(a) A prescription drug shall be dispensed only if its label bears the following:
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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. 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;
(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 § 453-52, the practitioner shall inform the patient, prior to 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 § 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 § 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.
(c) A prescription may be communicated in writing, orally, or by electronic transmission, and shall include the following information:
(1) The authorization of the practitioner noted as follows:
(A) Written prescriptions shall include the original signature of the practitioner;
(B) Oral prescriptions shall be promptly recorded by the pharmacist or medical oxygen distributor and shall include the practitioner’s oral code designation; and
(C) Electronic prescriptions shall be irrefutably traceable to the prescribing practitioner by a recognizable and unique practitioner identifier such as:
(i) A bitmap or graphic image of the prescriber’s handwritten signature and the prescriber’s oral code designation (or license number or other identifier if the prescriber is an out-of-state practitioner);
(ii) An electronic signature;
(iii) A digital signature; or
(iv) By other means as approved by the director;
(2) The date of issuance;
(3) The practitioner’s name, business telephone number, and business address, unless the practitioner is otherwise uniquely identified and the pharmacy or medical oxygen distributor dispensing the prescription has the prescriber’s contact information on file accessible within the dispensing area;
(4) The name, strength, and quantity of the drug to be dispensed, and specific directions for the drug’s use;
(5) Except as otherwise authorized for expedited partner therapy in § 453-52 or for an opioid antagonist in section 461-11.8, the name and address of the person for whom the prescription was written or the name of the owner of the animal for which the drug was prescribed, unless the pharmacy or medical oxygen distributor dispensing the prescription has the address on file accessible within the dispensing area;
(6) The room number and route of administration, if the patient is in an institutional facility; and
(7) The number of allowable refills, if the prescription is refillable. If the number of refills authorized by the practitioner is indicated using the terms “as needed” or “prn”, the prescription may be refilled up to twelve months from the date the original prescription was written. After the twelve-month period, the “as needed” or “prn” prescription may be refilled for a subsequent three-month period; provided:
(A) The prescription is refilled only once during the three-month period;
(B) The refill does not exceed a thirty-day supply of the drug;
(C) The refill does not provide any amount of the drug fifteen months beyond the date the original prescription was written;
(D) In the case of medical oxygen, the duration of therapy indicated on a certificate of medical necessity shall supersede any limitations or restrictions on refilling; and
(E) Subparagraphs (A) to (D) shall apply only to pharmacies and medical oxygen distributors practicing in the State.
(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.
(e) Prescription information may be transferred between pharmacies, between a pharmacy and a medical oxygen distributor, and between medical oxygen distributors for dispensing purposes; provided that:
(1) Medical oxygen distributors may communicate or receive prescription information related only to the dispensing of medical oxygen;
(2) The prescription information includes all elements of subsection (c)(2) to (7) and the following:
(A) Authentication of the transmitting pharmacy or medical oxygen distributor who is providing the prescription information including the following:
(i) The name of the pharmacist or medical oxygen distributor providing the information;
(ii) The name, telephone number, and address or location of the pharmacy or medical oxygen distributor firm providing the information; and
(iii) The serial number, prescription number, control number, or other unique identifier of the prescription record from which the information was transferred;
(B) The date the original prescription was issued;
(C) The date of the last refill; and
(D) The number of refills remaining.
(f) For the purposes of this section, a “prescription drug” is a drug intended for use by a person that:
(1) Is a habit forming drug to which section 328-15(4) applies;
(2) Because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner; or
(3) Is limited by an approved application under section 505 of the Federal Act, or section 328-17, to use under the professional supervision of a practitioner.
(g) Any drug other than medical oxygen dispensed pursuant to a prescription shall be exempt from the requirements of section 328-15 (except paragraphs (1), (9), (11), and (12), and the packaging requirements of paragraphs (7) and (8)), if the drug bears a label containing:
(1) The name and address of the pharmacy;
(2) The serial number and the date of the prescription or of its filling;
(3) The name of the practitioner;
(4) Except as otherwise authorized for expedited partner therapy in § 453-52 or for an opioid antagonist in section 461-11.8, the name of the patient;
(5) The directions for use; and
(6) Any cautionary statements contained in the prescription.
This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subsection (a), (b), (c), or (d).
(h) The director of health, by rule, may remove drugs subject to sections 328-15(4) and 328-17 from the requirements of subsection (a), (b), (c), or (d) when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the Federal Act by regulations issued thereunder may also, by rules issued by the director, be removed from the requirements of subsection (a), (b), (c), or (d).
(i) A drug that is subject to subsections (a), (b), (c), and (d) shall be deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement “Caution: Federal law prohibits dispensing without prescription”, “Caution: State law prohibits dispensing without prescription”, or “Rx only”. A drug to which subsections (a), (b), (c), and (d) do not apply shall be deemed to be misbranded if, at any time prior to dispensing, its label bears a caution statement quoted in the preceding sentence.
(j) Nothing in this section shall be construed to relieve any person from any requirement, prescribed by or under authority of law with respect to drugs now included or that may hereafter be included within the classifications of controlled substances as defined in the applicable federal and state laws relating to controlled substances.
(k) Oral code numbers or designations shall be issued by the department of law enforcement, pursuant to applicable laws and rules.
(l) Any person who transmits, maintains, or receives any prescription or prescription refill orally, in writing, or electronically shall ensure the security, integrity, and confidentiality of the prescription and any information contained therein.
