What's happening
This bill updates accreditation and purchasing requirements for nonresident pharmacy-related facilities and New York pharmacies to enhance prescription drug safety.
Why it matters
Expands oversight to out-of-state entities. The bill broadens the definition of "nonresident establishment" to include third-party logistics providers and outsourcing facilities, subjecting them to New York’s regulatory requirements if they ship, mail, or deliver prescription drugs or devices into the state.
Mandates national accreditation for wholesale distributors. Nonresident wholesalers and third-party logistics providers distributing prescription drugs in New York must obtain accreditation through the Verified-Accredited Wholesale Distributor (VAWD) program. This raises the bar for safety and supply chain integrity by requiring adherence to nationally recognized standards.
Tightens supply chain for New York pharmacies. All state-registered pharmacies are newly required to purchase prescription drugs and devices only from authorized manufacturers, New York-registered wholesalers, or registered nonresident establishments. This aims to reduce the risk of counterfeit or unsafe medications entering the supply chain.
Increases accountability and compliance. By clarifying the responsibilities of pharmacy owners and pharmacists (including supervision requirements), the bill reinforces the legal obligations to ensure drug quality, proper sourcing, and regulatory compliance—potentially decreasing the likelihood of drug diversion or contamination.
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Who cares
Out-of-state drug wholesalers and third-party logistics providers
Those registered in New York and engaged in wholesale drug distribution would need accreditation through the National Association of Boards of Pharmacy’s verified-accredited wholesale distributor program.
New York-registered pharmacies
They would have to obtain prescription drugs and devices directly from authorized manufacturers or at wholesale only from New York-registered wholesalers or department-registered nonresident establishments.
Out-of-state third-party logistics providers
Providers shipping prescription drugs or devices into New York would be added to the definition of nonresident establishments, including entities coordinating warehousing or distribution without taking title to the drugs.
Headline styles
Accredit Out-of-State Pharmacies
Plain English, a few words. Used as the page title.
Sponsors
Assembly Member · Assembly District 108
11 Co-sponsors
History
- Referred to higher education
- Referred to higher education
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
3873
2019-2020 Regular Sessions
IN ASSEMBLY
January 31, 2019
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 Committee on Higher Education
AN ACT to amend the education law, in relation to the accreditation of 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
The People of the State of New York, represented in Senate and Assembly, 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 establishments, authorized prescribers and/or patients residing in this state. Such establishments shall include, but not be limited to, pharmacies 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 responsible 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.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.