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Administering
Question: The Food and Drug Administration (FDA) made an allowance for
certain Risk Evaluation and Mitigation Strategies (REMS)-certified
healthcare providers (HCPs) to provide medically supervised treatment in
the patient's home during the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency. As an alternative to this, would DEA allow HCPs to
administer REMS-designated controlled substances to patients in the parking
lot at the HCPs' DEA-registered locations?
Answer: The Controlled Substances Act (CSA) and its implementing
regulations require a separate registration for each principal place of
business or professional practice where controlled substances are
manufactured, distributed, or dispensed, as set forth in 21 U.S.C. 822(e)
and 21 C.F.R. 1301.12(a). The term "dispense," as defined in 21 U.S.C.
802(10), means to "deliver a controlled substance to an ultimate user or
research subject by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled substance...."
Neither the CSA nor DEA regulations specifically address whether healthcare
providers may dispense controlled substances to patients in the parking
lots of their DEA-registered locations. Nevertheless, in consideration of
safety concerns for the aforementioned healthcare providers and their
patients, DEA is exercising its authorities to provide flexibilities in the
dispensing of controlled substances so as to permit the dispensing of
controlled substances in provider parking lots under certain conditions.
For the duration of the nationwide public health emergency declared by the
Secretary of Health and Human Services on January 31, 2020, as a result of
COVID-19 (unless this allowance is first modified or withdrawn by DEA), DEA
will consider it permissible under the CSA for healthcare providers to
provide medically supervised treatment using controlled substances,
including REMS-designated controlled substances, in the parking lots of
their DEA-registered healthcare facilities, so long as a provider's parking
lot is located immediately adjacent to the provider's DEA-registered
facility. This activity, however, must be carried out in compliance with
all other applicable federal, state, and tribal laws and regulations.
EO-DEA213, DEA-DC-043, July 28, 2020
Telemedicine
Question: I am registered with DEA in one state, but will be prescribing
controlled substances to patients in another state via telemedicine in a
manner permitted by the Ryan Haight Act. Will I need to hold a separate DEA
registration in the state where my patients are located?
Answer: Yes (with certain limited exceptions, including an exception
broadly applicable during the COVID-19 public health emergency). The
Controlled Substances Act (CSA) generally requires practitioners
prescribing controlled substances to patients in another state via
telemedicine to be registered in those patients' state. The CSA does so in
two distinct but partially overlapping ways.
First, unless subject to an exception, the CSA requires all practitioners
to be registered in the state in which the patients to which they are
prescribing controlled substances are located, regardless of whether the
prescribing is taking place via telemedicine. The CSA provides that every
person who dispenses, or who proposes to dispense, any controlled substance
shall obtain from DEA a registration issued in accordance with DEA rules
and regulations. See 21 U.S.C. 822(a)(2). Under the CSA, such dispensing
includes prescribing and administering controlled substances. Id. 802(10).
DEA may only register a person to dispense a controlled substance if that
person is permitted to do so by the jurisdiction in which his or her
patients are located. See id. 802(21), 823(f). Thus, unless an applicable
exception applies, DEA regulations require a practitioner to obtain a
separate DEA registration in each state in which a patient to whom he or
she prescribes a controlled substance is located when the prescription is
made, regardless of whether the prescription is made via telemedicine.
Second, in addition to this generally applicable registration requirement,
the CSA also contains provisions (added by the Ryan Haight Act) expressly
requiring a practitioner to be registered in the state in which the patient
to whom he is prescribing is located when he or she is engaged in certain
forms of telemedicine. Under the CSA, a prescription for a controlled
substance issued by means of the Internet must generally be predicated on
an in-person medical evaluation. See id. 829(e)(1). This requirement does
not apply, however, when a practitioner is practicing telemedicine as
defined by the CSA. The CSA's definition of the practice of telemedicine
includes multiple different categories of telemedicine. And, for certain of
these categories, the CSA specifically requires a practitioner of
telemedicine to have a DEA registration in the state in which the patient
is located. See, e.g., id. 802(54)(A)(ii)(III), (E), 831(h)(1)(B).
There are, however, certain limited exceptions to both the general and
telemedicine-specific registration requirements. Most notably, DEA is
permitted to waive practitioners' general registration requirements by
regulation when consistent with the public health and safety, id. 822(d),
and has done so for certain categories of practitioners. See 21 CFR
1301.23. The CSA also waives the telemedicine-specific requirement of
registration in the patients' state for telemedicine practitioners in these
categories. See 21 U.S.C. 802(54)(A)(ii)(III)(a), 831(h)(1)(B)(i). Thus,
practitioners in these registration-waived categories can prescribe
controlled substances to patients in another state via telemedicine without
being registered in that state.
Exceptions may also apply in certain other situations. In particular,
during the COVID-19 public health emergency, DEA has granted a temporary
exception to its regulations-Exception to Separate Registration
Requirements Across State Lines (DEA067), issued March 25, 2020-to allow
practitioners to prescribe controlled substances in states in which they
are not registered if the practitioner is registered with DEA in at least
one state and has permission under state law to practice using controlled
substances in the state where the dispensing occurs. In other words, under
this exception, a DEA-registered practitioner is not required to obtain
additional registration(s) with DEA in the additional state(s) where the
practitioner's dispensing (including prescribing and administering) occurs
if the practitioner is authorized to dispense controlled substances by both
the state in which the practitioner is registered with DEA and the state in
which the dispensing occurs. Practitioners may utilize this temporary
exception via in-person prescribing or prescribing via telemedicine. Id.
802(54)(D). A practitioner using this exception must continue to comply
with the laws and regulations of the state in which they are
DEA-registered, and the laws and regulations of the state in which they are
practicing, if different. DEA has granted this exception through the
duration of the COVID-19 public health emergency as declared by the
Secretary of Health and Human Services.
The CSA also authorizes the practice of telemedicine by a practitioner
registered in any state during certain limited medical emergency situations
requiring immediate intervention to avoid imminent and serious clinical
consequences, such as further injury or death. Id. 802(54)(F).
Thus, practitioners generally must be registered with DEA in a patient's
state to prescribe controlled substances to that patient via telemedicine,
but a number of exceptions to that requirement exist. EO-DEA192,
DEA-DC-044, July 28, 2020
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. 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.
DEA-DC-16, March 17, 2020
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. DEA070 - March 24, 2020
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 the OPIOID Public Health
Emergency (PHE) Information page.
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. DEA081, April 8, 2020
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 the OPIOID
Public Health Emergency (PHE) Information page.
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 OPIOID Public Health Emergency (PHE)
Information page.
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@dea.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@dea.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 the
OPIOID Public Health Emergency (PHE) Information page.
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@dea.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@dea.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 the
OPIOID Public Health Emergency (PHE) Information page.
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. EO-DEA082, April 7, 2020
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: 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?
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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DIVERSION CONTROL DIVISION
U.S. Department of Justice
Drug Enforcement Administration
DIVERSION CONTROL DIVISION
8701 Morrissette Drive
Springfield, VA 22152
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