S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2848
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 23, 2017
                                ___________
 
 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.
   § 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.
   § 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
 THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F AND G OF  THIS
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD06289-01-7

 A. 2848                             2
 
 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
 PROMULGATE  RULES AND REGULATIONS TO REQUIRE THE PERFORMANCE OF A CRIMI-

 A. 2848                             3
 
 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 WHOLESALER 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

 A. 2848                             4
 
 PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A STATE  AGENCY  THAT
 LIMITS  ITS DISTRIBUTION OF PRESCRIPTION DRUGS TO FACILITIES AND PRACTI-
 TIONERS WITHIN THE INSTITUTION'S NETWORK AND  OPERATIONS  AND  DOES  NOT
 SELL  OR  RETURN  SUCH  MEDICATIONS  TO MANUFACTURERS OR TO OTHER WHOLE-
 SALERS.
   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.
   § 4. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.