NY Educ L § 6816-A (2021)
2021 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.   * 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