What's happening
This bill adds accreditation and registration requirements for non-resident drug wholesalers and third-party logistics providers shipping prescription drugs to New York.
Why it matters
Stricter Oversight on Out-of-State Distributors. By requiring non-resident wholesalers and third-party logistics providers shipping prescription drugs to New York to obtain accreditation from the National Association of Boards of Pharmacy, the bill aims to reduce the risk of counterfeit, adulterated, or improperly handled medications entering the state.
Expanded Definition and Oversight. The legislation formally defines “third-party logistics providers” and brings them under the same registration and accreditation requirements as manufacturers and wholesalers, closing regulatory loopholes that could be exploited by entities not directly selling drugs but still handling them.
Tighter Supply Chain Controls for NY Pharmacies. New York pharmacies would be allowed to purchase prescription drugs and devices only from state-registered or department-registered non-resident suppliers, potentially reducing the chance of diversion, fraud, or sourcing from unverified suppliers, and increasing accountability throughout the supply chain.
Potential Impact on Drug Pricing and Access. With stricter requirements and limited sourcing options, pharmacies may face higher compliance costs or fewer supplier choices, which could impact the availability or pricing of certain drugs, especially those sourced from out-of-state distributors.
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Who cares
Headline styles
Tougher Rules for Out-of-State Pharmacies
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to higher education
- Referred to higher education
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Require Out-of-State Pharmacy Accreditation
In Assembly Committee · Higher Education · Sponsor John T. McDonald III
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
6125
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 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 the verified-accredited wholesale distributor program administered by the national association of boards of pharmacy.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD10964-01-7
S. 6125 2
§ 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.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
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
Purpose
The bill would amend the education law in order to require pharmacies and non-resident wholesalers and third party logistic suppliers to meet additional requirements, to assure equivalence to those establishments within New York State and thereby assure greater public protection.
Summary of provisions
Section 1. Amends education law section 6808-b to increase requirements for non-resident wholesalers and third party logistic providers, regis- tered by the education department through its Board of Pharmacy and require them to submit evidence that they meet standards equivalent to registered establishments located within New York State and subject to oversight, including on sight inspection by the department.
Section 2. Amends education law section 6808-e to require every New York pharmacy to purchase or obtain prescription drugs and devices for authorized manufacturers or registered wholesalers.
Section 3. Provides for the effective date.
Justification
While most wholesalers and third party logistic providers provide medi- cations safely and securely, a market still exists for gray and black- market medications. Networks of establishments, some of which have been convicted of selling adulterated, misbranded and/or counterfeit medica- tions or devices or supplies by the New York State Attorney General, expose patients to significant harm Whether it is medications or supply items such as blood glucose test strips, for example, these items are prescribed items for patients that play an important role in their over- all health care and therefore should not be distributed through the gray or black market as there is no certainty of quality control.
In response, NABP, working with its member boards of pharmacy, developed The Verified-Accredited Wholesale Distributors (VAWD) accreditation. This accreditation is for facilities engaged in the act of wholesale drug distribution. To become (VAWD) accredited and display the VAWD Seal, facilities must undergo a criteria of compliance review, which includes: a rigorous review of their operating policies and procedures, licensure verification, a survey of a facility's operations procedures and other factors. Requiring VAWD accreditation for non-resident estab- lishments will help protect the public from introduction of drugs into commerce that might otherwise by adulterated, misbranded and/or counter- feit.
Legislative history
New bill.
Fiscal implications
None
Effective date
This act shall take effect one year after it shall become a law.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.