S T A T E O F N E W Y O R K
________________________________________________________________________
5925
2013-2014 Regular Sessions
I N A S S E M B L Y
March 8, 2013
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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.
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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.