New York A 1412: Relates to exceptions from registration requirements for nonresident pharmacies in certain cases

Bill Text

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A01412 Summary:

BILL NOA01412 

&nbsp

SAME ASSAME AS S00406

&nbsp

SPONSORDinowitz

&nbsp

COSPNSRSeawright, Hevesi, Cook, Benedetto, Bichotte Hermelyn, Reyes, Rosenthal, Septimo, Stirpe, Ramos,
 Zaccaro, Davila, Levenberg

&nbsp

MLTSPNSR

&nbsp

Amd §6808-b, Ed L

&nbsp

Permits an exception from registration for nonresident pharmacies in cases of a specific patient need or a declared public health emergency under certain conditions.

Go to top A01412 Actions:

BILL NOA01412 

&nbsp

01/09/2025referred to higher education

01/07/2026referred to higher education

Go to topA01412 Committee&nbspVotes:

Go to topA01412 Floor&nbspVotes:

There are no Assembly votes for this bill in this legislative session.

Go to topA01412 Text:

 STATE OF NEW YORK
 ________________________________________________________________________

 1412

 2025-2026 Regular Sessions

 IN ASSEMBLY

 January 9, 2025
 ___________

 Introduced by M. of A. DINOWITZ, SEAWRIGHT, HEVESI, COOK, BENEDETTO,
 BICHOTTE HERMELYN, REYES, ROSENTHAL, SEPTIMO, STIRPE, RAMOS, ZACCARO,
 DAVILA, LEVENBERG -- 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:

 1 Section 1. Subdivision 2 of section 6808-b of the education law, as
 2 amended by chapter 567 of the laws of 2002, is amended to read as
 3 follows:
 4 2. Registration. (a) All nonresident establishments that ship, mail,
 5 or deliver prescription drugs and/or devices to other registered estab-
 6 lishments, authorized prescribers, and/or patients into this state shall
 7 be registered with the department; except that such registration shall
 8 not apply to intra-company transfers between any division, affiliate,
 9 subsidiaries, parent or other entities under complete common ownership
 10 and control. The provisions of this subdivision shall apply solely to
 11 nonresident establishments and shall not affect any other provision of
 12 this article.
 13 (b) Notwithstanding the provisions of this article, an unregistered
 14 nonresident establishment may ship, mail, or deliver prescription drugs
 15 and/or devices to registered establishments in this state in cases of a
 16 specific patient need or a declared public health emergency, provided
 17 that:
 18 (i) the unlicensed establishment is appropriately licensed in its home
 19 state, and documentation of the license verification can be maintained
 20 by the resident establishment in a manner determined by the department;

 EXPLANATION--Matter in italics (underscored) is new; matter in brackets
 [ ] is old law to be omitted.
 LBD01654-01-5

 A. 1412 2

 1 (ii) in cases of specific patient need, the registered establishment
 2 shall maintain documentation that the transfer is for such purpose in a
 3 manner determined by the department;
 4 (iii) the resident pharmacy complies with all recordkeeping require-
 5 ments of the department for each drug or device received from any unreg-
 6 istered nonresident establishment;
 7 (iv) all documentation and records are retained and are readily
 8 retrievable by the resident establishment for a period of six years;
 9 (v) the prescription drug or device was manufactured by an authorized
 10 FDA registered drug manufacturer and is not a compounded drug. The
 11 unregistered nonresident establishment shall only deliver or trade a
 12 drug or device salable on prescription only that it receives from a
 13 manufacturer, a wholesale distributor or a pharmacy in accordance with
 14 the federal Drug Supply Chain Security Act (DSCSA);
 15 (vi) the nonresident establishment from which the drug is being
 16 obtained receives a request for the drug that identifies the drug's
 17 brand name or generic name, quality, quantity, and size. Such drug shall
 18 not be expired at the time of the exchange;
 19 (vii) the drug being obtained includes with the drug a packaging
 20 checklist confirming that the drug being delivered or traded matches the
 21 information identified on the request, and the drug is deli