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This entry was published on 2017-10-27
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SECTION 6816-A
When substitution is required
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 6816-a. When substitution is required. 1. A pharmacist shall
substitute a less expensive drug product containing the same active
ingredients, dosage form and strength as the drug product prescribed,
ordered or demanded, provided that the following conditions are met:

(a) The prescription is written on a form which meets the requirements
of subdivision six of section sixty-eight hundred ten of this article
and the prescriber does not prohibit substitution, or in the case of
oral prescriptions, the prescriber must expressly state whether
substitution is to be permitted or prohibited. Any oral prescription
that does not include such an express statement shall not be filled; and

(b) The substituted drug product is contained in the list of drug
products established pursuant to paragraph (o) of subdivision one of
section two hundred six of the public health law; and

(c) The pharmacist shall indicate on the label affixed to the
immediate container in which the drug is sold or dispensed the name and
strength of the drug product and its manufacturer unless the prescriber
specifically states otherwise. The pharmacist shall record on the
prescription form the brand name or the name of the manufacturer of the
drug product dispensed.

2. In the event a patient chooses to have a prescription filled by an
out of state dispenser, the laws of that state shall prevail.

* 3. A pharmacist shall substitute a less expensive biological product
for a prescribed biological product provided that all of the following
conditions are met:

(a) the substituted biological product is either an interchangeable
biological product for the prescribed product or the substituted
biological product is one for which the prescribed product is an
interchangeable biological product;

(b) the prescriber does not designate that a substitution is
prohibited as described in subdivision six of section sixty-eight
hundred ten of this article; and

(c) the pharmacist indicates on the label affixed to the immediate
container in which the biological product is sold or distributed the
name and strength of the product and its manufacturer unless the
prescriber specifically states otherwise.

* NB Expires October 23, 2022

* 4. (a) Within five business days following the dispensing of a
substituted biological product, the dispensing pharmacist or the
pharmacist's designee shall communicate to the prescriber the specific
product provided to the patient, including the name of the product and
the manufacturer. The communication shall be conveyed to the prescriber
(i) by making an entry that is electronically accessible to the
prescriber through an interoperable electronic medical records system,
an electronic prescribing technology or a pharmacy record; or (ii) by
using facsimile, electronic transmission or other electronic means. If
an electronic means described in this paragraph is not available to the
pharmacist at the time of communication, the dispensing pharmacist or
the pharmacist's designee may communicate the information by telephone.

(b) Communication under paragraph (a) of this subdivision shall not be
required where:

(i) there is no FDA-approved interchangeable biological product for
the product prescribed; or

(ii) a refill prescription is not changed from the product dispensed
on the prior filling of the prescription.

* NB Expires October 23, 2022

* 5. The department shall maintain a link on its web site to the
current list of all biological products determined by the Federal Food
and Drug Administration to be an interchangeable biological product for
a specific biological product.

* NB Expires October 23, 2022