Amd SS6802, 6808 & 6824, add SS6810-a & 6810-b, Ed L
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
________________________________________________________________________
6546--A
2009-2010 Regular Sessions
IN ASSEMBLY
March 6, 2009
___________
Introduced by M. of A. PAULIN, TITONE, GOTTFRIED, GALEF, CLARK --
Multi-Sponsored by -- M. of A. ALFANO, BARRA, BOYLAND, CHRISTENSEN,
COLTON, COOK, DINOWITZ, HIKIND, HOOPER, JOHN, LATIMER, MILLER, ORTIZ,
RAIA, P. RIVERA, ROBINSON, SWEENEY, TOBACCO, WRIGHT -- read once and
referred to the Committee on Higher Education -- committee discharged,
bill amended, ordered reprinted as amended and recommitted to said
committee
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 transaction, resulting in a change of ownership, of a
5 prescription drug, originating from a manufacturer, through acquisition
6 by or transfer to one or more wholesalers, manufacturers, repackagers,
7 or pharmacies, until final sale or transfer to a pharmacy or other
8 person furnishing, administering, or dispensing the prescription drug,
9 as provided in section sixty-eight hundred ten-b of 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
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD09701-04-9
A. 6546--A 2
1 registration fee shall be [five hundred twenty] eight hundred dollars or
2 a pro rated portion thereof as determined by the department.
3 d. Change of location. In the event that the location of such place of
4 business shall be changed, the owner shall apply to the department for
5 inspection of the new location and endorsement of the registration for
6 the new location. The fee for inspection and endorsement shall be [one
7 hundred seventy] three hundred dollars, unless it appears to the satis-
8 faction of the department that the change in location is of a temporary
9 nature due to fire, flood or other disaster.
10 § 4. Subdivision 4 of section 6808 of the education law is amended by
11 adding six new paragraphs e, f, g, h, i and j to read as follows:
12 e. Applicant registration. Any applicant for registration as a whole-
13 saler or manufacturer shall be of good moral character, as determined by
14 the department. The requirements shall extend to all persons responsi-
15 ble for the distribution of a prescription drug for the applicant, as
16 determined by the department. Subject to the provisions of paragraphs f
17 and g of this subdivision, the department shall require photographs,
18 criminal history records search and fingerprints.
19 f. Criminal history records search. (1) Upon receipt of an application
20 for registration pursuant to this subdivision, the commissioner shall,
21 subject to the rules and regulations of the division of criminal justice
22 services, initiate a criminal history records search of the persons
23 identified in paragraph e of this subdivision. Prior to initiating the
24 background checks and fingerprinting process, the commissioner shall
25 furnish the applicant with the form described in paragraph g of this
26 subdivision and shall obtain the applicant's consent to the criminal
27 history records search. The commissioner shall obtain from each appli-
28 cant two sets of fingerprints and the division of criminal justice
29 services processing fee imposed pursuant to subdivision eight-a of
30 section eight hundred thirty-seven of the executive law and any fee
31 imposed by the federal bureau of investigation for a national criminal
32 history record check. The commissioner shall promptly transmit such
33 fingerprints and fees to the division of criminal justice services for
34 its full search and retain processing. The division of criminal justice
35 services is authorized to submit the fingerprints and the appropriate
36 fee to the federal bureau of investigation for a national criminal
37 history record check. The division of criminal justice services and the
38 federal bureau of investigation shall forward such criminal history
39 record to the commissioner in a timely manner. The release of such crim-
40 inal history record by the division of criminal justice services shall
41 be subject to the provisions of subdivision sixteen of section two
42 hundred ninety-six of the executive law. The commissioner shall consider
43 such criminal history record in accordance with the requirements of
44 article twenty-three-A of the correction law, for the purpose of estab-
45 lishing the good moral character of an individual as required in para-
46 graph e of this subdivision.
47 (2) For the purposes of this section the term "criminal history
48 record" shall mean a record of all convictions of crimes and any pending
49 criminal charges maintained on an individual by the division of criminal
50 justice services and the federal bureau of investigation.
51 Furthermore, upon notification that such applicant has been regis-
52 tered, the division of criminal justice services shall have the authori-
53 ty to provide subsequent criminal history notifications directly to the
54 commissioner. All such criminal history records processed and sent
55 pursuant to this subdivision shall be confidential pursuant to the
56 applicable federal and state laws, rules and regulations, and shall not
A. 6546--A 3
1 be published or in any way disclosed to persons other than the commis-
2 sioner, unless otherwise authorized by law.
3 (3) Notwithstanding any other provision of law to the contrary, the
4 commissioner is authorized to charge additional fees to applicants for
5 registration in an amount equal to the fees established pursuant to law
6 by the division of criminal justice services and the federal bureau of
7 investigation for the criminal history record searches mandated by this
8 subdivision.
9 g. Additional duties of the commissioner and department. (1) The
10 commissioner, in cooperation with the division of criminal justice
11 services and in accordance with all applicable provisions of law, shall
12 promulgate rules and regulations to require the fingerprinting of the
13 individuals identified in paragraph e of this subdivision, and for the
14 use of information derived from searches of the records of the division
15 of criminal justice services and the federal bureau of investigation
16 based on the use of such fingerprints, as provided in paragraph f of
17 this subdivision.
18 (2) The commissioner, in cooperation with the division of criminal
19 justice services, shall promulgate a form to be provided to all appli-
20 cants for registration pursuant to this subdivision that shall:
21 (i) inform the prospective applicant that the commissioner is required
22 to request his or her criminal history information from the division of
23 criminal justice services and the federal bureau of investigation and
24 review such information pursuant to this section, and provide a
25 description of the manner in which his or her fingerprint cards will be
26 used upon submission to the division of criminal justice services; and
27 (ii) inform the prospective applicant that he or she has the right to
28 obtain, review and seek correction of his or her criminal history infor-
29 mation pursuant to regulations and procedures established by the divi-
30 sion of criminal justice services.
31 (3) The department shall obtain the signed, informed consent of each
32 individual identified in paragraph e of this subdivision, on such form
33 supplied by the commissioner, which indicates that such person has:
34 (i) been informed of the rights and procedures necessary to obtain,
35 review and seek correction of his or her criminal history information;
36 (ii) been informed of the reason for the request for his or her crimi-
37 nal history information;
38 (iii) consented to such request for a report;
39 (iv) supplied on the form a current mailing or home address for such
40 individual;
41 (v) been informed that he or she may withdraw his or her consent,
42 regardless of whether the department has reviewed such individual's
43 criminal history information;
44 (vi) been informed that in the event the wholesaler's or manufactur-
45 er's registration pursuant to this subdivision has expired or otherwise
46 terminated, the commissioner shall notify the division of criminal
47 justice services of such expiration or termination, and the division of
48 criminal justice services shall destroy the fingerprints of the individ-
49 ual or individuals associated with such wholesaler's or manufacturer's
50 registration; and
51 (vii) been informed of the manner in which he or she may submit to the
52 commissioner any information that may be relevant to the consideration
53 of the applicant's registration including, where applicable, information
54 in support of his or her good moral character or rehabilitation thereof.
55 h. Performance or surety bond. Every wholesaler shall submit a
56 performance or surety bond of not less than one hundred thousand dollars
A. 6546--A 4
1 to the department to ensure compliance with the provisions of this arti-
2 cle, except that the department may waive such bond for certain not-for-
3 profit entities such as hospitals and correctional facilities that limit
4 distribution to their own facilities and do not return such medications
5 to other entities. Such waiver shall be made on the recommendation of
6 the state board of pharmacy. The department may also exempt a wholesaler
7 from the surety bond requirement when such wholesaler is owned and oper-
8 ated by a facility, subject to the provisions of article twenty-eight of
9 the public health law and other facilities governed by a state agency
10 that limits its distribution of prescription drugs to facilities and
11 practitioners within the institution's network and operations and does
12 not sell or return such medications to manufacturers or to other whole-
13 salers.
14 i. Wholesaler registration. The department may promulgate rules and
15 regulations to exempt from the requirements of paragraphs e, f, g and h
16 of this subdivision a wholesaler that has received accreditation from a
17 nationally recognized accreditation body approved by the commissioner
18 and that meets the licensing standards under this subdivision. The stan-
19 dards shall be defined by the commissioner pursuant to regulations.
20 j. Manufacturer registration. Notwithstanding the requirements for
21 registration under this subdivision, the commissioner shall exempt a
22 manufacturer licensed or approved by the federal food and drug adminis-
23 tration (FDA) or its successor agency to manufacture drugs or devices
24 with regard to such drugs or devices from the requirements of paragraphs
25 e, f, g and h of this subdivision in the event that such requirements
26 are not required by federal law or regulation unless the commissioner
27 determines that such requirements are necessary to prevent a risk to
28 prescription drug distribution in the state.
29 § 5. The education law is amended by adding a new section 6810-a to
30 read as follows:
31 § 6810-a. Unlawful transactions by manufacturers and wholesalers. It
32 shall be unlawful for a manufacturer, wholesaler or other person to:
33 1. Intentionally package, sell, transfer, distribute or deliver any
34 prescription drug that he or she knows is adulterated, misbranded, coun-
35 terfeit or has otherwise been rendered unfit for distribution.
36 2. Intentionally package, sell, transfer, distribute or deliver a
37 prescription drug to any wholesaler who is not licensed or registered
38 pursuant to this article.
39 A person who violates this section shall be guilty of a class D felo-
40 ny. In addition, any drug packaged, sold, transferred, distributed or
41 delivered in violation of this section shall be contraband and subject
42 to seizure by the board of pharmacy, the department of health or any law
43 enforcement officer of the state.
44 § 6. The education law is amended by adding a new section 6810-b to
45 read as follows:
46 § 6810-b. Pedigree. 1. a. Every manufacturer shall establish and main-
47 tain a pedigree for each prescription drug, and every wholesaler, phar-
48 macy or other person furnishing or dispensing a prescription drug shall
49 maintain a pedigree for each prescription drug.
50 b. For purposes of this section, "manufacturer" means a person who
51 prepares, derives, manufactures, produces or repackages a prescription
52 drug. Manufacturer also means the holder or holders of a new drug appli-
53 cation (NDA), an abbreviated new drug application (ANDA), or a biologics
54 license application (BLA), provided that such application has been
55 approved; a manufacturer's third party logistics provider; a private
56 label distributor (including colicensed partners) for whom the private
A. 6546--A 5
1 label distributor's prescription drugs are originally manufactured and
2 labeled for the distributor and have not been repackaged; or the
3 distributor agent for the manufacturer, contract manufacturer, or
4 private label distributor, whether the establishment is a member of the
5 manufacturer's affiliated group (regardless of whether the member takes
6 title to the drug) or is a contract distributor site.
7 c. For purposes of this section, "repackager" means a person or entity
8 that is registered with the federal food and drug administration as a
9 repackager and operates an establishment that packages finished drugs
10 from bulk or that repackages prescription drugs into different contain-
11 ers, excluding shipping containers.
12 d. For purposes of this section, "third party logistics provider"
13 means an entity licensed as a wholesaler that contracts with a manufac-
14 turer of prescription drugs to provide or coordinate warehousing,
15 distribution or other similar services on behalf of a manufacturer, but
16 for which there is no change of ownership in the prescription drugs.
17 2. A pedigree shall be in such form and contain such information as
18 shall be determined by the department. Each pedigree shall minimally
19 include for each distribution all of the following information:
20 a. the source of the prescription drug, including the name and princi-
21 pal address of the seller or transferor;
22 b. the proprietary and established name of the prescription drug, the
23 quantity of the prescription drug, its dosage form and dosage strength,
24 the date of the purchase or transfer, the invoice number, container
25 size, expiration date, lot number, national drug code, and, when avail-
26 able, standardized numerical identifier, of the prescription drug;
27 c. the business name and address of each owner of the prescription
28 drug and its shipping information, including the name and address of the
29 facility of each person certifying delivery or receipt of the
30 prescription drug; and
31 d. a certification under penalty of perjury from the designated repre-
32 sentative of the manufacturer, wholesaler or pharmacy that the informa-
33 tion contained therein is true and accurate.
34 3. A single pedigree shall include every change of ownership of a
35 prescription drug from its initial manufacture through to its final
36 transaction to a pharmacy or other person for furnishing, administering,
37 or dispensing the prescription drug, regardless of repackaging or
38 assignment of another national drug code directory number. Prescription
39 drugs that are repackaged shall be serialized by the repackager and a
40 pedigree shall be provided that references the pedigree of the original
41 package or packages provided by the manufacturer.
42 4. A pedigree shall track each prescription drug at the smallest pack-
43 age or immediate container distributed by the manufacturer, received and
44 distributed by the wholesaler or repackager, and received by the pharma-
45 cy or another person furnishing, administering, or dispensing the
46 prescription drug. For purposes of this section, "smallest package or
47 immediate container" of a prescription drug shall include any
48 prescription drug package or container made available to a repackager,
49 wholesaler, pharmacy, or other entity for repackaging or redistribution,
50 as well as the smallest unit made by the manufacturer for sale to the
51 pharmacy or other person furnishing, administering, or dispensing the
52 drug.
53 5. Any return of a prescription drug to a wholesaler or manufacturer
54 shall be documented on the same pedigree as the transaction that
55 resulted in the receipt of the prescription drug by the party returning
56 it.
A. 6546--A 6
1 6. The following transactions are exempt from the pedigree require-
2 ments created by this section:
3 a. An intracompany sale or transfer of a prescription drug. For
4 purposes of this section, "intracompany sale or transfer" means any
5 transaction for any valid business purpose between a division, subsid-
6 iary, parent, or affiliated or related company under the common owner-
7 ship and control of the same corporate or legal entity.
8 b. Prescription drugs received by the state or a local government
9 entity from a department or agency of the federal government or an agent
10 of the federal government specifically authorized to deliver
11 prescription drugs to the state or local government entity.
12 c. The provision of samples of prescription drugs by a manufacturer's
13 employee to an authorized prescriber, provided the samples are dispensed
14 without charge only to a patient of the prescriber.
15 d. (i) A sale, trade, or transfer of a radioactive drug between any
16 two entities licensed by the department of health or the federal nuclear
17 regulatory commission.
18 (ii) The exemption in this paragraph shall remain in effect unless the
19 department determines that the risk of counterfeiting or diversion of a
20 radioactive drug is sufficient to require a pedigree, in which event the
21 exemption in this paragraph shall become inoperative as provided in a
22 regulation promulgated by the department.
23 e. The sale, trade, or transfer of a dangerous drug that is labeled by
24 the manufacturer as "for veterinary use only".
25 f. The sale, trade, or transfer of compressed medical gas. For
26 purposes of this section, "compressed medical gas" means any substance
27 in its gaseous or cryogenic liquid form that meets medical purity stand-
28 ards and has application in a medical or homecare environment, includ-
29 ing, but not limited to, oxygen and nitrous oxide.
30 g. The sale, trade, or transfer of solutions. For purposes of this
31 section, "solutions" means any of the following:
32 (i) Those intravenous products that, by their formulation, are
33 intended for the replenishment of fluids and electrolytes, such as sodi-
34 um, chloride, and potassium and calories, such as dextrose and amino
35 acids, or both.
36 (ii) Those intravenous products used to maintain the equilibrium of
37 water and minerals in the body, such as dialysis solutions.
38 (iii) Products that are intended for irrigation or reconstitution, as
39 well as sterile water, whether intended for those purposes or for
40 injection.
41 h. Prescription drugs that are placed in a sealed package with a
42 medical device or medical supplies at the point of first shipment into
43 commerce by the manufacturer and the package remains sealed until the
44 drug and device are used, provided that the package is only used for
45 surgical purposes.
46 i. A product that meets either of the following criteria:
47 (i) A product comprised of two or more regulated components, such as a
48 drug/device, biologic/device, or drug/device/biologic, that are phys-
49 ically, chemically, or otherwise combined or mixed and produced as a
50 single entity.
51 (ii) Two or more separate products packaged together in a single pack-
52 age or as a unit and comprised of drug and device products or device and
53 biological products.
54 7. If a manufacturer, wholesaler, or pharmacy has reasonable cause to
55 believe that a prescription drug in, or having been in, its possession
56 is counterfeit or the subject of a fraudulent transaction, the manufac-
A. 6546--A 7
1 ture, wholesaler, or pharmacy shall notify the department within seven-
2 ty-two hours of obtaining such knowledge. This subdivision shall apply
3 to any prescription drug that has been sold or distributed in or through
4 this state.
5 8. Every pedigree shall be maintained for a period of three years or a
6 reasonable period of time as determined by the commissioner, and shall
7 be made available for inspection, upon reasonable notice, by the depart-
8 ment.
9 9. a. A pedigree shall be maintained in an electronic pedigree track-
10 ing or alternative system determined by the department to be feasible.
11 In determining whether an electronic pedigree tracking or alternative
12 system is feasible, the department shall consider whether such system or
13 format is:
14 (i) readily available with respect to all prescription drugs,
15 (ii) in a standardized non-proprietary data format and architecture,
16 and widely available to manufacturers, wholesalers and pharmacies so
17 that the system or format is capable of being used by manufacturers,
18 wholesalers and pharmacies from sale by the manufacturer through acqui-
19 sition by or transfer to a wholesaler, manufacturer or pharmacy until
20 final sale or transfer to a pharmacy or other person furnishing, admin-
21 istering or dispensing the prescription drug, and
22 (iii) consistent and compatible with federal requirements for an elec-
23 tronic pedigree tracking or alternative system and a standardized numer-
24 ical identifier.
25 b. The provisions of this section shall become operative on January
26 first, two thousand sixteen, which shall be the pedigree effective date;
27 provided, however, if an electronic pedigree tracking or alternative
28 system is not feasible by the pedigree effective date, the department
29 shall issue one-year extensions of the pedigree effective date until the
30 department determines such system to be feasible.
31 10. a. Commencing on July first, two thousand sixteen, a wholesaler or
32 other person furnishing a prescription drug shall not (i) sell, trans-
33 fer, distribute, or deliver a prescription drug without providing a
34 pedigree, or (ii) acquire a prescription drug without receiving a pedi-
35 gree. If an electronic pedigree tracking or alternative system is not
36 feasible by the pedigree effective date, the department may extend the
37 date upon which the provisions of this paragraph shall become operative
38 as it shall determine in its discretion.
39 b. Commencing on July first, two thousand seventeen, a pharmacy or
40 other person furnishing or dispensing a prescription drug shall not (i)
41 sell, transfer, distribute, or deliver a prescription drug without
42 providing a pedigree, or (ii) acquire a prescription drug without
43 receiving a pedigree. If an electronic pedigree tracking or alternative
44 system is not feasible by the pedigree effective date, the department
45 may extend the date upon which the provisions of this paragraph shall
46 become operative as it shall determine in its discretion.
47 11. a. (i) Upon the effective date of federal legislation or adoption
48 of a federal regulation governing the form or content of pedigree or the
49 standards and technologies for the identification, validation, tracking
50 and tracing and authentication for prescription drugs, the provisions of
51 this section that are inconsistent with such federal legislation or
52 federal regulation shall become inoperative.
53 (ii) Within ninety days of the enactment of federal legislation or
54 adoption of a federal regulation that is inconsistent with the
55 provisions of this section as provided in subparagraph (i) of this para-
56 graph, the department shall publish a notice stating which provisions of
A. 6546--A 8
1 this section are inoperative. The department shall have the authority to
2 adopt emergency regulations as it deems necessary in its determination
3 to reflect the inoperation of any provision of this section as provided
4 in this paragraph.
5 b. (i) If the federal food and drug administration enacts any rule or
6 standard or takes any other action that is inconsistent with any
7 provision of this section governing the form or content of pedigree or
8 the standards and technologies for the identification, validation,
9 tracking and tracing, and authentication for prescription drugs, such
10 provision of this section shall be deemed inoperative.
11 (ii) Within ninety days of the federal food and drug administration
12 enacting any rule or standard or taking any other action that is incon-
13 sistent with the provisions of this section as provided in subparagraph
14 (i) of this paragraph, the department shall publish a notice stating
15 which provisions of this section are inoperative. The department shall
16 have the authority to adopt emergency regulations as it deems necessary
17 in its determination to reflect the inoperation of any provision of this
18 section as provided in this paragraph.
19 12. a. All units of prescription drugs in the possession of a whole-
20 saler or pharmacy for which the manufacturer does not hold legal title
21 on the pedigree effective date shall not be subject to the pedigree
22 requirements set forth in this section; provided, however, if any such
23 units of prescription drugs are subsequently returned to the manufactur-
24 er, they shall be subject to the pedigree requirements if the manufac-
25 turer distributes such units in this state.
26 b. All units of prescription drugs in the possession of a manufacturer
27 for which the manufacturer does not hold legal title on the pedigree
28 effective date shall not be subject to the pedigree requirements set
29 forth in this section.
30 13. Any person who violates any provision of this section shall be
31 subject to a fine of not more than two thousand dollars per violation.
32 In addition, any prescription drug distributed, transferred, adminis-
33 tered, furnished, or dispensed in violation of this section shall be
34 contraband and subject to seizure either by the department, the state
35 board of pharmacy or any law enforcement officer of the state.
36 § 7. Section 6824 of the education law, as added by chapter 987 of the
37 laws of 1971, is amended to read as follows:
38 § 6824. Injunction proceedings. In addition to the remedies hereinaft-
39 er provided, the secretary is hereby authorized to apply to the court of
40 the proper venue for an injunction to restrain any person from (a)
41 introducing or causing to be introduced into commerce any adulterated or
42 misbranded drug, device or cosmetic; or (b) from introducing or causing
43 to be introduced in commerce any new drug which does not comply with the
44 provisions of this article; or (c) from disseminating or causing to be
45 disseminated a false advertisement; or (d) violating any provision of
46 section sixty-eight hundred ten-a of this article, without being
47 compelled to allege or prove that an adequate remedy at law does not
48 exist.
49 § 8. This act shall take effect on the one hundred eightieth day after
50 it shall have become a law. The department of education shall promulgate
51 rules and regulations, issue forms and take any other action necessary
52 to implement the provisions of this act on or before the pedigree effec-
53 tive date, as provided in paragraph b of subdivision 9 of section 6810-b
54 of the education law, as added by section six of this act.
