NY State Senate Bill 2017-S6104

Senate Bill S6104

2017-2018 Legislative Session

Requires non-resident pharmacy, manufacturing, wholesale or outsourcing facilities to be inspected and comply with the verified pharmacy program

download bill text pdf

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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Actions

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

2017-S6104 (ACTIVE) - Details

See Assembly Version of this Bill:: A7210
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §§6808 & 6808-b, Ed L

2017-S6104 (ACTIVE) - Summary

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.

2017-S6104 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S6104

 TITLE OF BILL :

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 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

 PURPOSE :

This bill would amend the education law in order to require
non-resident pharmacies that ship compounded sterile pharmaceutical
products to New York State patients 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 pharmacies registered by the education
department through its Board of Pharmacy, to submit evidence that they
meet standards equivalent to registered establishments located within

New York State and subject to oversight, including on sigh inspection,
by the department.

Section 2. Amends education law section 6808-b to require every New
York pharmacy to purchase or obtain prescription drugs and devices
from approved entities.

Section 3. Provides for the effective date.

 JUSTIFICATION :

In 2012, there was a national outbreak of fungal meningitis ultimately
linked to injections from a compounding pharmacy in the state of
Massachusetts. Ultimately, this outbreak caused by the tainted
compounded medicine include 64 fatalities, 732 sickened by infections
and a number of others who live with chronic pain as an aftermath of
the exposure to the tainted product. Investigators uncovered severely
sub-standard conditions at the compounding center. Prior to 2012, the
issue of bad actor compounders was on the Food and Drug
Administration's (FDA) radar and there were concerns expressed that
compounders are less stringently regulated than other drug makers,
however, FDA resources are not able to physically inspect all
locations and therefore they rely on customer complaints which is not
a proactive means to protect the public.

In New York State, pharmacies are licensed, inspected and monitored by
the New York State Board of Pharmacy in order to ensure safe supply of
compounded prescription medicine. That applies to only pharmacies
registered in New York State, therefore, for non-resident pharmacies,
oversight is left to the state of origin which may or may not have the
standards that New York State requires and New York State has limited
ability to inspect and monitor these pharmacies. In response to this
concern, the National Boards of Pharmacy (NABP), working with its
member boards of pharmacy from across all states, including New York,
developed an accreditation process for compounding pharmacies called
Verified Pharmacy Program (VPP). VPP provides a trusted source among
all state boards of pharmacy across the country to verify that VPP
certified pharmacies are compliant with non-sterile compounding and
sterile compounding practices are based on USP Chapters 795 ad 797,
respectively, which is the federal standard. Initial verification
includes a full review of the pharmacy's practice as well as an onsite
physical visit. Additionally, after inspection and certification,
pharmacies are subject to an ongoing compliance program which includes
at a minimum onsite inspections and reporting.

Passage of this bill will ensure that patients receiving compounded
prescriptions from other states are meeting a minimal standard of care
to protect them from unfortunate events such as the Massachusetts
contamination event.

 LEGISLATIVE HISTORY :

New bill.

 FISCAL IMPLICATIONS :

None

 EFFECTIVE DATE :
This act shall take effect one year after it shall become a law.

2017-S6104 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6104
 
                        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 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:
 
   Section  1.  Subdivisions  1  and 5 of section 6808-b of the education
 law, subdivision 1 as amended by section 5 of part D of  chapter  60  of
 the laws of 2014 and subdivision 5 as amended by chapter 567 of the laws
 of 2002, are amended to read as follows:
   1.  [Definition.] DEFINITIONS. A. The term "nonresident establishment"
 shall mean any pharmacy, manufacturer, wholesaler, THIRD-PARTY LOGISTICS
 PROVIDERS 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.
   5. Additional requirements. Nonresident pharmacies registered pursuant
 to this section shall:
   a. Provide a toll-free  telephone  number  that  is  available  during
 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
 
 communication between a patient in this state and a  pharmacist  at  the
 pharmacy who has access to the patient's records; [and]
   b.  Place  such  toll-free telephone number on a label affixed to each
 drug or device container[.]; AND
   C. IF ENGAGED IN THE SHIPMENT, MAILING OR DELIVERY OF COMPOUNDED STER-
 ILE PRODUCTS, DISPENSED PURSUANT TO PATIENT-SPECIFIC  PRESCRIPTIONS,  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.
   § 2. Paragraph e of subdivision 2 of section 6808 of 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 ENTITIES THAT HAVE DEMONSTRATED  COMPLI-
 ANCE  WITH  ALL STANDARDS OF THE VERIFIED PHARMACY PROGRAM ADMINISTRATED
 BY THE NATIONAL ASSOCIATION OF BOARDS OF  PHARMACY.  Every  owner  of  a
 pharmacy  or every pharmacist in charge of a pharmacy shall be responsi-
 ble 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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