S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1067
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 13, 2023
                                ___________
 
 Introduced  by  M.  of  A. DINOWITZ, SEAWRIGHT, HEVESI, COOK, BENEDETTO,
   BICHOTTE HERMELYN, REYES, L. ROSENTHAL,  SEPTIMO,  BYRNES,  STIRPE  --
   read once and referred to the Committee on Higher Education
 
 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:
   (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;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD03874-01-3
 A. 1067                             2
 
   (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
 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.