CHAPTER 20:51:30
TELEPHARMACY
Section
20:51:30:01 Definitions.
20:51:30:02 Application for remote pharmacy site.
20:51:30:03 Ownership or control by pharmacist required.
20:51:30:04 Board inspection.
20:51:30:05 License renewal.
20:51:30:06 License required.
20:51:30:07 Audiovisual link.
20:51:30:08 Remote pharmacy identification sign.
20:51:30:09 Restricted area posted.
20:51:30:10 Telephone number.
20:51:30:11 Pharmacist staffing requirements.
20:51:30:12 Technician and intern staffing requirements.
20:51:30:13 Pharmacist-to-technician ratio.
20:51:30:14 Prescription workload.
20:51:30:15 Requirements for prescription orders.
20:51:30:16 Requirements for operation.
20:51:30:17 Routine quality assurance required.
20:51:30:18 Use of automated prescription dispensing device.
20:51:30:01. Definitions. Terms defined in SDCL 36-11-71 have the same meaning when used in this chapter.
Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(1), 36-11-72.
Law Implemented: SDCL 36-11-71.
20:51:30:02. Application for remote pharmacy site. No
remote pharmacy may be established, operated, or maintained unless the board
issues a license. An application for licensure to establish,
operate, or maintain a remote pharmacy shall be made on a form provided
by the board. The applicant shall submit an initial license fee of $200 and
provide a set of blueprints and documentation showing that all requirements of
this chapter have been met. The applicant shall demonstrate to the board that
there is limited or no access to pharmacy services in the community. When
considering whether to approve an application, the board shall consider the
needs of the community. The board shall approve or disapprove an application
within 60 days of receipt.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(1).
Law
Implemented: SDCL 36-11-72(1).
20:51:30:03. Ownership
or control by pharmacist required. The board may not issue a permit to
conduct a remote pharmacy to any pharmacist applicant unless such pharmacist
applicant is an owner, or part owner, of the place of business from which the
pharmacist will practice telepharmacy, or unless the non-pharmacist owner of
the place of business from which the pharmacist will practice telepharmacy
files an affidavit on a form prescribed by the board delegating full and
complete authority to the pharmacist applicant to be in active management of
the place of business for the license year ending June 30.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(1).
Law
Implemented: SDCL 36-11-34, 36-11-72.
20:51:30:04. Board
inspection. No remote pharmacy may provide pharmacy services until the
board has inspected the remote pharmacy for minimum equipment, size, security,
and sanitation standards as set forth in § 20:51:07:01 and found the
remote pharmacy to be in compliance with such standards.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(1).
Law
Implemented: SDCL 36-11-71, 36-11-72.
20:51:30:05. License
renewal. A remote pharmacy license expires on June 30 of each year and may
be renewed annually by filing an application provided by the board. The renewal
fee is $200.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-72(1).
Law
Implemented: SDCL 36-11-72(1).
20:51:30:06. License
required. Any pharmacy licensed by the board may operate a remote pharmacy
in South Dakota. The remote pharmacy is considered an extension of the central
pharmacy. However, the remote pharmacy must have its own license as a pharmacy.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-72(1).
Law
Implemented: SDCL 36-11-72(1).
20:51:30:07. Audiovisual
link. There must be a continuously accessible, two-way audiovisual link
between the central pharmacy and the remote pharmacy. The transmission of
information through the computer link must make information available to the
central pharmacy and the remote pharmacy simultaneously. The video camera used
for the certification of prescriptions must be of sufficient quality and
resolution so that the certifying pharmacist can visually identify the markings
on tablets and capsules. A second camera is required to meet security needs if
the camera used to certify prescriptions is not able to monitor activities in
other parts of the remote site.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(2).
Law
Implemented: SDCL 36-11-72(2).
20:51:30:08. Remote
pharmacy identification sign. Each remote site shall display a sign easily
viewable by customers stating "This business is a remote pharmacy,
supervised by a pharmacist located at (insert
name of pharmacy and address)".
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(2),(5).
Law
Implemented: SDCL 36-11-72(2),(5).
20:51:30:09. Restricted
area posted. The remote pharmacy dispensing area shall be posted as a
restricted area. Only pharmacy technicians or pharmacy interns employed
directly and involved in processing prescriptions are permitted in the
dispensing area. There must be restricted access to the restricted area. The
security system at the remote pharmacy must allow for tracking of each entry
into the pharmacy. The pharmacist-in-charge shall review the log of entries at
least weekly.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(2),(5).
Law
Implemented: SDCL 36-11-72(2),(5).
20:51:30:10. Telephone number. The remote pharmacy must provide a telephone number that patients and prescribers may use to contact the central pharmacy. The telephone number must be printed on the label of each prescription container.
Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(1)(4), 36-11-46.6, 36-11-72(2)(5).
Law Implemented: SDCL 36-11-71.
20:51:30:11. Pharmacist
staffing requirements. Any pharmacist performing services in support of a
remote pharmacy, whether those services are performed at the central pharmacy
or the remote pharmacy, must be licensed by the board.
A copy of the pharmacist's license must be posted in any remote pharmacy to
which the pharmacist provides services.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-13, 36-11-72(3).
Law
Implemented: SDCL 36-11-72(3).
20:51:30:12. Technician and intern staffing requirements. Each remote pharmacy must be staffed with registered pharmacy technicians or pharmacy interns. A pharmacy technician working at a remote pharmacy without an onsite pharmacist, pharmacy intern, or experienced telepharmacy technician, must have a minimum of two thousand hours of experience as a registered pharmacy technician in accordance with chapter 20:51:29 and shall be certified in accordance with § 20:51:29:06. One thousand hours of this experience must be in a telepharmacy with an onsite pharmacist, intern, or another pharmacy technician meeting the experience requirements for technicians in this section. An intern may work at a remote pharmacy if the intern has at least five hundred hours of experience as a registered pharmacy intern in accordance with chapter 20:51:02.
Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(1)(13), 36-11-72(3).
Law Implemented: SDCL 36-11-2(26), 36-11-25, 36-11-71.
20:51:30:13. Pharmacist-to-technician
ratio. The pharmacist on duty at a central pharmacy may supervise no more
than the number of technicians allowed in accordance with § 20:51:29:19.
The total number of allowed technicians may be divided between the central
pharmacy and the remote pharmacy in any manner. However, each remote pharmacy
must have at least one pharmacy technician or pharmacy intern on duty when it
is open.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(3).
Law
Implemented: SDCL 36-11-72(3).
20:51:30:14. Prescription
workload. Any central pharmacy
providing telepharmacy services shall provide pharmacist staffing to meet the
prescription workload of both the central pharmacy and the remote pharmacy.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(3).
Law
Implemented: SDCL 36-11-72(3).
20:51:30:15. Requirements
for prescription orders. Only a registered pharmacist may take a verbal
prescription order. A pharmacy technician at the remote pharmacy may not accept
verbal orders for new prescriptions, but may accept written orders. A written
order for a new prescription may be entered at the central pharmacy or the
remote pharmacy. The pharmacist must approve or override all drug utilization
review alerts.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(5).
Law
Implemented: SDCL 36-11-72(5).
20:51:30:16. Requirements
for operation. The following requirements must be adhered to when operating
a remote pharmacy:
(1) The
remote pharmacy may only be open if a computer link, video link, and audio link
with the central pharmacy are functioning properly. If any link is not
functioning properly, the remote pharmacy must be closed unless a pharmacist is
working at the remote pharmacy;
(2) No
remote pharmacy may be open when the central pharmacy is closed, unless a
licensed pharmacist is working at the remote pharmacy;
(3) Any
prescription filled at the remote pharmacy must be profiled, reviewed, and
interpreted by a pharmacist at the central pharmacy before the prescription is
dispensed;
(4) Any
remotely dispensed prescriptions must have a label properly prepared in
accordance with § 20:51:05:21 attached to the final drug container before
the pharmacist certifies the dispensing process. This prescription
certification process must be done in real time. All prescription certification
must be documented in the computer record. The computer must be capable of
carrying the initials of the technician preparing the prescription and the
pharmacist verifying the prescription. Verification is required for both new
prescriptions and refills;
(5) When
the patient receives a prescription, the pharmacist must use audiovisual
communication to counsel the patient regarding use of the prescription being
dispensed. Counseling is required only for new prescriptions. The pharmacist
must meet the counseling standards in accordance with § 20:51:25:04;
(6) The
remote pharmacy must maintain a log, signed by the patient,
that documents a patient's refusal for counseling by the pharmacist.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(2),(3),(4),(5).
Law
Implemented: SDCL 36-11-72(2),(3),(4),(5).
20:51:30:17. Routine
quality assurance required. The pharmacist-in-charge must adhere to the
following procedures:
(1) An
inspection of the remote pharmacy shall be conducted by a licensed pharmacist
at weekly intervals or more if deemed necessary. Inspection must be documented
and kept on file at the remote pharmacy and available upon request by the
board;
(2) Implement
and conduct a quality assurance plan that provides for on-going review of
dispensing errors, with appropriate action taken, if necessary, to assure
patient safety;
(3) Verify
controlled substance prescriptions for both accuracy and legitimacy of the
original prescription by the pharmacist-in-charge or a designated pharmacist
during weekly inspection visits;
(4) Maintain
records of all controlled substances stocked by the remote pharmacy through a
daily perpetual inventory. Controlled substance perpetual inventory records
must be available for inspection by the board's inspectors. A remote pharmacy
stocking controlled drugs must be registered by the Drug Enforcement
Administration and South Dakota Department of Health;
(5) Conduct
an inventory of all controlled substances at least monthly to verify accuracy.
Source:
35 SDR 183, effective February 2, 2009.
General
Authority: SDCL 36-11-11(1), 36-11-72(4),(5).
Law
Implemented: SDCL 36-11-72(4),(5).
20:51:30:18. Use of automated prescription dispensing device. If the remote pharmacy uses an automated mechanical dispensing device, the stocking and loading of this device must either be checked by a pharmacist, prior to use, or employ a secure bar coding system or its equivalent. Policies and procedures consistent with § 20:51:17:02 regarding the operation of the automated mechanical distribution system must be developed and submitted to the board for consideration. After approval, these policies and procedures must be available at both the central pharmacy and the remote pharmacy.
Source: 35 SDR 183, effective February 2, 2009; 50 SDR 138, effective June 2, 2024.
General Authority: SDCL 36-11-11(1),(6), 36-11-72(6).
Law Implemented: SDCL 36-11-11(6), 36-11-72(6).