§ 6816-A — When substitution is required

§ 6816-a. When substitution is required. 1. A pharmacist shall\nsubstitute a less expensive drug product containing the same active\ningredients, dosage form and strength as the drug product prescribed,\nordered or demanded, provided that the following conditions are met:\n (a) The prescription is written on a form which meets the requirements\nof subdivision six of section sixty-eight hundred ten of this article\nand the prescriber does not prohibit substitution, or in the case of\noral prescriptions, the prescriber must expressly state whether\nsubstitution is to be permitted or prohibited. Any oral prescription\nthat does not include such an express statement shall not be filled; and\n (b) The substituted drug product is contained in the list of drug\nproducts established pursuant to paragraph (o) of subdivision one of\nsection two hundred six of the public health law; and\n (c) The pharmacist shall indicate on the label affixed to the\nimmediate container in which the drug is sold or dispensed the name and\nstrength of the drug product and its manufacturer unless the prescriber\nspecifically states otherwise. The pharmacist shall record on the\nprescription form the brand name or the name of the manufacturer of the\ndrug product dispensed.\n 2. In the event a patient chooses to have a prescription filled by an\nout of state dispenser, the laws of that state shall prevail.\n 3. A pharmacist shall substitute a less expensive biological product\nfor a prescribed biological product provided that all of the following\nconditions are met:\n (a) the substituted biological product is either an interchangeable\nbiological product for the prescribed product or the substituted\nbiological product is one for which the prescribed product is an\ninterchangeable biological product;\n (b) the prescriber does not designate that a substitution is\nprohibited as described in subdivision six of section sixty-eight\nhundred ten of this article; and\n (c) the pharmacist indicates on the label affixed to the immediate\ncontainer in which the biological product is sold or distributed the\nname and strength of the product and its manufacturer unless the\nprescriber specifically states otherwise.\n 4. (a) Within five business days following the dispensing of a\nsubstituted biological product, the dispensing pharmacist or the\npharmacist's designee shall communicate to the prescriber the specific\nproduct provided to the patient, including the name of the product and\nthe manufacturer. The communication shall be conveyed to the prescriber\n(i) by making an entry that is electronically accessible to the\nprescriber through an interoperable electronic medical records system,\nan electronic prescribing technology or a pharmacy record; or (ii) by\nusing facsimile, electronic transmission or other electronic means. If\nan electronic means described in this paragraph is not available to the\npharmacist at the time of communication, the dispensing pharmacist or\nthe pharmacist's designee may communicate the information by telephone.\n (b) Communication under paragraph (a) of this subdivision shall not be\nrequired where:\n (i) there is no FDA-approved interchangeable biological product for\nthe product prescribed; or\n (ii) a refill prescription is not changed from the product dispensed\non the prior filling of the prescription.\n 5. The department shall maintain a link on its web site to the current\nlist of all biological products determined by the Federal Food and Drug\nAdministration to be an interchangeable biological product for a\nspecific biological product.\n