S T A T E O F N E W Y O R K
________________________________________________________________________
5286
2011-2012 Regular Sessions
I N S E N A T E
May 3, 2011
___________
Introduced by Sen. LANZA -- read twice and ordered printed, and when
printed to be committed 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:
1 Section 1. Subparagraph 2 of paragraph a of subdivision 4 of section
2 6808 of the education law, as amended by chapter 62 of the laws of 1989,
3 is amended to read as follows:
4 (2) The application shall be accompanied by a fee of [eight hundred
5 twenty-five] TWELVE HUNDRED dollars.
6 S 2. Paragraphs b and d of subdivision 4 of section 6808 of the educa-
7 tion law, paragraph b as amended by chapter 538 of the laws of 2001 and
8 paragraph d as amended by chapter 62 of the laws of 1989, are amended to
9 read as follows:
10 b. Renewal of registration. All wholesalers' and manufacturers' regis-
11 trations shall be renewed on dates set by the department. The triennial
12 registration fee shall be [five hundred twenty] EIGHT HUNDRED dollars or
13 a pro rated portion thereof as determined by the department.
14 d. Change of location. In the event that the location of such place of
15 business shall be changed, the owner shall apply to the department for
16 inspection of the new location and endorsement of the registration for
17 the new location. The fee for inspection and endorsement shall be [one
18 hundred seventy] THREE HUNDRED dollars, unless it appears to the satis-
19 faction of the department that the change in location is of a temporary
20 nature due to fire, flood or other disaster.
21 S 3. Subdivision 4 of section 6808 of the education law is amended by
22 adding six new paragraphs e, f, g, h, i and j to read as follows:
23 E. APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A WHOLE-
24 SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY
25 THE DEPARTMENT. THE REQUIREMENTS SHALL EXTEND TO ALL PERSONS RESPONSI-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD06282-01-1
S. 5286 2
1 BLE FOR THE DISTRIBUTION OF A PRESCRIPTION DRUG FOR THE APPLICANT, AS
2 DETERMINED BY THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F
3 AND G OF THIS SUBDIVISION, THE DEPARTMENT SHALL REQUIRE PHOTOGRAPHS,
4 CRIMINAL HISTORY RECORDS SEARCH AND FINGERPRINTS.
5 F. CRIMINAL HISTORY RECORDS SEARCH. (1) UPON RECEIPT OF AN APPLICATION
6 FOR REGISTRATION PURSUANT TO THIS SUBDIVISION, THE COMMISSIONER SHALL,
7 SUBJECT TO THE RULES AND REGULATIONS OF THE DIVISION OF CRIMINAL JUSTICE
8 SERVICES, INITIATE A CRIMINAL HISTORY RECORDS SEARCH OF THE PERSONS
9 IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION. PRIOR TO INITIATING THE
10 BACKGROUND CHECKS AND FINGERPRINTING PROCESS, THE COMMISSIONER SHALL
11 FURNISH THE APPLICANT WITH THE FORM DESCRIBED IN PARAGRAPH G OF THIS
12 SUBDIVISION AND SHALL OBTAIN THE APPLICANT'S CONSENT TO THE CRIMINAL
13 HISTORY RECORDS SEARCH. THE COMMISSIONER SHALL OBTAIN FROM EACH APPLI-
14 CANT TWO SETS OF FINGERPRINTS AND THE DIVISION OF CRIMINAL JUSTICE
15 SERVICES PROCESSING FEE IMPOSED PURSUANT TO SUBDIVISION EIGHT-A OF
16 SECTION EIGHT HUNDRED THIRTY-SEVEN OF THE EXECUTIVE LAW AND ANY FEE
17 IMPOSED BY THE FEDERAL BUREAU OF INVESTIGATION FOR A NATIONAL CRIMINAL
18 HISTORY RECORD CHECK. THE COMMISSIONER SHALL PROMPTLY TRANSMIT SUCH
19 FINGERPRINTS AND FEES TO THE DIVISION OF CRIMINAL JUSTICE SERVICES FOR
20 ITS FULL SEARCH AND RETAIN PROCESSING. THE DIVISION OF CRIMINAL JUSTICE
21 SERVICES IS AUTHORIZED TO SUBMIT THE FINGERPRINTS AND THE APPROPRIATE
22 FEE TO THE FEDERAL BUREAU OF INVESTIGATION FOR A NATIONAL CRIMINAL
23 HISTORY RECORD CHECK. THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE
24 FEDERAL BUREAU OF INVESTIGATION SHALL FORWARD SUCH CRIMINAL HISTORY
25 RECORD TO THE COMMISSIONER IN A TIMELY MANNER. THE RELEASE OF SUCH CRIM-
26 INAL HISTORY RECORD BY THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL
27 BE SUBJECT TO THE PROVISIONS OF SUBDIVISION SIXTEEN OF SECTION TWO
28 HUNDRED NINETY-SIX OF THE EXECUTIVE LAW. THE COMMISSIONER SHALL CONSIDER
29 SUCH CRIMINAL HISTORY RECORD IN ACCORDANCE WITH THE REQUIREMENTS OF
30 ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW, FOR THE PURPOSE OF ESTAB-
31 LISHING THE GOOD MORAL CHARACTER OF AN INDIVIDUAL AS REQUIRED IN PARA-
32 GRAPH E OF THIS SUBDIVISION.
33 (2) FOR THE PURPOSES OF THIS SECTION THE TERM "CRIMINAL HISTORY
34 RECORD" SHALL MEAN A RECORD OF ALL CONVICTIONS OF CRIMES AND ANY PENDING
35 CRIMINAL CHARGES MAINTAINED ON AN INDIVIDUAL BY THE DIVISION OF CRIMINAL
36 JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION.
37 FURTHERMORE, UPON NOTIFICATION THAT SUCH APPLICANT HAS BEEN REGIS-
38 TERED, THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL HAVE THE AUTHORI-
39 TY TO PROVIDE SUBSEQUENT CRIMINAL HISTORY NOTIFICATIONS DIRECTLY TO THE
40 COMMISSIONER. ALL SUCH CRIMINAL HISTORY RECORDS PROCESSED AND SENT
41 PURSUANT TO THIS SUBDIVISION SHALL BE CONFIDENTIAL PURSUANT TO THE
42 APPLICABLE FEDERAL AND STATE LAWS, RULES AND REGULATIONS, AND SHALL NOT
43 BE PUBLISHED OR IN ANY WAY DISCLOSED TO PERSONS OTHER THAN THE COMMIS-
44 SIONER, UNLESS OTHERWISE AUTHORIZED BY LAW.
45 (3) NOTWITHSTANDING ANY OTHER PROVISION OF LAW TO THE CONTRARY, THE
46 COMMISSIONER IS AUTHORIZED TO CHARGE ADDITIONAL FEES TO APPLICANTS FOR
47 REGISTRATION IN AN AMOUNT EQUAL TO THE FEES ESTABLISHED PURSUANT TO LAW
48 BY THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF
49 INVESTIGATION FOR THE CRIMINAL HISTORY RECORD SEARCHES MANDATED BY THIS
50 SUBDIVISION.
51 G. ADDITIONAL DUTIES OF THE COMMISSIONER AND DEPARTMENT. (1) THE
52 COMMISSIONER, IN COOPERATION WITH THE DIVISION OF CRIMINAL JUSTICE
53 SERVICES AND IN ACCORDANCE WITH ALL APPLICABLE PROVISIONS OF LAW, SHALL
54 PROMULGATE RULES AND REGULATIONS TO REQUIRE THE FINGERPRINTING OF THE
55 INDIVIDUALS IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, AND FOR THE
56 USE OF INFORMATION DERIVED FROM SEARCHES OF THE RECORDS OF THE DIVISION
S. 5286 3
1 OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION
2 BASED ON THE USE OF SUCH FINGERPRINTS, AS PROVIDED IN PARAGRAPH F OF
3 THIS SUBDIVISION.
4 (2) THE COMMISSIONER, IN COOPERATION WITH THE DIVISION OF CRIMINAL
5 JUSTICE SERVICES, SHALL PROMULGATE A FORM TO BE PROVIDED TO ALL APPLI-
6 CANTS FOR REGISTRATION PURSUANT TO THIS SUBDIVISION THAT SHALL:
7 (I) INFORM THE PROSPECTIVE APPLICANT THAT THE COMMISSIONER IS REQUIRED
8 TO REQUEST HIS OR HER CRIMINAL HISTORY INFORMATION FROM THE DIVISION OF
9 CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION AND
10 REVIEW SUCH INFORMATION PURSUANT TO THIS SECTION, AND PROVIDE A
11 DESCRIPTION OF THE MANNER IN WHICH HIS OR HER FINGERPRINT CARDS WILL BE
12 USED UPON SUBMISSION TO THE DIVISION OF CRIMINAL JUSTICE SERVICES; AND
13 (II) INFORM THE PROSPECTIVE APPLICANT THAT HE OR SHE HAS THE RIGHT TO
14 OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFOR-
15 MATION PURSUANT TO REGULATIONS AND PROCEDURES ESTABLISHED BY THE DIVI-
16 SION OF CRIMINAL JUSTICE SERVICES.
17 (3) THE DEPARTMENT SHALL OBTAIN THE SIGNED, INFORMED CONSENT OF EACH
18 INDIVIDUAL IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, ON SUCH FORM
19 SUPPLIED BY THE COMMISSIONER, WHICH INDICATES THAT SUCH PERSON HAS:
20 (I) BEEN INFORMED OF THE RIGHTS AND PROCEDURES NECESSARY TO OBTAIN,
21 REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFORMATION;
22 (II) BEEN INFORMED OF THE REASON FOR THE REQUEST FOR HIS OR HER CRIMI-
23 NAL HISTORY INFORMATION;
24 (III) CONSENTED TO SUCH REQUEST FOR A REPORT;
25 (IV) SUPPLIED ON THE FORM A CURRENT MAILING OR HOME ADDRESS FOR SUCH
26 INDIVIDUAL;
27 (V) BEEN INFORMED THAT HE OR SHE MAY WITHDRAW HIS OR HER CONSENT,
28 REGARDLESS OF WHETHER THE DEPARTMENT HAS REVIEWED SUCH INDIVIDUAL'S
29 CRIMINAL HISTORY INFORMATION;
30 (VI) BEEN INFORMED THAT IN THE EVENT THE WHOLESALER'S OR MANUFACTUR-
31 ER'S REGISTRATION PURSUANT TO THIS SUBDIVISION HAS EXPIRED OR OTHERWISE
32 TERMINATED, THE COMMISSIONER SHALL NOTIFY THE DIVISION OF CRIMINAL
33 JUSTICE SERVICES OF SUCH EXPIRATION OR TERMINATION, AND THE DIVISION OF
34 CRIMINAL JUSTICE SERVICES SHALL DESTROY THE FINGERPRINTS OF THE INDIVID-
35 UAL OR INDIVIDUALS ASSOCIATED WITH SUCH WHOLESALER'S OR MANUFACTURER'S
36 REGISTRATION; AND
37 (VII) BEEN INFORMED OF THE MANNER IN WHICH HE OR SHE MAY SUBMIT TO THE
38 COMMISSIONER ANY INFORMATION THAT MAY BE RELEVANT TO THE CONSIDERATION
39 OF THE APPLICANT'S REGISTRATION INCLUDING, WHERE APPLICABLE, INFORMATION
40 IN SUPPORT OF HIS OR HER GOOD MORAL CHARACTER OR REHABILITATION THEREOF.
41 H. PERFORMANCE OR SURETY BOND. EVERY WHOLESALER SHALL SUBMIT A
42 PERFORMANCE OR SURETY BOND OF NOT LESS THAN ONE HUNDRED THOUSAND DOLLARS
43 TO THE DEPARTMENT TO ENSURE COMPLIANCE WITH THE PROVISIONS OF THIS ARTI-
44 CLE, EXCEPT THAT THE DEPARTMENT MAY WAIVE SUCH BOND FOR CERTAIN
45 NOT-FOR-PROFIT ENTITIES SUCH AS HOSPITALS AND CORRECTIONAL FACILITIES
46 THAT LIMIT DISTRIBUTION TO THEIR OWN FACILITIES AND DO NOT RETURN SUCH
47 MEDICATIONS TO OTHER ENTITIES. SUCH WAIVER SHALL BE MADE ON THE RECOM-
48 MENDATION OF THE STATE BOARD OF PHARMACY. THE DEPARTMENT MAY ALSO EXEMPT
49 A WHOLESALER FROM THE SURETY BOND REQUIREMENT WHEN SUCH WHOLESALER IS
50 OWNED AND OPERATED BY A FACILITY, SUBJECT TO THE PROVISIONS OF ARTICLE
51 TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A
52 STATE AGENCY THAT LIMITS ITS DISTRIBUTION OF PRESCRIPTION DRUGS TO
53 FACILITIES AND PRACTITIONERS WITHIN THE INSTITUTION'S NETWORK AND OPER-
54 ATIONS AND DOES NOT SELL OR RETURN SUCH MEDICATIONS TO MANUFACTURERS OR
55 TO OTHER WHOLESALERS.
S. 5286 4
1 I. WHOLESALER REGISTRATION. THE DEPARTMENT MAY PROMULGATE RULES AND
2 REGULATIONS TO EXEMPT FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND H
3 OF THIS SUBDIVISION A WHOLESALER THAT HAS RECEIVED ACCREDITATION FROM A
4 NATIONALLY RECOGNIZED ACCREDITATION BODY APPROVED BY THE COMMISSIONER
5 AND THAT MEETS THE LICENSING STANDARDS UNDER THIS SUBDIVISION. THE STAN-
6 DARDS SHALL BE DEFINED BY THE COMMISSIONER PURSUANT TO REGULATIONS.
7 J. MANUFACTURER REGISTRATION. NOTWITHSTANDING THE REQUIREMENTS FOR
8 REGISTRATION UNDER THIS SUBDIVISION, THE COMMISSIONER SHALL EXEMPT A
9 MANUFACTURER LICENSED OR APPROVED BY THE FEDERAL FOOD AND DRUG ADMINIS-
10 TRATION (FDA) OR ITS SUCCESSOR AGENCY TO MANUFACTURE DRUGS OR DEVICES
11 WITH REGARD TO SUCH DRUGS OR DEVICES FROM THE REQUIREMENTS OF PARAGRAPHS
12 E, F, G AND H OF THIS SUBDIVISION IN THE EVENT THAT SUCH REQUIREMENTS
13 ARE NOT REQUIRED BY FEDERAL LAW OR REGULATION UNLESS THE COMMISSIONER
14 DETERMINES THAT SUCH REQUIREMENTS ARE NECESSARY TO PREVENT A RISK TO
15 PRESCRIPTION DRUG DISTRIBUTION IN THE STATE.
16 S 4. The education law is amended by adding a new section 6810-a to
17 read as follows:
18 S 6810-A. UNLAWFUL TRANSACTIONS BY MANUFACTURERS AND WHOLESALERS. IT
19 SHALL BE UNLAWFUL FOR A MANUFACTURER, WHOLESALER OR OTHER PERSON TO:
20 1. INTENTIONALLY PACKAGE, SELL, TRANSFER, DISTRIBUTE OR DELIVER ANY
21 PRESCRIPTION DRUG THAT HE OR SHE KNOWS IS ADULTERATED, MISBRANDED, COUN-
22 TERFEIT OR HAS OTHERWISE BEEN RENDERED UNFIT FOR DISTRIBUTION.
23 2. INTENTIONALLY PACKAGE, SELL, TRANSFER, DISTRIBUTE OR DELIVER A
24 PRESCRIPTION DRUG TO ANY WHOLESALER WHO IS NOT LICENSED OR REGISTERED
25 PURSUANT TO THIS ARTICLE.
26 A PERSON WHO VIOLATES THIS SECTION SHALL BE GUILTY OF A CLASS D FELO-
27 NY. IN ADDITION, ANY DRUG PACKAGED, SOLD, TRANSFERRED, DISTRIBUTED OR
28 DELIVERED IN VIOLATION OF THIS SECTION SHALL BE CONTRABAND AND SUBJECT
29 TO SEIZURE BY THE BOARD OF PHARMACY, THE DEPARTMENT OF HEALTH OR ANY LAW
30 ENFORCEMENT OFFICER OF THE STATE.
31 S 5. Section 6824 of the education law, as added by chapter 987 of the
32 laws of 1971, is amended to read as follows:
33 S 6824. Injunction proceedings. In addition to the remedies hereinaft-
34 er provided, the secretary is hereby authorized to apply to the court of
35 the proper venue for an injunction to restrain any person from (a)
36 introducing or causing to be introduced into commerce any adulterated or
37 misbranded drug, device or cosmetic; or (b) from introducing or causing
38 to be introduced in commerce any new drug which does not comply with the
39 provisions of this article; or (c) from disseminating or causing to be
40 disseminated a false advertisement; OR (D) VIOLATING ANY PROVISION OF
41 SECTION SIXTY-EIGHT HUNDRED TEN-A OF THIS ARTICLE, without being
42 compelled to allege or prove that an adequate remedy at law does not
43 exist.
44 S 6. This act shall take effect on the one hundred eightieth day after
45 it shall have become a law.