A2460A-2011 Actions

• Jun 5, 2012: reported referred to codes
• Feb 23, 2012: print number 2460a
• Feb 23, 2012: amend and recommit to higher education
• Jan 4, 2012: referred to higher education
• Jan 18, 2011: referred to higher education

A2460A-2011 Text

 S T A T E   O F   N E W   Y O R K
 
 2460--A
 2011-2012 Regular Sessions
 I N  ASSEMBLY
 January 18, 2011
 
 Introduced  by  M. of A. PAULIN, TITONE, GOTTFRIED, GALEF -- Multi-Spon
 sored by --  M.  of  A.  BOYLAND,  BURLING,  COLTON,  COOK,  DINOWITZ,
 FARRELL,  HIKIND,  HOOPER, LATIMER, J. MILLER, ORTIZ, RAIA, P. RIVERA,
 ROBINSON, SWEENEY, TOBACCO, WRIGHT -- read once and  referred  to  the
 Committee on Higher Education -- recommitted to the Committee on High
 er  Education  in accordance with Assembly Rule 3, sec. 2 -- committee
 discharged, bill amended, ordered reprinted as amended and recommitted
 to said committee
 

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
 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
 [ ] is old law to be omitted.
 LBD06282-02-2
 
       A. 2460--A                          2
 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
 THE  DEPARTMENT.  THE REQUIREMENTS SHALL EXTEND TO ALL PERSONS RESPONSI
 BLE FOR THE DISTRIBUTION OF A PRESCRIPTION DRUG FOR  THE  APPLICANT,  AS
 DETERMINED  BY THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F
 AND G OF THIS SUBDIVISION, THE  DEPARTMENT  SHALL  REQUIRE  PHOTOGRAPHS,
 CRIMINAL HISTORY RECORDS SEARCH AND FINGERPRINTS.
 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 TO THE COMMISSIONER IN A TIMELY MANNER. THE RELEASE OF SUCH CRIM
 INAL  HISTORY  RECORD BY THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL
 BE SUBJECT TO THE PROVISIONS  OF  SUBDIVISION  SIXTEEN  OF  SECTION  TWO
 HUNDRED NINETY-SIX OF THE EXECUTIVE LAW. THE COMMISSIONER SHALL CONSIDER
 SUCH  CRIMINAL  HISTORY  RECORD  IN  ACCORDANCE WITH THE REQUIREMENTS OF
 ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW, FOR THE PURPOSE OF  ESTAB
 LISHING  THE  GOOD MORAL CHARACTER OF AN INDIVIDUAL AS REQUIRED IN PARA
 GRAPH E OF THIS SUBDIVISION.
 (2) FOR THE PURPOSES  OF  THIS  SECTION  THE  TERM  "CRIMINAL  HISTORY
 RECORD" SHALL MEAN A RECORD OF ALL CONVICTIONS OF CRIMES AND ANY PENDING
 CRIMINAL CHARGES MAINTAINED ON AN INDIVIDUAL 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.
 (3)  NOTWITHSTANDING  ANY  OTHER PROVISION OF LAW TO THE CONTRARY, THE
 COMMISSIONER IS AUTHORIZED TO CHARGE ADDITIONAL FEES TO  APPLICANTS  FOR
 REGISTRATION  IN AN AMOUNT EQUAL TO THE FEES ESTABLISHED PURSUANT TO LAW
 BY THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL  BUREAU  OF
 
       A. 2460--A                          3
 INVESTIGATION  FOR THE CRIMINAL HISTORY RECORD SEARCHES MANDATED BY THIS
 SUBDIVISION.
 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  FINGERPRINTING  OF  THE
 INDIVIDUALS  IDENTIFIED  IN PARAGRAPH E OF THIS SUBDIVISION, AND FOR THE
 USE OF INFORMATION DERIVED FROM SEARCHES OF THE RECORDS OF THE  DIVISION
 OF  CRIMINAL  JUSTICE  SERVICES  AND THE FEDERAL BUREAU OF INVESTIGATION
 BASED ON THE USE OF SUCH FINGERPRINTS, AS PROVIDED  IN  PARAGRAPH  F  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.
 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. 2460--A                          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. The education law is amended by adding a new  section  6810-a  to
 read as follows:

 

S  6810-A.  UNLAWFUL TRANSACTIONS BY MANUFACTURERS AND WHOLESALERS. IT
 SHALL BE UNLAWFUL FOR A MANUFACTURER, WHOLESALER OR OTHER PERSON TO:

 1. INTENTIONALLY PACKAGE, SELL, TRANSFER, DISTRIBUTE  OR  DELIVER  ANY
 PRESCRIPTION DRUG THAT HE OR SHE KNOWS IS ADULTERATED, MISBRANDED, COUN
 TERFEIT OR HAS OTHERWISE BEEN RENDERED UNFIT FOR DISTRIBUTION.
 2.  INTENTIONALLY  PACKAGE,  SELL,  TRANSFER,  DISTRIBUTE OR DELIVER A
 PRESCRIPTION DRUG TO ANY WHOLESALER WHO IS NOT  LICENSED  OR  REGISTERED
 PURSUANT TO THIS ARTICLE.
 A  PERSON WHO VIOLATES THIS SECTION SHALL BE GUILTY OF A CLASS D FELO
 NY.  IN ADDITION, ANY DRUG PACKAGED, SOLD, TRANSFERRED,  DISTRIBUTED  OR
 DELIVERED  IN  VIOLATION OF THIS SECTION SHALL BE CONTRABAND AND SUBJECT
 TO SEIZURE BY THE DEPARTMENT,  THE  DEPARTMENT  OF  HEALTH  OR  ANY  LAW
 ENFORCEMENT OFFICER OF THE STATE.
 

S 5.

Section 6824 of the education law, as added by chapter 987 of the
 laws of 1971, is amended to read as follows:

 

S 6824. Injunction proceedings. In addition to the remedies hereinaft
 er provided, the secretary is hereby authorized to apply to the court of
 the  proper  venue  for  an  injunction  to restrain any person from (a)
 introducing or causing to be introduced into commerce any adulterated or
 misbranded drug, device or cosmetic; or (b) from introducing or  causing
 to be introduced in commerce any new drug which does not comply with the
 provisions  of  this article; or (c) from disseminating or causing to be
 disseminated a false advertisement; OR (D) VIOLATING  ANY  PROVISION  OF
 SECTION  SIXTY-EIGHT  HUNDRED  TEN-A  OF  THIS  ARTICLE,  without  being
 compelled to allege or prove that an adequate remedy  at  law  does  not
 exist.
 

S 6. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.

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