| 48 | | - | SECTION 1. The legislature finds that prescription refills play an important role in allowing patients to obtain their medication without frequent office visits. Refills also support patient adherence to medications for chronic conditions. Typical pharmacotherapy requires a patient's adherence to the regimen to achieve the therapeutic outcome, especially in patients with chronic conditions. Abrupt cessation or unplanned interruption of therapy may lead to undesirable outcomes. It is paramount for the pharmacist to ensure the patient's regimen is not disrupted and medications are dispensed in a timely manner. The legislature further finds that during times of natural disasters or public health emergencies, there may be significant challenges that impede a patient's ability to timely receive a necessary prescription. For example, the coronavirus disease 2019 pandemic forced some providers to limit office hours. Additionally, quarantine mandates forced patients to cancel existing appointments. These challenges resulted in gap periods without medications. The purpose of this Act is to provide clear guidance for pharmacists to act in the best interest of patients by minimizing gap periods without medications during a declared state of emergency by allowing pharmacists to refill prescriptions for persons directly impacted by the emergency for up to a thirty-day supply if the practitioner is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. SECTION 2. Chapter 461, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows: "§461- Refills without practitioner's authorization during state of emergency. (a) During a declared state of emergency pursuant to section 127A-14, a prescription for persons directly impacted by the emergency may be refilled up to a thirty-day supply without the practitioner's authorization if the practitioner is unavailable to authorize the refill and if, in the registered pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. (b) Before refilling a prescription pursuant to this section, the registered pharmacist shall make every reasonable effort to contact the practitioner. The registered pharmacist shall make an appropriate record, including the basis for proceeding under this section. (c) The registered pharmacist shall inform the patient that the prescription was refilled pursuant to this section. (d) The registered pharmacist shall notify the practitioner no later than twenty-four hours after the dispensing of any refills pursuant to this section. Notification to a practitioner under this subsection may be made by phone, facsimile, or electronic mail. (e) The practitioner who issued a prescription shall not incur any liability as the result of a registered pharmacist refilling that prescription pursuant to this section. (f) Notwithstanding any law to the contrary, a person may possess a substance dispensed pursuant to this section. (g) Nothing in this section shall authorize a registered pharmacist to refill a prescription for a controlled substance as defined in section 329-1." SECTION 3. Section 328-16, Hawaii Revised Statutes, is amended as follows: 1. By amending subsections (a) and (b) to read: "(a) A prescription drug shall be dispensed only if its label bears the following: (1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the dispensing practitioner's office; (2) Except as otherwise authorized for expedited partner therapy in section 453-52 or an opioid antagonist in section 461-11.8, the name of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; (3) The serial number of the prescription; (4) The date the prescription was prepared; (5) The name of the practitioner if the seller is not the practitioner; (6) The name, strength, and quantity of the drug; (7) The "use by" date for the drug, which shall be: (A) The expiration date on the manufacturer's container; or (B) One year from the date the drug is dispensed, whichever is earlier; (8) The number of refills available, if any; (9) In the case of the dispensing of an equivalent generic drug product, the statement "same as (brand name of the drug product prescribed or the referenced listed drug name)", or words of similar meaning; (10) In the case of the dispensing of an interchangeable biological product, the statement "interchangeable with (brand name of the biological product prescribed or the referenced biological drug name)", or words of similar meaning; and (11) Specific directions for the drug's use; provided that if the specific directions for use are too lengthy for inclusion on the label, the notation "take according to written instructions" may be used if separate written instructions for use are actually issued with the drug by the practitioner or the pharmacist, but in no event shall the notation "take as directed", referring to oral instructions, be considered acceptable. If any prescription for a drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescription unless subsequently authorized to do so by the practitioner[.] or pursuant to section 461- . The act of dispensing a prescription drug other than a professional sample or medical oxygen contrary to this subsection shall be deemed to be an act that results in a drug being misbranded while held for sale. (b) In addition to the requirements enumerated in subsection (a), a prescription drug shall be dispensed only: (1) By a pharmacist pursuant to a valid prescription or section 453-52, 461-1, [or] 461-11.8[;], or 461- ; (2) By a medical oxygen distributor pursuant to a prescription or certificate of medical necessity; provided that the drug to be dispensed is medical oxygen; or (3) By a practitioner to an ultimate user; provided that: (A) Except as otherwise authorized for expedited partner therapy in section 453-52, the practitioner shall inform the patient, [prior to] before dispensing any drug other than a professional sample, that the patient may have a written, orally ordered, or electronically transmitted or conveyed prescription directed to a pharmacy or a medical oxygen distributor of the patient's own choice; (B) The practitioner shall promptly record in the practitioner's records: (i) The prescription in full; (ii) The name, strength, and quantity of the drug, and specific directions for the drug's use; (iii) The date the drug was dispensed; (iv) Except as otherwise authorized for expedited partner therapy in section 453-52 or for an opioid antagonist in section 461-11.8, the name and address of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; and (v) Prescription drugs dispensed or prescribed for expedited partner therapy as authorized under section 453-52 or for an opioid antagonist in section 461-11.8; (C) The records described in subparagraph (B) shall be subject to the inspection of the department or its agents at all times; and (D) No undisclosed rebate, refund, commission, preference, discount, or other consideration, whether in the form of money or otherwise, has been offered to the practitioner as compensation or inducement to dispense or prescribe any specific drug in preference to other drugs that might be used for the identical therapeutic indication." 2. By amending subsection (d) to read: "(d) Any prescription may be refilled by the pharmacy and a prescription for medical oxygen may be refilled by the medical oxygen distributor if that refilling is authorized by the practitioner either: (1) In the original prescription; or (2) By oral or electronic order, which shall be promptly recorded and filed by the receiving pharmacist or medical oxygen distributor[.], or the refilling is conducted pursuant to section 461- ." SECTION 4. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 5. This Act shall take effect upon its approval. |
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| 47 | + | SECTION 1. The legislature finds that prescription refills play an important role in allowing patients to obtain their medication without frequent office visits. Refills also support patient adherence to medications for chronic conditions. Typical pharmacotherapy requires a patient's adherence to the regimen to achieve the therapeutic outcome, especially in patients with chronic conditions. Abrupt cessation or unplanned interruption of therapy may lead to undesirable outcomes. It is paramount for the pharmacist to ensure the patient's regimen is not disrupted and medications are dispensed in a timely manner. The legislature further finds that during times of natural disasters or public health emergencies, there may be significant challenges that impede a patient's ability to timely receive a necessary prescription. For example, the coronavirus disease 2019 pandemic forced some providers to limit office hours. Additionally, quarantine mandates forced patients to cancel existing appointments. These challenges resulted in gap periods without medications. The purpose of this Act is to provide clear guidance for pharmacists to act in the best interest of patients by minimizing gap periods without medications during a declared state of emergency by allowing pharmacists to refill prescriptions for persons directly impacted by the emergency for up to a thirty-day supply if the practitioner is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. SECTION 2. Chapter 461, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows: "§461- Refills without practitioner's authorization during state of emergency. (a) During a declared state of emergency pursuant to section 127A-14, a prescription for persons directly impacted by the emergency may be refilled up to a thirty-day supply without the practitioner's authorization if the practitioner is unavailable to authorize the refill and if, in the registered pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. (b) Before refilling a prescription pursuant to this section, the registered pharmacist shall make every reasonable effort to contact the practitioner. The registered pharmacist shall make an appropriate record, including the basis for proceeding under this section. (c) The registered pharmacist shall inform the patient that the prescription was refilled pursuant to this section. (d) The registered pharmacist shall notify the practitioner no later than twenty-four hours after the dispensing of any refills pursuant to this section. Notification to a practitioner under this subsection may be made by phone, facsimile, or electronic mail. (e) The practitioner who issued a prescription shall not incur any liability as the result of a registered pharmacist refilling that prescription pursuant to this section. (f) Notwithstanding any law to the contrary, a person may possess a substance dispensed pursuant to this section. (g) Nothing in this section shall authorize a registered pharmacist to refill a prescription for a controlled substance as defined in section 329-1." SECTION 3. Section 328-16, Hawaii Revised Statutes, is amended as follows: 1. By amending subsections (a) and (b) to read: "(a) A prescription drug shall be dispensed only if its label bears the following: (1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the dispensing practitioner's office; (2) Except as otherwise authorized for expedited partner therapy in section 453-52 or an opioid antagonist in section 461-11.8, the name of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; (3) The serial number of the prescription; (4) The date the prescription was prepared; (5) The name of the practitioner if the seller is not the practitioner; (6) The name, strength, and quantity of the drug; (7) The "use by" date for the drug, which shall be: (A) The expiration date on the manufacturer's container; or (B) One year from the date the drug is dispensed, whichever is earlier; (8) The number of refills available, if any; (9) In the case of the dispensing of an equivalent generic drug product, the statement "same as (brand name of the drug product prescribed or the referenced listed drug name)", or words of similar meaning; (10) In the case of the dispensing of an interchangeable biological product, the statement "interchangeable with (brand name of the biological product prescribed or the referenced biological drug name)", or words of similar meaning; and (11) Specific directions for the drug's use; provided that if the specific directions for use are too lengthy for inclusion on the label, the notation "take according to written instructions" may be used if separate written instructions for use are actually issued with the drug by the practitioner or the pharmacist, but in no event shall the notation "take as directed", referring to oral instructions, be considered acceptable. If any prescription for a drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescription unless subsequently authorized to do so by the practitioner[.] or pursuant to section 461- . The act of dispensing a prescription drug other than a professional sample or medical oxygen contrary to this subsection shall be deemed to be an act that results in a drug being misbranded while held for sale. (b) In addition to the requirements enumerated in subsection (a), a prescription drug shall be dispensed only: (1) By a pharmacist pursuant to a valid prescription or section 453-52, 461-1, [or] 461-11.8[;], or 461- ; (2) By a medical oxygen distributor pursuant to a prescription or certificate of medical necessity; provided that the drug to be dispensed is medical oxygen; or (3) By a practitioner to an ultimate user; provided that: (A) Except as otherwise authorized for expedited partner therapy in section 453-52, the practitioner shall inform the patient, [prior to] before dispensing any drug other than a professional sample, that the patient may have a written, orally ordered, or electronically transmitted or conveyed prescription directed to a pharmacy or a medical oxygen distributor of the patient's own choice; (B) The practitioner shall promptly record in the practitioner's records: (i) The prescription in full; (ii) The name, strength, and quantity of the drug, and specific directions for the drug's use; (iii) The date the drug was dispensed; (iv) Except as otherwise authorized for expedited partner therapy in section 453-52 or for an opioid antagonist in section 461-11.8, the name and address of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; and (v) Prescription drugs dispensed or prescribed for expedited partner therapy as authorized under section 453-52 or for an opioid antagonist in section 461-11.8; (C) The records described in subparagraph (B) shall be subject to the inspection of the department or its agents at all times; and (D) No undisclosed rebate, refund, commission, preference, discount, or other consideration, whether in the form of money or otherwise, has been offered to the practitioner as compensation or inducement to dispense or prescribe any specific drug in preference to other drugs that might be used for the identical therapeutic indication." 2. By amending subsection (d) to read: "(d) Any prescription may be refilled by the pharmacy and a prescription for medical oxygen may be refilled by the medical oxygen distributor if that refilling is authorized by the practitioner either: (1) In the original prescription; or (2) By oral or electronic order, which shall be promptly recorded and filed by the receiving pharmacist or medical oxygen distributor[.], or the refilling is conducted pursuant to section 461- ." SECTION 4. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. SECTION 5. This Act shall take effect on July 1, 2040. |
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| 49 | 48 | | |
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| 50 | 49 | | SECTION 1. The legislature finds that prescription refills play an important role in allowing patients to obtain their medication without frequent office visits. Refills also support patient adherence to medications for chronic conditions. Typical pharmacotherapy requires a patient's adherence to the regimen to achieve the therapeutic outcome, especially in patients with chronic conditions. Abrupt cessation or unplanned interruption of therapy may lead to undesirable outcomes. It is paramount for the pharmacist to ensure the patient's regimen is not disrupted and medications are dispensed in a timely manner. |
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| 51 | 50 | | |
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| 52 | 51 | | The legislature further finds that during times of natural disasters or public health emergencies, there may be significant challenges that impede a patient's ability to timely receive a necessary prescription. For example, the coronavirus disease 2019 pandemic forced some providers to limit office hours. Additionally, quarantine mandates forced patients to cancel existing appointments. These challenges resulted in gap periods without medications. |
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| 53 | 52 | | |
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| 54 | 53 | | The purpose of this Act is to provide clear guidance for pharmacists to act in the best interest of patients by minimizing gap periods without medications during a declared state of emergency by allowing pharmacists to refill prescriptions for persons directly impacted by the emergency for up to a thirty-day supply if the practitioner is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. |
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| 55 | 54 | | |
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| 56 | 55 | | SECTION 2. Chapter 461, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows: |
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| 57 | 56 | | |
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| 58 | 57 | | "§461- Refills without practitioner's authorization during state of emergency. (a) During a declared state of emergency pursuant to section 127A-14, a prescription for persons directly impacted by the emergency may be refilled up to a thirty-day supply without the practitioner's authorization if the practitioner is unavailable to authorize the refill and if, in the registered pharmacist's professional judgment, failure to refill the prescription may interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. |
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| 59 | 58 | | |
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| 60 | 59 | | (b) Before refilling a prescription pursuant to this section, the registered pharmacist shall make every reasonable effort to contact the practitioner. The registered pharmacist shall make an appropriate record, including the basis for proceeding under this section. |
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| 61 | 60 | | |
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| 62 | 61 | | (c) The registered pharmacist shall inform the patient that the prescription was refilled pursuant to this section. |
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| 63 | 62 | | |
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| 64 | 63 | | (d) The registered pharmacist shall notify the practitioner no later than twenty-four hours after the dispensing of any refills pursuant to this section. Notification to a practitioner under this subsection may be made by phone, facsimile, or electronic mail. |
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| 65 | 64 | | |
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| 66 | 65 | | (e) The practitioner who issued a prescription shall not incur any liability as the result of a registered pharmacist refilling that prescription pursuant to this section. |
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| 67 | 66 | | |
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| 68 | 67 | | (f) Notwithstanding any law to the contrary, a person may possess a substance dispensed pursuant to this section. |
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| 69 | 68 | | |
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| 70 | 69 | | (g) Nothing in this section shall authorize a registered pharmacist to refill a prescription for a controlled substance as defined in section 329-1." |
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| 71 | 70 | | |
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| 72 | 71 | | SECTION 3. Section 328-16, Hawaii Revised Statutes, is amended as follows: |
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| 73 | 72 | | |
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| 74 | 73 | | 1. By amending subsections (a) and (b) to read: |
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| 75 | 74 | | |
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| 76 | 75 | | "(a) A prescription drug shall be dispensed only if its label bears the following: |
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| 77 | 76 | | |
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| 78 | 77 | | (1) The name, business address, and telephone number of the seller. The business address shall be the physical location of the pharmacy or the dispensing practitioner's office; |
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| 79 | 78 | | |
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| 80 | 79 | | (2) Except as otherwise authorized for expedited partner therapy in section 453-52 or an opioid antagonist in section 461-11.8, the name of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; |
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| 81 | 80 | | |
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| 82 | 81 | | (3) The serial number of the prescription; |
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| 83 | 82 | | |
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| 84 | 83 | | (4) The date the prescription was prepared; |
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| 85 | 84 | | |
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| 86 | 85 | | (5) The name of the practitioner if the seller is not the practitioner; |
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| 87 | 86 | | |
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| 88 | 87 | | (6) The name, strength, and quantity of the drug; |
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| 89 | 88 | | |
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| 90 | 89 | | (7) The "use by" date for the drug, which shall be: |
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| 91 | 90 | | |
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| 92 | 91 | | (A) The expiration date on the manufacturer's container; or |
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| 93 | 92 | | |
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| 94 | 93 | | (B) One year from the date the drug is dispensed, |
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| 95 | 94 | | |
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| 96 | 95 | | whichever is earlier; |
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| 97 | 96 | | |
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| 98 | 97 | | (8) The number of refills available, if any; |
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| 99 | 98 | | |
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| 100 | 99 | | (9) In the case of the dispensing of an equivalent generic drug product, the statement "same as (brand name of the drug product prescribed or the referenced listed drug name)", or words of similar meaning; |
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| 101 | 100 | | |
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| 102 | 101 | | (10) In the case of the dispensing of an interchangeable biological product, the statement "interchangeable with (brand name of the biological product prescribed or the referenced biological drug name)", or words of similar meaning; and |
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| 103 | 102 | | |
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| 104 | 103 | | (11) Specific directions for the drug's use; provided that if the specific directions for use are too lengthy for inclusion on the label, the notation "take according to written instructions" may be used if separate written instructions for use are actually issued with the drug by the practitioner or the pharmacist, but in no event shall the notation "take as directed", referring to oral instructions, be considered acceptable. |
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| 105 | 104 | | |
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| 106 | 105 | | If any prescription for a drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescription unless subsequently authorized to do so by the practitioner[.] or pursuant to section 461- . The act of dispensing a prescription drug other than a professional sample or medical oxygen contrary to this subsection shall be deemed to be an act that results in a drug being misbranded while held for sale. |
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| 107 | 106 | | |
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| 108 | 107 | | (b) In addition to the requirements enumerated in subsection (a), a prescription drug shall be dispensed only: |
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| 109 | 108 | | |
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| 110 | 109 | | (1) By a pharmacist pursuant to a valid prescription or section 453-52, 461-1, [or] 461-11.8[;], or 461- ; |
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| 111 | 110 | | |
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| 112 | 111 | | (2) By a medical oxygen distributor pursuant to a prescription or certificate of medical necessity; provided that the drug to be dispensed is medical oxygen; or |
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| 113 | 112 | | |
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| 114 | 113 | | (3) By a practitioner to an ultimate user; provided that: |
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| 115 | 114 | | |
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| 116 | 115 | | (A) Except as otherwise authorized for expedited partner therapy in section 453-52, the practitioner shall inform the patient, [prior to] before dispensing any drug other than a professional sample, that the patient may have a written, orally ordered, or electronically transmitted or conveyed prescription directed to a pharmacy or a medical oxygen distributor of the patient's own choice; |
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| 117 | 116 | | |
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| 118 | 117 | | (B) The practitioner shall promptly record in the practitioner's records: |
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| 119 | 118 | | |
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| 120 | 119 | | (i) The prescription in full; |
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| 121 | 120 | | |
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| 122 | 121 | | (ii) The name, strength, and quantity of the drug, and specific directions for the drug's use; |
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| 123 | 122 | | |
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| 124 | 123 | | (iii) The date the drug was dispensed; |
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| 125 | 124 | | |
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| 126 | 125 | | (iv) Except as otherwise authorized for expedited partner therapy in section 453-52 or for an opioid antagonist in section 461-11.8, the name and address of the person for whom the drug was prescribed or the name of the owner of the animal for which the drug was prescribed; and |
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| 127 | 126 | | |
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| 128 | 127 | | (v) Prescription drugs dispensed or prescribed for expedited partner therapy as authorized under section 453-52 or for an opioid antagonist in section 461-11.8; |
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| 129 | 128 | | |
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| 130 | 129 | | (C) The records described in subparagraph (B) shall be subject to the inspection of the department or its agents at all times; and |
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| 131 | 130 | | |
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| 132 | 131 | | (D) No undisclosed rebate, refund, commission, preference, discount, or other consideration, whether in the form of money or otherwise, has been offered to the practitioner as compensation or inducement to dispense or prescribe any specific drug in preference to other drugs that might be used for the identical therapeutic indication." |
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| 133 | 132 | | |
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| 134 | 133 | | 2. By amending subsection (d) to read: |
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| 135 | 134 | | |
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| 136 | 135 | | "(d) Any prescription may be refilled by the pharmacy and a prescription for medical oxygen may be refilled by the medical oxygen distributor if that refilling is authorized by the practitioner either: |
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| 137 | 136 | | |
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| 138 | 137 | | (1) In the original prescription; or |
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| 139 | 138 | | |
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| 140 | 139 | | (2) By oral or electronic order, which shall be promptly recorded and filed by the receiving pharmacist or medical oxygen distributor[.], |
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| 141 | 140 | | |
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| 142 | 141 | | or the refilling is conducted pursuant to section 461- ." |
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| 143 | 142 | | |
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| 144 | 143 | | SECTION 4. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored. |
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| 145 | 144 | | |
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