(1) A prescription drug dispensed
pursuant to an order must be labeled as follows:
(a) Drugs compounded and dispensed pursuant to a chart order for a patient
in a hospital must bear a label containing the name of the outlet, the name and
location of the patient, the identification of the drug, and, when applicable, any
suitable control numbers, the expiration date, any warnings, and any precautionary
statements.
(b) The symptom or purpose for which the drug is being prescribed must
appear on the label, if, after being advised by the practitioner, the patient or the
patient's authorized representative so requests. If the practitioner does not provide
the symptom or purpose for which a drug is being prescribed, the pharmacist may
fill the prescription order without contacting the practitioner, patient, or patient's
representative.
(2) (a) Except as otherwise required by law, any drug dispensed pursuant to a
prescription order must bear a label prepared and placed on or securely attached to
the medicine container stating at least the name and address of the prescription
drug outlet, the serial number and the date of the prescription or of its dispensing,
the name of the drug dispensed unless otherwise requested by the practitioner, the
name of the practitioner, the name of the patient, and, if stated in the prescription,
the directions for use and cautionary statements, if any, contained in the
prescription.
(b) Notwithstanding the labeling requirements described in subsection (2)(a)
of this section, at the practitioner's request, a prescription label for mifepristone,
misoprostol, or the generic alternatives to those prescriptions may include the
name of the prescribing health-care practice instead of the name of the
practitioner, provided the practitioner includes the name of the health-care practice
on the paper or electronic form of the prescription.
(3) The board shall promulgate rules concerning the labeling requirements
for a prescription drug that is dispensed to a patient for outpatient use and contains
an opioid, except for an opioid prescribed for treatment of a substance use disorder
or that is a partial opioid antagonist, which rules must include a warning to indicate
risks such as overdose and addiction.
(4) (a) As used in this subsection (4), unless the context otherwise requires:
(I) Patient means a patient and a patient's caretaker.
(II) Patient's external accessible device means a commercially available
computer, mobile phone, or other communications device that is able to receive
electronic information transmitted from an external source and provide the
electronic information in a form and format accessible to a patient.
(III) Prescription drug reader means an electronic device that is able to
obtain information from an electronic label affixed to a container of a prescription
drug and provide the information in an audio format accessible to the patient.
(b) On and after July 1, 2025, except as provided in subsections (4)(c) and
(4)(d) of this section, when dispensing a prescription drug to a patient who notifies a
pharmacy of difficulty seeing or reading standard printed labels on a prescription
drug container, the pharmacy shall provide the patient with a method to access the
prescription drug label information required pursuant to subsections (1) to (3) of this
section by the patient's choice of:
(I) An electronic label affixed to the prescription drug container that
transmits prescription drug label information, directions, and written instructions to
a patient's external accessible device, including a patient's compatible prescription
drug reader;
(II) A prescription drug reader provided to the patient at no cost;
(III) A prescription drug label in braille or large print; or
(IV) Any other method included in the best practices for access to
prescription drug labeling information by the United States access board, or its
successor organization.
(c) A pharmacy complies with subsection (4)(b) of this section if:
(I) The pharmacy offers a patient an alternative method to access a
prescription drug label other than the methods specified in subsections (4)(b)(I) to
(4)(b)(IV) of this section; and
(II) The board affirms that the alternative method offered to a patient
pursuant to subsection (4)(c)(I) of this section is substantially similar to the method
of access the patient requested and meets the needs of the patient.
(d) If a patient requests a method of access that the pharmacy has not yet
been asked to provide to any other patient, the pharmacy must not take more than
twenty-eight days to comply with subsection (4)(b) of this section. The pharmacy
shall make reasonable efforts to ensure patient safety and access during the time it
takes to provide the requested method of accessibility.
(e) Pharmacies shall make good faith, sustained, periodic, and reasonable
efforts to inform the public that prescription drug label information is available in
accessible formats for individuals who have difficulty seeing or reading standard
printed labels on prescription drug containers.
(f) Pharmacies shall otherwise follow best practices as recommended by the
United States access board, or its successor organization, for pharmacies in
providing independent access to prescription drug label information.
(g) By January 1, 2025, the board shall adopt rules necessary to implement
this subsection (4).