TITLE 68: PROFESSIONS AND OCCUPATIONS
CHAPTER VII: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS
PART 1330 PHARMACY PRACTICE ACT
SECTION 1330.510 TELEPHARMACY
Section 1330.510 Telepharmacy
a) Telepharmacy shall be limited to the types of operations described in this Section. Each site where such operations occur shall be a separately licensed pharmacy. Home pharmacies that are located outside of Illinois must be licensed as a nonresident pharmacy. Nonresident pharmacies shall abide by all Illinois laws and rules when filling prescriptions for Illinois residents, except that the dispensing pharmacist and the pharmacist-in-charge shall not be required to be licensed in Illinois, except as otherwise provided in this Part.
b) Remote Dispensing Site
1) Written prescriptions presented to the remote dispensing site shall be scanned into the electronic data processing equipment to ensure initial dispensing and each refill and the original prescription may be viewed on the monitor at both the remote dispensing site and home pharmacy site. Unless otherwise provided by federal law, all written prescriptions shall be delivered to the home pharmacy for filing within 72 hours. Records shall be maintained at the home pharmacy in files separate from the home pharmacy files.
2) A remote site is considered to be under the supervision of the pharmacist-in-charge of the home pharmacy.
3) The remote site shall use its home pharmacy and pharmacy management system.
A) The system shall assign consecutive prescription numbers.
B) All records must be maintained at the home pharmacy.
C) Prescriptions dispensed at the remote site shall be distinguishable from those dispensed from the home pharmacy.
D) Daily reports must be separated for the home and remote site.
4) A pharmacist at the home pharmacy must verify each prescription before it leaves the remote site.
A) Pharmacist and pharmacy technician initials or unique identifiers must appear on the prescription record and the prescription label.
B) A pharmacist shall electronically compare via video link the stock bottle, drug dispensed, the strength and its beyond use date. The entire label must be checked for accuracy on the video link.
C) The remote dispensing site shall utilize a barcode system that prints the barcode of the stock bottle on the label of the dispensed drug. If the stock bottle does not have a barcode, the pharmacy shall create one. The technician shall scan both the stock bottle and the label of the dispensed drug to verify that the drug dispensed is the same as the drug in the stock bottle for each prescription dispensed.
D) A pharmacy may utilize a different electronic verification system that accomplishes the same purpose after review and approval of the Division.
5) Counseling must be done by a pharmacist via video link and audio link before the drug or medical device is released. The pharmacist providing counseling, pursuant to this subsection, must be employed or contracted by the home pharmacy or by a pharmacy contracted with the home pharmacy and have access to all relevant patient information maintained by the home pharmacy.
6) A pharmacist-in-charge or his or her designated pharmacist must complete monthly inspections of the remote site. Inspection criteria must be included in the policies and procedures for the site. The inspection report must be available on site for pharmacy investigator inspection.
7) Controlled substances shall be kept at the remote site in accordance with the Act and this Part. All records must be stored at the home pharmacy and at the remote site.
8) There shall be a working computer link, video link and audio link to a pharmacist at a home pharmacy whenever the prescription area is open to the public. The communication link must be checked daily and the remote site pharmacy must be closed if the link malfunctions, unless a pharmacist is physically present at the remote site.
A) The pharmacy technician located at the remote dispensing site must have one year of experience and be registered as a certified pharmacy technician, or be a student pharmacist.
B) New prescriptions received at the remote dispensing site may be entered into the remote computer system with all verification, interaction, checking and profile review by the pharmacist at the home pharmacy.
C) Each pharmacist at the home pharmacy may electronically supervise no more than 3 remote sites that are simultaneously open.
9) The facility must have a sign clearly identifying it as a remote dispensing site.
10) Security of filled prescriptions must be maintained by storing them in a separate lock drawer or cabinet.
11) The facility shall have an area for patient consultation, exclusive of any waiting area.
c) Remote Consultation Site
1) These sites have no prescription inventory.
2) Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are allowed at these sites.
3) These sites must be staffed with a pharmacy technician or certified pharmacy technician who has the knowledge necessary to use computer audio/video link for dispensing and consultation to occur. Pharmacist and pharmacy technician initials or unique identifiers must appear on the prescription record and the prescription label.
4) Written prescriptions may be received at a remote consultation site. All written prescriptions presented at a remote consultation site shall be delivered to the home pharmacy within 72 hours.
5) Security of filled prescriptions must be maintained by storing them in a separate lock drawer or cabinet.
6) Recordkeeping shall be conducted by the pharmacist (time/date) when dispensing and counseling occurred.
7) The facility shall have a room for patient consultation exclusive of any waiting area.
8) The facility must have a sign clearly identifying it as a remote consultation site.
d) Automated Pharmacy Systems (Section 22(b) of the Act)
1) Remote Automated Pharmacy Systems (RAPS)
A) These devices shall maintain a prescription drug inventory that is controlled electronically by the home pharmacy or, when operated by a pharmacy contracted with the home pharmacy, by the contracted pharmacy, which shall be utilized to dispense patient specific prescriptions.
B) These systems shall have prescription inventory, which must be secured in an automated pharmacy system and electronically connected to and controlled by the home pharmacy.
C) A pharmacist must approve all the prescription orders before they are released from the RAPS.
D) Dispensing and counseling are performed by a pharmacist employed or contracted by the home pharmacy via audio and video link.
E) All filled prescription must have a label that meets the requirements of the Act attached to the final drug container.
F) The pharmacist-in-charge of the home pharmacy, or a designated registrant, shall conduct and complete monthly inspections of the RAPS. Inspection criteria must be included in the policies and procedures for the site. The report must be available to the pharmacy investigators when requested.
G) The RAPS must be licensed with the Division as an automated pharmacy system and will be subject to random inspection by pharmacy investigators. Notwithstanding that the RAPS shall possess a license, the home pharmacy shall remain responsible for inventory control and billing. For purposes of random inspections, a pharmacist with access to the system must be available at the site within one hour, or as otherwise approved by the drug compliance investigator. In the event the Chief Pharmacy Coordinator determines that the RAPS poses a significant risk of patient harm, the RAPS must be disabled until such time as the pharmacist with access to the system is available to the site.
H) Medication dispensed at the automated pharmacy system site may only be packaged by a licensed manufacturer or repackager, or prepackaged by a licensed pharmacy in compliance with this Section. Prepackaging must occur at the home pharmacy, a pharmacy sharing common ownership with the home pharmacy, or a pharmacy that has contracted with the home pharmacy to perform prepackaging services. The following requirements shall apply whenever medications are prepackaged by a pharmacy other than the home pharmacy:
i) The prepackaging pharmacy shall be licensed in Illinois as a resident or nonresident pharmacy.
ii) The prepackaging pharmacy shall share a common database with the home pharmacy, or have in place an electronic or manual process to ensure that both pharmacies have access to records to verify the identity, lot numbers and expiration dates of the prepackaged medications stocked in the RAPS.
iii) The prepackaging pharmacy shall maintain appropriate records to identify the responsible pharmacist who verified the accuracy of the prepackaged medication.
I) Written prescriptions may be received at an RAPS. All written prescriptions presented to an RAPS shall be scanned utilizing imaging technology that permits the reviewing pharmacist to determine its authenticity. The sufficiency of the technology shall be determined by the Department. If sufficient technology is not used, the written prescriptions must be delivered to the home pharmacy and reviewed by a pharmacist prior to being dispensed to the patient.
A) A kiosk is a device that maintains individual patient prescription drugs that were verified and labeled at the home pharmacy.
B) A home pharmacy may only use the kiosk with prior approval of a patient.
C) A kiosk located on the same premises or campus of the home pharmacy shall operate under the same license as the home pharmacy. However, a kiosk must be licensed with the Division if it is not so located.
D) A kiosk shall:
i) When located on the same premises or campus as the pharmacy, inform a patient, if he or she is using the device when the pharmacy is open, that the patient may address questions and concerns regarding the prescription to a pharmacist at the pharmacy;
ii) When not located on the same premises or campus as the pharmacy, inform a patient, if he is using the device when the pharmacy is closed, that he or she may immediately direct any questions and concerns regarding the prescription to a licensed pharmacist via a pharmacy provided audio/video link;
iii) Inform a patient that a prescription is not available to be delivered by the device if the pharmacist has determined that he or she desires to counsel the patient in person regarding the prescription.
3) A pharmacy may use an automated pharmacy system to deliver prescriptions to a patient when the device:
A) Is secured against a wall or floor;
B) Provides a method to identify the patient and delivers the prescription only to that patient or the patient's authorized agent;
C) Has adequate security systems and procedures to prevent unauthorized access, to comply with federal and State regulations, and to maintain patient confidentiality;
D) Records the time and date that the patient removed the prescription from the system.
4) A licensed automated pharmacy system shall not be utilized by prescribers. Nothing in this Section shall prevent a prescriber from utilizing an automated pharmacy system in connection with his or her own dispensing. However, a prescriber may not utilize or access an automated pharmacy system licensed pursuant to this Section.
e) All pharmacists performing services in support of a remote dispensing site, remote consultation site, kiosk, or RAPS must display a copy or electronic image of their licenses at the remote site where they provide services, or shall otherwise make their license visible to the patient, and be licensed in this State, unless employed by a pharmacy licensed in Illinois as a nonresident pharmacy, in which case, the pharmacist providing the services shall hold an active license as a pharmacist in the state in which the nonresident pharmacy is located and only the pharmacist-in-charge of the remote site must be licensed in Illinois.
f) Each remote site must display a sign, easily viewable by the customer, that states:
1) The facility is a telepharmacy supervised by a pharmacist located at (address); and
2) The pharmacist is required to talk to you, over an audio/visual link, each time you pick up a prescription.
g) No remote site may be open when the home pharmacy is closed, unless a pharmacist employed or contracted by the home pharmacy, or by a pharmacy contracted with the home pharmacy, is present at the remote site or is remotely providing supervision and consultation as required under this Section.
(Source: Amended at 42 Ill. Reg. 20022, effective November 9, 2018)