N.J. Stat. tit. 24, ch. 6K

N.J. Stat. § 24:6K-1 Definitions relative to dispensing certain biological products.

1. As used in this act: "Biological product" means a "biological product" as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings. "Interchangeable" means "interchangeable" as defined in subsection (i) of section 351 of the Public Health Service Act (42 U.S.C. s.262(i)) and indicated as interchangeable by the federal Food and Drug Administration in the "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," sometimes referred to as the "Purple Book." "Therapeutically equivalent" means a therapeutic equivalence rating of "A" has been listed by the federal Food and Drug Administration in the "Approved Drug Products with Therapeutic Equivalence Evaluations," sometimes referred to as the "Orange Book." L.2015, c.130, s.1.

N.J. Stat. § 24:6K-2 Link to current lists of all biological products.

2. The New Jersey State Board of Pharmacy shall maintain a link to the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable pursuant to section 351 of the Public Health Service Act (42 U.S.C. s.262) on the Board of Pharmacy's Internet website. L.2015, c.130, s.2.

N.J. Stat. § 24:6K-3 Conditions for substitution.

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 pharmacist who substitutes a biological product in compliance with this section 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. 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. L.2015, c.130, s.3.

N.J. Stat. § 24:6K-4 Rules, regulations.

7. The Commissioner of Health and the Director of the Division of Consumer Affairs, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), may adopt rules and regulations necessary to implement the provisions of this act. L.2015, c.130, s.7.