- Summary
- Actions
- Committee Votes
- Floor Votes
- Memo
- Text
- LFIN
- Chamber Video/Transcript
S09448 Summary:
BILL NO | S09448 |
  | |
SAME AS | SAME AS A05413-A |
  | |
SPONSOR | BROUK |
  | |
COSPNSR | |
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MLTSPNSR | |
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Amd §6808-b, Ed L | |
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Permits an exception from registration for nonresident pharmacies in cases of a specific patient need or a declared public health emergency under certain conditions. |
S09448 Actions:
BILL NO | S09448 | |||||||||||||||||||||||||||||||||||||||||||||||||
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05/27/2022 | REFERRED TO HIGHER EDUCATION | |||||||||||||||||||||||||||||||||||||||||||||||||
06/02/2022 | COMMITTEE DISCHARGED AND COMMITTED TO RULES | |||||||||||||||||||||||||||||||||||||||||||||||||
06/02/2022 | ORDERED TO THIRD READING CAL.1918 | |||||||||||||||||||||||||||||||||||||||||||||||||
06/02/2022 | PASSED SENATE | |||||||||||||||||||||||||||||||||||||||||||||||||
06/02/2022 | DELIVERED TO ASSEMBLY | |||||||||||||||||||||||||||||||||||||||||||||||||
06/02/2022 | referred to higher education | |||||||||||||||||||||||||||||||||||||||||||||||||
06/03/2022 | substituted for a5413a | |||||||||||||||||||||||||||||||||||||||||||||||||
06/03/2022 | ordered to third reading rules cal.769 | |||||||||||||||||||||||||||||||||||||||||||||||||
06/03/2022 | passed assembly | |||||||||||||||||||||||||||||||||||||||||||||||||
06/03/2022 | returned to senate | |||||||||||||||||||||||||||||||||||||||||||||||||
12/12/2022 | DELIVERED TO GOVERNOR | |||||||||||||||||||||||||||||||||||||||||||||||||
12/23/2022 | VETOED MEMO.176 |
S09448 Committee Votes:
Go to topS09448 Floor Votes:
ER
Abbate
Yes
Chandler-Waterm
Yes
Forrest
Yes
Joyner
Yes
O'Donnell
Yes
Simon
Yes
Abinanti
Yes
Clark
Yes
Friend
Yes
Kelles
Yes
Otis
Yes
Simpson
Yes
Anderson
Yes
Colton
Yes
Frontus
Yes
Kim
Yes
Palmesano
Yes
Smith
Yes
Angelino
Yes
Conrad
Yes
Galef
Yes
Lalor
Yes
Paulin
Yes
Smullen
Yes
Ashby
Yes
Cook
Yes
Gallagher
Yes
Lavine
Yes
Peoples-Stokes
Yes
Solages
Yes
Aubry
Yes
Cruz
Yes
Gallahan
Yes
Lawler
Yes
Pheffer Amato
Yes
Steck
Yes
Barclay
Yes
Cunningham
Yes
Gandolfo
Yes
Lemondes
Yes
Pretlow
Yes
Stern
Yes
Barnwell
Yes
Cusick
Yes
Gibbs
Yes
Lucas
ER
Quart
Yes
Stirpe
Yes
Barrett
Yes
Cymbrowitz
Yes
Giglio JA
Yes
Lunsford
Yes
Ra
Yes
Tague
Yes
Benedetto
Yes
Darling
Yes
Giglio JM
Yes
Lupardo
Yes
Rajkumar
Yes
Tannousis
Yes
Bichotte Hermel
Yes
Davila
Yes
Glick
Yes
Magnarelli
Yes
Ramos
Yes
Tapia
Yes
Blankenbush
Yes
De Los Santos
Yes
Gonzalez-Rojas
Yes
Mamdani
Yes
Reilly
Yes
Taylor
Yes
Brabenec
Yes
DeStefano
Yes
Goodell
Yes
Manktelow
Yes
Reyes
Yes
Thiele
Yes
Braunstein
Yes
Dickens
Yes
Gottfried
Yes
McDonald
Yes
Rivera J
Yes
Vanel
Yes
Bronson
Yes
Dilan
Yes
Griffin
Yes
McDonough
Yes
Rivera JD
Yes
Walczyk
ER
Brown E
Yes
Dinowitz
Yes
Gunther
Yes
McMahon
ER
Rosenthal D
Yes
Walker
Yes
Brown K
Yes
DiPietro
Yes
Hawley
Yes
Meeks
Yes
Rosenthal L
Yes
Wallace
Yes
Burdick
Yes
Durso
Yes
Hevesi
Yes
Mikulin
ER
Rozic
Yes
Walsh
Yes
Burgos
ER
Eichenstein
Yes
Hunter
Yes
Miller
Yes
Salka
Yes
Weinstein
Yes
Burke
Yes
Englebright
Yes
Hyndman
Yes
Mitaynes
Yes
Santabarbara
Yes
Weprin
Yes
Buttenschon
Yes
Epstein
Yes
Jackson
Yes
Montesano
Yes
Sayegh
Yes
Williams
Yes
Byrne
Yes
Fahy
Yes
Jacobson
Yes
Morinello
Yes
Schmitt
Yes
Woerner
Yes
Byrnes
Yes
Fall
Yes
Jean-Pierre
Yes
Niou
Yes
Seawright
Yes
Zebrowski
Yes
Cahill
Yes
Fernandez
Yes
Jensen
Yes
Nolan
Yes
Septimo
Yes
Zinerman
Yes
Carroll
Yes
Fitzpatrick
Yes
Jones
Yes
Norris
Yes
Sillitti
Yes
Mr. Speaker
‡ Indicates voting via videoconference
S09448 Text:
Go to top STATE OF NEW YORK ________________________________________________________________________ 9448 IN SENATE May 27, 2022 ___________ Introduced by Sen. BROUK -- read twice and ordered printed, and when printed to be committed 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; 21 (ii) in cases of specific patient need, the registered establishment 22 shall maintain documentation that the transfer is for such purpose in a 23 manner determined by the department; 24 (iii) the resident pharmacy complies with all recordkeeping require- 25 ments of the department for each drug or device received from any unreg- 26 istered nonresident establishment; EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD09095-04-2S. 9448 2 1 (iv) all documentation and records are retained and are readily 2 retrievable by the resident establishment for a period of six years; 3 (v) the prescription drug or device was manufactured by an authorized 4 FDA registered drug manufacturer and is not a compounded drug. The 5 unregistered nonresident establishment shall only deliver or trade a 6 drug or device salable on prescription only that it receives from a 7 manufacturer, a wholesale distributor or a pharmacy in accordance with 8 the federal Drug Supply Chain Security Act (DSCSA); 9 (vi) the nonresident establishment from which the drug is being 10 obtained receives a request for the drug that identifies the drug's 11 brand name or generic name, quality, quantity, and size. Such drug shall 12 not be expired at the time of the exchange; 13 (vii) the drug being obtained includes with the drug a packaging 14 checklist confirming that the drug being delivered or traded matches the 15 information identified on the request, and the drug is delivered or 16 traded in the original manufacturer's packaging, whether sealed or 17 unsealed, with package insert, the drug's national drug code, lot 18 number, and expiration date conspicuously identified on the packaging. 19 If the original manufacturer's packaging is unsealed at the time of the 20 delivery or trade, the delivery or trade may include a quantity of the 21 drug that is less than the quantity contained in the original manufac- 22 turer's packaging. However, a pharmacy shall not trade or deliver more 23 than one unsealed or partial quantity of the drug during any consecutive 24 ninety-day period; 25 (viii) notwithstanding the language of this section, nothing shall be 26 interpreted to allow for the sale, trade or exchange of a controlled 27 substance as defined by article thirty-three of the public health law; 28 and 29 (ix) the sale/transfer price of any item exchanged under this section 30 may not exceed one hundred percent of the item's Wholesale Acquisition 31 Cost (WAC) at the time of the sale. 32 (c) A pharmacy that receives notification from an unregistered 33 nonresident establishment that a delivery or trade involved a drug or 34 device salable on prescription only that is an illegitimate, recalled, 35 or counterfeit product shall immediately notify the state board of phar- 36 macy, and the FDA. 37 (d) Any unregistered nonresident establishment involved in a sale, 38 exchange, or transaction under this section is subject to the jurisdic- 39 tion of the state of New York regarding said sale, exchange or trans- 40 action. Such establishment shall cooperate with agents of the state of 41 New York if said agent is conducting an audit or investigation into the 42 sale, exchange or transaction, and violations of this section shall be 43 punishable according to regulations promulgated by the department and 44 the laws of this state. 45 (e) For purposes of this subdivision "specific patient need" is 46 defined as the transfer of a product from one pharmacy to another to 47 fill a prescription for an identified patient. Such term does not 48 include the transfer of a product from one pharmacy to another for the 49 purpose of increasing or replenishing stock in anticipation of a poten- 50 tial need in accordance with the federal Drug Supply Chain Security Act. 51 § 2. This act shall take effect on the ninetieth day after it shall 52 become a law.