Guidance Documents
Guidance Documents
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws.?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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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).
| Component | Document | Issued | Posted | ID | Topic | Overview | Notice |
|---|---|---|---|---|---|---|---|
| Diversion Control Program (DEA) | Civil Unrest Q&A RE Transfer of Prescriptions | July 6, 2020 | July 13, 2020 | DEA-DC-041 | Controlled Substance Prescriptions |
Question and answer concerning a pharmacists ability to dispense controlled substances during civil unrest. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Destruction of Damaged C/S | June 12, 2020 | June 23, 2020 | DEA-DC-040 | Controlled Substance Security |
Questions and answer concerning pharmacys destruction of damaged controlled substances due to the civil unrest. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Pharmacy Prescription Transfer | June 10, 2020 | June 23, 2020 | DEA-DC-038 | Controlled Substance Prescriptions |
Question and answer concerning controlled substance prescription transfers during civil unrest. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Pharmacy Closure (Pharmacy) | June 10, 2020 | June 23, 2020 | DEA-DC-039 | Controlled Substance Security |
Question and answer addressing what steps? must be taken if a pharmacy is closing permanently due to the civil unrest. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Offsite Dosing Option | June 9, 2020 | June 10, 2020 | DEA-DC-036 | General |
Question and answer concerning off-site dosing of narcotic treatment program patients during civil unrest. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A: Moving of Controlled Substances (Practitioners) | June 9, 2020 | June 11, 2020 | DEA-DC-155 | DEA Registration |
Question and answer concerning practitioners needing to move controlled substances due to civil unrest and looting. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Pharmacy move CS without Address Change | June 7, 2020 | June 12, 2020 | DEA-DC-034 | DEA Registration |
Question and answer concerning moving controlled substances to another address without changing the address of the DEA registered location. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Suspicious Order Reporting | June 6, 2020 | June 12, 2020 | DEA-DC-035 | DEA Records and Reports |
Question and Answer concerning suspicious order reporting during the civil unrest and looting. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Theft and Loss | June 5, 2020 | June 12, 2020 | DEA-DC157 | DEA Records and Reports |
Question and answer concerning reporting of theft and/or loss of controlled substances during civil unrest and looting. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy) | June 4, 2020 | June 4, 2020 | DEA-DC-031 | DEA Registration |
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. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Office Site Delivery Buprenorphine | April 28, 2020 | April 28, 2020 | DEA-DC-030 | DEA Records and Reports |
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. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Exception (5% Rule) | April 13, 2020 | April 13, 2020 | DEA-DC-029 | General |
During the Covid19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances (CS) in excess of five percent of their total number of dosage units of?CS distributed to other registered dispensers during this calendar year, without registering as a distributor.? All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 OTP Signed Delivery Exception to Regs | April 11, 2020 | April 11, 2020 | DEA-DC-027 | General |
During the Covid-19 Public Health Emergency, DEA will permit distributors to deliver narcotic substances to Narcotic Treatment Programs without requiring immediate signature by the NTP’s authorized individual accepting delivery.? Distributors must confirm physical possession by the NTP and complete additional recordkeeping requirements in a timely manner. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Exception (Campus Registration) | April 11, 2020 | April 11, 2020 | DEA-DC-028 | DEA Registration |
Due to the Covid-19 Public Health Emergency, DEA-registered hospital/clinics may utilize alternate satellite hospital/clinic locations providing temporary services under their current registrations. DEA will allow such satellite hospitals/clinics to handle controlled substances and to receive shipments of controlled substances directly from distributors.? DEA must be notified by all registered hospital/clinics of any satellite locations intending to handle controlled substances. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) | Industry Letter: Business Premises Guidance for FFLs | April 10, 2020 | April 10, 2020 | DOJ-1331246 | Firearms |
Letter to all federal firearms licensees (FFLs) in response to questions from industry members regarding the legality of firearm sales and deliveries exterior to the brick-and-mortar structure at which the firearms business is licensed, in light of?the March 13, 2020, declaration of a national emergency concerning the outbreak of the novel coronavirus disease (COVID-19), and the Department of Homeland Security’s subsequent classification of firearms businesses as essential. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 H.D.A. Question and Responses | April 10, 2020 | June 4, 2020 | DEA-DC-032 | DEA Records and Reports |
Due to the Covid-19 Public Health Emergency, DEA has issued guidance to Distributors to ensure regulatory compliance regarding secure delivery of controlled substance shipments to hospitals, pharmacies and NTPs, documentation and recordkeeping, due diligence requirements, and authorization for emergency alternate distribution sites. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Off-Site OTP Delivery Method | April 7, 2020 | April 7, 2020 | DEA-DC-025 | General |
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 |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 QA EPCS Hospitals & Remote ID Proofing | April 5, 2020 | April 5, 2020 | DEA-DC-026 | Controlled Substance Prescriptions |
During the COVID-19 public health emergency, DEA-registered hospitals/clinics may conduct remote identity proofing of individual practitioners to issue authentication credentials to eligible practitioners engaged in electronic prescribing of controlled substances, in conformance with existing regulations. DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication to do so. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 SAMHSA Telemedicine (Phone) | March 31, 2020 | March 31, 2020 | DEA-DC-022 | Controlled Substance Prescriptions |
In light of the nationwide public health emergency declared by the HHS on 1-31-20, for the duration of this public health emergency, unless DEA specifies earlier, DEA has establish guidance concerning the use of a telephone call to conduct a telemedicine visit using controlled substances. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Prescribing Chart | March 31, 2020 | March 31, 2020 | DEA-DC-023 | Controlled Substance Prescriptions |
In response to the COVID19 public health emergency(PHE) declared by HHS, the DEA has adopted policies to allow DEA reg. practitioners to prescribe controlled substances(CS) without having to interact in-person with their patients. This chart only addresses prescribing CS and doesn’t address administering or direct dispensing of CS, including by OTPs or hospitals. These go into effect 3-31-20, and will remain in effect for the duration of the PHE, unless DEA specifies an earlier date. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Emergency CII Call In Exception | March 28, 2020 | March 28, 2020 | DEA-DC-021 | Controlled Substance Prescriptions |
This is a guidance letter clarifying the circumstances under which oral schedule II prescriptions are permitted and provides temporary exceptions due to the COVID-19 Public Health Emergency declared by the Secretary of Health and Human Services.? |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Faxing DEA Form 222s - COVID-19 | March 26, 2020 | March 26, 2020 | DEA-DC-019 | DEA Records and Reports |
On March 26, 2020, due to the HHS declared health crises, DEA has granted 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. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | 65% Bulk Manufacture Exception | March 26, 2020 | March 26, 2020 | DEA-DC-020 | General |
Due to the current public health crisis declared by HHS on 1-31-20, DEA grants an exception of 21 CFR 1303.24(b) that normally require the inventory for individual manufacturers to remain at 65% or less.? All DEA reg. bulk manufacturers are allowed to exceed the 65% ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredient(s). This exception does not authorize any manufacturer to exceed his previously established annual manufacturing quota. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | Separate Registration In Each State (Reciprocity) | March 25, 2020 | March 25, 2020 | DEA-DC-018 | DEA Registration |
Due to the COVID-19 public health emergency declared by HHS on 1-31-20, the DEA is granting an exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. However, under this temporary exception, practitioners may dispense controlled 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. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |
| Diversion Control Program (DEA) | COVID-19 Q&A Mail Methadone | March 24, 2020 | March 24, 2020 | DEA-DC-024 | General |
DEA’s regulations prohibiting mail delivery of methadone to NTP patients remain in effect. DEA believes that the potential for diversion and abuse of methadone for MAT treatment of narcotic dependent persons is too high to permit NTPs to dispense via the USPS. To ensure continued access during the COVID-19 health emergency, DEA has authorized NTP employees, law enforcement and National Guard personnel to deliver methadone to patients who cannot travel to the NTP. |
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 document that is not accessible through this guidance portal, or similar guidance portals for other Executive Branch departments and agencies, 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 might not represent the Department’s authoritative or official position, and, in those situations, are not entitled 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). |