Proposed Rule2021-24948
Regulation of Telepharmacy Practice
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 17, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 219 (Wednesday, November 17, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking Number, your
comment has been successfully submitted, and there is no need to
resubmit the same comment.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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]
BILLING CODE P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.