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.