S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   10479
 
                           I N  A S S E M B L Y
 
                               May 29, 2024
                                ___________
 
 Introduced by COMMITTEE ON RULES -- (at request of M. of A. Blumencranz)
   -- read once and referred to the Committee on Health
 
 AN ACT to amend the public health law and the education law, in relation
   to  the  labeling of prescriptions that are manufactured or compounded
   in a foreign country and subject to approval by the federal  Food  and
   Drug Administration foreign drug inspection program

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Short title. This act shall be known and may  be  cited  as
 the "foreign drug transparency act".
   §  2.  Subdivision  3  of  section  280-a of the public health law, as
 amended by chapter 128 of the laws  of  2022,  is  amended  to  read  as
 follows
   3.  Prescriptions.  A  pharmacy  benefit manager may not substitute or
 cause the substituting of one prescription drug for another in  dispens-
 ing  a  prescription,  or  alter or cause the altering of the terms of a
 prescription, except with the approval of the prescriber or as explicit-
 ly required or permitted by law, including regulations of the department
 of financial services or the department of  health.  The  superintendent
 and  commissioner,  in  coordination  with each other, are authorized to
 promulgate regulations to determine when  substitution  of  prescription
 drugs  may  be  required  or permitted. A PHARMACY BENEFIT MANAGER SHALL
 DISCLOSE TO A HEALTH PLAN, PHARMACY AND PATIENT WHETHER  A  PRESCRIPTION
 DRUG  WAS  MANUFACTURED  OR COMPOUNDED IN A FOREIGN COUNTRY; WHETHER THE
 PRESCRIPTION WAS APPROVED BY THE FEDERAL FOOD  AND  DRUG  ADMINISTRATION
 FOREIGN  DRUG INSPECTION PROGRAM; AND THE DATE OF THE LAST INSPECTION OF
 SUCH PRESCRIPTION DRUG BY  THE  FEDERAL  FOOD  AND  DRUG  ADMINISTRATION
 FOREIGN DRUG INSPECTION PROGRAM.
   § 3. Subdivision 1 of section 6810 of the education law, as amended by
 section  2  of  part  V of chapter 57 of the laws of 2012, is amended to
 read as follows
   1. No drug for which a prescription is required by the  provisions  of
 the Federal Food, Drug and Cosmetic Act or by the commissioner of health
 shall   be  distributed  or  dispensed  to  any  person  except  upon  a
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD15348-01-4
 A. 10479                            2
 
 prescription written by  a  person  legally  authorized  to  issue  such
 prescription.  Such  drug shall be compounded or dispensed by a licensed
 pharmacist, and no such drug shall be dispensed without affixing to  the
 immediate container in which the drug is sold or dispensed a label bear-
 ing  the  name and address of the owner of the establishment in which it
 was dispensed, the date compounded, the number of the prescription under
 which it is recorded in the pharmacist's prescription files, the name of
 the prescriber, the name and address of the patient, and the  directions
 for  the  use of the drug by the patient as given upon the prescription,
 AND THE COUNTRY IN WHICH THE DRUG WAS MANUFACTURED OR COMPOUNDED; WHETH-
 ER THE DRUG WAS APPROVED BY THE FEDERAL  FOOD  AND  DRUG  ADMINISTRATION
 FOREIGN  DRUG INSPECTION PROGRAM; AND THE DATE OF THE LAST INSPECTION OF
 SUCH PRESCRIPTION DRUG BY  THE  FEDERAL  FOOD  AND  DRUG  ADMINISTRATION
 FOREIGN DRUG INSPECTION PROGRAM. SUCH LABEL SHALL BE EMPHASIZED BY BEING
 HIGHLIGHTED  IN  YELLOW  COLOR  OR IN BOLD TYPE OR BOTH AND PRINTED IN A
 MINIMUM OF A TWELVE-POINT FONT; IF SAID DRUG WAS  NOT  APPROVED  BY  THE
 FEDERAL  FOOD  AND  DRUG ADMINISTRATION FOREIGN DRUG INSPECTION PROGRAM,
 SUCH INFORMATION SHALL BE CONTAINED WITHIN THE LABEL WITH A WARNING SIGN
 AND IN A MINIMUM SIZE FOURTEEN-POINT FONT. All labels shall  conform  to
 such  rules  and regulations as promulgated by the commissioner pursuant
 to  section  sixty-eight  hundred  twenty-nine  of  this  article.   The
 prescribing  and  dispensing  of  a drug which is a controlled substance
 shall be subject to additional requirements provided in article  thirty-
 three  of  the  public  health  law.  The words "drug" and "prescription
 required drug" within the meaning of this article shall not be construed
 to include soft or hard contact lenses, eyeglasses, or any other  device
 for  the  aid or correction of vision. Nothing in this subdivision shall
 prevent a pharmacy from furnishing a drug to another pharmacy which does
 not have such drug in stock for the purpose of filling a prescription.
   § 4. This act shall take effect immediately.