State Codes and Statutes
Statutes > Connecticut > Title20 > Chap400j > Sec20-619Sec. 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".
