S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  5413--A
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             February 16, 2021
                                ___________
 
 Introduced  by  M.  of  A. DINOWITZ, SEAWRIGHT, HEVESI, COOK, BENEDETTO,
   FERNANDEZ, BICHOTTE HERMELYN, REYES, L. ROSENTHAL, SEPTIMO, BYRNES  --
   read  once and referred to the Committee on Higher Education -- recom-
   mitted to the Committee on Higher Education in accordance with  Assem-
   bly  Rule  3,  sec.  2  -- committee discharged, bill amended, ordered
   reprinted as amended and recommitted to said committee
 
 AN ACT to amend the education law, in relation to  the  registration  of
   nonresident  pharmacies,  manufacturers,  wholesalers  and outsourcing
   facilities that deliver prescription drugs  to  other  establishments,
   authorized prescribers and patients residing in this state
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Subdivision 2 of section 6808-b of the  education  law,  as
 amended  by  chapter  567  of  the  laws  of 2002, is amended to read as
 follows:
   2. Registration. (A) All nonresident establishments that  ship,  mail,
 or  deliver prescription drugs and/or devices to other registered estab-
 lishments, authorized prescribers, and/or patients into this state shall
 be registered with the department; except that such  registration  shall
 not  apply  to  intra-company transfers between any division, affiliate,
 subsidiaries, parent or other entities under complete  common  ownership
 and  control.  The  provisions of this subdivision shall apply solely to
 nonresident establishments and shall not affect any other  provision  of
 this article.
   (B)  NOTWITHSTANDING  THE  PROVISIONS OF THIS ARTICLE, AN UNREGISTERED
 NONRESIDENT ESTABLISHMENT MAY SHIP, MAIL, OR DELIVER PRESCRIPTION  DRUGS
 AND/OR  DEVICES TO REGISTERED ESTABLISHMENTS IN THIS STATE IN CASES OF A
 SPECIFIC PATIENT NEED OR A DECLARED PUBLIC  HEALTH  EMERGENCY,  PROVIDED
 THAT:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD09095-02-2
 A. 5413--A                          2
 
              

   (I) THE UNLICENSED ESTABLISHMENT IS APPROPRIATELY LICENSED IN ITS HOME
 STATE,  AND  DOCUMENTATION OF THE LICENSE VERIFICATION CAN BE MAINTAINED
 BY THE RESIDENT ESTABLISHMENT IN A MANNER DETERMINED BY THE DEPARTMENT;
   (II)  IN  CASES OF SPECIFIC PATIENT NEED, THE REGISTERED ESTABLISHMENT
 SHALL MAINTAIN DOCUMENTATION THAT THE TRANSFER IS FOR SUCH PURPOSE IN  A
 MANNER DETERMINED BY THE DEPARTMENT;
   (III)  THE  RESIDENT PHARMACY COMPLIES WITH ALL RECORDKEEPING REQUIRE-
 MENTS OF THE DEPARTMENT FOR EACH DRUG OR DEVICE RECEIVED FROM ANY UNREG-
 ISTERED NONRESIDENT ESTABLISHMENT;
   (IV) ALL DOCUMENTATION  AND  RECORDS  ARE  RETAINED  AND  ARE  READILY
 RETRIEVABLE BY THE RESIDENT ESTABLISHMENT FOR A PERIOD OF SIX YEARS;
   (V)  THE PRESCRIPTION DRUG OR DEVICE WAS MANUFACTURED BY AN AUTHORIZED
 FDA REGISTERED DRUG MANUFACTURER AND IS NOT  A  COMPOUNDED  DRUG.    THE
 UNREGISTERED  NONRESIDENT  ESTABLISHMENT  SHALL  ONLY DELIVER OR TRADE A
 DRUG OR DEVICE SALABLE ON PRESCRIPTION ONLY  THAT  IT  RECEIVES  FROM  A
 MANUFACTURER,  A  WHOLESALE DISTRIBUTOR OR A PHARMACY IN ACCORDANCE WITH
 THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT (DSCSA);
   (VI) THE NONRESIDENT  ESTABLISHMENT  FROM  WHICH  THE  DRUG  IS  BEING
 OBTAINED  RECEIVES  A  REQUEST  FOR  THE DRUG THAT IDENTIFIES THE DRUG'S
 BRAND NAME OR GENERIC NAME, QUALITY, QUANTITY, AND SIZE. SUCH DRUG SHALL
 NOT BE EXPIRED AT THE TIME OF THE EXCHANGE;
   (VII)  THE DRUG BEING OBTAINED INCLUDES  WITH  THE  DRUG  A  PACKAGING
 CHECKLIST CONFIRMING THAT THE DRUG BEING DELIVERED OR TRADED MATCHES THE
 INFORMATION  IDENTIFIED  ON  THE  REQUEST,  AND THE DRUG IS DELIVERED OR
 TRADED IN THE  ORIGINAL  MANUFACTURER'S  PACKAGING,  WHETHER  SEALED  OR
 UNSEALED,  WITH  PACKAGE  INSERT,  THE  DRUG'S  NATIONAL  DRUG CODE, LOT
 NUMBER, AND EXPIRATION DATE CONSPICUOUSLY IDENTIFIED ON  THE  PACKAGING.
 IF  THE ORIGINAL MANUFACTURER'S PACKAGING IS UNSEALED AT THE TIME OF THE
 DELIVERY OR TRADE, THE DELIVERY OR TRADE MAY INCLUDE A QUANTITY  OF  THE
 DRUG  THAT  IS LESS THAN THE QUANTITY CONTAINED IN THE ORIGINAL MANUFAC-
 TURER'S PACKAGING.  HOWEVER, A PHARMACY SHALL NOT TRADE OR DELIVER  MORE
 THAN ONE UNSEALED OR PARTIAL QUANTITY OF THE DRUG DURING ANY CONSECUTIVE
 NINETY-DAY PERIOD;
   (VIII)  NOTWITHSTANDING THE LANGUAGE OF THIS SECTION, NOTHING SHALL BE
 INTERPRETED  TO  ALLOW  FOR  THE SALE, TRADE OR EXCHANGE OF A CONTROLLED
 SUBSTANCE AS DEFINED BY ARTICLE THIRTY-THREE OF THE PUBLIC  HEALTH  LAW;
 AND
   (IX)  THE SALE/TRANSFER PRICE OF ANY ITEM EXCHANGED UNDER THIS SECTION
 MAY  NOT  EXCEED ONE HUNDRED PERCENT OF THE ITEM'S WHOLESALE ACQUISITION
 COST (WAC) AT THE TIME OF THE SALE.
   (C)   A PHARMACY  THAT  RECEIVES  NOTIFICATION  FROM  AN  UNREGISTERED
 NONRESIDENT  ESTABLISHMENT  THAT  A DELIVERY OR TRADE INVOLVED A DRUG OR
 DEVICE SALABLE ON PRESCRIPTION ONLY THAT IS AN  ILLEGITIMATE,  RECALLED,
 OR COUNTERFEIT PRODUCT SHALL IMMEDIATELY NOTIFY THE STATE BOARD OF PHAR-
 MACY, AND THE FDA.
   (D)    ANY  UNREGISTERED NONRESIDENT ESTABLISHMENT INVOLVED IN A SALE,
 EXCHANGE, OR TRANSACTION UNDER THIS SECTION IS SUBJECT TO THE  JURISDIC-
 TION  OF  THE  STATE OF NEW YORK REGARDING SAID SALE, EXCHANGE OR TRANS-
 ACTION.  SUCH ESTABLISHMENT SHALL COOPERATE WITH AGENTS OF THE STATE  OF
 NEW  YORK IF SAID AGENT IS CONDUCTING AN AUDIT OR INVESTIGATION INTO THE
 SALE, EXCHANGE OR TRANSACTION, AND VIOLATIONS OF THIS SECTION  SHALL  BE
 PUNISHABLE  ACCORDING  TO  REGULATIONS PROMULGATED BY THE DEPARTMENT AND
 THE LAWS OF THIS STATE.
   (E) FOR PURPOSES  OF  THIS  SUBDIVISION  "SPECIFIC  PATIENT  NEED"  IS
 DEFINED  AS  THE  TRANSFER  OF A PRODUCT FROM ONE PHARMACY TO ANOTHER TO
 FILL A PRESCRIPTION FOR  AN  IDENTIFIED  PATIENT.  SUCH  TERM  DOES  NOT
 A. 5413--A                          3
 
 INCLUDE  THE  TRANSFER OF A PRODUCT FROM ONE PHARMACY TO ANOTHER FOR THE
 PURPOSE OF INCREASING OR REPLENISHING STOCK IN ANTICIPATION OF A  POTEN-
 TIAL NEED IN ACCORDANCE WITH THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT.
   §  2.  This  act shall take effect on the ninetieth day after it shall
 become a law.