S T A T E O F N E W Y O R K
________________________________________________________________________
3873
2019-2020 Regular Sessions
I N A S S E M B L Y
January 31, 2019
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Introduced by M. of A. McDONALD, GALEF, MONTESANO, McDONOUGH, ORTIZ,
DICKENS, GOTTFRIED, RIVERA -- Multi-Sponsored by -- M. of A. COOK,
D'URSO, SIMON, THIELE, WRIGHT -- read once and referred to the Commit-
tee on Higher Education
AN ACT to amend the education law, in relation to the accreditation of
non-resident pharmacy, manufacturing, wholesale or outsourcing facili-
ties that ship, mail or deliver prescription drugs or devices to other
establishments, authorized prescribers and/or patients residing in New
York
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Subdivision 1 of section 6808-b of the education law, as
amended by section 5 of part D of chapter 60 of the laws of 2014, is
amended, subdivisions 6, 7, 8 and 9 are renumbered 7, 8, 9 and 10 and a
new subdivision 6 is added to read as follows:
1. [Definition.] DEFINITIONS. A. The term "nonresident establishment"
shall mean any pharmacy, manufacturer, wholesaler, THIRD-PARTY LOGISTICS
PROVIDER or outsourcing facility located outside of the state that
ships, mails or delivers prescription drugs or devices to other estab-
lishments, authorized prescribers and/or patients residing in this
state. Such establishments shall include, but not be limited to, pharma-
cies that transact business through the use of the internet.
B. THE TERM "THIRD-PARTY LOGISTICS PROVIDER" SHALL MEAN AN ENTITY THAT
PROVIDES OR COORDINATES WAREHOUSING, DISTRIBUTION, OR OTHER SERVICES ON
BEHALF OF A MANUFACTURER, BUT DOES NOT TAKE TITLE TO THE PRESCRIPTION
DRUG OR HAVE GENERAL RESPONSIBILITY TO DIRECT THE PRESCRIPTION DRUG'S
SALE OR DISPOSITION.
6. ADDITIONAL REQUIREMENTS. NON-RESIDENT WHOLESALERS AND THIRD-PARTY
LOGISTICS PROVIDERS REGISTERED PURSUANT TO THIS SECTION AND ENGAGED IN
THE ACT OF WHOLESALE DRUG DISTRIBUTION SHALL BE ACCREDITED PURSUANT TO
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD00576-01-9
A. 3873 2
THE VERIFIED-ACCREDITED WHOLESALE DISTRIBUTOR PROGRAM ADMINISTERED BY
THE NATIONAL ASSOCIATION OF BOARDS OF PHARMACY.
§ 2. Paragraph e of subdivision 2 of section 6808 of the education
law, as amended by chapter 62 of the laws of 1989, is amended to read as
follows:
e. Conduct of a pharmacy. Every owner of a pharmacy is responsible for
the strength, quality, purity and the labeling thereof of all drugs,
toxic substances, devices and cosmetics, dispensed or sold, subject to
the guaranty provisions of this article and the public health law.
EVERY NEW YORK STATE REGISTERED PHARMACY SHALL PURCHASE OR OBTAIN
PRESCRIPTION DRUGS AND DEVICES DIRECTLY FROM AUTHORIZED MANUFACTURERS OR
AT WHOLESALE ONLY FROM NEW YORK STATE REGISTERED WHOLESALERS, OR THOSE
NON-RESIDENT ESTABLISHMENTS REGISTERED BY THE DEPARTMENT. Every owner of
a pharmacy or every pharmacist in charge of a pharmacy shall be respon-
sible for the proper conduct of this pharmacy. Every pharmacy shall be
under the immediate supervision and management of a licensed pharmacist
at all hours when open. No pharmacist shall have personal supervision of
more than one pharmacy at the same time.
§ 3. This act shall take effect on the three hundred sixty-fifth day
after it shall have become a law. Effective immediately the addition,
amendment and/or repeal of any rule or regulation necessary for the
implementation of this act on its effective date are authorized to be
made on or before such date.