Relates to penalties for counterfeit drugs; establishes pedigree meaning an electronic record containing information regarding each distribution of a prescription drug, originating from a manufacturer, through acquisition by or transfer to one or more wholesalers, manufacturers, or pharmacies, until final sale or transfer to a pharmacy or other person furnishing, administering, or dispensing the prescription drug.
STATE OF NEW YORK
________________________________________________________________________
4592
2009-2010 Regular Sessions
IN SENATE
April 24, 2009
___________
Introduced by Sen. SCHNEIDERMAN -- 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 penalties for counter-
feit drugs
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 6802 of the education law is amended by adding a
2 new subdivision 23 to read as follows:
3 23. "Pedigree" means an electronic record containing information
4 regarding each distribution of a prescription drug, originating from a
5 manufacturer, through acquisition by or transfer to one or more whole-
6 salers, manufacturers, or pharmacies, until final sale or transfer to a
7 pharmacy or other person furnishing, administering, or dispensing the
8 prescription drug, as provided in section sixty-eight hundred ten-b of
9 this article.
10 § 2. Subparagraph 2 of paragraph a of subdivision 4 of section 6808 of
11 the education law, as amended by chapter 62 of the laws of 1989, is
12 amended to read as follows:
13 (2) The application shall be accompanied by a fee of [eight hundred
14 twenty-five] twelve hundred dollars.
15 § 3. Paragraphs b and d of subdivision 4 of section 6808 of the educa-
16 tion law, paragraph b as amended by chapter 538 of the laws of 2001 and
17 paragraph d as amended by chapter 62 of the laws of 1989, are amended to
18 read as follows:
19 b. Renewal of registration. All wholesalers' and manufacturers' regis-
20 trations shall be renewed on dates set by the department. The triennial
21 registration fee shall be [five hundred twenty] eight hundred dollars or
22 a pro rated portion thereof as determined by the department.
23 d. Change of location. In the event that the location of such place of
24 business shall be changed, the owner shall apply to the department for
25 inspection of the new location and endorsement of the registration for
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD09701-01-9
S. 4592 2
1 the new location. The fee for inspection and endorsement shall be [one
2 hundred seventy] three hundred dollars, unless it appears to the satis-
3 faction of the department that the change in location is of a temporary
4 nature due to fire, flood or other disaster.
5 § 4. Subdivision 4 of section 6808 of the education law is amended by
6 adding six new paragraphs e, f, g, h, i and j to read as follows:
7 e. Applicant registration. Any applicant for registration as a whole-
8 saler or manufacturer shall be of good moral character, as determined by
9 the department. The requirements shall extend to all persons responsi-
10 ble for the distribution of a prescription drug for the applicant, as
11 determined by the department. Subject to the provisions of paragraphs f
12 and g of this subdivision, the department shall require photographs,
13 criminal history records search and fingerprints.
14 f. Criminal history records search. (1) Upon receipt of an application
15 for registration pursuant to this subdivision, the commissioner shall,
16 subject to the rules and regulations of the division of criminal justice
17 services, initiate a criminal history records search of the persons
18 identified in paragraph e of this subdivision. Prior to initiating the
19 background checks and fingerprinting process, the commissioner shall
20 furnish the applicant with the form described in paragraph g of this
21 subdivision and shall obtain the applicant's consent to the criminal
22 history records search. The commissioner shall obtain from each appli-
23 cant two sets of fingerprints and the division of criminal justice
24 services processing fee imposed pursuant to subdivision eight-a of
25 section eight hundred thirty-seven of the executive law and any fee
26 imposed by the federal bureau of investigation for a national criminal
27 history record check. The commissioner shall promptly transmit such
28 fingerprints and fees to the division of criminal justice services for
29 its full search and retain processing. The division of criminal justice
30 services is authorized to submit the fingerprints and the appropriate
31 fee to the federal bureau of investigation for a national criminal
32 history record check. The division of criminal justice services and the
33 federal bureau of investigation shall forward such criminal history
34 record to the commissioner in a timely manner. The release of such crim-
35 inal history record by the division of criminal justice services shall
36 be subject to the provisions of subdivision sixteen of section two
37 hundred ninety-six of the executive law. The commissioner shall consider
38 such criminal history record in accordance with the requirements of
39 article twenty-three-A of the correction law, for the purpose of estab-
40 lishing the good moral character of an individual as required in para-
41 graph e of this subdivision.
42 (2) For the purposes of this section the term "criminal history
43 record" shall mean a record of all convictions of crimes and any pending
44 criminal charges maintained on an individual by the division of criminal
45 justice services and the federal bureau of investigation.
46 Furthermore, upon notification that such applicant has been regis-
47 tered, the division of criminal justice services shall have the authori-
48 ty to provide subsequent criminal history notifications directly to the
49 commissioner. All such criminal history records processed and sent
50 pursuant to this subdivision shall be confidential pursuant to the
51 applicable federal and state laws, rules and regulations, and shall not
52 be published or in any way disclosed to persons other than the commis-
53 sioner, unless otherwise authorized by law.
54 (3) Notwithstanding any other provision of law to the contrary, the
55 commissioner is authorized to charge additional fees to applicants for
56 registration in an amount equal to the fees established pursuant to law
S. 4592 3
1 by the division of criminal justice services and the federal bureau of
2 investigation for the criminal history record searches mandated by this
3 subdivision.
4 g. Additional duties of the commissioner and department. (1) The
5 commissioner, in cooperation with the division of criminal justice
6 services and in accordance with all applicable provisions of law, shall
7 promulgate rules and regulations to require the fingerprinting of the
8 individuals identified in paragraph e of this subdivision, and for the
9 use of information derived from searches of the records of the division
10 of criminal justice services and the federal bureau of investigation
11 based on the use of such fingerprints, as provided in paragraph f of
12 this subdivision.
13 (2) The commissioner, in cooperation with the division of criminal
14 justice services, shall promulgate a form to be provided to all appli-
15 cants for registration pursuant to this subdivision that shall:
16 (i) inform the prospective applicant that the commissioner is required
17 to request his or her criminal history information from the division of
18 criminal justice services and the federal bureau of investigation and
19 review such information pursuant to this section, and provide a
20 description of the manner in which his or her fingerprint cards will be
21 used upon submission to the division of criminal justice services; and
22 (ii) inform the prospective applicant that he or she has the right to
23 obtain, review and seek correction of his or her criminal history infor-
24 mation pursuant to regulations and procedures established by the divi-
25 sion of criminal justice services.
26 (3) The department shall obtain the signed, informed consent of each
27 individual identified in paragraph e of this subdivision, on such form
28 supplied by the commissioner, which indicates that such person has:
29 (i) been informed of the rights and procedures necessary to obtain,
30 review and seek correction of his or her criminal history information;
31 (ii) been informed of the reason for the request for his or her crimi-
32 nal history information;
33 (iii) consented to such request for a report;
34 (iv) supplied on the form a current mailing or home address for such
35 individual;
36 (v) been informed that he or she may withdraw his or her consent,
37 regardless of whether the department has reviewed such individual's
38 criminal history information;
39 (vi) been informed that in the event the wholesaler's or manufactur-
40 er's registration pursuant to this subdivision has expired or otherwise
41 terminated, the commissioner shall notify the division of criminal
42 justice services of such expiration or termination, and the division of
43 criminal justice services shall destroy the fingerprints of the individ-
44 ual or individuals associated with such wholesaler's or manufacturer's
45 registration; and
46 (vii) been informed of the manner in which he or she may submit to the
47 commissioner any information that may be relevant to the consideration
48 of the applicant's registration including, where applicable, information
49 in support of his or her good moral character or rehabilitation thereof.
50 h. Performance or surety bond. Every wholesaler shall submit a
51 performance or surety bond of not less than one hundred thousand dollars
52 to the department to ensure compliance with the provisions of this arti-
53 cle, except that the department may waive such bond for certain not-for-
54 profit entities such as hospitals and correctional facilities that limit
55 distribution to their own facilities and do not return such medications
56 to other entities. Such waiver shall be made on the recommendation of
S. 4592 4
1 the state board of pharmacy. The department may also exempt a wholesaler
2 from the surety bond requirement when such wholesaler is owned and oper-
3 ated by a facility, subject to the provisions of article twenty-eight of
4 the public health law and other facilities governed by a state agency
5 that limits its distribution of prescription drugs to facilities and
6 practitioners within the institution's network and operations and does
7 not sell or return such medications to manufacturers or to other whole-
8 salers.
9 i. Wholesaler registration. The department may promulgate rules and
10 regulations to exempt from the requirements of paragraphs e, f, g and h
11 of this subdivision a wholesaler that has received accreditation from a
12 nationally recognized accreditation body approved by the commissioner
13 and that meets the licensing standards under this subdivision. The stan-
14 dards shall be defined by the commissioner pursuant to regulations.
15 j. Manufacturer registration. Notwithstanding the requirements for
16 registration under this subdivision, the commissioner shall exempt a
17 manufacturer licensed or approved by the federal food and drug adminis-
18 tration (FDA) or its successor agency to manufacture drugs or devices
19 with regard to such drugs or devices from the requirements of paragraphs
20 e, f, g and h of this subdivision in the event that such requirements
21 are not required by federal law or regulation unless the commissioner
22 determines that such requirements are necessary to prevent a risk to
23 prescription drug distribution in the state.
24 § 5. The education law is amended by adding a new section 6810-a to
25 read as follows:
26 § 6810-a. Unlawful transactions by manufacturers and wholesalers. It
27 shall be unlawful for a manufacturer, wholesaler or other person to:
28 1. Intentionally package, sell, transfer, distribute or deliver any
29 prescription drug that he or she knows is adulterated, misbranded, coun-
30 terfeit or has otherwise been rendered unfit for distribution.
31 2. Intentionally package, sell, transfer, distribute or deliver a
32 prescription drug to any wholesaler who is not licensed or registered
33 pursuant to this article.
34 A person who violates this section shall be guilty of a class D felo-
35 ny. In addition, any drug packaged, sold, transferred, distributed or
36 delivered in violation of this section shall be contraband and subject
37 to seizure by the board of pharmacy, the department of health or any law
38 enforcement officer of the state.
39 § 6. The education law is amended by adding a new section 6810-b to
40 read as follows:
41 § 6810-b. Pedigree. 1. Every manufacturer shall establish and maintain
42 a pedigree for each prescription drug, and every wholesaler, pharmacy or
43 other person furnishing or dispensing a prescription drug shall main-
44 tain, a pedigree for each prescription drug.
45 2. A pedigree shall be in such form and contain such information as
46 shall be determined by the department. Each pedigree shall minimally
47 include for each distribution all of the following information:
48 a. the source of the prescription drug, including the name and princi-
49 pal address of the seller or transferor;
50 b. the proprietary and established name of the prescription drug, the
51 amount of the prescription drug, its dosage form and dosage strength,
52 the date of the purchase or transfer, the invoice number, container
53 size, number of containers, expiration date, lot number, national drug
54 code, and, if available, standardized numerical identifier, of the
55 prescription drug;
S. 4592 5
1 c. the business name and address of each owner of the prescription
2 drug and its shipping information, including the name and address of the
3 facility of each person certifying delivery or receipt of the
4 prescription drug; and
5 d. a certification under penalty of perjury from the designated repre-
6 sentative of the manufacturer, wholesaler or pharmacy that the informa-
7 tion contained therein is true and accurate.
8 3. Every pedigree shall be maintained for a period of three years or a
9 reasonable period of time as determined by the commissioner, and shall
10 be made available for inspection, upon reasonable notice, by the depart-
11 ment.
12 4. A pedigree shall be maintained in an electronic pedigree tracking
13 system or other technology format acceptable to the department beginning
14 January first, two thousand twelve, which shall be the pedigree effec-
15 tive date. If an electronic pedigree tracking system or alternative
16 format is not feasible by the pedigree effective date, the department
17 shall issue one-year extensions of the pedigree effective date until the
18 department determines such format to be feasible. In determining whether
19 an electronic pedigree tracking system or alternative technology format
20 is feasible, the department shall consider whether such system or format
21 is:
22 a. readily available with respect to all prescription drugs,
23 b. in a standardized non-proprietary data format and architecture, and
24 widely available to manufacturers, wholesalers and pharmacies so that
25 the system or format is capable of being used by manufacturers, whole-
26 salers and pharmacies from sale by the manufacturer through acquisition
27 by or transfer to a wholesaler, manufacturer or pharmacy until final
28 sale or transfer to a pharmacy or other person furnishing, administering
29 or dispensing the prescription drug, and
30 c. consistent with federal requirements for a standardized numerical
31 identifier.
32 5. Any person who violates any provision of this section shall be
33 subject to a fine of not more than two thousand dollars per violation.
34 In addition, any prescription drug distributed, transferred, adminis-
35 tered, furnished, or dispensed in violation of this section shall be
36 contraband and subject to seizure either by the department, the state
37 board of pharmacy or any law enforcement officer of the state.
38 § 7. Section 6824 of the education law, as added by chapter 987 of the
39 laws of 1971, is amended to read as follows:
40 § 6824. Injunction proceedings. In addition to the remedies hereinaft-
41 er provided, the secretary is hereby authorized to apply to the court of
42 the proper venue for an injunction to restrain any person from (a)
43 introducing or causing to be introduced into commerce any adulterated or
44 misbranded drug, device or cosmetic; or (b) from introducing or causing
45 to be introduced in commerce any new drug which does not comply with the
46 provisions of this article; or (c) from disseminating or causing to be
47 disseminated a false advertisement; or (d) violating any provision of
48 section sixty-eight hundred ten-a of this article, without being
49 compelled to allege or prove that an adequate remedy at law does not
50 exist.
51 § 8. This act shall take effect on the one hundred eightieth day after
52 it shall have become a law. The department of education shall promulgate
53 rules and regulations, issue forms and take any other action necessary
54 to implement the provisions of this act on or before the pedigree effec-
55 tive date, as provided in subdivision 4 of section 6810-b of the educa-
56 tion law, as added by section six of this act.
