TITLE 856 INDIANA BOARD OF PHARMACY

Amends 856 IAC 1-1.1-3 to update the definition of "in personal attendance". Adds 856 IAC 1-1.1-4 to define "reasonable visual and vocal distance". Adds 856 IAC 1-1.1-5 to define "supervision". Adds 856 IAC 1-1.1-6 to define "pharmaceutical care". Adds 856 IAC 1-1.1-7 to define "real-time online database". Adds 856 IAC 1-1.1-8 to define "unlicensed person". Adds 856 IAC 1-1.1-9 to define "electronic database". Adds 856 IAC 1-1.1-10 to define "electronic record or image". Amends 856 IAC 1-29-1 concerning the approval of electronic data processing system. Amends 856 IAC 1-29-3 to update the hard copy of daily dispensing, verification and retention, and back-up capability requirements. Amends 856 IAC 1-29-6 to update data entry and supervision requirements. Amends 856 IAC 1-29-9 to update the applicability of 856 IAC 1-29. Amends 856 IAC 1-31-1 to update facsimile machines requirements. Amends 856 IAC 1-31-2 to update the requirements for the use of a facsimile machine to electronically transmit a prescription or drug order. Adds 856 IAC 1-31-3 concerning facsimile prescription or drug order maintenance. Amends 856 IAC 1-32-2 to update the requirements for noncontrolled and controlled substance prescription transfers. Amends 856 IAC 1-32-4 to update the responsibilities of pharmacists. Adds 856 IAC 1-32-5 concerning electronic transfers. Amends 856 IAC 1-34-2 to update security feature requirements. Amends 856 IAC 1-37-1 to update the requirements for central fill or processing, or both, of prescriptions and drug orders. Adds 856 IAC 1-37-1.1 regarding central fill or processing, or both, facilities. Adds 856 IAC 1-37-1.2 concerning central fill or processing, or both, supervision. Adds 856 IAC 1-37-1.3 concerning central fill or processing, or both, remote practice. Amends 856 IAC 1-37-2 updating the contracting for central fill or processing, or both, requirements. Adds 856 IAC 1-37-2.1 concerning contracting for central fill or processing, or both, policies and procedures. Amends 856 IAC 1-37-3 updating policy and procedures manual requirements. Adds 856 IAC 1-41 concerning cognitive services. Adds 856 IAC 1-42 concerning remote pharmacy practice. Amends 856 IAC 2-4-1 to update records and inventories requirements. Adds 856 IAC 2-6-1.5 concerning signature requirements. Amends 856 IAC 2-6-4 concerning issuance of prescriptions and information required. Amends 856 IAC 2-6-7 to update schedule II controlled substances, prescription required, and exception requirements. Amends 856 IAC 2-6-9 to update schedule II controlled substances partial filling of prescriptions requirements. Amends 856 IAC 2-6-10 to update schedule II controlled substances, label information, and exceptions requirements. Amends 856 IAC 2-6-12 to update schedules III and IV controlled substances requirements. Amends 856 IAC 2-6-13 to update schedules III, IV, and V controlled substances, refilling prescriptions, and retrievable information requirements. Amends 856 IAC 2-6-17 to update schedule V controlled substances, prescription requirements, refilling, and exceptions requirements. Amends 856 IAC 2-6-18 to update dispensing without a prescription and delivery of devices requirements. Repeals 856 IAC 1-35-2 and 856 IAC 1-35-3. Effective 30 days after filing with the Publisher.

SECTION 1. 856 IAC 1-1.1-3 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-2; IC 25-26-13-18

Sec. 3. The term "In personal attendance", as the same is in for the purposes of IC 25-26-13-18(a) of the Pharmacy Practice Act, means being physically present in the area specified as the dimensions of the pharmacy in the relevant pharmacy permit application. This section in no way restricts functions listed under the practice of pharmacy definition in IC 25-26-13-2 that are unrelated to the direct filling, dispensing, distribution, and storage of a legend drug product.

SECTION 2. 856 IAC 1-1.1-4 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-18

Sec. 4. The standard for "reasonable visual and vocal distance", as found in IC 25-26-13-18(a)(4) of the Pharmacy Practice Act, can be met by a pharmacist being physically present within the licensed permitted area or by a means that provides for adequate supervision of technicians as individually approved by the board.

SECTION 3. 856 IAC 1-1.1-5 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 5. For purposes of this article, "supervision" means the physical or real-time act of oversight and management by a managing pharmacist, pharmacist in charge, or qualifying pharmacist of another individual's work or work product. Unless otherwise stated in this article, individuals practicing pharmacy must be directly supervised either through a direct line of sight and hearing, or via technological means that allow a supervisor to adequately ensure quality of care and patient services. In accordance with other sections in this article, if a facility is using technology to allow indirect supervision, they must have documented policies and procedures and other adequate safeguards to protect against patient harm, diversion, and privacy incidents.

SECTION 4. 856 IAC 1-1.1-6 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 6. For purposes of this article, "pharmaceutical care" includes the spectrum of services and products provided by a board licensee to a patient or consumer in the normal course of practice. The term includes, but is not limited to, dispensing legend drug product and delivery of cognitive services.

SECTION 5. 856 IAC 1-1.1-7 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 7. "Real-time online database" means a database that is continuously updated in real time and allows users to share and store patient information and interface with each other in a secure environment over the Internet or an intranet. Where appropriate, facilities or companies utilizing this type of database will comply with other applicable federal or state laws and regulations that govern e-commerce, privacy, access, or sharing of patient information, such as, but not limited to, U.S. Drug Enforcement Administration regulations that outline what information must be maintained and included in any electronic transfer transaction.

SECTION 6. 856 IAC 1-1.1-8 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 8. "Unlicensed person" means any individual that is not HIPAA trained and does not hold a valid license, certification, permit, or registration issued by the board. Unlicensed persons are prohibited from performing pharmacy dispensing functions related to legend drug product in the pharmacy dispensing environment. The pharmacy dispensing environment includes the secured area where legend drug product is stored, reviewed, bottled, and dispensed (this does not include palleted legend drug product not yet reviewed or received by the pharmacist staff and held in a separate or distinct storage area). This prohibition does not apply to the presence of supervised cleaning staff, delivery personnel, or individuals present on site to perform administrative or operational functions and directly supervised by the pharmacist.

SECTION 7. 856 IAC 1-1.1-9 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 9. "Electronic database" means a record of information stored electronically that can be accessed using applications designed to securely store, retrieve, and organize information required to be maintained according to applicable state and federal pharmacy laws and regulations.

SECTION 8. 856 IAC 1-1.1-10 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 10. "Electronic record or image" means a record or image capable of being copied, reproduced, or created via technology designed to capture information in one (1) form and reproduce it in an electronic medium presentable and usable to an end user. For example, an electronic image could be a scanned version of a written prescription. An electronic record or image must be capable of being securely stored and retrieved after the date of creation for subsequent use or evaluation, or both. Such a record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted.

SECTION 9. 856 IAC 1-29-1 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 1. (a) No electronic data processing system may be used by a pharmacist pursuant to a Type I, Type III, and Type VI category I or category III pharmacy permit as an alternative to his or her recordation of prescription information unless that system has been approved by the Indiana board. of pharmacy (board).

(b) No electronic data processing system may be used by a pharmacist as an alternative to his or her recordation of information directly on the original prescription pursuant to under IC 25-26-13-25(c), without the approval of the board, and such an electronic data processing system does not qualify for approval unless it satisfies at a minimum the requirements found in this rule. Any such system must be approved by the board before initial installation in Indiana. Any pharmacy installing such a system must make a written request to the board for approval. Approval is subject to withdrawal for cause so that the pharmacist must in such a case discontinue use of the system as an alternative.

SECTION 10. 856 IAC 1-29-3 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 3. (a) A pharmacy using an electronic data processing system must provide a separate hard copy printout of prescription or drug order and refill data for each day's dispensing or other board approved uniformly maintained readily retrievable system. This hard copy printout or other board approved system shall include the following:

(b) The dispensing pharmacist must verify that the data is correct to the best of his or her knowledge and date and sign the document or log book in the same manner as he or she would sign a check or legal document.

(c) This documentation shall be maintained for a period of five (5) two (2) years from the dispensing date. The daily hard copy printout may be replaced with a monthly printout or other permanent documentation containing the same information.

(d) Each system must have the capability of informational backup and such documentation must be stored in a secure location.

(e) If the electronic data processing system can capture an unalterable and legible digital image of the prescription or drug order, the digital image may be considered the original prescription record as follows:

(f) The electronic data processing system must be capable of maintaining, printing, and providing, upon a request by the board or the board's compliance officers, all of the prescription information required by state law and regulations of the board within seventy-two (72) hours of the request.

SECTION 11. 856 IAC 1-29-6 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 6. When electronic data processing equipment is utilized in any pharmacy, input of drug information shall be performed by a pharmacist or under the immediate and personal supervision of a pharmacist. The pharmacist must certify the accuracy of the information entered and verify the prescription or drug order.

SECTION 12. 856 IAC 1-29-9 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 9. This rule applies to pharmacies with Type I, Type III, Type IV, and Type VI category I and category III permits.

SECTION 13. 856 IAC 1-31-1 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-2

Sec. 1. As used in this rule, "facsimile machine" means a machine that electronically transmits exact images through connection with a telephone telecommunications network.

SECTION 14. 856 IAC 1-31-2 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-1-9; IC 25-26-13-15

Sec. 2. Prescription or drug orders for legend drugs, including schedules II through V substances, may be transmitted by facsimile machine from an authorized prescribing practitioner or an authorized employee or agent of the individual practitioner to a pharmacy under the following restrictions:

SECTION 15. 856 IAC 1-31-3 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-1-9; IC 25-26-13-25

Sec. 3. The facsimile serves as the original written prescription or drug order, and it shall be maintained in accordance with IC 25-26-13-25.

SECTION 16. 856 IAC 1-32-2 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 2. (a) Prescription information for legend drugs that are not controlled substances may be transferred at any time during the lifetime of the prescription up to one (1) year after the date of the original filling, originally issued by the prescriber or when the original number of authorized refills expires, whichever comes first.

(b) Except as limited by the requirement of subsection (a), prescriptions for legend drugs that are not controlled substances may be transferred any number of times.

(c) If any authorized refills remain, prescriptions for schedule III, schedule IV, and schedule V controlled substances may be transferred only once within six (6) months from the date the prescription was issued. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

(d) Prescriptions for schedule II controlled substances may not be transferred.

SECTION 17. 856 IAC 1-32-4 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 4. Transfer of prescription information under this rule must be communicated between licensed pharmacists or licensed pharmacist interns in accordance with this title and all applicable U.S. Drug Enforcement Administration regulations and must meet the following requirements:

SECTION 18. 856 IAC 1-32-5 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13-25

Sec. 5. (a) Two (2) or more pharmacies may establish and use a common electronic file to maintain required information related to the practice of the profession of pharmacy.

(b) Pharmacies using such a common electronic file are not required to transfer prescriptions or information for dispensing purposes between or among pharmacies participating in the same common prescription file as described in section 4 of this rule provided the following:

SECTION 19. 856 IAC 1-34-2 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 16-42-19-5

Sec. 2. (a) All controlled substance prescriptions written by licensed Indiana practitioners, as defined by IC 16-42-19-5, must contain the following security features:

(b) Nothing in this rule shall prevent licensed Indiana practitioners from utilizing the following:

SECTION 20. 856 IAC 1-37-1 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 1. "Centralized prescription "Central fill or processing, or both, of prescriptions and drug order processing" orders" means, to the extent permissible by law, the filling or processing by a pharmacy of a request from another pharmacy, provider, payor, pharmacy benefit manager, or patient to do the following according to IC 25-26-13:

SECTION 21. 856 IAC 1-37-1.1 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26

Sec. 1.1. A pharmacy that performs centralized functions may perform:

SECTION 22. 856 IAC 1-37-1.2 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 1.2. Central fill or processing, or both, activities must occur in a permitted pharmacy environment under the supervision of a qualifying pharmacist as defined in IC 25-26-13.

SECTION 23. 856 IAC 1-37-1.3 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26

Sec. 1.3. Permitted central fill or central processing pharmacies may engage in remote practice and supervision, but only to the extent that the remote practice and supervision relates to the processing functions discussed in this rule or the delivery of cognitive services defined in 856 IAC 1-41, or both. Those facilities that choose to engage in remote practice shall comply with the following:

SECTION 24. 856 IAC 1-37-2 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26

Sec. 2. A permitted pharmacy licensed or registered by the board, may perform or outsource centralized prescription processing services and contract for central fill or processing, or both, functions provided the involved parties have:

SECTION 25. 856 IAC 1-37-2.1 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26

Sec. 2.1. The pharmacy shall maintain as part of its documented policies and procedures a section addressing its contractual relationship regarding any outsourced or contractually provided services that are performed by another entity.

SECTION 26. 856 IAC 1-37-3 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 25-26

Sec. 3. The parties performing or contracting for centralized prescription central fill or processing, or both, services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the board for review, upon request, and that includes, but it is not limited to, the following:

SECTION 27. 856 IAC 1-41 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 1. (a) As used in this rule, "cognitive services" means those services provided by a licensed pharmacist (or registered pharmacist intern under the supervision of a licensed pharmacist) that involve the delivery of patient care, counseling, or professional advice that may facilitate pharmaceutical care. The term includes, but is not limited to, the following functions:

(b) The term does not include the following activities:

Affected: IC 25-26-13

Sec. 2. The delivery of cognitive services occurs between a licensed pharmacist (or a registered pharmacist intern under the supervision of a licensed pharmacist) and:

Affected: IC 25-26-13

Sec. 3. In order to provide or deliver cognitive services, an individual must have an active license in good standing in a state that has at least the same minimum standards for licensure as the state of Indiana including, but not limited to, passage of the North American Pharmacist Licensure Examination (NAPLEX).

SECTION 28. 856 IAC 1-42 IS ADDED TO READ AS FOLLOWS:

Affected: IC 25-26-13

Sec. 1. "Remote pharmacy practice" means the provision of pharmaceutical services not related to physically handling or dispensing pharmaceutical drugs or devices. This rule is intended to govern the practice of licensed pharmacists acting as independent contractors whether or not directly employed or affiliated with an entity that is licensed by the board to practice pharmacy into or out of the state of Indiana. This service also does not include the provision of pharmaceutical care that is conducted within the physical confines or premises of a permitted in-state pharmacy or a registered nonresident pharmacy. This rule is not intended to overrule or supersede the provisions, practices, and requirements listed in 856 IAC 1-37.

Affected: IC 25-26-13

Sec. 2. The following are permissible activities covered by the remote practice pharmacy:

Affected: IC 25-26-13

Sec. 3. Individuals who wish to engage in the remote practice of pharmacy in or into the state of Indiana as provided in this rule must satisfy the following licensure requirements:

Affected: IC 25-26-13

Sec. 4. Pharmacists that provide or engage in remote practice of pharmacy services must employ security and privacy standards and protocols that adequately protect patient privacy and health. Accordingly, a pharmacist must satisfy the following requirements:

Affected: IC 25-26-13

Sec. 5. Pharmacists that engage in remote practice of pharmacy services are required to:

Affected: IC 25-26-13

Sec. 6. Remote pharmacy practice shall be conducted in a work environment that is conducive to providing quality patient treatment decisions, private counseling, or other health care related activities permissible under 856 IAC 1-41 but that do not include dispensing. Individuals that practice remotely are prohibited from practicing in a space that serves as their primary living, household, or family space. For example, if working out of a home environment, the individual should perform this work in a dedicated office space that is not actively used as a bedroom, living room, or other miscellaneous family space. This space should be open and accessible for an inspection by board staff if required. Work product or equipment in this space should be capable of being properly secured to protect patient privacy.

Affected: IC 25-26-13

Sec. 7. A pharmacist that is providing remote practice of pharmacy services shall develop, implement, review, revise, and comply with policies and procedures for the services they provide. These policies and procedures should reflect the nature and extent of the services they perform. In the event a pharmacist is performing services via a contract with another service provider, dispensing pharmacy, or other institution, their contract shall stipulate or designate, or both, whose policies and procedures control for the services being performed. At a minimum, the policies and procedures shall include the following:

SECTION 29. 856 IAC 2-4-1 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-7

Sec. 1. (a) Every registrant shall keep records and maintain inventories in conformance with the record keeping and inventorying requirements of federal law and regulation.

(b) For purposes of this section, article, "readily retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some manner visually identifiable apart from other items appearing on the records. Manufacturers, distributors, and research records or electronic data processing printouts shall be made available within five (5) working days after a request by the Indiana board of pharmacy for such records or information on controlled substances transactions.

(c) Each registered pharmacy shall maintain, for a period of two (2) years, its prescriptions of controlled substances by maintaining any of the following:

(d) Electronically transmitted prescriptions must be maintained in accordance with applicable federal regulations.

SECTION 30. 856 IAC 2-6-1.5 IS ADDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 1.5. All references to "signed" in this rule shall include either:

SECTION 31. 856 IAC 2-6-4 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 4. Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed, on, the day when issued and shall bear the full name and address of the patient, and the name, address, and federal controlled substance registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). either in writing or electronically in accordance with applicable federal regulations. Where an oral order is not permitted, prescriptions shall be:

The (b) Nonelectronically prescribed prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations, or applicable federal regulations.

(b) (c) An intern, resident, or foreign-trained physician exempted from registration under section 3.14(c), 856 IAC 2-3-5(c) shall include on all prescriptions issued by him or her the federal controlled substance registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in section 3.14(c), 856 IAC 2-3-5(c) in lieu of the registration number of the practitioner required by this section. Each prescription shall have the name of the intern, resident, or foreign-trained physician stamped or printed on it, as well as the signature of the physician.

(c) (d) An official exempted from registration under section 3.15 856 IAC 2-3-6 shall include on all prescriptions issued by him or her, his or her branch of service or agency (e.g., (for example, "U.S. Army" or "Public Health Service") and his or her service identification number in lieu of the federal controlled substance registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his or her Social Security identification number. Each prescription shall have the name of the officer stamped, typed, or hand-printed on it, as well as the signature of the officer.

(e) A prescription issued electronically by a practitioner exempted under subsections (c) and (d) shall conform to applicable federal regulations.

SECTION 32. 856 IAC 2-6-7 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48

Sec. 7. (a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in subsection (d).

(b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to section 6 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, as defined by in subsection (e), a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner provided the following:

(e) For the purpose of authorizing an oral prescription of a controlled substance listed in schedule II of IC 35-48 as amended, "emergency situation" means those situations in which the prescribing practitioner determines the following:

SECTION 33. 856 IAC 2-6-9 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-2-6; IC 35-48-3-9

Sec. 9. (a) The partial filling of a prescription for a controlled substance listed in schedule II under IC 35-48-2-6, as amended, is permissible if the pharmacist is unable to supply the full quantity called for in a prescription written either manually or electronically in accordance with applicable federal regulations, or emergency oral prescription and makes a notation of the quantity supplied on the face of the written prescription, (or on the written record of the emergency oral prescription or electronically recorded if electronically transmitted. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling. However, if the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

(b) A prescription prescribed, either in writing or electronically in accordance with applicable federal regulations, for a schedule II controlled substance written for patients in long-term care facilities may be filled in partial quantities to include individual dosage units. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the:

(c) A prescription for a schedule II controlled substance written prescribed, either in writing or electronically in accordance with applicable federal regulations, for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. The pharmacist has a responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription the patient is "terminally ill". A prescription that is partially filled and does not contain the notation "terminally ill" shall be deemed to have been filled in violation of this section. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the:

SECTION 34. 856 IAC 2-6-10 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 10. Labeling of substances. (a) The pharmacist filling a written prescription, an electronically transmitted prescription, or an emergency oral prescription for a controlled substance listed in 856 IAC 2-2-3, Schedule II, shall affix to the package a label showing the following:

(b) The requirements of paragraph subsection (a) of this section do not apply when a controlled substance listed in 856 IAC 2-2-3, Schedule II, is prescribed for administration to an ultimate user who is institutionalized, provided that: the following:

SECTION 35. 856 IAC 2-6-12 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 12. (a) A pharmacist may dispense a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5, which is a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a prescribing individual practitioner or an oral prescription made by a prescribing individual practitioner or a practitioner's authorized agent and promptly reduced to writing by the pharmacist containing all information required in 856 IAC 2-6-4 section 4 of this rule, except for the signature of the prescribing individual practitioner.

(b) An individual practitioner may administer or dispense a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5 in the course of his or her professional practice without a prescription, subject to 856 IAC 2-6-6. section 6 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5 pursuant to a written prescription signed by a prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in 856 IAC 2-6-4, section 4 of this rule, except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to 856 IAC 2-6-6. section 6 of this rule.

SECTION 36. 856 IAC 2-6-13 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-2; IC 35-48-3-9

Sec. 13. (a) No prescription for a controlled substance listed in schedule III (IC 35-48-2-8), schedule IV (IC 35-48-2-10), or schedule V (IC 35-48-2-12) shall be filled or refilled more than six (6) months after the date on which such prescription was issued, and no such prescription shall be authorized to be refilled more than five (5) times.

(b) Each refill of a prescription shall be recorded by one (1) of the following methods:

(c) The following prescription information shall be retrievable by using or entering the serial number of the prescription:

(d) Additional refills for prescriptions for controlled substances listed in schedule III (IC 35-48-2-8), schedule IV (IC 35-48-2-10), or schedule V (IC 35-48-2-12) may be added to the original prescription on pursuant to an oral authorization transmitted to the pharmacist by the original prescribing practitioner providing the following conditions are met:

(e) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five (5) refill, six (6) month limitation.

SECTION 37. 856 IAC 2-6-17 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 17. Requirement of prescription. (a) A pharmacist may dispense a controlled substance listed in 856 IAC 2-2-6, Schedule V, pursuant to a prescription as required for controlled substances listed in 856 IAC 2-2-4 and 856 IAC 2-2-5, Schedules III and IV, in section 6.21 12 of this rule. A prescription for a controlled substance listed in 856 IAC 2-2-6, Schedule V, may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If no such authorization is given, the prescription may not be refilled. A pharmacist dispensing such substance pursuant to a prescription shall label the substance in accordance with section 6.24 15 of this rule and file the prescription in accordance with section 6.25. [section] 16 of this rule.

(b) An individual practitioner may administer or dispense a controlled substance listed in 856 IAC 2-2-6, Schedule V, in the course of his or her professional practice without a prescription, subject to section 6.24. 15 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in 856 IAC 2-2-6, Schedule V, only pursuant to:

SECTION 38. 856 IAC 2-6-18 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 35-48-3-9

Sec. 18. (a) A controlled substance listed in schedule V in the Controlled Substance Act, IC 35-48, which that does not require a prescription under federal, state, or local law or a device known as a hypodermic syringe and/or or needle, or both, for human use may be dispensed only by a pharmacist or a pharmacist intern under the direct supervision of a pharmacist without a prescription to a purchaser at retail, provided that: the following:

(b) Delivery of devices, as described above, to inpatients of institutions is exempt from this section.

(c) The delivery of a device known as a hypodermic syringe-needle other than by a pharmacist or pharmacist intern in a licensed pharmacy or a licensed practitioner in his or her lawful place of practice is prohibited.

SECTION 39. THE FOLLOWING ARE REPEALED: 856 IAC 1-35-2; 856 IAC 1-35-3.

DIN: 20130717-IR-856120619FRA

Composed: Apr 23,2024 8:17:59PM EDT

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