S4601: Requires pharmacist or pharmacist's designee to notify consumer of substituted drug or biological…

[First Reprint] SENATE, No. 4601 STATE OF NEW JERSEY 222nd LEGISLATURE INTRODUCED SEPTEMBER 28, 2026 Sponsored by: Senator JOSEPH F. VITALE District 19 (Middlesex) Senator LINDA R. GREENSTEIN District 14 (Mercer and Middlesex) Co-Sponsored by: Senator Mukherji SYNOPSIS Requires pharmacist or pharmacist's designee to notify consumer of substituted drug or biological product. CURRENT VERSION OF TEXT As reported by the Senate Health, Human Services and Senior Citizens Committee on October 5, 2026, with amendments. An Act concerning notification of drug or biological product substitutions and amending P.L.1977, c.240 and P.L.2015, c.130. Be It Enacted by the Senate and General Assembly of the State of New Jersey: 1. Section 8 of P.L.1977, c.240 (C.24:6E-7) is amended to read as follows: 8. Every prescription blank shall be imprinted with the words, "substitution permissible" and "do not substitute" and shall contain space for the physician's or other authorized prescriber's initials next to the chosen option. Notwithstanding any other law, unless the physician or other authorized prescriber explicitly states that there shall be no substitution when transmitting an oral prescription or, in the case of a written prescription, indicates that there shall be no substitution by initialing the prescription blank next to "do not substitute," a different brand name or nonbrand name drug product of the same established name shall be dispensed by a pharmacist if such different brand name or nonbrand name drug product shall reflect a lower cost to the consumer and is contained in the latest list of interchangeable drug products published by the council; provided, however, where the prescriber indicates "substitution permissible, and requests the pharmacist to notify [ him ] the prescriber of the substitution," the pharmacist shall transmit notice, either orally or by written notice to be mailed no later than the end of the business day, to the prescriber specifying the drug product actually dispensed and the name of the manufacturer thereof. However, no drug interchange shall be made unless a savings to the consumer results, and the pharmacist passes such savings on to the consumer in full by charging no more than the regular and customary retail price for the drug to be substituted. For prescriptions filled other than by mail, the consumer may, if a substitution is indicated and prior to having [ his ] the prescription filled, request the pharmacist or [ his ] the pharmacist's agent to inform [ him ] the consumer of the price savings that would result from substitution. If the consumer is not satisfied with said price savings [ he ] the consumer may, upon request, be dispensed the drug product prescribed by the physician. The pharmacist shall make a notation of such request upon the prescription blank. If a pharmacist dispenses a different brand name or non-brand name drug product of the same established name, the pharmacist or the pharmacist's agent shall notify the consumer of the substitution at the time the drug product is dispensed 1 , except that the pharmacist or the pharmacist's agent shall only be required to notify a consumer the first time the pharmacist dispenses the substituted drug product. If a pharmacist further substitutes a drug product previously substituted by the pharmacist, the pharmacist or the pharmacist's agent shall notify the consumer the first time the new substitution is dispensed 1 . (cf: P.L.1977, c.240, s.8) 2. Section 3 of P.L.2015, c.130 (C.24:6K-3) is amended to read as follows: 3. a. A pharmacist may substitute a biological product for a prescribed biological product, provided that the following conditions are met: (1) the authorized prescriber has not indicated that there shall be no substitution as set forth in section 8 of P.L.1977, c.240 (C.24:6E-7); and (2) the biological product to be substituted has been determined by the federal Food and Drug Administration to be: (a) interchangeable with the prescribed biological product; or (b) therapeutically equivalent to the prescribed biological product. b. If a pharmacist dispenses a biological product, the pharmacist or the pharmacist's designee shall, within five business days following the dispensing of the biological product, communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. No communication shall be required under this subsection when: (1) there is no biological product that has been determined by the federal Food and Drug Administration to be either: (a) interchangeable with the product prescribed; or (b) therapeutically equivalent to the product prescribed; or (2) a refill prescription is not changed from the product dispensed on the prior filling of the prescription. c. The communication requirement under subsection b. of this section may be satisfied by making an entry in an interoperable electronic medical records system or an electronic pharmacy record that can be accessed electronically by the prescriber, or through the use of another electronic prescribing technology that can be accessed electronically by the prescriber. Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescriber. Otherwise, the communication may be conveyed using other electronic means, if available, or by facsimile. d. [ A ] If a pharmacist [ who ] substitutes a biological product in compliance with this section : (1) the pharmacist shall record, on the prescription label and record of dispensing, the product name and manufacturer of the biological product dispensed, followed by the words: "Substituted for" and the name of the biological product for which the prescription was written ; and (2) the pharmacist, or the pharmacist's designee, shall notify the patient of the substitution at the time the biological product is dispensed 1 , except that the pharmacist or the pharmacist's designee shall only be required to notify a consumer the first time the pharmacist dispenses the substituted biological product. If a pharmacist further substitutes a biological product previously substituted by the pharmacist, the pharmacist or the pharmacist's designee shall notify the consumer the first time the new substitution is dispensed 1 . e. The same recordkeeping requirements as apply to the dispensing of drugs shall apply to the dispensing of biological products. f. A pharmacist who substitutes a biological product in compliance with this section shall incur no greater liability in filling the prescription by dispensing the biological product than would be incurred in filling the prescription by dispensing the prescribed biological product. (cf: P.L.2015, c.130, s.3) 3. This act shall take effect immediately.