Civil Unrest/Looting Registration Guidance Documents Q&A
Damage to Pharmacies
Answer: DEA regulations authorize pharmacies to destroy controlled substances, or cause controlled substances to be destroyed, in a variety of ways, so long as the pharmacy acts in accordance with all other applicable federal, state, tribal, and local laws and regulations, and the controlled substances are rendered non-retrievable. See, e.g., 21 CFR 1317.05(a), 1317.90, 1317.95. In most circumstances, however, DEA recommends that a pharmacy take the following steps to allow for the safe destruction of controlled substances and maintain records:
1) Contact a DEA-registered reverse distributor who will work with you to receive the controlled substances you need destroyed.
2) Safely transfer the controlled substances (and any debris mixed in with them) into containers, and seal the containers.
3) Sealed containers should be given a serial number or item number for tracking purposes.
4) You should document your transfer of these sealed containers to a reverse distributor on an invoice. The invoice should note the number of sealed containers and each container’s serial number. This will act as the record of receipt for the reverse distributor. 21 CFR 1304.21(d).
5) Sealed containers should then be sent to a reverse distributor through a common or contract carrier or picked up by a reverse distributor under their standard operating procedures. 21 CFR 1317.05(a)(2). If a common or contract carrier is used, sealed containers must only be delivered to the reverse distributor’s registered location. 21 CFR 1317.15(b)(2)(i).
6) The reverse distributor will destroy entire sealed containers and document the destruction on a DEA Form 41. 21 CFR 1304.21(e).
7) To account for lost, damaged, or stolen controlled substances (including through looting) that need to be destroyed, you should file a DEA Form 106 (report of Theft or Loss of Controlled Substances) based on pre-riot inventories and other pharmacy records. 21 CFR 1301.76(b). Forms may be accessed through this DEA link. You are required to maintain complete and accurate records. 21 U.S.C. 827(a)(3). EO-DEA210, July 13, 2020, DEA-DC-042
Transfer of Prescriptions
Answer: If you are unable to conduct business, it is recommended that you advise your patients of the following regarding how they may obtain their schedule II prescription medications from another pharmacy.
If your patient received a paper prescription that you have not filled, you generally may simply suggest that your patient take that prescription to another pharmacy. Your patients also may contact their doctor to obtain a new paper or electronic prescription for a schedule II controlled substance. The original pharmacy should document on the original schedule II prescription that it is void, the date the prescription was voided, and the reason for voiding the prescription. See 21 CFR 1311.200(h) (requiring a pharmacy that receives an original electronic prescription which it cannot dispense to mark the electronic version as voided or cancelled). In addition, in the case of an emergency situation, a practitioner may issue an emergency oral prescription to a pharmacy subject to certain requirements. 21 CFR 1306.11(d). Please refer to DEA's guidance regarding certain limited exceptions to these emergency oral prescription requirements during the COVID-19 Public Health Emergency on the DEA COVID-19 Information Page.
DEA recommends that you contact your state pharmacy authority to ensure that you remain in compliance with state pharmacy laws and guidance. Please contact your local DEA Field Office for additional information.
EO-DEA207, June 6, 2020, DEA-DC-041
Expedited Replacement of DEA Form 222s
Answer: DEA would be happy to assist, please contact DEA's registration unit at: DEA.Registration.Help@dea.gov. Please include in the email your name, DEA Registration number, contact phone number, and reason for the emergency shipment of DEA Form 222s. You may also telephone the Registration unit at (800) 882-9539. EO-DEA158, June 3, 2020
Registration of New Building at Same Address (Pharmacy)
Answer: If a pharmacy's temporary structure would be located at the same registered address (e.g., a temporary structure located at the address's parking lot), it is permissible to operate a temporary pharmacy at the same registered address under certain conditions. If a temporary pharmacy is deployed, it is recommended that you notify your local DEA Field Office of the new security established at your temporary location. The temporary pharmacy is authorized to operate under the same DEA number that was issued to the destroyed or heavily damaged pharmacy. The temporary structure must comply with all regulatory requirements applicable to registered pharmacies. In particular, please note that security controls for controlled substances stored or dispensed in the temporary structure must be adequate to comply with 21 CFR 1301.71, including the requirements specifically listed at 21 CFR 1301.75(b).
If the destroyed or heavily damaged pharmacy is temporarily moved to a different physical address, the address on the DEA registration for the pharmacy must be modified to reflect the new physical address. 21 CFR 1301.51. The DEA registration may be modified to the new physical address by using the online modification form. Also, registrants should ensure that applicable state and local law allows for this type of transfer. Again, it is recommended that the pharmacy personnel contact the local DEA Field Office for assistance in DEA record-keeping and security requirements. As with temporary structures at the same address, the temporary location at the new address must also comply with all regulatory requirements applicable to registered pharmacies, including security control requirements. EO-DEA156, June 4, 2020
Narcotic Treatment Program (NTP)
Answer: While not necessarily an exhaustive list, the following are a few suggested options for providing doses to NTP patients during civil unrest:
1. An NTP may coordinate with another NTP for guest dosing. To do so, the NTP may refer patients to another NTP for dosing.
2. At this time, under the COVID-19 public health emergency, DEA is permitting NTPs to repeatedly use the same alternate location to deliver take-home methadone doses to their patients without separately registering that location with DEA. Off-site location delivery of methadone is only available for patients who are authorized to take home doses of methadone to use on their own and is not available for patients who must have individual doses of methadone administered or dispensed directly to them by the OTP each day. For additional information please see the DEA guidance document on registered NTPs dispensing methadone during the public health emergency. DEA is also permitting NTPs to regularly use the same off-site location to deliver take-home buprenorphine doses to their patients without separately registering that location with DEA during the public health emergency. For additional information on providing take-home buprenorphine doses, please see the DEA guidance document on registered NTPs dispensing buprenorphine. The delivery of take-home methadone and buprenorphine doses through off-site unregistered locations is subject to the conditions and limitations described in the DEA guidance documents at the links above.
3. An NTP may also authorize an NTP staff member, law enforcement officer, or National Guard personnel to make doorstop deliveries of take-home doses of methadone or buprenorphine in an approved lock-box, as allowed by another exception granted by DEA during this public health emergency. Please see the letter announcing this exception. Delivery of take-home doses in this manner is subject to the conditions and limitations described in that letter.
Your state's opioid treatment authority may impose additional requirements; please consult with your state's opioid treatment authority to ensure your actions are compliant with both state and federal law. Please contact your local DEA Field Office for assistance with any of these activities. EO-DEA163, June 9, 2020
Answer: Yes, you may modify your DEA registration and change your address to another location, or to your mailing address, provided it is a physical location and not a Post Office box, if state law permits. You may modify your registration online. 21 CFR 1301.51. If an emergency is ongoing, DEA is exercising its flexibility to allow you to move your controlled substances to the new location prior to the submission of your DEA registration modification. You must continue to comply with all security and recordkeeping requirements, including, but not limited to, 21 CFR 1301.75(b), which requires you to store all controlled substances in a securely locked, substantially constructed cabinet.
Further questions can be directed to your local DEA Field Office. EO-DEA155, June 9, 2020
Answer: When possible, secure all drugs for assessment. Any controlled substances damaged by fire or water, exposed to high temperatures, or otherwise damaged should be collected for proper disposal. Any pharmacy that desires to dispose of controlled substances must do so in accordance with the DEA regulations, including recordkeeping (21 CFR Part 1317). A pharmacy can promptly destroy controlled substances by rendering them non-retrievable using an on-site method of destruction. See 21 CFR 1317.05(a)(1). Alternatively, a pharmacy can promptly deliver that controlled substance to a reverse distributor's registered location by common or contract carrier pick-up or by reverse distributor pick-up at the pharmacy's registered location. See 21 CFR 1317.05(a)(2). EO-DEA162, June 12, 2020
Answer: If you intend to discontinue business activities altogether, please promptly notify your local DEA Field Office. You must return your certificate of registration for cancellation and any unexecuted order forms (DEA 222s) to the attention of the DEA Registration Unit at 8701 Morrissette Drive, Springfield, VA 22152. 21 CFR 1301.52. You must also dispose of any controlled substances in your inventory in accordance with 21 CFR 1317.05.
Further questions can be directed to your local DEA Field Office.
Please also contact your state regulatory boards for additional guidance. EO-DEA166, June 10, 2020
Answer: If you are unable to conduct business, it is recommended that you advise your patients of the following regarding how they may obtain their controlled substance medications from another pharmacy.
DEA regulations allow for the transfer of original prescription information for a schedule III-V controlled substance to another pharmacy for refill purposes on a one-time basis only. However, if your pharmacy electronically shares a real-time, online database with another pharmacy, original prescription information may be transferred to allow that pharmacy to refill the prescription up to the maximum number of refills permitted by law and the prescriber's authorization. 21 CFR 1306.25(a).
Please note, all transfers must be communicated directly between two licensed pharmacists and comply with all other applicable requirements of 21 CFR 1306.25(b)–(e).
DEA recommends that you contact your state pharmacy authority to ensure that you remain in compliance with state pharmacy laws and guidance. Please contact your local DEA Field Office for additional information. EO-DEA164, June 10, 2020
Question: Could the DEA provide distributors with guidance on reporting of suspicious orders for pharmacies that need to replenish stocks of controlled substances lost or damaged due to looting/rioting or pharmacies that may need to acquire additional stocks due to closure of neighboring pharmacies?
Answer: The Controlled Substances Act requires that all DEA registrants that distribute controlled substances report suspicious orders to DEA. 21 U.S.C. 832(a)(3). The term suspicious order "may include, but is not limited to: (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; and (C) orders of controlled substances of unusual frequency." 21 U.S.C. 802(57) and 21 CFR 1301.74(b).
DEA recognizes that a pharmacy may need to replace a substantial portion, or all, of its controlled substance stock due to losses caused by looting or rioting. DEA also recognizes that a pharmacy may need to order additional stocks of controlled substances that exceed its normal ordering patterns due to increased legitimate customer demand arising from the closure of neighboring pharmacies.
Upon receiving orders falling within the definition of "suspicious order," registrants must conduct appropriate due diligence by considering all relevant circumstances to determine if there is a legitimate basis for the order. 21 CFR 1301.74(c). If the registrant cannot determine that the order is legitimate, the order must be reported as suspicious. 21 CFR 1301.74(b). EO-DEA159, June 9, 2020
Answer: Yes. You may store schedule II, III, IV, and V controlled substances in a safe, or in a securely locked, substantially constructed cabinet in your pharmacy to prevent theft or loss. 21 CFR 1301.75(b). EO-DEA165, June 7, 2020
Question: My pharmacy has been looted or may be looted in the near future as a result of the ongoing civil unrest and rioting. I don't want to change my registered pharmacy address, but I want to move my controlled substances stock to a secure warehouse until possible rioting or looting ends. Is it permissible for me to do this?
Answer: You may choose to move your controlled substance and inventory to a warehouse for storage and safekeeping under certain circumstances.
First, you should ensure that this movement of controlled substances stock is allowed by applicable state and local law. Second, the move must be consistent with DEA physical security regulations, including your obligation to ensure that your controlled substances are stored securely and otherwise protected against theft and loss. See, e.g., 21 CFR 1301.71(a), 1301.75(b).
Third, the warehouse to which you plan to move your controlled substances inventory must either be registered with DEA or a registration exemption must apply. In particular, you may move your controlled substance inventory from your registered location to an unregistered warehouse for storage or safekeeping if that inventory will thereafter be returned to you at your original location, i.e., the same registered location from which it was moved. If that inventory will instead be moved to another location after being stored at the warehouse, the warehouse itself must be registered with DEA. See 21 CFR 1301.12(b)(1).
Fourth, you must transfer any schedule II controlled substances to the warehouse using a DEA Form 222 or the equivalent electronic order form, unless the warehouse is exempt from the requirement of DEA registration because, as just explained, your controlled substances will be returned to you at your original registered location after temporary storage at the warehouse. See 21 CFR 1305.03(a). Regardless of whether you are required to use DEA Form 222, however, your records must reflect the movement of the controlled substances to and (if they are returned to you) from the warehouse.
If the option of temporary warehouse storage is allowed by state and local law, DEA recommends you contact your local DEA Field Office regarding further logistics of utilizing a warehouse to store controlled substances on a temporary basis. EO-DEA161, June 7, 2020
Controlled Substances: 21 CFR 1301.76(b) requires that a registrant notify their DEA Division Office, in writing, within one business day of discovery of such theft or loss of controlled substances. A registrant can meet the "in writing" requirement by sending an email to the below listed DEA point of contact for your state. The registrant must also complete and submit a DEA Form 106 online. Registrants are encouraged to perform an accounting to determine the quantities of controlled substances lost or stolen and make the necessary report on a DEA Form 106 as soon as practicable.
SLCPs: 21 CFR 1314.15 requires that a regulated person must, whenever possible, orally report to their DEA Division Office any unusual or excessive loss or disappearance of an SLCP at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved. A written report of loss must be filed within 15 days after the regulated person becomes aware of the circumstances of the event. 21 CFR 1314.15(c). Section 1314.15(e) provides a suggested format for the report. EO-DEA157, June 5, 2020
Below is a listed of each states DEA point of contact for theft or losses during the civil unrest:
|DI Faith King
|DI Ariel Flores
|DI Hoang Vo
|DI Mathew D. Bissonnette
|DI Veronica Corona
|GS Lynnette Wingert
|California (Southern) San Diego & Imperial Counties
|Pamela S. Meyer
|DPM Silvia N. Colon
|D/I Javier Cruz
|District of Columbia
|GS Dianne Kellum
|A/DPM James Graumlich
|GS David F. Graham
|GS Gary Whisenand
|Illinois (Northern half)
|Megan N. Almendinger
|Illinois (Southern half)
|DI Mark Gman
|Indiana (Northern half)
|Michael J. Feraldo
|Indiana (Southern half)
|Billy P. Lane
|DI Amy Nelson
|GS Dwayne Holsapple
|GS Ben Vinson
|DI William K. Wilson
|GS Niketa Prince
|Kathy L. Federico
|GS Chenin Donahue
|DI Christopher Martinez
|DI Mark Gman
|DI Alida Lefebvre
|GS Shannon Keller
|GS Jayne Griffin
|DI Jason Martino (Camden)
|DI Tony Rego
|DPM Heather McMurry
|New York City, Long Island, & Surrounding
|DI Jonathan Rivera
|New York Upstate
|DI Kevin O'Neil
|GS Stephanie A. Evans
|GS Chenin Donahue
|Ohio Central - Columbus
|Ohio Northern - Cleveland
|GS Adam H. Roberson
|GS Shannon Keller
|GS James Stevens
|DPM Heather McMurry
|DI Alida Lefebvre
|GS Edward Logan
|GS Coralie Terpening
|GS Jennifer Reed
|A/GS Heather Wehrle
Disclaimer: Guidance documents, like this document, 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 the Department's 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.