CHAPTER 330

FORMERLY

HOUSE BILL NO. 757

AS AMENDED BY HOUSE AMENDMENTS NOS.

3 AND 4

AN ACT TO AMEND CHAPTER 25, TITLE 24 OF THE DELAWARE CODE RELATING TO THE SUBSTITUTION OF DRUGS; AND PROVIDING FOR A DRUG PRODUCT SELECTION ACT.

Be it enacted by the General Assembly of the State of Delaware:

Section 1. Amend §2589, Chapter 25, Title 24 of the Delaware Code by designating the present section as new subsection (a), and by adding thereto the following new subsections:

"(b) Notwithstanding the provisions of subsection (a) hereof, when a pharmacist receives a prescription for a brand or trade name drug product, the pharmacist may dispense a therapeutically equivalent drug product if the following conditions are met:

(1) the prescriber, in the case of a written prescription, places his signature on the signatures line alongside the words 'Substitution Permitted' provided for •pursuant to subsection (c) or, in the case of a verbal prescription, states that substitution may be made; and

(2) the pharmacist informs the patient or the patient's adult representative of the savings which the patient will obtain as a result of substitution and passes on to the patient or patient's representative the full difference in actual acquisition costs between the drug prescribed and the drug substituted; and

(3) the pharmacist indicates on the prescription label the name of the manufacturer or supplier of the drug substituted, unless the prescriber otherwise indicates. In addition, the pharmacist shall record on the prescription the name of the manufacturer of the substituted drug product; and

(4) the prescribed drug is not among the drugs or classes of drugs which appear on the Non-Equavalent Drug List provided in subsection (d).

(c) Prescription Form. Every prescription written in this State by a practitioner licensed in Delaware shall be on prescription forms containing two lines for the practitioner's signature. Alongside the first line shall be clearly printed the words 'Dispense As Written'; alongside the second signature lines shall be clearly printed the words 'Substitution Permitted'. Prescription forms containing he appropriate signature lines shall be used by every prescriber of prescription drugs by no later than six (6) months from the date of passage of this Act.

(d) Non-Equivalent Drug List. (1) Advisory Board.

(i) In the Department of Health and Social Services there shall be a Delaware Drug Advisory Board (hereinafter referred to as 'Board') which shall have the responsibility for determining and designating drugs by generic classes which are not equivalent in effectiveness and may not be substituted in accordance with procedures set out herein. The Board shall have six members, consisting of two physicians, one of whom shall be an osteopathic physician; one pharmacist; one dentist; the Director of the Division of Public Health and the Director of Division of Consumer Affairs.

() All appointed members of the Board shall be appointed by the Governor. In making his appointments, the Governor shall consider the recommendations of the Medical Society of Delaware, the Delaware Pharmaceutical Society, the Delaware Dental Society, and the Delaware State Osteopathic Medical Society.

(iii) The six appointed members of the Board shall serve for terms of three years and until their successors shall be appointed and qualify, except that the terms of initial appointees to the Board shall be staggered by the Governor so that the terms of two are for two years and the terms of two are for one year each. Appointed members of the Board may be appointed for no more than two consecutive full three-year terms.

(iv) The Board shall elect from among its members a Chairman, a Vice-Chairman and Secretary. These officers shall hold office for a term of one year, and shall have authority to administer oaths, swear witnesses, and verify affidavits in matters before the Board. Officers may be reelected to subsequent terms without limit, subject only to the limitation on terms for appointed members of the Board.

(v) A quorum for action by the Board shall be four members. No fees or other compensation shall be paid for services of members of the Board.

(vi) The Secretary of the Board shall keep a full record of the proceedings of the Board, which record shall at all reasonable times be open to public inspection.

(2) Non-Equivalent List Preparation.

(i) The Board shall select non-equivalent drugs by generic class or otherwise based upon the following: (a) scientific data; (b) experience of prescriber; (c) professional judgments of pharmacists; and (d) other pertinent information bearing on the objectives of the Board. Included in the non-equivalent list shall be any drug for which the U.S. Food and Drug Administration has, by regulation, established a bio-equivalence requirement until such requirement has been met.

From time to time, the Secretary shall make other additions to or deletions from the list in accordance with advances in medical and pharmaceutical research in the best interests and for the health, safety and welfare of the people of this State.

Within thirty (30) days after the preparation of the initial list and a reasonable time after each addition or deletion thereto, the Secretary shall mail a copy thereto to each pharmacist registered with the State Board of Pharmacy and to each prescriber."

Section 2. The Pharmacy Control Office of the Department of Health and Social Services shall from time to time monitor prescription drug prices to determine what influence, if any, this Act has on the retail prices of prescription drugs.

Section 3. Within 6 months after the effective date of this Act, the Division of Public Health shall promulgate a Non-Equivalent Drug List of those drugs by generic class which the Delaware Drug Advisory Board determine together include drug products which are not equivalent in effectiveness. No pharmacist may dispense a generically equivalent drug product under the provisions of this Act until a Non-Equivalent Drug List has been promulgated and circulated by the Secretary of the Department of Health and Social Services.

Section 4. This act may be cited and referred to as the Delaware Drug Product Selection Act.

Approved March 27, 1976