N.J. Admin. Code § 13:39-7.23

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-7.23 - Biological products

(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 N.J.S.A. 24:6E-7; and

2. The biological product to be substituted has been determined by the Federal Food and Drug Administration (FDA) to be:

i. Interchangeable with the prescribed biological product; or

ii. 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 FDA to be either:

i. Interchangeable with the product prescribed; or

ii. 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 (b) above 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 subsection 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 recordkeeping requirements of this subchapter and N.J.A.C. 13:39-9, as applicable, which apply to the dispensing of drugs shall apply to the dispensing of biological products.

(f) The Board shall maintain a link to the current list of all biological products determined by the FDA to be interchangeable pursuant to section 351 of the Public Health Service Act ( 42 U.S.C. § 262 ) on the Board's website.

N.J. Admin. Code § 13:39-7.23

Adopted by 49 N.J.R. 3761(a), effective 12/4/2017