S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                   60

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 7, 2015
                               ___________

Introduced by M. of A. PAULIN, TITONE, GOTTFRIED, GALEF -- read once and
  referred to the Committee on Higher Education

AN  ACT  to  amend  the  education  law,  in relation to wholesalers and
  manufacturers of prescription drugs

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1.  Subparagraph 2 of paragraph a of subdivision 4 of section
6808 of the education law, as amended by chapter 62 of the laws of 1989,
is amended to read as follows:
  (2) The application shall be accompanied by a fee  of  [eight  hundred
twenty-five] TWELVE HUNDRED dollars.
  S 2. Paragraphs b and d of subdivision 4 of section 6808 of the educa-
tion  law, paragraph b as amended by chapter 538 of the laws of 2001 and
paragraph d as amended by chapter 62 of the laws of 1989, are amended to
read as follows:
  b. Renewal of registration. All wholesalers' and manufacturers' regis-
trations shall be renewed on dates set by the department. The  triennial
registration fee shall be [five hundred twenty] EIGHT HUNDRED dollars or
a pro rated portion thereof as determined by the department.
  d. Change of location. In the event that the location of such place of
business  shall  be changed, the owner shall apply to the department for
inspection of the new location and endorsement of the  registration  for
the  new  location. The fee for inspection and endorsement shall be [one
hundred seventy] THREE HUNDRED dollars, unless it appears to the  satis-
faction  of the department that the change in location is of a temporary
nature due to fire, flood or other disaster.
  S 3. Subdivision 4 of section 6808 of the education law is amended  by
adding six new paragraphs e, f, g, h, i and j to read as follows:
  E.  APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A WHOLE-
SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
              

                                                           LBD00540-01-5

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THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F AND G OF  THIS
SUBDIVISION,  THE  DEPARTMENT  SHALL  REQUIRE A CRIMINAL HISTORY RECORDS
SEARCH FOR OFFICERS, DIRECTORS AND OWNERS OF SUCH WHOLESALER OR MANUFAC-
TURER.  FOR  THE PURPOSES OF THIS PARAGRAPH, "OWNER" SHALL MEAN A PERSON
WHO HAS A TEN PERCENT OR GREATER OWNERSHIP INTEREST IN  SUCH  WHOLESALER
OR MANUFACTURER.
  F. CRIMINAL HISTORY RECORDS SEARCH. (1) UPON RECEIPT OF AN APPLICATION
FOR  REGISTRATION  PURSUANT TO THIS SUBDIVISION, THE COMMISSIONER SHALL,
SUBJECT TO THE RULES AND REGULATIONS OF THE DIVISION OF CRIMINAL JUSTICE
SERVICES, INITIATE A CRIMINAL HISTORY  RECORDS  SEARCH  OF  THE  PERSONS
IDENTIFIED  IN PARAGRAPH E OF THIS SUBDIVISION.  PRIOR TO INITIATING THE
BACKGROUND CHECKS AND FINGERPRINTING  PROCESS,  THE  COMMISSIONER  SHALL
FURNISH  THE  APPLICANT  WITH  THE FORM DESCRIBED IN PARAGRAPH G OF THIS
SUBDIVISION AND SHALL OBTAIN THE APPLICANT'S  CONSENT  TO  THE  CRIMINAL
HISTORY  RECORDS  SEARCH. THE COMMISSIONER SHALL OBTAIN FROM EACH APPLI-
CANT TWO SETS OF FINGERPRINTS  AND  THE  DIVISION  OF  CRIMINAL  JUSTICE
SERVICES  PROCESSING  FEE  IMPOSED  PURSUANT  TO  SUBDIVISION EIGHT-A OF
SECTION EIGHT HUNDRED THIRTY-SEVEN OF THE  EXECUTIVE  LAW  AND  ANY  FEE
IMPOSED  BY  THE FEDERAL BUREAU OF INVESTIGATION FOR A NATIONAL CRIMINAL
HISTORY RECORD CHECK. THE  COMMISSIONER  SHALL  PROMPTLY  TRANSMIT  SUCH
FINGERPRINTS  AND  FEES TO THE DIVISION OF CRIMINAL JUSTICE SERVICES FOR
ITS FULL SEARCH AND RETAIN PROCESSING. THE DIVISION OF CRIMINAL  JUSTICE
SERVICES  IS  AUTHORIZED  TO SUBMIT THE FINGERPRINTS AND THE APPROPRIATE
FEE TO THE FEDERAL BUREAU  OF  INVESTIGATION  FOR  A  NATIONAL  CRIMINAL
HISTORY  RECORD CHECK. THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE
FEDERAL BUREAU OF INVESTIGATION  SHALL  FORWARD  SUCH  CRIMINAL  HISTORY
RECORD, IF ANY, TO THE COMMISSIONER IN A TIMELY MANNER.  CRIMINAL HISTO-
RY  INFORMATION  PROVIDED  BY  THE DIVISION OF CRIMINAL JUSTICE SERVICES
PURSUANT TO THIS SUBDIVISION SHALL BE FURNISHED ONLY BY  MAIL  OR  OTHER
METHOD OF SECURE AND CONFIDENTIAL DELIVERY, ADDRESSED TO THE COMMISSION-
ER.  SUCH  INFORMATION AND THE ENVELOPE IN WHICH IT IS ENCLOSED, IF ANY,
SHALL BE PROMINENTLY MARKED "CONFIDENTIAL," AND SHALL AT  ALL  TIMES  BE
MAINTAINED  BY  THE  OFFICE  IN A SECURE PLACE.   THE COMMISSIONER SHALL
CONSIDER SUCH CRIMINAL HISTORY RECORD IN ACCORDANCE  WITH  THE  REQUIRE-
MENTS  OF  ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW AND SUBDIVISIONS
FIFTEEN AND SIXTEEN OF SECTION TWO HUNDRED NINETY-SIX OF  THE  EXECUTIVE
LAW.
  (2)  FOR  THE  PURPOSES  OF  THIS  SECTION  THE TERM "CRIMINAL HISTORY
RECORD" SHALL MEAN A RECORD OF ALL CONVICTIONS OF CRIMES THAT  HAVE  NOT
BEEN VACATED, REVERSED OR SEALED, AND ANY PENDING CRIMINAL CHARGES MAIN-
TAINED  BY  THE  DIVISION  OF  CRIMINAL JUSTICE SERVICES AND THE FEDERAL
BUREAU OF INVESTIGATION.
  FURTHERMORE, UPON NOTIFICATION THAT SUCH  APPLICANT  HAS  BEEN  REGIS-
TERED, THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL HAVE THE AUTHORI-
TY  TO PROVIDE SUBSEQUENT CRIMINAL HISTORY NOTIFICATIONS DIRECTLY TO THE
COMMISSIONER. ALL SUCH  CRIMINAL  HISTORY  RECORDS  PROCESSED  AND  SENT
PURSUANT  TO  THIS  SUBDIVISION  SHALL  BE  CONFIDENTIAL PURSUANT TO THE
APPLICABLE FEDERAL AND STATE LAWS, RULES AND REGULATIONS, AND SHALL  NOT
BE  PUBLISHED  OR IN ANY WAY DISCLOSED TO PERSONS OTHER THAN THE COMMIS-
SIONER, UNLESS OTHERWISE AUTHORIZED BY LAW.  ANY  PERSON  WHO  WILLFULLY
PERMITS  THE  RELEASE  OF  ANY CONFIDENTIAL CRIMINAL HISTORY INFORMATION
CONTAINED IN THE REPORT TO PERSONS NOT  PERMITTED  BY  THIS  SECTION  TO
RECEIVE SUCH INFORMATION SHALL BE GUILTY OF A MISDEMEANOR.
  G.  ADDITIONAL  DUTIES  OF  THE  COMMISSIONER  AND DEPARTMENT. (1) THE
COMMISSIONER, IN COOPERATION  WITH  THE  DIVISION  OF  CRIMINAL  JUSTICE
SERVICES  AND IN ACCORDANCE WITH ALL APPLICABLE PROVISIONS OF LAW, SHALL

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PROMULGATE RULES AND REGULATIONS TO REQUIRE THE PERFORMANCE OF A  CRIMI-
NAL  HISTORY  RECORDS CHECK OF THE INDIVIDUALS IDENTIFIED IN PARAGRAPH E
OF THIS SUBDIVISION.
  (2)  THE  COMMISSIONER,  IN  COOPERATION WITH THE DIVISION OF CRIMINAL
JUSTICE SERVICES, SHALL PROMULGATE A FORM TO BE PROVIDED TO  ALL  APPLI-
CANTS FOR REGISTRATION PURSUANT TO THIS SUBDIVISION THAT SHALL:
  (I) INFORM THE PROSPECTIVE APPLICANT THAT THE COMMISSIONER IS REQUIRED
TO  REQUEST HIS OR HER CRIMINAL HISTORY INFORMATION FROM THE DIVISION OF
CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU  OF  INVESTIGATION  AND
REVIEW  SUCH  INFORMATION  PURSUANT  TO  THIS  SECTION,  AND  PROVIDE  A
DESCRIPTION OF THE MANNER IN WHICH HIS OR HER FINGERPRINT CARDS WILL  BE
USED UPON SUBMISSION TO THE DIVISION OF CRIMINAL JUSTICE SERVICES; AND
  (II)  INFORM THE PROSPECTIVE APPLICANT THAT HE OR SHE HAS THE RIGHT TO
OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFOR-
MATION PURSUANT TO REGULATIONS AND PROCEDURES ESTABLISHED BY  THE  DIVI-
SION OF CRIMINAL JUSTICE SERVICES.
  (3)  THE  DEPARTMENT SHALL OBTAIN THE SIGNED, INFORMED CONSENT OF EACH
INDIVIDUAL IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, ON  SUCH  FORM
SUPPLIED BY THE COMMISSIONER, WHICH INDICATES THAT SUCH PERSON HAS:
  (I)  BEEN  INFORMED  OF THE RIGHTS AND PROCEDURES NECESSARY TO OBTAIN,
REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFORMATION;
  (II) BEEN INFORMED OF THE REASON FOR THE REQUEST FOR HIS OR HER CRIMI-
NAL HISTORY INFORMATION;
  (III) CONSENTED TO SUCH REQUEST FOR A REPORT;
  (IV) SUPPLIED ON THE FORM A CURRENT MAILING OR HOME ADDRESS  FOR  SUCH
INDIVIDUAL;
  (V)  BEEN  INFORMED  THAT  HE  OR SHE MAY WITHDRAW HIS OR HER CONSENT,
REGARDLESS OF WHETHER THE  DEPARTMENT  HAS  REVIEWED  SUCH  INDIVIDUAL'S
CRIMINAL HISTORY INFORMATION;
  (VI)  BEEN  INFORMED THAT IN THE EVENT THE WHOLESALER'S OR MANUFACTUR-
ER'S REGISTRATION PURSUANT TO THIS SUBDIVISION HAS EXPIRED OR  OTHERWISE
TERMINATED,  THE  COMMISSIONER  SHALL  NOTIFY  THE  DIVISION OF CRIMINAL
JUSTICE SERVICES OF SUCH EXPIRATION OR TERMINATION, AND THE DIVISION  OF
CRIMINAL JUSTICE SERVICES SHALL DESTROY THE FINGERPRINTS OF THE INDIVID-
UAL  OR  INDIVIDUALS ASSOCIATED WITH SUCH WHOLESALER'S OR MANUFACTURER'S
REGISTRATION; AND
  (VII) BEEN INFORMED OF THE MANNER IN WHICH HE OR SHE MAY SUBMIT TO THE
COMMISSIONER ANY INFORMATION THAT MAY BE RELEVANT TO  THE  CONSIDERATION
OF THE APPLICANT'S REGISTRATION INCLUDING, WHERE APPLICABLE, INFORMATION
IN SUPPORT OF HIS OR HER GOOD MORAL CHARACTER OR REHABILITATION THEREOF.
  (4)  UPON  RECEIPT  OF  CRIMINAL  HISTORY INFORMATION PURSUANT TO THIS
SECTION AND BEFORE MAKING ANY DETERMINATION  THEREON,  THE  COMMISSIONER
SHALL PROVIDE THE INDIVIDUAL WITH A COPY OF SUCH CRIMINAL HISTORY INFOR-
MATION  AND  A  COPY OF ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW AND
INFORM SUCH INDIVIDUAL OF HIS OR HER RIGHT TO  SEEK  CORRECTION  OF  ANY
INCORRECT  INFORMATION  CONTAINED  IN  SUCH CRIMINAL HISTORY INFORMATION
PURSUANT TO THE REGULATIONS AND PROCEDURES ESTABLISHED BY  THE  DIVISION
OF CRIMINAL JUSTICE SERVICES.
  H.  PERFORMANCE  OR  SURETY  BOND.  EVERY  WHOLESALER  SHALL  SUBMIT A
PERFORMANCE OR SURETY BOND OF NOT LESS THAN ONE HUNDRED THOUSAND DOLLARS
TO THE DEPARTMENT TO ENSURE COMPLIANCE WITH THE PROVISIONS OF THIS ARTI-
CLE, EXCEPT  THAT  THE  DEPARTMENT  MAY  WAIVE  SUCH  BOND  FOR  CERTAIN
NOT-FOR-PROFIT  ENTITIES  SUCH  AS HOSPITALS AND CORRECTIONAL FACILITIES
THAT LIMIT DISTRIBUTION TO THEIR OWN FACILITIES AND DO NOT  RETURN  SUCH
MEDICATIONS  TO  OTHER ENTITIES. THE DEPARTMENT MAY ALSO EXEMPT A WHOLE-
SALER FROM THE SURETY BOND REQUIREMENT WHEN SUCH WHOLESALER IS OWNED AND

A. 60                               4

OPERATED  BY  A  FACILITY,  SUBJECT  TO  THE   PROVISIONS   OF   ARTICLE
TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A
STATE  AGENCY  THAT  LIMITS  ITS  DISTRIBUTION  OF PRESCRIPTION DRUGS TO
FACILITIES  AND PRACTITIONERS WITHIN THE INSTITUTION'S NETWORK AND OPER-
ATIONS AND DOES NOT SELL OR RETURN SUCH MEDICATIONS TO MANUFACTURERS  OR
TO OTHER WHOLESALERS.
  I.  WHOLESALER  REGISTRATION.  THE DEPARTMENT MAY PROMULGATE RULES AND
REGULATIONS TO EXEMPT FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND  H
OF  THIS SUBDIVISION A WHOLESALER THAT HAS RECEIVED ACCREDITATION FROM A
NATIONALLY RECOGNIZED ACCREDITATION BODY APPROVED  BY  THE  COMMISSIONER
AND THAT MEETS THE LICENSING STANDARDS UNDER THIS SUBDIVISION. THE STAN-
DARDS SHALL BE DEFINED BY THE COMMISSIONER PURSUANT TO REGULATIONS.
  J.  MANUFACTURER  REGISTRATION.  NOTWITHSTANDING  THE REQUIREMENTS FOR
REGISTRATION UNDER THIS SUBDIVISION, THE  COMMISSIONER  SHALL  EXEMPT  A
MANUFACTURER  LICENSED OR APPROVED BY THE FEDERAL FOOD AND DRUG ADMINIS-
TRATION (FDA) OR ITS SUCCESSOR AGENCY TO MANUFACTURE  DRUGS  OR  DEVICES
WITH REGARD TO SUCH DRUGS OR DEVICES FROM THE REQUIREMENTS OF PARAGRAPHS
E,  F,  G  AND H OF THIS SUBDIVISION IN THE EVENT THAT SUCH REQUIREMENTS
ARE NOT REQUIRED BY FEDERAL LAW OR REGULATION  UNLESS  THE  COMMISSIONER
DETERMINES  THAT  SUCH  REQUIREMENTS  ARE NECESSARY TO PREVENT A RISK TO
PRESCRIPTION DRUG DISTRIBUTION IN THE STATE.
  S 4. This act shall take effect on the one hundred eightieth day after
it shall have become a law.