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 following types of operations. Each site where such operations occur shall be a separately licensed pharmacy.
1) Remote Dispensing Site
A) 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. 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.
B) A remote site is considered to be under the supervision of the pharmacist-in-charge of the home pharmacy.
C) The remote site shall use its home pharmacy and pharmacy management system.
i) The system shall assign consecutive prescription numbers.
ii) All records must be maintained at the home pharmacy.
iii) Prescriptions dispensed at the remote site shall be distinguishable from those dispensed from the home pharmacy.
iv) Daily reports must be separated for the home and remote site.
D) A pharmacist at the home pharmacy must verify each prescription before it leaves the remote site.
i) Pharmacist and pharmacy technician initials or unique identifiers must appear on the prescription record and the prescription label.
ii) 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.
iii) The remote dispensing site shall utilize a barcode system that prints the barcode of the stock bottle on the label of the dispensed drug. 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.
iv) A pharmacy may utilize a different electronic verification system that accomplishes the same purpose after review and approval of the Division.
E) Counseling must be done by a pharmacist via video link and audio link before the script is released. The pharmacist must counsel the patient or the patient's agent on all new prescriptions and refills.
F) 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.
G) 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.
H) 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.
i) The pharmacy technician must have one year of experience and be registered as a certified pharmacy technician.
ii) 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.
iii) Each pharmacist at the home pharmacy may electronically supervise no more than 3 remote sites that are simultaneously open.
I) The facility must have a sign clearly identifying it as a remote dispensing site.
2) Remote Consultation Site
A) These sites have no prescription inventory.
B) Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are allowed at these sites.
C) 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.
D) 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.
E) Security of filled prescriptions must be maintained by a separate lock drawer or cabinet.
F) Record keeping shall be conducted by the pharmacist (time/date) when dispensing and counseling occurred.
G) The facility shall have a room for patient consultation exclusive of any waiting area.
H) The facility must have a sign clearly identifying it as a remote consultation site.
3) Remote Automated Pharmacy Systems (RAPS)
A) These sites have prescription inventory, which must be secured in an automated dispensing device connected to the home pharmacy.
B) A pharmacist, or prescriber when the RAPS is located on the same premises as the prescriber, must approve all the prescription orders before they are released from the automated dispensing device.
C) Dispensing and counseling are performed by a pharmacist employed by the home pharmacy via audio link and video link or by the prescriber when the RAPS is located on the same premises as the prescriber.
D) All filled prescription must have a label that meets the requirements of the Act attached to the final drug container.
E) The pharmacist-in-charge of the home pharmacy, or a designated registrant, shall conduct and complete monthly inspections of the remote telepharmacy dispensing machine site. Inspection criteria must be included in the policies and procedures for the site. The report must be available to the pharmacy investigators when requested.
F) The RAPS must be licensed with the Division and will be subject to random inspection by pharmacy investigators. For purposes of random inspections, a pharmacist with access to the system must be available at the site within one hour.
4) Medication dispensed at the automated pharmacy system site may only be packaged by a licensed manufacturer or repackager. Prepackaging must occur at the home pharmacy in compliance with Section 1330.730.
c) All pharmacists performing services in support of the remote sites must display a copy of their licenses in any remote site where they provide services.
d) 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.
e) No remote site may be open when the home pharmacy is closed, unless the pharmacist is present at the remote site. No employees are allowed access to the remote site when the home pharmacy is closed. The security system must allow for tracking of entries into a pharmacy. The pharmacist-in-charge must review the log of entries weekly.