Senate Bill S6125

2017-2018 Legislative Session

Relates to the accreditation of non-resident pharmacy, manufacturing, wholesale or outsourcing facilities that ship, mail or deliver prescription drugs or devices to entities in New York

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Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 03, 2018	referred to higher education
May 11, 2017	referred to higher education

2017-S6125 (ACTIVE) - Details

See Assembly Version of this Bill:: A7217
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §§6808 & 6808-b, Ed L
Versions Introduced in 2019-2020 Legislative Session:: A3873

2017-S6125 (ACTIVE) - Summary

Relates 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.

2017-S6125 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S6125

SPONSOR: LAVALLE
 
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.

2017-S6125 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6125
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                               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 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
 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  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.

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Senate Bill S6125

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Archive: Last Bill Status - In Senate Committee Higher Education Committee

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2017-S6125 (ACTIVE) - Details

2017-S6125 (ACTIVE) - Summary

2017-S6125 (ACTIVE) - Sponsor Memo

2017-S6125 (ACTIVE) - Bill Text download pdf

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Sponsored By

Kenneth P. LaValle

Archive: Last Bill Status - In Senate Committee Higher Education Committee

Actions

2017-S6125 (ACTIVE) - Details

2017-S6125 (ACTIVE) - Summary

2017-S6125 (ACTIVE) - Sponsor Memo

2017-S6125 (ACTIVE) - Bill Text download pdf

Comments