Indiana § 25-26-13-33 - Places that require a pharmacy permit; exceptions

§ 25-26-13-33. Places that require a pharmacy permit; exceptions

Sec. 33. (a) This section does not apply to a mail order or Internet based pharmacy (as defined by IC 25-26-18-1) to the extent that the pharmacy is allowed to operate under IC 25-26-18.

(b) A person may not own or operate a store, facility, or other place of business in Indiana where:

(1) prescriptions are accepted to be filled; or

(2) prescription drugs or devices are:

(A) ordered;

(B) offered or advertised for sale; or

(C) paid for;

unless the person has a pharmacy permit issued under this chapter.

As added by P.L.48-2015, SEC.5.

IC 25-26-13.5Chapter 13.5. Remote Dispensing Facilities

25-26-13.5-1Definitions 25-26-13.5-1.5"Automated dispensing system" 25-26-13.5-2"Patient care" 25-26-13.5-3"Remote dispensing facility" 25-26-13.5-4"Telepharmacy" 25-26-13.5-5Registration required; required information; exempt pharmacies; location of supervising pharmacy 25-26-13.5-6Registration of remote dispensing facility; requirements; operating under a contract 25-26-13.5-6.5Registration procedure for automated dispensing systems; supervising pharmacy located in Indiana 25-26-13.5-6.7Registration required before operation; establishment of minimum standards and practices 25-26-13.5-7Policies and procedures of a supervising pharmacy engaging in telepharmacy 25-26-13.5-8Repealed 25-26-13.5-8.5Pharmacy responsibilities 25-26-13.5-9Staffing requirements; rules on continuing education requirement 25-26-13.5-10Electronic record keeping system 25-26-13.5-11Video and audio communication system; retention of recordings; requirements; nonoperating system 25-26-13.5-12Maintenance of controlled substance dispensing records 25-26-13.5-13Effect of supervising pharmacy being closed 25-26-13.5-14Security; review; storage area 25-26-13.5-15Dispensing controlled substances; automated dispensing machines; deliveries; storage 25-26-13.5-16Pharmacy technicians; prescription records; verification system 25-26-13.5-17Suspension of registration 25-26-13.5-18Rules

IC 25-26-13.5-1Definitions Sec. 1. The definitions set forth in IC 25-26-13-2 apply to this chapter.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-1.5"Automated dispensing system" Sec. 1.5. (a) As used in this chapter, "automated dispensing system" means a mechanical or electronic system that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for the drugs.

(b) The term does not include an automated dispensing system that is located in a hospital licensed under IC 16-21-2, an ambulatory outpatient surgical center licensed under IC 16-21-2, a health facility licensed under IC 16-28, or a pharmacy licensed under IC 25-26-13.

As added by P.L.246-2019, SEC.11.

IC 25-26-13.5-2"Patient care" Sec. 2. As used in this chapter, "patient care" means patient care activities provided by a pharmacist, regardless of whether drugs or devices are dispensed, that are intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. The term includes the following:

(1) Drug review.

(2) Drug monitoring.

(3) Drug and device dispensing.

(4) Oral and sterile compounding verification.

(5) Medication therapy management.

(6) Patient assessment.

(7) Patient counseling.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-3"Remote dispensing facility" Sec. 3. As used in this chapter, "remote dispensing facility" means a facility where prescription drugs are prepared or dispensed without the requirement of the use of an onsite pharmacist and where pharmacist supervision may be provided remotely. However, the term does not include a facility that is located in a hospital licensed under IC 16-21-2, an ambulatory outpatient surgical center licensed under IC 16-21-2, a health facility licensed under IC 16-28, or an automated dispensing system.

As added by P.L.202-2017, SEC.12. Amended by P.L.246-2019, SEC.12.

IC 25-26-13.5-4"Telepharmacy" Sec. 4. As used in this chapter, "telepharmacy" means to provide patient care by a pharmacy and pharmacist licensed under IC 25-26 through the use of telecommunications or other technology:

(1) to a patient or the patient's representative who is at a distance and located in a state or jurisdiction of the United States; and

(2) where the pharmacy and pharmacist is located in Indiana.

However, the term does not include patient care through the use of telecommunications or other technology by a pharmacy or pharmacist that is located in a hospital licensed under IC 16-21-2, an ambulatory outpatient surgical center licensed under IC 16-21-2, or a health facility licensed under IC 16-28.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-5Registration required; required information; exempt pharmacies; location of supervising pharmacy Sec. 5. (a) The registration required under this chapter is in addition to any other registration or permit required under this article.

(b) The board shall establish a registration procedure for remote dispensing facilities. An application for registration of a remote dispensing facility must include the following information:

(1) A description of the technology being used at the facility, including information concerning any of the following:

(A) Telepharmacy communication.

(B) Electronic record keeping.

(C) Electronic verification systems.

(2) Operating specifications of the facility, including the following:

(A) Location of the facility.

(B) Ownership of the facility.

(C) Staffing of the facility, including the number of pharmacists and pharmacy technicians to be employed at the facility.

(D) The current number of remote dispensing facilities operated by the applicant.

(3) A scale drawing of the facility that illustrates the following:

(A) The layout and location of the electronic communication systems. The information collected under this clause is confidential and may not be disclosed.

(B) The location of the patient counseling area.

(C) Access points to the electronic communication systems.

(4) Identification of the proposed supervising pharmacy.

(c) This subsection does not apply to a remote dispensing facility that serves only hospital pharmacies. A supervising pharmacy of a remote dispensing facility must be located in Indiana and licensed under this article.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-6Registration of remote dispensing facility; requirements; operating under a contract Sec. 6. (a) Before a remote dispensing facility may do business in Indiana, the remote dispensing facility must be registered with the board under this chapter and in the manner prescribed by the board.

(b) Before a pharmacy licensed under this article may operate a remote dispensing facility, the pharmacy must register with the board under this chapter.

(c) A facility must meet the following requirements in order to be registered as a remote dispensing facility under this chapter:

(1) If the remote dispensing facility is not jointly owned by the pharmacy, operate under a contract with a supervising pharmacy.

(2) Be supervised by a pharmacist who is licensed under this article and who is designated by the supervising pharmacy to be responsible for oversight of the remote dispensing facility.

(3) Be located at least ten (10) miles from an existing retail pharmacy unless:

(A) the applicant with the proposed remote dispensing facility demonstrates to the board how the proposed remote dispensing facility will promote public health; or

(B) the remote dispensing facility exclusively serves the patients of:

(i) a community mental health center established under IC 12-29;

(ii) a health care facility (as defined in IC 16-28-13-0.5); or

(iii) a physician clinic.

(4) Maintain a patient counseling area.

(5) Display a sign visible to the public indicating that the location is a remote dispensing facility. The sign must include the following information:

(A) That the facility provides remote services supervised by a pharmacist located in another pharmacy.

(B) The identification and address of the supervising pharmacy.

(C) Disclosure that a pharmacist is required to speak to the consumer using audio and video communication systems any time a new drug or device is dispensed at the remote dispensing facility.

(D) Whether patient counseling is provided on a prescription drug refill at the remote dispensing facility.

(E) That the facility is under continuous video surveillance and that the video is recorded.

(d) If the remote dispensing facility is operating under a contract with a supervising pharmacy, the contract must:

(1) specify the responsibilities of each party to the contract; and

(2) be available for review by the board at the board's request.

As added by P.L.202-2017, SEC.12. Amended by P.L.207-2021, SEC.39; P.L.143-2022, SEC.64.

IC 25-26-13.5-6.5Registration procedure for automated dispensing systems; supervising pharmacy located in Indiana Sec. 6.5. (a) The registration required under this chapter is in addition to any other registration or permit required under this article.

(b) The board shall establish a registration procedure for automated dispensing systems. An application for registration of an automated dispensing system must include the following information:

(1) A description of the automated dispensing system being used at the facility, including information concerning any of the following:

(A) Telepharmacy communication.

(B) Electronic record keeping.

(C) Electronic verification systems.

(2) Operating specifications of the automated dispensing system, including the following:

(A) Location of the facility using the automated dispensing system.

(B) Ownership of the automated dispensing system.

(C) Identification of personnel responsible for operation of the automated dispensing system.

(3) A scale drawing that illustrates the layout and location of the automated dispensing system.

(4) Identification of the proposed supervising pharmacy.

(c) A supervising pharmacy of an automated dispensing system must be located in Indiana and licensed under this article.

As added by P.L.246-2019, SEC.13.

IC 25-26-13.5-6.7Registration required before operation; establishment of minimum standards and practices Sec. 6.7. (a) Before a pharmacy may operate an automated dispensing system, the automated dispensing system must be registered with the board under this chapter and in the manner prescribed by the board.

(b) The board shall establish minimum standards and practices that ensure the safety, accuracy, security, record keeping, and patient confidentiality of an automated dispensing system.

As added by P.L.246-2019, SEC.14.

IC 25-26-13.5-7Policies and procedures of a supervising pharmacy engaging in telepharmacy Sec. 7. A supervising pharmacy shall implement policies and procedures that address each of the following before engaging in the practice of telepharmacy under this chapter:

(1) Minimum standards and practices that ensure the safety, accuracy, security, sanitation, record keeping, and patient confidentiality at the remote dispensing facility. The standards and practices must include the following:

(A) Identification of personnel authorized to accept delivery of the drugs and to have access to drug storage and dispensing areas at the remote dispensing facility.

(B) Procedures for the procurement of drugs and devices at the remote dispensing facility and any automated dispensing machine system used.

(C) Criteria for the required inspection of the remote dispensing facility by a pharmacist.

(2) The adoption of training standards required for personnel employed at a remote dispensing facility to ensure the competence and ability of employees in operating the electronic verification, electronic record keeping, and communication systems.

(3) A written plan for recovery from an event that interrupts or prevents pharmacist supervision of the remote dispensing facility.

(4) Policies concerning the dispensing of prescription drugs.

As added by P.L.202-2017, SEC.12. Amended by P.L.143-2022, SEC.65.

IC 25-26-13.5-8RepealedAs added by P.L.202-2017, SEC.12. Amended by P.L.246-2019, SEC.15. Repealed by P.L.143-2022, SEC.66.

IC 25-26-13.5-8.5Pharmacy responsibilities Sec. 8.5. A pharmacy operating a remote dispensing facility is responsible for ensuring the following:

(1) The remote dispensing facility is sufficiently staffed to avoid the risk of harm to public health and safety.

(2) The pharmacist servicing the remote dispensing facility is in good standing with the board.

(3) A pharmacy may not operate more than one (1) remote dispensing facility at a time, unless otherwise approved by the board.

(4) A pharmacist must be able to be physically present at the remote dispensing facility within a certain time set by the board to address emergencies and safety issues that arise.

(5) A pharmacist shall visit the remote dispensing facility at least as often as required by the board to inspect the facility, address personnel matters, complete any forms required by the board concerning the required inspection, and maintain records in the manner specified by the board.

(6) If the remote dispensing facility is located at a hospital or physician clinic and uses an automated dispensing machine, a pharmacist must maintain an up to date inventory of any schedule II controlled substances. An inventory of all controlled substances must be completed at least once a month.

(7) The pharmacy must develop a continuous quality improvement program, which must include a reporting mechanism for errors that occur concerning the remote dispensing facility. Information concerning the remote dispensing facility must be made available to the board upon request.

As added by P.L.143-2022, SEC.67.

IC 25-26-13.5-9Staffing requirements; rules on continuing education requirement Sec. 9. (a) There must be at least one (1) pharmacist working at a remote dispensing facility for every six (6) pharmacist interns, licensed pharmacy technicians, and pharmacy technicians in training at the supervising pharmacy and remote dispensing facility. However, an individual whose only duty is to act as the cashier is not included in the number of employees that may work for one (1) pharmacist under this subsection.

(b) A remote dispensing facility that is not staffed by a pharmacist must be staffed by at least one (1) pharmacy technician who meets the following requirements:

(1) Is licensed under IC 25-26-19.

(2) Has at least two thousand (2,000) hours of experience working as a pharmacy technician in a pharmacy licensed under this article and under the direct supervision of a pharmacist.

(3) Has successfully passed a certification examination offered by the Pharmacy Technician Certification Board or another nationally recognized certification body approved by the board.

(4) If the remote dispensing facility is located in a hospital or physician clinic setting, either:

(A) has graduated from a pharmacy technician training program accredited by the Accreditation Council for Pharmacy Education or the American Society of Health System Pharmacists; or

(B) obtained the hours described in subdivision (2) before July 1, 2017.

(5) Is supervised by a pharmacist at the supervising pharmacy at all times that the remote dispensing facility is operational. As used in this subdivision, supervision does not require that the pharmacist be physically present at the remote dispensing facility as long as the pharmacist is supervising telepharmacy operations electronically through a computer link, video link, and audio link.

(6) Is currently in good standing with the board.

(c) A pharmacy technician in training may not work at a remote dispensing facility unless a pharmacist is on site.

(d) The board shall adopt rules that require pharmacy technicians working at a remote dispensing facility that is not staffed by a pharmacist to complete continuing education requirements established by the board.

As added by P.L.202-2017, SEC.12. Amended by P.L.246-2019, SEC.16; P.L.143-2022, SEC.68; P.L.140-2026, SEC.4.

IC 25-26-13.5-10Electronic record keeping system Sec. 10. A remote dispensing facility and the supervising pharmacy must use a common electronic record keeping system that is capable of the following:

(1) Allowing the electronic records to be available to and accessible from both the supervising pharmacy and the remote dispensing facility.

(2) Distinguishing between prescriptions filled at the supervising pharmacy and those filled at the remote dispensing facility.

(3) Allowing pharmacies to generate labels at the supervising pharmacy.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-11Video and audio communication system; retention of recordings; requirements; nonoperating system Sec. 11. (a) A supervising pharmacy of a remote dispensing facility must maintain a video and audio communication system that provides for effective communication between the supervising pharmacy, the remote dispensing facility, and any consumers. The system must do the following:

(1) Provide an adequate number of views of the entire remote dispensing facility.

(2) Facilitate adequate pharmacist supervision.

(3) Allow an appropriate exchange of visual, verbal, and written communications for patient counseling and other matters concerning the lawful transaction of business.

(b) The remote dispensing facility must retain a recording of facility surveillance, excluding patient communications, for at least thirty (30) days.

(c) A pharmacist is adequately supervising through the use of video surveillance by maintaining constant visual supervision and auditory communication with the remote dispensing facility and by maintaining full supervisory control of the automated system, if applicable. The auditory communication must be available, as needed, with the remote dispensing facility and the pharmacist.

(d) A video monitor that is being used to properly identify and communicate with consumers must meet the following requirements:

(1) Provide both the supervising pharmacy and the remote dispensing facility with direct visual contact between the pharmacist and the consumer.

(2) Be secure and compliant with the federal Health Insurance Portability and Accountability Act (HIPAA).

(e) If any component of the communication system is not in operating order, the remote dispensing facility shall remain closed until the communication system is fully operational, unless a pharmacist is located at the remote dispensing facility.

As added by P.L.202-2017, SEC.12. Amended by P.L.246-2019, SEC.17; P.L.207-2021, SEC.40; P.L.143-2022, SEC.69.

IC 25-26-13.5-12Maintenance of controlled substance dispensing records Sec. 12. The remote dispensing facility must maintain records of any dispensing of a controlled substance at the remote dispensing facility, unless the remote dispensing facility has received approval to centrally store the records in compliance with federal law.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-13Effect of supervising pharmacy being closed Sec. 13. A remote dispensing facility may not be open and employees may not have access to the facility when the supervising pharmacy is closed, unless a pharmacist is on duty at the remote dispensing facility.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-14Security; review; storage area Sec. 14. (a) A remote dispensing facility shall have adequate security. The security must do the following:

(1) Record the entrance and exit of individuals to the facility.

(2) Use alarms or other comparable monitoring systems that protect the equipment, records, drug supply, devices, and other items from unauthorized access, acquisition, or use.

(3) Use at least two (2) factoring credentials for employee entry to the remote dispensing facility, using two (2) of the following:

(A) A knowledge factor, including a password.

(B) Biometrics.

(C) An inanimate object.

(b) A pharmacist shall periodically review the record of entries into the remote dispensing facility.

(c) The prescription storage area may remain open while a pharmacist or pharmacy technician is on duty.

As added by P.L.202-2017, SEC.12. Amended by P.L.143-2022, SEC.70.

IC 25-26-13.5-15Dispensing controlled substances; automated dispensing machines; deliveries; storage Sec. 15. (a) A controlled substance may not be dispensed at the remote dispensing facility unless:

(1) the facility maintains a perpetual inventory of controlled substances; and

(2) the supervising pharmacist checks the Indiana scheduled prescription electronic collection and tracking program established by IC 25-1-13-4 or as directed by the board before:

(A) verification of the finished controlled substance prescription; and

(B) counseling the patient.

(b) Drugs may be transported to a remote dispensing facility that uses an automated dispensing machine only in a sealed container with a list identifying each drug, drug strength, and quantity included in the container.

(c) A delivery of drugs may be accepted at the remote dispensing facility only if a pharmacist or a licensed pharmacy technician is present to accept delivery and verify and sign for the receipt of the drugs, unless the drugs are placed in a secured delivery area that complies with federal and state law.

(d) If the delivery is received by a pharmacy technician, a pharmacist at the supervising pharmacy shall ensure through the use of the electronic audio and video communication system or bar code technology that the pharmacy technician has accurately restocked the drugs.

(e) A remote dispensing facility must store drugs in a manner that:

(1) complies with federal and state law;

(2) protects the identity, safety, security, and integrity of the drug; and

(3) limits access to:

(A) a pharmacist employed by the supervising pharmacy; and

(B) a pharmacy technician who has written authorization of a pharmacist to access the facility.

As added by P.L.202-2017, SEC.12. Amended by P.L.143-2022, SEC.71.

IC 25-26-13.5-16Pharmacy technicians; prescription records; verification system Sec. 16. (a) If a pharmacy technician at a remote dispensing facility enters prescription drug information into an automated pharmacy system, a pharmacist at the supervising pharmacy shall, before approving the prescription, verify the information entered against a faxed, electronic, or video image of the original prescription.

(b) The pharmacy technician may do any of the following:

(1) Transmit the prescription drug order to the pharmacist by scanning the order into the electronic record keeping system as long as the image is legible and does not obscure the prescription drug information.

(2) Make the original prescription available to the pharmacist by placing the prescription in view of the video communication system. The pharmacist shall also verify the accuracy of the drug dispensed and check the prescription drug label for accuracy.

(3) Fax the prescription to the pharmacist, unless prohibited by law for controlled substances.

(c) Both the initials or other unique identifier of the pharmacy technician and the pharmacist involved in the dispensing must appear on the prescription record.

(d) The remote dispensing facility must use an electronic verification system that confirms the drug stock selected to fill the prescription is the same as the drug indicated on the prescription label.

(e) The pharmacist shall verify each prescription before it is dispensed.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-17Suspension of registration Sec. 17. The board may suspend a registration under this chapter if the facility poses a danger to the public.

As added by P.L.202-2017, SEC.12.

IC 25-26-13.5-18Rules Sec. 18. The board may adopt rules under IC 4-22-2 necessary to implement this chapter.

As added by P.L.202-2017, SEC.12. Amended by P.L.209-2018, SEC.11; P.L.246-2019, SEC.18; P.L.11-2023, SEC.83.

IC 25-26-14Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers

25-26-14-1Application of chapter 25-26-14-1.5"Adulterated" 25-26-14-1.7"Authenticate" 25-26-14-1.8"Authorized distributor" 25-26-14-2"Blood" 25-26-14-3"Blood component" 25-26-14-3.7"Chain drug warehouse" 25-26-14-4"Board" 25-26-14-4.1"Co-licensed products" 25-26-14-4.2"Compendium" 25-26-14-4.3"Contraband" 25-26-14-4.4"Counterfeit" 25-26-14-4.5"Deliver" 25-26-14-4.6"Designated representative" 25-26-14-4.7"Distribute" 25-26-14-5"Drug sample" 25-26-14-6"Health care entity" 25-26-14-6.5"Label" 25-26-14-6.6"Labeling" 25-26-14-7"Legend drug" 25-26-14-8"Manufacturer" 25-26-14-8.3"Misbranded" 25-26-14-8.5"Normal distribution chain of custody" 25-26-14-8.7"Pedigree" 25-26-14-9"Person" 25-26-14-9.2"Practitioner" 25-26-14-9.3"Repackage" 25-26-14-10"Sale" 25-26-14-10.3"Third party inspection provider" 25-26-14-10.5"Third party logistics provider" 25-26-14-11"Wholesale distribution" 25-26-14-12"Wholesale drug distributor" 25-26-14-13Rules 25-26-14-14Accreditation and license for wholesale distribution of legend drugs; provisional license 25-26-14-14.2Inspection and license required for third party logistics of legend drugs 25-26-14-14.5Pedigree required 25-26-14-15Information for grant and renewal of license; surety bond; inspection; reporting change in information 25-26-14-15.5Repealed 25-26-14-16Distributor qualifications; criminal history and financial background check 25-26-14-16.5Designated representative; application; experience requirement; continuing education 25-26-14-16.6Designated agent; service of process 25-26-14-17Applicant assurances as condition of license 25-26-14-17.2For cause authentication 25-26-14-17.3Repealed 25-26-14-17.8Purchase from unlicensed wholesale drug distributor; requirements; for cause authentication; random authentication; quarantine 25-26-14-17.9Use of trade or business name 25-26-14-18Denial of license; review of board action 25-26-14-19Inspection of premises; recordkeeping 25-26-14-20Employee qualifications 25-26-14-21Renewal of licenses; lapsed licenses 25-26-14-21.5Prohibitions; sanctions 25-26-14-22Violations of chapter; license revocation; penalties 25-26-14-23Purchase from unlicensed person; offense 25-26-14-24Injunction 25-26-14-25Refusal of inspection; offense 25-26-14-26Offenses 25-26-14-27Offenses 25-26-14-28Expired 25-26-14-29Third party logistics provider license requirements 25-26-14-30Third party logistics provider inspection report standards 25-26-14-31Third party logistics provider renewal; expiration; requirements 25-26-14-32Third party logistics provider rules