SPONSOR:	Sen. Poore & Sen. Hall-Long & Rep. Barbieri
	Sens. Ennis, Henry, Townsend; Rep. Longhurst

DELAWARE STATE SENATE

147th GENERAL ASSEMBLY

SENATE BILL NO. 118

AN ACT TO AMEND TITLE 24 OF THE DELAWARE CODE RELATING TO PHARMACISTS.

Section 1. Amend Chapter 25, Subchapter VI, Title 24 of the Delaware Code by making insertions as shown by underlining and deletions as shown by strike through as follows:

§ 2549A. Substitution of biosimilar biological products.

(a) In this section, the following definitions shall apply:

(1) “Biological product” has the meaning stated in 42 U.S.C. § 262(I).

(2) “Biosimilar” has the meaning stated in 42 U.S.C. § 262(I).

(3) “Drug” has the meaning stated in § 2502 of this Title and includes a biological product.

(4) “Interchangeable” has the meaning stated in 42 U.S.C. § 262(I).

(5) “Product” has the meaning stated in 42 U.S.C. 26 § 262(I).

(b) A pharmacist may substitute a biosimilar biological product for a prescribed biological Product only if:

(1) The biosimilar biological product has been approved by the U.S. Food and Drug Administration to be interchangeable with the prescribed biological Product; and

(2) The authorized prescriber does not state expressly that the prescription is to be dispensed only as directed.

(c) If a pharmacist substitutes an interchangeable biosimilar biological product for a prescribed biological Product, the pharmacist or pharmacist’s designee, shall:

(1) Notify the patient in writing that the biosimilar product dispensed has been approved by the U.S. Food and Drug Administration as an interchangeable biosimilar biological product for the prescribed biological Product;

(2) Provide electronic, fax, written, or telephonic notification of the substitution to the authorized prescriber or the authorized prescriber’s staff within 48 hours after the dispensing of the interchangeable biosimilar biological product; and

(3) Record on the prescription label and record of dispensing:

(i) The product name of the interchangeable biosimilar biological product followed by the words “substituted for” and the name of the biological Product for which the prescription was written; and

(ii) The manufacturer of the interchangeable biosimilar biological product.

(d) Records of substitutions of interchangeable biosimilar biological products shall be maintained for at least 3 years after the dispensing date.

(e) A pharmacist who substitutes an interchangeable biosimilar biological prodct in compliance with this section incurs no greater liability in filling the prescription by dispensing the interchangeable biosimilar biological product than would be incurred in filling the prescription by dispensing the prescribed biological reference product.

(f) Where a prescriber of biological products in this State desires that the brand named product be dispensed, the prescriber must handwrite on the prescription form “Brand Necessary” or “Brand Medically Necessary” below the signature line.