Sec. 20-619. (Formerly Sec. 20-185a). Substitution of generic drugs. Regulations.
Sec. 20-619. (Formerly Sec. 20-185a). Substitution of generic drugs. Regulations. (a) For the purposes of section 20-579 and this section:
(1) "Brand name" means the proprietary or trade name selected by the manufacturer
and placed upon a drug product, its container, label or wrapping at the time of packaging;
(2) "Generic name" means the established name designated in the official United
States Pharmacopoeia/National Formulary, official Homeopathic Pharmacopoeia of the
United States, or official United States adopted names or any supplement to any of them;
(3) "Therapeutically equivalent" means drug products that are approved under the
provisions of the federal Food, Drug and Cosmetics Act for interstate distribution and
that will provide essentially the same efficacy and toxicity when administered to an
individual in the same dosage regimen; and
(4) "Dosage form" means the physical formulation or medium in which the product
is intended, manufactured and made available for use, including, but not limited to,
tablets, capsules, oral solutions, aerosol, inhalers, gels, lotions, creams, ointments, transdermals and suppositories, and the particular form of any physical formulation or medium that uses a specific technology or mechanism to control, enhance or direct the
release, targeting, systemic absorption, or other delivery of a dosage regimen in the body.
(b) Except as limited by subsections (c) and (e) of this section, unless the purchaser
instructs otherwise, the pharmacist may substitute a generic drug product with the same
strength, quantity, dose and dosage form as the prescribed drug product which is, in the
pharmacist's professional opinion, therapeutically equivalent. When the prescribing
practitioner is not reasonably available for consultation and the prescribed drug does
not use a unique delivery system technology, the pharmacist may substitute an oral
tablet, capsule or liquid form of the prescribed drug as long as the form dispensed has
the same strength, dose and dose schedule and is therapeutically equivalent to the drug
prescribed. The pharmacist shall inform the patient or a representative of the patient,
and the practitioner of the substitution at the earliest reasonable time.
(c) A prescribing practitioner may specify in writing or by a telephonic or other
electronic communication that there shall be no substitution for the specified brand name
drug product in any prescription, provided (1) in any prescription for a Medicaid, state-administered general assistance, or ConnPACE recipient, such practitioner specifies the
basis on which the brand name drug product and dosage form is medically necessary
in comparison to a chemically equivalent generic drug product substitution, and (2) the
phrase "BRAND MEDICALLY NECESSARY", shall be in the practitioner's handwriting on the prescription form or on an electronically-produced copy of the prescription
form or, if the prohibition was communicated by telephonic or other electronic communication that did not reproduce the practitioner's handwriting, a statement to that effect
appears on the form. The phrase "BRAND MEDICALLY NECESSARY" shall not be
preprinted or stamped or initialed on the form. If the practitioner specifies by telephonic
or other electronic communication that did not reproduce the practitioner's handwriting
that there shall be no substitution for the specified brand name drug product in any
prescription for a Medicaid, state-administered general assistance, or ConnPACE recipient, written certification in the practitioner's handwriting bearing the phrase "BRAND
MEDICALLY NECESSARY" shall be sent to the dispensing pharmacy within ten days.
(d) Each pharmacy shall post a sign in a location easily seen by patrons at the counter
where prescriptions are dispensed stating that, "THIS PHARMACY MAY BE ABLE
TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE." The printing on the sign shall be in block letters
not less than one inch in height.
(e) A pharmacist may substitute a drug product under subsection (b) of this section
only when there will be a savings in cost passed on to the purchaser. The pharmacist
shall disclose the amount of the savings at the request of the patient.
(f) Except as provided in subsection (g) of this section, when a pharmacist dispenses
a substitute drug product as authorized by subsection (b) of this section, the pharmacist
shall label the prescription container with the name of the dispensed drug product. If
the dispensed drug product does not have a brand name, the prescription label shall
indicate the generic name of the drug product dispensed along with the name of the drug
manufacturer or distributor.
(g) A prescription dispensed by a pharmacist shall bear upon the label the name of
the drug in the container unless the prescribing practitioner writes "DO NOT LABEL",
or words of similar import, on the prescription or so designates in an oral or electronic
transmission of the prescription.
(h) Neither the failure to instruct by the purchaser as provided in subsection (b) of
this section nor the fact that a sign has been posted as provided in subsection (d) of this
section shall be a defense on the part of a pharmacist against a suit brought by any such
purchaser.
(i) The commissioner, with the advice and assistance of the commission, shall adopt
regulations, in accordance with chapter 54, to carry out the provisions of this section.
(P.A. 76-166, S. 1, 8; P.A. 94-32, S. 1; P.A. 95-264, S. 40; P.A. 99-175, S. 39; June Sp. Sess. P.A. 00-2, S. 42, 53; P.A.
04-76, S. 31.)
History: P.A. 94-32 added definition of "dosage form" and made technical changes; P.A. 95-264 made technical changes
in definitions, deleted definition of "substitute" and added Subsecs. (b) to (i) re substitutions; Sec. 20-185a transferred to
Sec. 20-619 in 1997; P.A. 99-175 made technical changes and amended Subsec. (i) to add provision requiring adoption
of regulations to be consistent with chapter 54; June Sp. Sess. P.A. 00-2 amended Subsec. (c) by adding provisions requiring
practitioner to specify basis of medical necessity in prescriptions for assistance recipients, by deleting "NO SUBSTITUTION" phrase requirements and by making conforming and technical changes, effective July 1, 2000; P.A. 04-76 amended
Subsec. (c) by deleting references to "general assistance".