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Assembly Bill A3842

2013-2014 Legislative Session

Pedigree for prescription drugs

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Archive: Last Bill Status - In Assembly Committee

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2013-A3842 (ACTIVE) - Details

See Senate Version of this Bill:
S3904
Current Committee:
Assembly Health
Law Section:
Public Health Law
Laws Affected:
Amd §§270, add §280-a, Pub Health L

2013-A3842 (ACTIVE) - Summary

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.

2013-A3842 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  3842

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                            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:

  Section 1. Section 270 of the public health law is amended by adding a
new subdivision 15 to read as follows:
  15. "PEDIGREE"  MEANS  AN  ELECTRONIC  RECORD  CONTAINING  INFORMATION
REGARDING  EACH  TRANSACTION,  RESULTING  IN A CHANGE OF OWNERSHIP, OF A
PRESCRIPTION DRUG, ORIGINATING FROM A MANUFACTURER, THROUGH  ACQUISITION
BY  OR  TRANSFER TO ONE OR MORE WHOLESALERS, MANUFACTURERS, REPACKAGERS,
OR PHARMACIES, UNTIL FINAL SALE OR  TRANSFER  TO  A  PHARMACY  OR  OTHER
PERSON  FURNISHING,  ADMINISTERING, OR DISPENSING THE PRESCRIPTION DRUG,
AS PROVIDED IN SECTION TWO HUNDRED EIGHTY-A OF THIS ARTICLE.
  S 2. The public health law is amended by adding a new section 280-a to
read as follows:
  S 280-A. PEDIGREE. 1. A. EVERY MANUFACTURER SHALL ESTABLISH AND  MAIN-
TAIN  A PEDIGREE FOR EACH PRESCRIPTION DRUG, AND EVERY WHOLESALER, PHAR-
MACY OR OTHER PERSON FURNISHING OR DISPENSING A PRESCRIPTION DRUG  SHALL
MAINTAIN A PEDIGREE FOR EACH PRESCRIPTION DRUG.
  B.  FOR  PURPOSES  OF  THIS SECTION, "MANUFACTURER" MEANS A PERSON WHO
PREPARES, DERIVES, MANUFACTURES, PRODUCES OR REPACKAGES  A  PRESCRIPTION
DRUG. MANUFACTURER ALSO MEANS THE HOLDER OR HOLDERS OF A NEW DRUG APPLI-
CATION (NDA), AN ABBREVIATED NEW DRUG APPLICATION (ANDA), OR A BIOLOGICS
LICENSE  APPLICATION  (BLA),  PROVIDED  THAT  SUCH  APPLICATION HAS BEEN
APPROVED; A MANUFACTURER'S THIRD PARTY  LOGISTICS  PROVIDER;  A  PRIVATE
LABEL  DISTRIBUTOR  (INCLUDING COLICENSED PARTNERS) FOR WHOM THE PRIVATE
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
              

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