Regulation of Telepharmacy Practice, 64096-64099 [2021-24948]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Proposed Rules]
[Pages 64096-64099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24948]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Chapter II

[Docket No. DEA-759]
RIN 1117-AB74


Regulation of Telepharmacy Practice

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Advanced notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this 
advanced notice of proposed rulemaking to obtain further information 
regarding the practice of telepharmacy. Telepharmacy is not 
specifically defined by the Controlled Substances Act (CSA) or DEA 
regulations; however, to the extent telepharmacies dispense controlled 
substances, they are under the purview of the CSA and DEA. DEA is 
considering promulgating regulations regarding telepharmacy and seeks 
to be fully informed about the practice, industry, and state regulation 
of telepharmacy.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before January 18, 2022. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``RIN 1117-AB74/Docket No. DEA-759'' on all correspondence, including 
any attachments.
     Electronic comments: DEA encourages that all comments be 
submitted electronically through the Federal eRulemaking Portal, which 
provides the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. 
Please go to https://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission, you will receive a Comment Tracking Number for your 
comment. Please be aware that

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submitted comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted, and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary. Should you wish to mail a 
paper comment in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, VA 22152-2639.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by DEA for public inspection online 
at https://www.regulations.gov. Such information includes personal 
identifying information (such as your name, address, etc.) that you 
voluntarily submit. The Freedom of Information Act applies to all 
comments received. If you want to submit personal identifying 
information (such as your name, address, etc.) as part of your comment, 
but do not want it to be made publicly available, you must include the 
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of 
your comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to https://www.regulations.gov may include 
any personal identifying information (such as your name, address, etc.) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this advanced notice of proposed rulemaking 
is available at https://www.regulations.gov for ease of reference.

Background and Purpose

I. Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
the Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act (CSA) and the Controlled 
Substances Import and Export Act (CSIEA), (21 U.S.C. 801-971), as 
amended. DEA publishes the implementing regulations for these statutes 
in 21 CFR parts 1300 to end. These regulations are designed to ensure a 
sufficient supply of controlled substances for medical, scientific, and 
other legitimate purposes, and to deter the diversion of controlled 
substances for illicit purposes.
    As mandated by the CSA, DEA establishes and maintains a closed 
system of control for manufacturing, distribution, and dispensing of 
controlled substances, and requires any person who manufactures, 
distributes, dispenses, imports, exports, or conducts research or 
chemical analysis with controlled substances to register with DEA, 
unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA 
authorizes the Administrator of DEA (by delegation of authority from 
the Attorney General) to register an applicant to manufacture, 
distribute or dispense controlled substances if the Administrator 
determines such registration is consistent with the public interest. 21 
U.S.C. 823. The CSA further authorizes the Administrator to promulgate 
regulations necessary and appropriate to execute the functions of 
subchapter I (Control and Enforcement) and subchapter II (Import and 
Export) of the CSA. 21 U.S.C. 871(b) and 958(f). Pursuant to these 
authorities, DEA is considering promulgating regulations regarding 
telepharmacy and seeks to be fully informed about the practice, 
industry, and state regulation of telepharmacy.

II. Telepharmacy

    The term telepharmacy is not currently defined by the CSA or DEA 
regulation. Generally speaking, however, telepharmacy is considered to 
be the provision of pharmacist care by a remote pharmacist, through the 
use of telecommunications and other technologies, to a patient located 
at a dispensing site. Such pharmacist care may include, but is not 
limited to: The dispensing and distribution of prescription drugs, drug 
use review, patient counseling services, and drug therapy monitoring. 
Depending on the relevant state authority and regulations, 
telepharmacies may fill paper prescriptions or electronic 
prescriptions.
    While the practice of telepharmacy varies from state to state, they 
generally fall within one of two categories: (i) Brick and mortar 
remote sites; and (ii) self-service, automated machines. Brick and 
mortar remote sites are traditional, storefront businesses, physically 
staffed by non-pharmacist employees, e.g., pharmacy technicians, who 
are remotely supervised by a pharmacist located in a separate 
``parent'' or ``hub'' pharmacy, via continuous and real-time computer, 
video, and audio links (i.e., telecommunication connection). Depending 
on the state, a pharmacy technician may assist the remote pharmacist by 
receiving and inputting prescriptions into the pharmacy's information 
management system and preparing prescriptions for dispensing.
    Self-service, automated machines are kiosks, resembling an 
Automatic Teller Machine (ATM), which contain pharmacy prescription 
medication/inventory, labeling equipment, and the telecommunication 
technology that connects the patient-user to the remote pharmacist via 
real-time video and audio links. Such automated machines may accept 
prescriptions or refill orders, store prepackaged or repackaged 
medications, label and dispense patient-specific prescriptions, and 
ultimately dispense the prescription to the patient-user.
    Telepharmacy has expanded nationwide over the past two decades to 
address the need for pharmacy care in rural and other underserved 
communities, which may have a difficult time recruiting or supporting 
the employment of a pharmacist full-time. Despite the benefit of 
increased access to pharmacist care, such telepharmacies may pose a 
heightened risk of diversion by not having a pharmacist physically 
present to supervise and oversee remote sites and by not having any in-
person monitoring

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of automated machines. As many of these telepharmacies may dispense 
controlled substances, DEA is considering promulgating regulations for 
a special or modified telepharmacy registration.

III. Online Pharmacies Under the Ryan Haight Act

    As telepharmacies utilize the internet to dispense controlled 
substances, they may constitute Online Pharmacies under the Ryan Haight 
Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) and 
must therefore either: (1) Obtain a modified registration under 21 CFR 
1301.19; or (2) meet one of the exceptions to an Online Pharmacy under 
21 CFR 1300.04(h). The terms ``internet'' and ``online pharmacy'' are 
defined in the CSA. The internet is ``collectively the myriad of 
computer and telecommunications facilities, including equipment and 
operating software, which comprise the interconnected worldwide network 
of networks that employ the Transmission Control Protocol/internet 
Protocol, or any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio.'' 21 U.S.C. 802 
(50) and 21 CFR 1300.04(g).
    An online pharmacy is defined as any ``person, entity, or internet 
site, whether in the United States or abroad, that knowingly or 
intentionally delivers, distributes, or dispenses, or offers or 
attempts to deliver, distribute, or dispense, a controlled substance by 
means of the internet.'' 21 U.S.C. 802 (52) and 21 CFR 1300.04(h). It 
is unlawful for any person or entity to operate as an online pharmacy, 
unless that person or entity is a DEA registered pharmacy under 21 CFR 
1301.13 and DEA has approved and issued that person or entity a 
modified registration. 21 U.S.C. 823(f) and 21 CFR 1301.13(a). DEA may 
deny registration of an internet pharmacy if it determines the issuance 
of the necessary license modification would be inconsistent with the 
public interest. 21 CFR 1301.19(a). To date, there are no online 
pharmacies registered with DEA.
    Paragraph (h) of 21 CFR 1300.04, provides ten exceptions to the 
definition of ``online pharmacy,'' eight of which come directly from 
the Ryan Haight Act. 21 CFR 1300.04(h)(1)-(10); 21 U.S.C. 802(52)(B). 
The first seven exceptions of the regulation provide exemptions for: 
DEA-registered manufacturers, distributors, and non-pharmacy 
practitioners; certain hospitals and other health care facilities 
associated with the United States government, and their respective 
agents and employees; advertisements that do not attempt to facilitate 
an actual transaction involving a controlled substance; and non-
domestic persons, entities, or internet sites that do not facilitate 
the delivery, distribution, or dispensing of a controlled substance to 
persons in the U.S. The last three exceptions exempt pharmacies whose 
dispensing of controlled substances by means of the internet consists 
solely of: Filling or refilling prescriptions for controlled substances 
in schedules III-V; filling prescriptions that were electronically 
prescribed; and transmitting prescription information between a 
pharmacy and an automated dispensing system located in a long-term care 
facility. Telepharmacies may not use the internet to facilitate the 
dispensing of controlled substances unless they have been issued a 
modified registration under 21 CFR 1301.19 or fall within one of these 
exceptions.

IV. Electronic Prescriptions of Controlled Substances (EPCS) Exception

    The one exception DEA finds applicable in the context of 
telepharmacy is the Electronic Prescriptions of Controlled Substances 
(EPCS) exception. The EPCS exception provides that a DEA-registered 
pharmacy is not an Online Pharmacy if: ``. . . [its] dispensing of 
controlled substances by means of the internet consists solely of 
filling prescriptions that were electronically prescribed in a manner 
authorized by [chapter II of title 21 of the CFR] and otherwise in 
compliance with the [Controlled Substances Act]'' (emphasis added). 21 
CFR 1300.04(h)(9). Pharmacies are authorized to fill electronically 
transmitted prescriptions for controlled substances provided that the 
pharmacy complies with the requirements of parts 1306 and 1311 of the 
regulations. 21 CFR 1306.08. Under this EPCS exception, telepharmacies 
are permitted to fill electronic prescriptions of controlled substances 
in compliance with DEA's EPCS regulations; however, they are not 
permitted to fill paper prescriptions of controlled substances. The 
EPCS exception does not, however, constitute a legal safe harbor that 
would excuse or cure other regulatory violations; telepharmacies must 
still otherwise comply with DEA regulations regarding registration, 
prescriptions, security, recordkeeping, and reporting.

V. State Regulations

    DEA is aware that several states have authorized telepharmacy 
practice under their general legislative authority and through a 
variety of state regulatory entities, including state boards of 
pharmacy and state licensing commissions. While DEA has obtained some 
information regarding state telepharmacy regulations, it does not 
believe that the information it has is complete. Therefore, as 
discussed further below, DEA is specifically seeking information from 
state regulatory authorities regarding states' legislative and/or 
regulatory requirements for telepharmacy licensing and regulations.

Comments Requested

    DEA is soliciting information from the state regulatory 
authorities, national and professional associations, industry, 
telepharmacy vendors and servicers, and the general public so that DEA 
may obtain a better understanding of telepharmacy and how it is 
currently working. DEA seeks to promulgate requirements for 
telepharmacies in light of the growth of this telehealth service 
nationwide, particularly in how they dispense controlled substances. 
Commenters are encouraged to include the question number enumerated 
below in their response (e.g., ``I.4'' or ``II.20''). Although all 
comments are welcome, DEA is particularly interested in comments 
regarding the questions listed below and any other pertinent 
information and input on telepharmacy.
I. State Regulatory Authorities
    1. Please describe the organization and operation of telepharmacy 
practices authorized in your state. E.g., does your state permit or 
license both remote dispensing sites and automated machines?
    2. How many telepharmacies are currently authorized or licensed in 
your state? Do you foresee even greater growth of telepharmacies in 
your state?
    3. Please describe the telepharmacy licensing process in your 
state, including the criteria by which a licensing application is or 
will be approved or denied.
    4. Is a patient-practitioner relationship required prior to 
telepharmacy services for a controlled and/or non-controlled drug 
product?
    5. How many remote dispensing sites/automated machines can one 
remote pharmacist supervise at one time? If multiple remote sites, what 
happens when the pharmacist is needed by multiple remote dispensing 
sites at the same time?
    6. Are there limits to how many remote pharmacists or organizations 
can access a dispensing site or automated machine?

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    7. Is there a controlled substance volume limit/restriction with 
telepharmacies?
    8. What additional policies and procedures are required of 
telepharmacies that are not required of other pharmacies?
    9. What additional security requirements are required of 
telepharmacies that are not required of other retail or community 
pharmacies?
    10. Are there any regulatory considerations or policies regarding 
transfer of controlled and/or non-controlled substances to remote sites 
(in cases where drugs are stored at the remote site)?
    11. Do remote dispensing sites or automated machines need to be at 
the same location as (or within a certain distance from) the remote 
pharmacist? Do the remote dispensing sites or automated machines need 
to be a certain distance from another remote dispensing site or 
automated machine?
    12. Does the remote pharmacist need to be in the same state (board 
jurisdiction) as the remote sites or automated machines?
    13. Are there other restrictions on where a remote site or 
automated machine may be located? E.g., are they only permitted at 
hospitals? Can an automated machine be placed outside a gas station or 
convenience store, or in proximity to a school? Does your state allow 
telepharmacy services in nursing homes, assisted living facilities, or 
for hospice programs?
    14. Does your state allow interstate practice of telepharmacy, i.e. 
the practice of telepharmacy across state lines? Do out-of-state 
pharmacists providing telepharmacy services into your state need to 
register with your state board?
    15. Can a remote pharmacist with an out-of-state license, who is 
authorized under federal law to care for patients in your state (e.g., 
Department of Veterans Affairs pharmacists), serve as the pharmacist 
for a dispensing site or automated machine?
    16. What recordkeeping and reporting requirements are there for 
telepharmacies?
    17. Please describe the state's inspection process for 
telepharmacies.
    18. Do the pharmacy technicians that staff remote sites need to be 
certified or licensed by the state? Can telepharmacies hire pharmacy 
technicians with criminal histories?
    19. Does your state limit the type or manner of prescriptions that 
can be filled by the remote site or automated machine? Are they only 
allowed to fill non-controlled substances? Do they only fill electronic 
prescriptions as opposed to paper prescriptions? Are faxed 
prescriptions permitted?
    20. Are there any specific regulations or considerations regarding 
prescribing and dispensing of opioid reversal agents by telepharmacy or 
automated machines?
    21. Please provide examples of major issues associated with 
telepharmacy that have been reported to your state regulatory 
authorities?
    22. Please provide any information that could be used to help DEA 
quantify or discuss qualitatively the potential costs and benefits of a 
rule that would either promote or restrict the use of telepharmacy.
II. Industry and Health Care Providers
    23. Are the remote sites or automated machines typically owned and 
operated by the owner of the parent or hub pharmacy? If they do not 
share owners, how is recordkeeping handled?
    24. How are locations selected for the remote sites or automated 
machines? If locations are based on the sociodemographic of a region or 
community, can you provide the data or information considered.
    25. What additional training, if any, do you provide telepharmacy 
pharmacists and telepharmacy support staff?
    26. With the absence of the pharmacist at the remote site and 
automated machine, how does the pharmacist adequately supervise and 
oversee telepharmacy technicians and staff?
    27. If controlled substances are dispensed at your telepharmacy 
practice, are they stored and accounted for separately from non-
controlled substances?
    28. If your practice has not implemented the use of electronic 
prescriptions, what is preventing you from full implementation?
    29. For those that have not adopted telepharmacy, what are the 
reasons or barriers to adopting telepharmacy?
    30. How does the pharmacist make his or her final verification of 
the filled prescription remotely?
    31. Is your remote site or automated machine registered with the 
DEA? If so, under what business activity?
    32. If you are a remote pharmacist at a telepharmacy, how many 
remote sites and automated machines can you adequately supervise during 
the same period of time?
    33. Please provide any information that could be used to help DEA 
quantify or discuss qualitatively the potential costs and benefits of a 
rule that would either promote or restrict the use of telepharmacy.
III. Telepharmacy Vendors and Servicers
    34. Please describe how telepharmacy technology and systems 
safeguard against diversion by the public at large, as well as by 
employees at remote sites and automated machines.
    35. From a design standpoint, how are automated machines used in 
telepharmacy practices similar and dissimilar from the Automatic 
Dispensing Systems (ADSs) used at Long Term Care Facilities?
    36. Are your telepharmacy technology and systems Health Insurance 
Portability and Accountability Act compliant?
    37. Are your telepharmacy technology and systems accessible for 
individuals with disabilities, e.g., such as hearing impaired or blind 
persons?
    38. Do you offer 24/7 surveillance of the telepharmacy remote site 
or automated machine?
    39. Please provide any information that could be used to help DEA 
quantify or discuss qualitatively the potential costs and benefits of a 
rule that would either promote or restrict the use of telepharmacy.

Statutory and Executive Order Review

    This advanced notice of proposed rulemaking (ANPRM) has been 
drafted and reviewed in accordance with Executive Order 12866, 
``Regulatory Planning and Review'' and Executive Order 13563, 
``Improving Regulation and Regulatory Review.'' The Office of 
Management and Budget has determined that this ANPRM is a significant 
regulatory action under Executive Order 12866, section 3(f), and 
accordingly this ANPRM has been reviewed by the Office of Management 
and Budget. However, this action does not propose or impose any 
requirements.
    Furthermore, the requirements of the Regulatory Flexibility Act 
(RFA) do not apply to this action because, at this stage, it is an 
ANPRM and not a ``rule'' as defined in 5 U.S.C. 601. Following review 
of the comments received in response to this ANPRM, if DEA proceeds 
with a notice or notices of proposed rulemaking regarding this matter, 
DEA will conduct all relevant analyses as required by statute or 
Executive order.

Anne Milgram,
Administrator.
[FR Doc. 2021-24948 Filed 11-16-21; 8:45 am]
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