2023 New York Laws › EDN - Education › Title 8 - The Professions › Article 137 - Pharmacy › 6816-A - When Substitution Is Required.

§ 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.
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.
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.