
| Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023 | DEA-DC-66 | Registration | This 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. | 03/22/2023 | 03/22/2023 | Registration | Registration | No |
| Faxing DEA Form 222s - COVID-19 | DEA-DC-19 | Records and Reports | In 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. | 03/25/2020 | 03/26/2020 | Records and Reports | COVID-19 | No |
| List 1 Chemical Importers Dear Registrant Letter | DEA-DC-55 | Registration | DEA 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. | 06/08/2022 | 06/10/2022 | Registration | Registration | No |
| Narcotic Treatment Program Manual | DEA-DC-56 | Manuals | This 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. | 06/22/2022 | 06/23/2022 | Other | Manuals | No |
| National Health Emergency and Telemedicine - COVID-19 | DEA-DC-16 | Telemedicine - COVID-19 | On 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. | 03/17/2020 | 03/18/2020 | Other | Telemedicine | No |
| Pharmacist Guide to Prescription Fraud | DEA-DC-2 | Pharmacist Guide | This 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. | | 01/29/2020 | Controlled Substance Prescriptions | Guide | No |
| Pharmacist Manual | DEA-DC-46R1 | Manuals | The DEA Pharmacist Manual. | 08/02/2022 | 08/02/2022 | Other | Manuals | No |
| Practitioners Manual | DEA-DC-71 | Other | This 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. | 06/14/2023 | 06/14/2023 | Other | Other | No |
| Prescribing Buprenorphine under the Mainstreaming Addiction Treatment Act (the MAT Act) for Opioid Use Disorder (OUD) | DEA-DC-78 | Prescription | This 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. | 11/28/2023 | 11/28/2023 | Controlled Substance Prescriptions | Prescriptions | No |
| Preventing Diversion | DEA-DC-13 | Preventing Diversion | The 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. | | 01/29/2020 | Other | Pamphlet | No |
| Preventing the Retail Diversion of Pseudoephedrine | DEA-DC-4 | Pseudoephedrine Diversion | Summary 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. | | 01/29/2020 | Other | Pamphlet | No |
| Q&A Home as a Registered Address | DEA-DC-52 | Registration | This 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. | 07/08/2021 | 07/08/2021 | Registration | Registration | No |
| Q&A Spilled Methadone Reporting | DEA-DC-51 | Records and Reports | Explanation concerning the reporting of spilled methadone. | 06/17/2021 | 07/08/2021 | Records and Reports | Spilled Methadone | No |
| Q&A: Sending Prescriptions via email | DEA-DC-49 | Prescriptions | Question and Answer concerning E-mailing prescriptions for controlled substances. | 11/20/2020 | 12/29/2020 | Controlled Substance Prescriptions | Prescriptions | No |
| QA Can I Use a PO Box | DEA-DC-50 | DEA Registration | This guidance document answers the question: "If a registrant may use a post office box or private mailbox address as the registered address." | 12/09/2020 | 12/29/2020 | Registration | Registration | No |
| QA Double Blind Study | DEA-DC-48 | Double Blind Study | Question 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. | 10/13/2020 | 10/20/2020 | Other | Double Blind Study | No |
| QA Pharmacy Delivery of Buprenorphine Prescription under SUPPORT Act | DEA-DC-45 | Buprenorphine | Q&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. | 09/18/2020 | 09/21/2020 | Other | Buprenorphine | No |
| QA Telemedicine - DEA Registration in other states | DEA-DC-44 | Telemedicine - DEA Registration | Question and Answer concerning registering with DEA and prescribing controlled substances in more than one state. | 07/28/2020 | 07/30/2020 | Controlled Substance Prescriptions | Telemedicine | No |
| QA re Black Bag Exception | DEA-DC-47 | Administering | Q&A answering whether a physician transport controlled substances and administer controlled substances at the patient’s home residence (the so-called "black bag exception"). | 10/08/2020 | 10/20/2020 | Other | Black Bag | No |
| Questions and Answers for Pharmacies (EPCS) | DEA-DC-10 | Pharmacies and EPCS | Questions 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. | 03/31/2010 | 01/29/2020 | Controlled Substance Prescriptions | EPCS | No |
| Questions and Answers for Prescribing Practitioners (EPCS) | DEA-DC-9R1 | Records and Reports | 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). | 03/31/2020 | 07/24/2023 | Records and Reports | Prescriptions | No |
| Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and Intermediaries | DEA-DC-11 | EPCS | Questions 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). | 03/31/2010 | 01/29/2020 | Controlled Substance Prescriptions | EPCS | No |
| Recognize the Abuser | DEA-DC-3 | Public Information | This 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. | | 01/29/2020 | Other | Pamphlet | No |
| Registrant Email - Disposal of Controlled Substances | DEA-DC-68 | Other | This guidance document provides clarification concerning disposal. | 04/14/2023 | 04/14/2023 | Other | Other | No |
| Reporting Regulated Transactions Involving Listed Chemicals | DEA-DC-74 | Records and Reports | This 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. | 08/30/2023 | 08/30/2023 | Records and Reports | Records and Reports | No |
| Reporting Theft, Loss, or Missing Sealed Inner Liners from DEA-Registered Authorized Collector Locations | DEA-DC-58 | Destruction | This 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. | 09/13/2022 | 09/16/2022 | Records and Reports | Destruction | No |
| Reporting Theft, Loss, or Missing Sealed Inner Liners from Federal, State, Tribal, or Local Law Enforcement Agencies | DEA-DC-60 | Destruction | This 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. | 09/13/2022 | 09/16/2022 | Records and Reports | Destruction | No |
| Required Training with Respect to Opioid Use Disorder (OUD) for DEA-Registered Practitioners | DEA-DC-75 | Other | This 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. | 08/31/2023 | 08/31/2023 | Other | Other | No |
| 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 Altogether | DEA-DC-70 | Records and Reports | This 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. | 04/26/2023 | 04/26/2023 | Records and Reports | Records and Reports | No |
| Researchers Manual | DEA-DC-57 | Manuals | The 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. | 06/22/2022 | 06/23/2022 | Other | Manuals | No |
| SAMHSA NTP Deliveries Exception | DEA-DC-15 | NTP - COVID-19 | On 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. | 03/16/2020 | 03/16/2020 | Other | NTP | No |
| Separate Registration In Each State (Reciprocity) | DEA-DC-18 | Registration - COVID-19 | On 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. | 03/25/2020 | 03/25/2020 | Registration | COVID-19 | No |
| Transportation of Sealed Inner Liners by DEA-Registered Authorized Collectors or Common Courier Drivers | DEA-DC-61 | Destruction | This 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. | 09/13/2022 | 09/16/2022 | Records and Reports | Destruction | No |
| Updated DEA Registration Certificate after Removal of X-Waiver | DEA-DC-67 | Registration | This 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. | 03/23/2023 | 03/23/2023 | Registration | Registration | No |
| Use of Existing DEA-Form 222s (U.S. Official Order Forms – Schedules I & II) after Removal of X-Waiver | DEA-DC-69 | Records and Reports | This 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. | 04/02/2023 | 04/04/2023 | Records and Reports | Records and Reports | No |
| Use of Mobile Devices in the Issuance of EPCS | DEA-DC-8 | Mobile Devices and EPCS | 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. | 08/16/2018 | 01/29/2020 | Controlled Substance Prescriptions | EPCS | No |
| Use of Telemedicine While Providing Medication Assisted Treatment (MAT) | DEA-DC-7 | Telemedicine and Medication Assisted Treatment | The 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). | 05/05/2018 | 01/29/2020 | Other | Telemedicine | No |
| Veterinary Medicine Mobility Act of 2014 | DEA-DC-14 | Veterinary Medicine Mobility Act of 2014 | The 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. | 02/25/2016 | 01/29/2020 | Other | Policy Statement | No |
