Requires non-resident pharmacy, manufacturing, wholesale or outsourcing facilities that ship, mail or deliver prescription drugs or devices to other establishments, authorized prescribers and/or patients residing in New York to be inspected within two years of application and demonstrate compliance with all standards of the verified pharmacy program administered by the National Association of Boards of Pharmacy.
STATE OF NEW YORK
________________________________________________________________________
6104
2017-2018 Regular Sessions
IN SENATE
May 11, 2017
___________
Introduced by Sen. LAVALLE -- 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 requiring non-resident
pharmacy, manufacturing, wholesale or outsourcing facilities that
ship, mail or deliver prescription drugs or devices to other estab-
lishments, authorized prescribers and/or patients residing in New York
to be inspected within two years of application and demonstrate
compliance with all standards of the verified pharmacy program admin-
istered by the National Association of Boards of Pharmacy
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivisions 1 and 5 of section 6808-b of the education
2 law, subdivision 1 as amended by section 5 of part D of chapter 60 of
3 the laws of 2014 and subdivision 5 as amended by chapter 567 of the laws
4 of 2002, are amended to read as follows:
5 1. [Definition.] Definitions. a. The term "nonresident establishment"
6 shall mean any pharmacy, manufacturer, wholesaler, third-party logistics
7 providers or outsourcing facility located outside of the state that
8 ships, mails or delivers prescription drugs or devices to other estab-
9 lishments, authorized prescribers and/or patients residing in this
10 state. Such establishments shall include, but not be limited to, pharma-
11 cies that transact business through the use of the internet.
12 b. The term "third-party logistics provider" shall mean an entity that
13 provides or coordinates warehousing, distribution, or other services on
14 behalf of a manufacturer, but does not take title to the prescription
15 drug or have general responsibility to direct the prescription drug's
16 sale or disposition.
17 5. Additional requirements. Nonresident pharmacies registered pursuant
18 to this section shall:
19 a. Provide a toll-free telephone number that is available during
20 normal business hours and at least forty hours per week, to enable
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD10972-01-7
S. 6104 2
1 communication between a patient in this state and a pharmacist at the
2 pharmacy who has access to the patient's records; [and]
3 b. Place such toll-free telephone number on a label affixed to each
4 drug or device container[.]; and
5 c. If engaged in the shipment, mailing or delivery of compounded ster-
6 ile products, dispensed pursuant to patient-specific prescriptions, be
7 inspected within two years of application and demonstrate compliance
8 with all standards of the verified pharmacy program administered by the
9 National Association of Boards of Pharmacy.
10 § 2. Paragraph e of subdivision 2 of section 6808 of education law, as
11 amended by chapter 62 of the laws of 1989, is amended to read as
12 follows:
13 e. Conduct of a pharmacy. Every owner of a pharmacy is responsible for
14 the strength, quality, purity and the labeling thereof of all drugs,
15 toxic substances, devices and cosmetics, dispensed or sold, subject to
16 the guaranty provisions of this article and the public health law. Every
17 New York state registered pharmacy shall purchase or obtain prescription
18 drugs and devices directly from entities that have demonstrated compli-
19 ance with all standards of the verified pharmacy program administrated
20 by the National Association of Boards of Pharmacy. Every owner of a
21 pharmacy or every pharmacist in charge of a pharmacy shall be responsi-
22 ble for the proper conduct of this pharmacy. Every pharmacy shall be
23 under the immediate supervision and management of a licensed pharmacist
24 at all hours when open. No pharmacist shall have personal supervision of
25 more than one pharmacy at the same time.
26 § 3. This act shall take effect on the three hundred sixty-fifth day
27 after it shall have become a law.