Defines pedigree for prescription drugs as 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
________________________________________________________________________
3842
2013-2014 Regular Sessions
IN ASSEMBLY
January 29, 2013
___________
Introduced by M. of A. PAULIN, TITONE, GOTTFRIED, GALEF, CLARK --
Multi-Sponsored by -- M. of A. BOYLAND, COLTON, COOK, DINOWITZ,
HIKIND, HOOPER, ORTIZ, RAIA, ROBINSON, SWEENEY, WRIGHT -- read once
and referred to the Committee on Health
AN ACT to amend the public health law, in relation to pedigree for
prescription drugs
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 270 of the public health law is amended by adding a
2 new subdivision 15 to read as follows:
3 15. "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 two hundred eighty-a of this article.
10 § 2. The public health law is amended by adding a new section 280-a to
11 read as follows:
12 § 280-a. Pedigree. 1. a. Every manufacturer shall establish and main-
13 tain a pedigree for each prescription drug, and every wholesaler, phar-
14 macy or other person furnishing or dispensing a prescription drug shall
15 maintain a pedigree for each prescription drug.
16 b. For purposes of this section, "manufacturer" means a person who
17 prepares, derives, manufactures, produces or repackages a prescription
18 drug. Manufacturer also means the holder or holders of a new drug appli-
19 cation (NDA), an abbreviated new drug application (ANDA), or a biologics
20 license application (BLA), provided that such application has been
21 approved; a manufacturer's third party logistics provider; a private
22 label distributor (including colicensed partners) for whom the private
23 label distributor's prescription drugs are originally manufactured and
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD03185-03-3
A. 3842 2
1 labeled for the distributor and have not been repackaged; or the
2 distributor agent for the manufacturer, contract manufacturer, or
3 private label distributor, whether the establishment is a member of the
4 manufacturer's affiliated group (regardless of whether the member takes
5 title to the drug) or is a contract distributor site.
6 c. For purposes of this section, "repackager" means a person or entity
7 that is registered with the federal food and drug administration as a
8 repackager and operates an establishment that packages finished drugs
9 from bulk or that repackages prescription drugs into different contain-
10 ers, excluding shipping containers.
11 d. For purposes of this section, "third party logistics provider"
12 means an entity licensed as a wholesaler that contracts with a manufac-
13 turer of prescription drugs to provide or coordinate warehousing,
14 distribution or other similar services on behalf of a manufacturer, but
15 for which there is no change of ownership in the prescription drugs.
16 2. A pedigree shall be in such form and contain such information as
17 shall be determined by the department in consultation with the depart-
18 ment of education. Each pedigree shall minimally include for each
19 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. 3842 3
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 or the federal nuclear regulato-
17 ry commission.
18 (ii) The exemption in this paragraph shall remain in effect unless the
19 department, in consultation with the department of education, determines
20 that the risk of counterfeiting or diversion of a radioactive drug is
21 sufficient to require a pedigree, in which event the exemption in this
22 paragraph shall become inoperative as provided in a regulation promul-
23 gated by the department.
24 e. The sale, trade, or transfer of a dangerous drug that is labeled by
25 the manufacturer as "for veterinary use only".
26 f. The sale, trade, or transfer of compressed medical gas. For
27 purposes of this section, "compressed medical gas" means any substance
28 in its gaseous or cryogenic liquid form that meets medical purity stand-
29 ards and has application in a medical or homecare environment, includ-
30 ing, but not limited to, oxygen and nitrous oxide.
31 g. The sale, trade, or transfer of solutions. For purposes of this
32 section, "solutions" means any of the following:
33 (i) Those intravenous products that, by their formulation, are
34 intended for the replenishment of fluids and electrolytes, such as sodi-
35 um, chloride, and potassium and calories, such as dextrose and amino
36 acids, or both.
37 (ii) Those intravenous products used to maintain the equilibrium of
38 water and minerals in the body, such as dialysis solutions.
39 (iii) Products that are intended for irrigation or reconstitution, as
40 well as sterile water, whether intended for those purposes or for
41 injection.
42 h. Prescription drugs that are placed in a sealed package with a
43 medical device or medical supplies at the point of first shipment into
44 commerce by the manufacturer and the package remains sealed until the
45 drug and device are used, provided that the package is only used for
46 surgical purposes.
47 i. A product that meets either of the following criteria:
48 (i) A product comprised of two or more regulated components, such as a
49 drug/device, biologic/device, or drug/device/biologic, that are phys-
50 ically, chemically, or otherwise combined or mixed and produced as a
51 single entity.
52 (ii) Two or more separate products packaged together in a single pack-
53 age or as a unit and comprised of drug and device products or device and
54 biological products.
55 7. If a manufacturer, wholesaler, or pharmacy has reasonable cause to
56 believe that a prescription drug in, or having been in, its possession
A. 3842 4
1 is counterfeit or the subject of a fraudulent transaction, the manufac-
2 turer, wholesaler, or pharmacy shall notify the department and the
3 department of education within seventy-two hours of obtaining such know-
4 ledge. This subdivision shall apply to any prescription drug that has
5 been sold or distributed in or through this state.
6 8. Every pedigree shall be maintained for a period of three years or a
7 reasonable period of time as determined by the commissioner, in consul-
8 tation with the department of education, and shall be made available for
9 inspection, upon reasonable notice, by the department and the department
10 of education.
11 9. a. A pedigree shall be maintained in an electronic pedigree track-
12 ing or alternative system determined by the department, in consultation
13 with the department of education, to be feasible. In determining whether
14 an electronic pedigree tracking or alternative system is feasible, the
15 department, in consultation with the department of education, shall
16 consider whether such system or format is:
17 (i) readily available with respect to all prescription drugs,
18 (ii) in a standardized non-proprietary data format and architecture,
19 and widely available to manufacturers, wholesalers and pharmacies so
20 that the system or format is capable of being used by manufacturers,
21 wholesalers and pharmacies from sale by the manufacturer through acqui-
22 sition by or transfer to a wholesaler, manufacturer or pharmacy until
23 final sale or transfer to a pharmacy or other person furnishing, admin-
24 istering or dispensing the prescription drug, and
25 (iii) consistent and compatible with federal requirements for an elec-
26 tronic pedigree tracking or alternative system and a standardized numer-
27 ical identifier.
28 b. The provisions of this section shall become operative on January
29 first, two thousand sixteen, which shall be the pedigree effective date;
30 provided, however, if an electronic pedigree tracking or alternative
31 system is not feasible by the pedigree effective date, the department,
32 in consultation with the department of education, shall issue one-year
33 extensions of the pedigree effective date until the department, in
34 consultation with the department of education, determines such system to
35 be feasible.
36 10. a. Commencing on July first, two thousand sixteen, a wholesaler or
37 other person furnishing a prescription drug shall not (i) sell, trans-
38 fer, distribute, or deliver a prescription drug without providing a
39 pedigree, or (ii) acquire a prescription drug without receiving a pedi-
40 gree. If an electronic pedigree tracking or alternative system is not
41 feasible by the pedigree effective date, the department, in consultation
42 with the department of education, may extend the date upon which the
43 provisions of this paragraph shall become operative as it shall deter-
44 mine in its discretion.
45 b. Commencing on July first, two thousand seventeen, a pharmacy or
46 other person furnishing or dispensing a prescription drug shall not (i)
47 sell, transfer, distribute, or deliver a prescription drug without
48 providing a pedigree, or (ii) acquire a prescription drug without
49 receiving a pedigree. If an electronic pedigree tracking or alternative
50 system is not feasible by the pedigree effective date, the department,
51 in consultation with the department of education, may extend the date
52 upon which the provisions of this paragraph shall become operative as it
53 shall determine in its discretion.
54 11. a. (i) Upon the effective date of federal legislation or adoption
55 of a federal regulation governing the form or content of pedigree or the
56 standards and technologies for the identification, validation, tracking
A. 3842 5
1 and tracing and authentication for prescription drugs, the provisions of
2 this section that are inconsistent with such federal legislation or
3 federal regulation shall become inoperative.
4 (ii) Within ninety days of the enactment of federal legislation or
5 adoption of a federal regulation that is inconsistent with the
6 provisions of this section as provided in subparagraph (i) of this para-
7 graph, the department shall publish a notice stating which provisions of
8 this section are inoperative. The department shall have the authority to
9 adopt emergency regulations as it deems necessary, in consultation with
10 the department of education, in its determination to reflect the inoper-
11 ation of any provision of this section as provided in this paragraph.
12 b. (i) If the federal food and drug administration enacts any rule or
13 standard or takes any other action that is inconsistent with any
14 provision of this section governing the form or content of pedigree or
15 the standards and technologies for the identification, validation,
16 tracking and tracing, and authentication for prescription drugs, such
17 provision of this section shall be deemed inoperative.
18 (ii) Within ninety days of the federal food and drug administration
19 enacting any rule or standard or taking any other action that is incon-
20 sistent with the provisions of this section as provided in subparagraph
21 (i) of this paragraph, the department shall publish a notice stating
22 which provisions of this section are inoperative. The department shall
23 have the authority to adopt emergency regulations as it deems necessary
24 in its determination, in consultation with the department of education,
25 to reflect the inoperation of any provision of this section as provided
26 in this paragraph.
27 12. a. All units of prescription drugs in the possession of a whole-
28 saler or pharmacy for which the manufacturer does not hold legal title
29 on the pedigree effective date shall not be subject to the pedigree
30 requirements set forth in this section; provided, however, if any such
31 units of prescription drugs are subsequently returned to the manufactur-
32 er, they shall be subject to the pedigree requirements if the manufac-
33 turer distributes such units in this state.
34 b. All units of prescription drugs in the possession of a manufacturer
35 for which the manufacturer does not hold legal title on the pedigree
36 effective date shall not be subject to the pedigree requirements set
37 forth in this section.
38 13. Any person who violates any provision of this section shall be
39 subject to a fine of not more than two thousand dollars per violation.
40 In addition, any prescription drug distributed, transferred, adminis-
41 tered, furnished, or dispensed in violation of this section shall be
42 contraband and subject to seizure either by the department, the state
43 board of pharmacy or any law enforcement officer of the state.
44 § 3. This act shall take effect on the one hundred eightieth day after
45 it shall have become a law. The department of health, in consultation
46 with the department of education, shall promulgate rules and regu-
47 lations, issue forms and take any other action necessary to implement
48 the provisions of this act on or before the pedigree effective date, as
49 provided in paragraph b of subdivision 9 of section 280-a of the public
50 health law, as added by section two of this act.
