Diversion Control Division, US Department of Justice, Drug Enforcement Administration

COVID-19 Information Page  >  COVID-19 FAQ

COVID-19 FAQ

Questions & Answers

Telemedicine

Question: Can telemedicine now be used under the conditions outlined in Title 21, United States Code (U.S.C.), Section 802(54)(D)?

Narcotic Treatment Program

Question: Can a narcotic treatment program (NTP) order and store additional amounts of methadone during the COVID-19 crisis where these additional quantities would not fit in the schedule II controlled substances safe?

Question: Can a narcotic treatment program (NTP) mail methadone to enrolled patients at their home using the U.S Postal Service?

National Drug Supply

Question: I’ve heard talk of methadone shortages during the pandemic. Are there possible threats of a methadone shortage as a result of the COVID-19 outbreak?

Suspicious Orders and Due Diligence

Question: The government's current recommendations around social distancing have implications for distributors. For example, some of the regular due diligence functions carried out by the distributor to fulfill "Know Your Customer" expectations may have to be delayed, such as pharmacy site visits. Most wholesalers have imposed travel restrictions on their associates which would preclude these visits until such time the spread of the virus is under control, which could be several months. Many pharmacies are likewise trying to limit unnecessary visits at their locations, especially those that do not directly involve servicing patients with medical needs. How can distributors practice social distancing while remaining in compliance with the CSA and DEA regulations?

Question: Distributors are seeing changes in controlled substances ordering behavior by their customers, particularly by DEA-registered pharmacies and hospitals. Some of this behavior is driven by customer fears of disruption to the supply chain. In other instances, prescribing behavior intended to limit social exposure at hospitals, clinics, and pharmacies (such as prescribing in larger quantities to supply the patient for a great period of time), may also lead to changes in pharmacy ordering behavior. What is DEA's guidance for distributors when faced with the issue of changes in customer ordering activity involving controlled substances tied to COVID-19?

Prescriptions

Question: How do U.S. citizens in foreign countries, who cannot leave due to Covid-19, get their controlled substance medication from the United States?

Question: During the COVID-19 public health emergency, may DEA-registered hospitals/clinics conduct remote identity proofing of individual practitioners eligible to use the hospital/clinic’s electronic prescription application to sign prescriptions for controlled substances?

Records and Reports

Question: Can registered pharmacies postpone biennial controlled substance inventories during the nationwide public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID-19)?

Question: Due to Coronavirus Disease 2019 (COVID-19) social distancing measures, pharmacies that are receiving shipments of controlled substances from distributors are refusing to physically sign manifests as Proof of Delivery. What can distributors do to document that the pharmacy received the order upon delivery?

Question: In view of COVID-19, some distributors' customers are establishing what they refer to as "safe zones" to which they want their distributor to deliver their orders of controlled substances. These "safe zones" are not on the premises of a DEA-registered location and are being established to promote social distancing, because at some point customers will not want delivery drivers to enter their clean environment. Is there a way that distributors can legitimately make deliveries of controlled substances to these "safe zones?"

Question: Some purchasers are having difficulty or are not able to mail DEA-222 forms to their distributors. Can DEA make an allowance during the COVID-19 public health emergency so that purchasers may fax or scan the DEA-222 forms to the supplier registrants in lieu of mailing the hard copy?

Question: Emergency Alternate sites: How can a distributor set up an alternate location from which to deliver controlled substances to pharmacies and hospitals in the event that a distributor's registered location(s) becomes inoperative due to COVID-19-related circumstances?

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Question: Whereas it is generally understood that distributors deliver controlled substances to their customers, is there anything in the law that prevents a customer from coming to the distribution center to pick up their order?

Registration

Question: Emergency Alternate sites: How can a distributor set up an alternate location from which to deliver controlled substances to pharmacies and hospitals in the event that a distributor's registered location(s) becomes inoperative due to COVID-19-related circumstances?

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Question: Whereas it is generally understood that distributors deliver controlled substances to their customers, is there anything in the law that prevents a customer from coming to the distribution center to pick up their order?

Pseudoephedrine And Listed Chemicals

Question: During the COVID-19, am I required to make customers sign a logbook to purchase over-the-counter pseudoephedrine products?

Miscellaneous

Question: Does DEA have any recommendations for how health care systems should best deploy registrants that are at a high risk for infection during the COVID-19 health emergency?


Telemedicine

Question: Can telemedicine now be used under the conditions outlined in Title 21, United States Code (U.S.C.), Section 802(54)(D)?

Answer: Yes. While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency under 42 U.S.C. 247d (section 319 of the Public Health Service Act), as set forth in 21 U.S.C. 802(54)(D). Secretary Azar declared such a public health emergency with regard to COVID-19 on January 31, 2020 (https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus.html). On March 16, 2020, the Secretary, with the concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States. Accordingly, as of March 16, 2020, and continuing for as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:

  • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
  • The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and
  • The practitioner is acting in accordance with applicable Federal and State laws.

Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.

The term "practitioner" in this context includes a physician, dentist, veterinarian, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which s/he practices to prescribe controlled substances in the course of his/her professional practice (21 U.S.C. 802(21)).

Important note: If the prescribing practitioner has previously conducted an in-person medical evaluation of the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the Secretary of Health and Human Services, so long as the prescription is issued for a legitimate medical purpose and the practitioner is acting in the usual course of his/her professional practice. In addition, for the prescription to be valid, the practitioner must comply with applicable Federal and State laws.

Narcotic Treatment Program (NTP)

Question: Can a narcotic treatment program (NTP) order and store additional amounts of methadone during the COVID-19 crisis where these additional quantities would not fit in the schedule II controlled substances safe?

Answer: Questions relating to the physical security of the handling of controlled substances need to be forwarded and addressed to your local DEA field office. The local DEA field office is directly responsible for the registrants in their area of responsibility. They will able to assist you relating to physical security issues. Contact your Local DEA Field Office for assistance. (DEA071 – March 22, 2020)

Question: Can a narcotic treatment program (NTP) mail methadone to enrolled patients at their home using the U.S Postal Service?

Answer: No. The Controlled Substances Act (CSA) generally permits the dispensing and delivery of controlled substances by mail from a DEA-registered pharmacy to a legitimate ultimate user pursuant to a valid prescription. However, the CSA and DEA regulations include additional controls for narcotic drugs used for maintenance or detoxification treatment. See 21 U.S.C. 823(g); 21 CFR 1301.28, 1301.74(i)-(l), 1306.07. Due to the high risk of diversion posed by maintenance or detoxification treatment using the schedule II narcotic methadone, DEA regulations provide that an NTP may not prescribe methadone for maintenance or detoxification treatment, and may only administer or dispense it directly to a narcotic dependent person for the purpose of maintenance or detoxification treatment. 21 CFR 1301.74(i), 1306.07.

Recently, in light of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, DEA has waived some of the limitations regarding methadone dispensing for maintenance and detoxification treatment to ensure continued access during the COVID-19 (Coronavirus) emergency. At this time, DEA has authorized employees of the NTP to personally deliver methadone to patients who otherwise cannot travel to the NTP (DEA NTP Delivery Guidance). In addition, DEA has issued a waiver to permit law enforcement and National Guard personnel to deliver methadone directly to patients of NTPs (DEA NTP Delivery Guidance). However, it remains the assessment of the DEA Diversion Control Division that the potential for diversion and abuse of methadone for maintenance and detoxification treatment of narcotic dependent persons is too high to extend the waiver further to permit dispensing via the U.S. Postal Service or other common carriers. Thus, DEA’s regulations prohibiting such delivery have not been waived and remain in effect.

National Drug Supply

Question: I’ve heard talk of methadone shortages during the pandemic. Are there possible threats of a methadone shortage as a result of the COVID-19 outbreak?

Answer: DEA has no information at this time indicating there is a shortage of the methadone oral dosage forms used in maintenance and detoxification treatment of opioid use disorder as a result of the pandemic. Although FDA has indicated that injectable methadone hydrochloride is currently experiencing drug shortages, DEA does not foresee any issue with obtaining methadone oral tablets or oral solution during this public health emergency. Methadone is domestically manufactured and DEA routinely interacts with the manufacturers and the FDA to ensure there is no shortage of the raw materials to manufacture the oral dosage forms. For more information on drug shortages generally, including the current shortage of methadone HCl injection, please consult FDA's drug shortages website.

Suspicious Orders and Due Diligence

Question: The government's current recommendations around social distancing have implications for distributors. For example, some of the regular due diligence functions carried out by the distributor to fulfill "Know Your Customer" expectations may have to be delayed, such as pharmacy site visits. Most wholesalers have imposed travel restrictions on their associates which would preclude these visits until such time the spread of the virus is under control, which could be several months. Many pharmacies are likewise trying to limit unnecessary visits at their locations, especially those that do not directly involve servicing patients with medical needs. How can distributors practice social distancing while remaining in compliance with the CSA and DEA regulations?

Answer: Distributors still remain responsible for maintaining effective controls against diversion by "knowing their customer" and conducting the appropriate due diligence. During the COVID-19 public health emergency declared by the Secretary, due diligence and site inspections via teleconferencing may be acceptable alternatives when the ability to conduct on-site inspections is determined to be impractical by the registrant. Distributors are also still able to obtain and review their customers' utilization reports and other documents as part of their due diligence. This paragraph is not meant to be all encompassing in terms of what distributors should be doing as part of their due diligence, rather, it is provided as examples of some of the evaluations distributors should conduct.

Question: Distributors are seeing changes in controlled substances ordering behavior by their customers, particularly by DEA-registered pharmacies and hospitals. Some of this behavior is driven by customer fears of disruption to the supply chain. In other instances, prescribing behavior intended to limit social exposure at hospitals, clinics, and pharmacies (such as prescribing in larger quantities to supply the patient for a great period of time), may also lead to changes in pharmacy ordering behavior. What is DEA's guidance for distributors when faced with the issue of changes in customer ordering activity involving controlled substances tied to COVID-19?

Answer: DEA is aware from its engagement with its federal partners and other controlled substances stakeholders that various DEA registrants may be changing their ordering patterns in order to fulfill their customers' and/or patients' needs. Distributors (and other registrants that distribute controlled substances) continue to have an obligation to maintain a system to detect suspicious orders of controlled substances and to inform their local DEA field office when suspicious orders are discovered. 21 CFR 1301.74(b). At the same time, recent significant increases in demand for certain controlled substances by pharmacies and hospitals may be attributable to legitimate needs arising out of the COVID-19 pandemic. When in doubt about the legitimacy of an order, distributors should carefully assess the circumstances surrounding the order, including the nature of the practice engaged in by the registrant placing the order, as well as the types, quantities and dosage forms of the controlled substances being ordered. Distributors should inquire with their customers to obtain an explanation for the deviation from their normal ordering patterns and document the changes in ordering behavior and the possible reasons for it in its due diligence file for each customer.

DEA has already drafted guidance on the prescribing of controlled substances in light of COVID-19. Please check DEA's COVID-19 guidance webpage

Prescriptions

Question: How do U.S. citizens in foreign countries, who cannot leave due to Covid-19, get their controlled substance medication from the United States?

Answer: Federal law and international treaties prohibit the exportation of controlled substances unless the exportation is made by a DEA registered exporter. Therefore, a U.S. citizen in a foreign country due to Covid-19 may only receive his/her medications from the United States if the medication is exported by a DEA registered exporter. In addition, a U.S. citizen may have to comply with applicable laws of the country into which the controlled substance is being imported. However, a U.S. citizen may also seek assistance from the United States Department of State, Office of Overseas Citizens Services, at 1-202-501-4444 from overseas or 1-888-407-4747 from the U.S. and visit the following Department of State Website.

Question: During the COVID-19 public health emergency, may DEA-registered hospitals/clinics conduct remote identity proofing of individual practitioners eligible to use the hospital/clinic’s electronic prescription application to sign prescriptions for controlled substances?

Answer: Yes, DEA regulations generally authorize the use of remote identity proofing when issuing authentication credentials for use in the electronic prescribing of controlled substances (EPCS), even in the absence of a public health emergency. If a hospital/clinic wishes to conduct remote identity proofing, DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication.

DEA regulations require individual practitioners engaged in EPCS, including individual practitioners working under the DEA registration of a hospital or clinic pursuant to 21 CFR 1301.22(c), to obtain an authentication credential and use that credential to electronically sign prescriptions for controlled substances. See, e.g., 21 CFR 1311.120, 1311.140. A hospital, clinic, or other institutional practitioner may obtain the necessary authentication credentials for individual practitioners eligible to use the institution’s EPCS application in either of two basic ways.

First, the hospital/clinic may elect to conduct its own in-house identity proofing as part of its credentialing process of these individual practitioners and itself authorize the issuance of the authentication credentials. If an institutional practitioner chooses to conduct its own internal identity proofing, DEA regulations require that process to meet a number of specific requirements. See 21 CFR 1311.110. DEA regulations, however, do not require that this process occur in-person. Thus, if the hospital/clinic is able to remotely conduct identity proofing in a manner that satisfies these DEA regulatory requirements, it may do so.

Second, rather than conducting its own identity proofing, a hospital/clinic may require practitioners to obtain identity proofing and authentication credentials in the same manner as practitioners not operating under an institution’s DEA registration, i.e., through a credential service provider (CSP) or certificate authority (CA). See 21 CFR 1311.105. DEA regulations require CSPs and CAs to conduct identity proofing at Assurance Level 3 or above of the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-1, "Electronic Authentication Guideline," which allows either in-person or remote identity proofing. (Since those regulations were published, changes in technology have led to the creation of new, updated NIST guidelines, NIST SP 800-63-3, "Digital Identity Guidelines." Under NIST SP 800-63-3, the relevant identity proofing assurance level is Identity Assurance Level 2. Identity Assurance Level 2 of NIST SP 800-63-3, like Assurance Level 3 of NIST SP 800-63-1, allows either in-person or remote identity proofing).

Thus, DEA regulations generally allow hospitals and clinics (as well as CSPs and CAs) to remotely conduct the identity proofing necessary to issue EPCS authentication credentials to individual practitioners. A DEA registered hospital/clinic may also want to check with their state regulatory boards to maintain compliance with any state rules or regulations regarding this matter.

Records and Reports

Question: Can registered pharmacies postpone biennial controlled substance inventories during the nationwide public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID-19)?

Answer: No. A biennial inventory is required under the Controlled Substances Act (CSA) as enacted by Congress. 21 U.S.C. 827(a)(1) requires that "every registrant under [Subchapter I-Control and Enforcement] shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the manufacture, distribution or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant’s regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply." As such, the statutory text of the CSA requires registrants engaged in the manufacture, distribution, and dispensing of controlled substances to conduct an inventory no less often than biennially. DEA's regulations implementing this provision permit such registrants to conduct the inventory "on any date which is within two years of the previous biennial inventory date," but the regulations, like the statute, do not permit the inventory to be delayed beyond two years. 21 CFR 1304.11. No waiver or exemption is currently in effect to excuse general compliance with this requirement for dispensers, including pharmacies. Any questions about the applicability of these requirements to a registrant’s particular situation should be directed to the Diversion Control Division Policy Section at (571) 362-3260.

Question: Due to Coronavirus Disease 2019 (COVID-19) social distancing measures, pharmacies that are receiving shipments of controlled substances from distributors are refusing to physically sign manifests as Proof of Delivery. What can distributors do to document that the pharmacy received the order upon delivery?

Answer: Neither the Controlled Substances Act (CSA) nor the DEA regulations require a pharmacy to sign for receipt of a shipment of controlled substances. However, the CSA and DEA regulations do require all registrants to maintain records of all controlled substances received, sold, delivered, or otherwise disposed of. 21 USC 827(a)(3); 21 CFR 1304.21(a). It is also a sound practice from a diversion control perspective for registrants to document delivery and receipt of shipments.

Question: In view of COVID-19, some distributors' customers are establishing what they refer to as "safe zones" to which they want their distributor to deliver their orders of controlled substances. These "safe zones" are not on the premises of a DEA-registered location and are being established to promote social distancing, because at some point customers will not want delivery drivers to enter their clean environment. Is there a way that distributors can legitimately make deliveries of controlled substances to these "safe zones?"

Answer: The DEA regulations provide that controlled substances must be shipped only to the purchaser and the location printed by DEA on the Form 222 or associated with the digital certificate used to sign the order (with limited exceptions inapplicable here). 21 CFR 1305.13(c) & 1305.22(f). 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 COVID-19, DEA is exercising its authorities to provide flexibility with regard to the requirements of 21 CFR 1305.13(c) & 1305.22(f). Specifically, for the remainder of the time that the public health emergency declared by the Secretary is in effect (unless DEA specifies an earlier date), DEA will consider the requirements of 21 CFR 1305.13(c) & 1305.22(f) satisfied if all of the following conditions are met:

  • The driver who is not admitted into the physical building at the DEA-registered location delivers the controlled substances to the property owned or leased by the registrant that corresponds to the DEA-registered location.
  • The delivery is picked up by an agent or employee of the receiving registrant.
  • Such agent or employee of the registrant comes outside, identifies himself/herself, and picks up the package.
  • The delivery driver records this delivery in their log, and observes the individual take the shipment inside.
  • The entity delivering the controlled substances must ensure that this is a person-to-person delivery of the controlled substances order. In other words, the controlled substances cannot be left at a location for pickup at another time by the DEA registrant. The agent or employee of the DEA registrant that ordered the controlled substances must appear in person at the time of delivery to physically receive the controlled substances order.

Note: The preceding answer is applicable to the delivery of drugs to DEA-registered pharmacies and hospital/clinics. If the receiving customer is a narcotic treatment program, the requirements of 21 CFR 1301.74(h) must also be satisfied with respect to deliveries of narcotics, in addition to the requirements stated above. This exception is posted at DEA's COVID-19 guidance webpage

In addition, it should be noted that, as stated in 21 CFR 1301.74(a), "before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Administration or with the appropriate State controlled substances registration agency, if any, to determine that the person is registered to possess the controlled substance." Thus, distributors must make a good faith effort to determine that the entity to which they are delivering the controlled substances order is registered with the DEA. Following the bulleted steps above is one way to do so.

Question: Some purchasers are having difficulty or are not able to mail DEA-222 forms to their distributors. Can DEA make an allowance during the COVID-19 public health emergency so that purchasers may fax or scan the DEA-222 forms to the supplier registrants in lieu of mailing the hard copy?

Answer: DEA has already drafted guidance on this matter. The guidance document can be found in the DEA's COVID-19 guidance webpage

Question: Emergency Alternate sites: How can a distributor set up an alternate location from which to deliver controlled substances to pharmacies and hospitals in the event that a distributor's registered location(s) becomes inoperative due to COVID-19-related circumstances?

Answer: The DEA-registered distributor requesting to establish an alternate site must submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location. Please note that this alternate site is subject to inspection by DEA personnel at any time. The distributor is not authorized to handle controlled substances at the alternate location until DEA issues it a registration for the location. DEA is making every effort to expeditiously review any application for an emergency DEA number and intends to expedite the pre-registration process when warranted.

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Answer: Before addressing this question, we wish to emphasize that DEA is making every effort to expeditiously review any application for an emergency DEA registration number and intends to expedite the pre-registration process when warranted. The DEA registrant requesting to establish an alternate site should submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA registration number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location.

Please also see the answer to the question and answer regarding what alternate delivery methods will be considered compliant with 21 CFR 1305.13(c) and 1305.22(f) during the COVID-19 public health emergency. In addition, to address the scenario in which, due to COVID-19 related considerations, the purchaser that has recently set up location for which the purchaser's DEA-222 forms do not yet reflect its new location, DEA is issuing an exception to the regulations. This exception is posted at DEA's COVID-19 guidance webpage

Question: Whereas it is generally understood that distributors deliver controlled substances to their customers, is there anything in the law that prevents a customer from coming to the distribution center to pick up their order?

Answer: Nothing in the CSA or DEA regulations prohibits a DEA registrant from picking up their controlled substances order from the distributor's location in lieu of having the controlled substances shipped by the distributor. In such circumstances, the registrant picking up the order must then take the controlled substances that it received to its registered location. The controlled substances may not be taken by the registrant to an alternative unregistered site. The purchaser must abide by the applicable security requirements set forth in the DEA regulations, including, but not limited to, those in 21 CFR 1301.71, and otherwise provide effective controls and procedures to guard against theft and diversion of controlled substances.

Please note that a third party courier is not authorized to pick up an order for the purchaser, as they are not the purchaser. The supplier can deliver it themselves to the purchaser, or they can use a common or contract carrier, but safeguarding the delivery of controlled substances remains the distributor's responsibility until is accepted by the purchaser. Thus, the supplier must notify DEA if there is a loss in transit. 21 CFR 1301.74(c). In the case of will-call, the purchaser picks up the drugs. Thus, the supplier has turned the product over to the purchaser.

DEA suggests that the staff from the purchaser that is picking up the drugs from the distribution center take a picture of the boxes/containers they are picking up. The purpose of the picture is to make sure the packages are not tampered with. Additionally, DEA would suggest that once the packages have been delivered to the registered location, that a second employee verifies what is on the DEA-222/invoice.

Registration

Question: Emergency Alternate sites: How can a distributor set up an alternate location from which to deliver controlled substances to pharmacies and hospitals in the event that a distributor's registered location(s) becomes inoperative due to COVID-19-related circumstances?

Answer: The DEA-registered distributor requesting to establish an alternate site must submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location. Please note that this alternate site is subject to inspection by DEA personnel at any time. The distributor is not authorized to handle controlled substances at the alternate location until DEA issues it a registration for the location. DEA is making every effort to expeditiously review any application for an emergency DEA number and intends to expedite the pre-registration process when warranted.

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Answer: Before addressing this question, we wish to emphasize that DEA is making every effort to expeditiously review any application for an emergency DEA registration number and intends to expedite the pre-registration process when warranted. The DEA registrant requesting to establish an alternate site should submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA registration number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location.

Please also see the answer to the question and answer regarding what alternate delivery methods will be considered compliant with 21 CFR 1305.13(c) and 1305.22(f) during the COVID-19 public health emergency. In addition, to address the scenario in which, due to COVID-19 related considerations, the purchaser that has recently set up location for which the purchaser's DEA-222 forms do not yet reflect its new location, DEA is issuing an exception to the regulations. This exception is posted at DEA's COVID-19 guidance webpage

Question: Whereas it is generally understood that distributors deliver controlled substances to their customers, is there anything in the law that prevents a customer from coming to the distribution center to pick up their order?

Answer: Nothing in the CSA or DEA regulations prohibits a DEA registrant from picking up their controlled substances order from the distributor's location in lieu of having the controlled substances shipped by the distributor. In such circumstances, the registrant picking up the order must then take the controlled substances that it received to its registered location. The controlled substances may not be taken by the registrant to an alternative unregistered site. The purchaser must abide by the applicable security requirements set forth in the DEA regulations, including, but not limited to, those in 21 CFR 1301.71, and otherwise provide effective controls and procedures to guard against theft and diversion of controlled substances.

Please note that a third party courier is not authorized to pick up an order for the purchaser, as they are not the purchaser. The supplier can deliver it themselves to the purchaser, or they can use a common or contract carrier, but safeguarding the delivery of controlled substances remains the distributor's responsibility until is accepted by the purchaser. Thus, the supplier must notify DEA if there is a loss in transit. 21 CFR 1301.74(c). In the case of will-call, the purchaser picks up the drugs. Thus, the supplier has turned the product over to the purchaser.

DEA suggests that the staff from the purchaser that is picking up the drugs from the distribution center take a picture of the boxes/containers they are picking up. The purpose of the picture is to make sure the packages are not tampered with. Additionally, DEA would suggest that once the packages have been delivered to the registered location, that a second employee verifies what is on the DEA-222/invoice.

Pseudoephedrine And Listed Chemicals

Question: During the COVID-19, am I required to make customers sign a logbook to purchase over-the-counter pseudoephedrine products?

Answer: Yes. A signature to purchase pseudoephedrine (without a prescription) is required as part of the Combat Methamphetamine Epidemic Act of 2005. See 21 U.S.C. 830(e)(1)(A).

DEA understands the concern that requiring a signature for the purchase of pseudoephedrine could undermine public health efforts to combat the spread of the coronavirus. If a customer is worried about using a stylus or pen to sign the logbook, gloves or a sterilized stylus/pen could be offered for the customer to use.

Miscellaneous

Question: Does DEA have any recommendations for how health care systems should best deploy registrants that are at a high risk for infection during the COVID-19 health emergency?

Answer: Although DEA is concerned for the safety of all its registrants, we must defer any questions regarding safe medical practices to the Center for Disease Control. Also, listed at the end of this page are links to all 50 states medical boards, pharmacy boards, and emergency operations pages.


EO13891 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.

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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