S T A T E   O F   N E W   Y O R K
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                                  5925

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                              March 8, 2013
                               ___________

Introduced  by  M. of A. PAULIN, TITONE, GOTTFRIED, GALEF -- Multi-Spon-
  sored by -- M. of  A.    BOYLAND,  COLTON,  COOK,  DINOWITZ,  FARRELL,
  HIKIND,  HOOPER,  ORTIZ,  RAIA, ROBINSON, SWEENEY, WRIGHT -- 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:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD05506-03-3

              

A. 5925                             2

  E. APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A  WHOLE-
SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY
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.

A. 5925                             3

  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
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

A. 5925                             4

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
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.