S T A T E   O F   N E W   Y O R K
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                                 6546--A

                       2009-2010 Regular Sessions

                          I N  A S S E M B L Y

                              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:

  Section  1.  Section  6802 of the education law is amended by adding a
new subdivision 23 to read as follows:
  23. "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 SIXTY-EIGHT HUNDRED TEN-B OF THIS ARTICLE.
  S 2. Subparagraph 2 of paragraph a of subdivision 4 of section 6808 of
the education law, as amended by chapter 62 of  the  laws  of  1989,  is
amended to read as follows:
  (2)  The  application  shall be accompanied by a fee of [eight hundred
twenty-five] TWELVE HUNDRED dollars.
  S 3. Paragraphs b and d of subdivision 4 of section 6808 of the educa-
tion law, paragraph b as amended by chapter 538 of the laws of 2001  and
paragraph d as amended by chapter 62 of the laws of 1989, are amended to
read as follows:
  b. Renewal of registration. All wholesalers' and manufacturers' regis-
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

registration fee shall be [five hundred twenty] EIGHT HUNDRED dollars or
a pro rated portion thereof as determined by the department.
  d. Change of location. In the event that the location of such place of
business  shall  be changed, the owner shall apply to the department for
inspection of the new location and endorsement of the  registration  for
the  new  location. The fee for inspection and endorsement shall be [one
hundred seventy] THREE HUNDRED dollars, unless it appears to the  satis-
faction  of the department that the change in location is of a temporary
nature due to fire, flood or other disaster.
  S 4. Subdivision 4 of section 6808 of the education law is amended  by
adding six new paragraphs e, f, g, h, i and j to read as follows:
  E.  APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A WHOLE-
SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY
THE DEPARTMENT.  THE REQUIREMENTS SHALL EXTEND TO ALL PERSONS  RESPONSI-
BLE  FOR  THE  DISTRIBUTION OF A PRESCRIPTION DRUG FOR THE APPLICANT, AS
DETERMINED BY THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS  F
AND  G  OF  THIS  SUBDIVISION, THE DEPARTMENT SHALL REQUIRE PHOTOGRAPHS,
CRIMINAL HISTORY RECORDS SEARCH AND FINGERPRINTS.
  F. CRIMINAL HISTORY RECORDS SEARCH. (1) UPON RECEIPT OF AN APPLICATION
FOR REGISTRATION PURSUANT TO THIS SUBDIVISION, THE  COMMISSIONER  SHALL,
SUBJECT TO THE RULES AND REGULATIONS OF THE DIVISION OF CRIMINAL JUSTICE
SERVICES,  INITIATE  A  CRIMINAL  HISTORY  RECORDS SEARCH OF THE PERSONS
IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION.  PRIOR TO INITIATING  THE
BACKGROUND  CHECKS  AND  FINGERPRINTING  PROCESS, THE COMMISSIONER SHALL
FURNISH THE APPLICANT WITH THE FORM DESCRIBED IN  PARAGRAPH  G  OF  THIS
SUBDIVISION  AND  SHALL  OBTAIN THE APPLICANT'S  CONSENT TO THE CRIMINAL
HISTORY RECORDS SEARCH. THE COMMISSIONER SHALL OBTAIN FROM  EACH  APPLI-
CANT    TWO  SETS  OF  FINGERPRINTS AND THE DIVISION OF CRIMINAL JUSTICE
SERVICES PROCESSING FEE  IMPOSED  PURSUANT  TO  SUBDIVISION  EIGHT-A  OF
SECTION  EIGHT  HUNDRED  THIRTY-SEVEN  OF  THE EXECUTIVE LAW AND ANY FEE
IMPOSED BY THE FEDERAL BUREAU OF INVESTIGATION FOR A  NATIONAL  CRIMINAL
HISTORY  RECORD  CHECK.  THE  COMMISSIONER  SHALL PROMPTLY TRANSMIT SUCH
FINGERPRINTS AND FEES TO THE DIVISION OF CRIMINAL JUSTICE  SERVICES  FOR
ITS  FULL SEARCH AND RETAIN PROCESSING. THE DIVISION OF CRIMINAL JUSTICE
SERVICES IS AUTHORIZED TO SUBMIT THE FINGERPRINTS  AND  THE  APPROPRIATE
FEE  TO  THE  FEDERAL  BUREAU  OF  INVESTIGATION FOR A NATIONAL CRIMINAL
HISTORY RECORD CHECK. THE DIVISION OF CRIMINAL JUSTICE SERVICES AND  THE
FEDERAL  BUREAU  OF  INVESTIGATION  SHALL  FORWARD SUCH CRIMINAL HISTORY
RECORD TO THE COMMISSIONER IN A TIMELY MANNER. THE RELEASE OF SUCH CRIM-
INAL HISTORY RECORD BY THE DIVISION OF CRIMINAL JUSTICE  SERVICES  SHALL
BE  SUBJECT  TO  THE  PROVISIONS  OF  SUBDIVISION SIXTEEN OF SECTION TWO
HUNDRED NINETY-SIX OF THE EXECUTIVE LAW. THE COMMISSIONER SHALL CONSIDER
SUCH CRIMINAL HISTORY RECORD IN  ACCORDANCE  WITH  THE  REQUIREMENTS  OF
ARTICLE  TWENTY-THREE-A OF THE CORRECTION LAW, FOR THE PURPOSE OF ESTAB-
LISHING THE GOOD MORAL CHARACTER OF AN INDIVIDUAL AS REQUIRED  IN  PARA-
GRAPH E OF THIS SUBDIVISION.
  (2)  FOR  THE  PURPOSES  OF  THIS  SECTION  THE TERM "CRIMINAL HISTORY
RECORD" SHALL MEAN A RECORD OF ALL CONVICTIONS OF CRIMES AND ANY PENDING
CRIMINAL CHARGES MAINTAINED ON AN INDIVIDUAL BY THE DIVISION OF CRIMINAL
JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION.
  FURTHERMORE, UPON NOTIFICATION THAT SUCH  APPLICANT  HAS  BEEN  REGIS-
TERED, THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL HAVE THE AUTHORI-
TY  TO PROVIDE SUBSEQUENT CRIMINAL HISTORY NOTIFICATIONS DIRECTLY TO THE
COMMISSIONER. ALL SUCH  CRIMINAL  HISTORY  RECORDS  PROCESSED  AND  SENT
PURSUANT  TO  THIS  SUBDIVISION  SHALL  BE  CONFIDENTIAL PURSUANT TO THE
APPLICABLE FEDERAL AND STATE LAWS, RULES AND REGULATIONS, AND SHALL  NOT

A. 6546--A                          3

BE  PUBLISHED  OR IN ANY WAY DISCLOSED TO PERSONS OTHER THAN THE COMMIS-
SIONER, UNLESS OTHERWISE AUTHORIZED BY LAW.
  (3)  NOTWITHSTANDING  ANY  OTHER PROVISION OF LAW TO THE CONTRARY, THE
COMMISSIONER IS AUTHORIZED TO CHARGE ADDITIONAL FEES TO  APPLICANTS  FOR
REGISTRATION  IN AN AMOUNT EQUAL TO THE FEES ESTABLISHED PURSUANT TO LAW
BY THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL  BUREAU  OF
INVESTIGATION  FOR THE CRIMINAL HISTORY RECORD SEARCHES MANDATED BY THIS
SUBDIVISION.
  G. ADDITIONAL DUTIES OF  THE  COMMISSIONER  AND  DEPARTMENT.  (1)  THE
COMMISSIONER,  IN  COOPERATION  WITH  THE  DIVISION  OF CRIMINAL JUSTICE
SERVICES AND IN ACCORDANCE WITH ALL APPLICABLE PROVISIONS OF LAW,  SHALL
PROMULGATE  RULES  AND  REGULATIONS TO REQUIRE THE FINGERPRINTING OF THE
INDIVIDUALS IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, AND  FOR  THE
USE  OF INFORMATION DERIVED FROM SEARCHES OF THE RECORDS OF THE DIVISION
OF CRIMINAL JUSTICE SERVICES AND THE  FEDERAL  BUREAU  OF  INVESTIGATION
BASED  ON  THE  USE  OF SUCH FINGERPRINTS, AS PROVIDED IN PARAGRAPH F OF
THIS SUBDIVISION.
  (2) THE COMMISSIONER, IN COOPERATION WITH  THE  DIVISION  OF  CRIMINAL
JUSTICE  SERVICES,  SHALL PROMULGATE A FORM TO BE PROVIDED TO ALL APPLI-
CANTS FOR REGISTRATION PURSUANT TO THIS SUBDIVISION THAT SHALL:
  (I) INFORM THE PROSPECTIVE APPLICANT THAT THE COMMISSIONER IS REQUIRED
TO REQUEST HIS OR HER CRIMINAL HISTORY INFORMATION FROM THE DIVISION  OF
CRIMINAL  JUSTICE  SERVICES  AND THE FEDERAL BUREAU OF INVESTIGATION AND
REVIEW  SUCH  INFORMATION  PURSUANT  TO  THIS  SECTION,  AND  PROVIDE  A
DESCRIPTION  OF THE MANNER IN WHICH HIS OR HER FINGERPRINT CARDS WILL BE
USED UPON SUBMISSION TO THE DIVISION OF CRIMINAL JUSTICE SERVICES; AND
  (II) INFORM THE PROSPECTIVE APPLICANT THAT HE OR SHE HAS THE RIGHT  TO
OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFOR-
MATION  PURSUANT  TO REGULATIONS AND PROCEDURES ESTABLISHED BY THE DIVI-
SION OF CRIMINAL JUSTICE SERVICES.
  (3) THE DEPARTMENT SHALL OBTAIN THE SIGNED, INFORMED CONSENT  OF  EACH
INDIVIDUAL  IDENTIFIED  IN PARAGRAPH E OF THIS SUBDIVISION, ON SUCH FORM
SUPPLIED BY THE COMMISSIONER, WHICH INDICATES THAT SUCH PERSON HAS:
  (I) BEEN INFORMED OF THE RIGHTS AND PROCEDURES  NECESSARY  TO  OBTAIN,
REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFORMATION;
  (II) BEEN INFORMED OF THE REASON FOR THE REQUEST FOR HIS OR HER CRIMI-
NAL HISTORY INFORMATION;
  (III) CONSENTED TO SUCH REQUEST FOR A REPORT;
  (IV)  SUPPLIED  ON THE FORM A CURRENT MAILING OR HOME ADDRESS FOR SUCH
INDIVIDUAL;
  (V) BEEN INFORMED THAT HE OR SHE MAY  WITHDRAW  HIS  OR  HER  CONSENT,
REGARDLESS  OF  WHETHER  THE  DEPARTMENT  HAS REVIEWED SUCH INDIVIDUAL'S
CRIMINAL HISTORY INFORMATION;
  (VI) BEEN INFORMED THAT IN THE EVENT THE WHOLESALER'S  OR  MANUFACTUR-
ER'S  REGISTRATION PURSUANT TO THIS SUBDIVISION HAS EXPIRED OR OTHERWISE
TERMINATED, THE COMMISSIONER  SHALL  NOTIFY  THE  DIVISION  OF  CRIMINAL
JUSTICE  SERVICES OF SUCH EXPIRATION OR TERMINATION, AND THE DIVISION OF
CRIMINAL JUSTICE SERVICES SHALL DESTROY THE FINGERPRINTS OF THE INDIVID-
UAL OR INDIVIDUALS ASSOCIATED WITH SUCH WHOLESALER'S  OR  MANUFACTURER'S
REGISTRATION; AND
  (VII) BEEN INFORMED OF THE MANNER IN WHICH HE OR SHE MAY SUBMIT TO THE
COMMISSIONER  ANY  INFORMATION THAT MAY BE RELEVANT TO THE CONSIDERATION
OF THE APPLICANT'S REGISTRATION INCLUDING, WHERE APPLICABLE, INFORMATION
IN SUPPORT OF HIS OR HER GOOD MORAL CHARACTER OR REHABILITATION THEREOF.
  H. PERFORMANCE  OR  SURETY  BOND.  EVERY  WHOLESALER  SHALL  SUBMIT  A
PERFORMANCE OR SURETY BOND OF NOT LESS THAN ONE HUNDRED THOUSAND DOLLARS

A. 6546--A                          4

TO THE DEPARTMENT TO ENSURE COMPLIANCE WITH THE PROVISIONS OF THIS ARTI-
CLE,  EXCEPT  THAT  THE  DEPARTMENT  MAY  WAIVE  SUCH  BOND  FOR CERTAIN
NOT-FOR-PROFIT ENTITIES SUCH AS HOSPITALS  AND  CORRECTIONAL  FACILITIES
THAT  LIMIT  DISTRIBUTION TO THEIR OWN FACILITIES AND DO NOT RETURN SUCH
MEDICATIONS TO OTHER ENTITIES. SUCH WAIVER SHALL BE MADE ON  THE  RECOM-
MENDATION OF THE STATE BOARD OF PHARMACY. THE DEPARTMENT MAY ALSO EXEMPT
A  WHOLESALER  FROM  THE SURETY BOND REQUIREMENT WHEN SUCH WHOLESALER IS
OWNED AND OPERATED BY A FACILITY, SUBJECT TO THE PROVISIONS  OF  ARTICLE
TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A
STATE  AGENCY  THAT  LIMITS  ITS  DISTRIBUTION  OF PRESCRIPTION DRUGS TO
FACILITIES AND PRACTITIONERS WITHIN THE INSTITUTION'S NETWORK AND  OPER-
ATIONS  AND DOES NOT SELL OR RETURN SUCH MEDICATIONS TO MANUFACTURERS OR
TO OTHER WHOLESALERS.
  I. WHOLESALER REGISTRATION. THE DEPARTMENT MAY  PROMULGATE  RULES  AND
REGULATIONS  TO EXEMPT FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND H
OF THIS SUBDIVISION A WHOLESALER THAT HAS RECEIVED ACCREDITATION FROM  A
NATIONALLY  RECOGNIZED  ACCREDITATION  BODY APPROVED BY THE COMMISSIONER
AND THAT MEETS THE LICENSING STANDARDS UNDER THIS SUBDIVISION. THE STAN-
DARDS SHALL BE DEFINED BY THE COMMISSIONER PURSUANT TO REGULATIONS.
  J. MANUFACTURER REGISTRATION.  NOTWITHSTANDING  THE  REQUIREMENTS  FOR
REGISTRATION  UNDER  THIS  SUBDIVISION,  THE COMMISSIONER SHALL EXEMPT A
MANUFACTURER LICENSED OR APPROVED BY THE FEDERAL FOOD AND DRUG  ADMINIS-
TRATION  (FDA)  OR  ITS SUCCESSOR AGENCY TO MANUFACTURE DRUGS OR DEVICES
WITH REGARD TO SUCH DRUGS OR DEVICES FROM THE REQUIREMENTS OF PARAGRAPHS
E, F, G AND H OF THIS SUBDIVISION IN THE EVENT  THAT  SUCH  REQUIREMENTS
ARE  NOT  REQUIRED  BY FEDERAL LAW OR REGULATION UNLESS THE COMMISSIONER
DETERMINES THAT SUCH REQUIREMENTS ARE NECESSARY TO  PREVENT  A  RISK  TO
PRESCRIPTION DRUG DISTRIBUTION IN THE STATE.
  S  5.  The  education law is amended by adding a new section 6810-a to
read as follows:
  S 6810-A. UNLAWFUL TRANSACTIONS BY MANUFACTURERS AND  WHOLESALERS.  IT
SHALL BE UNLAWFUL FOR A MANUFACTURER, WHOLESALER OR OTHER PERSON TO:
  1.  INTENTIONALLY  PACKAGE,  SELL, TRANSFER, DISTRIBUTE OR DELIVER ANY
PRESCRIPTION DRUG THAT HE OR SHE KNOWS IS ADULTERATED, MISBRANDED, COUN-
TERFEIT OR HAS OTHERWISE BEEN RENDERED UNFIT FOR DISTRIBUTION.
  2. INTENTIONALLY PACKAGE, SELL,  TRANSFER,  DISTRIBUTE  OR  DELIVER  A
PRESCRIPTION  DRUG  TO  ANY WHOLESALER WHO IS NOT LICENSED OR REGISTERED
PURSUANT TO THIS ARTICLE.
  A PERSON WHO VIOLATES THIS SECTION SHALL BE GUILTY OF A CLASS D  FELO-
NY.    IN ADDITION, ANY DRUG PACKAGED, SOLD, TRANSFERRED, DISTRIBUTED OR
DELIVERED IN VIOLATION OF THIS SECTION SHALL BE CONTRABAND  AND  SUBJECT
TO SEIZURE BY THE BOARD OF PHARMACY, THE DEPARTMENT OF HEALTH OR ANY LAW
ENFORCEMENT OFFICER OF THE STATE.
  S  6.  The  education law is amended by adding a new section 6810-b to
read as follows:
  S 6810-B. 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

A. 6546--A                          5

LABEL  DISTRIBUTOR'S  PRESCRIPTION DRUGS ARE ORIGINALLY MANUFACTURED AND
LABELED FOR THE  DISTRIBUTOR  AND  HAVE  NOT  BEEN  REPACKAGED;  OR  THE
DISTRIBUTOR  AGENT  FOR  THE  MANUFACTURER,  CONTRACT  MANUFACTURER,  OR
PRIVATE  LABEL DISTRIBUTOR, WHETHER THE ESTABLISHMENT IS A MEMBER OF THE
MANUFACTURER'S AFFILIATED GROUP (REGARDLESS OF WHETHER THE MEMBER  TAKES
TITLE TO THE DRUG) OR IS A CONTRACT DISTRIBUTOR SITE.
  C. FOR PURPOSES OF THIS SECTION, "REPACKAGER" MEANS A PERSON OR ENTITY
THAT  IS  REGISTERED  WITH THE FEDERAL FOOD AND DRUG ADMINISTRATION AS A
REPACKAGER AND OPERATES AN ESTABLISHMENT THAT  PACKAGES  FINISHED  DRUGS
FROM  BULK OR THAT REPACKAGES PRESCRIPTION DRUGS INTO DIFFERENT CONTAIN-
ERS, EXCLUDING SHIPPING CONTAINERS.
  D. FOR PURPOSES OF THIS  SECTION,  "THIRD  PARTY  LOGISTICS  PROVIDER"
MEANS  AN ENTITY LICENSED AS A WHOLESALER THAT CONTRACTS WITH A MANUFAC-
TURER OF  PRESCRIPTION  DRUGS  TO  PROVIDE  OR  COORDINATE  WAREHOUSING,
DISTRIBUTION  OR OTHER SIMILAR SERVICES ON BEHALF OF A MANUFACTURER, BUT
FOR WHICH THERE IS NO CHANGE OF OWNERSHIP IN THE PRESCRIPTION DRUGS.
  2. A PEDIGREE SHALL BE IN SUCH FORM AND CONTAIN  SUCH  INFORMATION  AS
SHALL  BE  DETERMINED  BY  THE DEPARTMENT. EACH PEDIGREE SHALL MINIMALLY
INCLUDE FOR EACH DISTRIBUTION ALL OF THE FOLLOWING INFORMATION:
  A. THE SOURCE OF THE PRESCRIPTION DRUG, INCLUDING THE NAME AND PRINCI-
PAL ADDRESS OF THE SELLER OR TRANSFEROR;
  B. THE PROPRIETARY AND ESTABLISHED NAME OF THE PRESCRIPTION DRUG,  THE
QUANTITY  OF THE PRESCRIPTION DRUG, ITS DOSAGE FORM AND DOSAGE STRENGTH,
THE DATE OF THE PURCHASE OR  TRANSFER,  THE  INVOICE  NUMBER,  CONTAINER
SIZE,  EXPIRATION DATE, LOT NUMBER, NATIONAL DRUG CODE, AND, WHEN AVAIL-
ABLE, STANDARDIZED NUMERICAL IDENTIFIER, OF THE PRESCRIPTION DRUG;
  C. THE BUSINESS NAME AND ADDRESS OF EACH  OWNER  OF  THE  PRESCRIPTION
DRUG AND ITS SHIPPING INFORMATION, INCLUDING THE NAME AND ADDRESS OF THE
FACILITY   OF   EACH  PERSON  CERTIFYING  DELIVERY  OR  RECEIPT  OF  THE
PRESCRIPTION DRUG; AND
  D. A CERTIFICATION UNDER PENALTY OF PERJURY FROM THE DESIGNATED REPRE-
SENTATIVE OF THE MANUFACTURER, WHOLESALER OR PHARMACY THAT THE  INFORMA-
TION CONTAINED THEREIN IS TRUE AND ACCURATE.
  3.  A  SINGLE  PEDIGREE  SHALL  INCLUDE EVERY CHANGE OF OWNERSHIP OF A
PRESCRIPTION DRUG FROM ITS INITIAL  MANUFACTURE  THROUGH  TO  ITS  FINAL
TRANSACTION TO A PHARMACY OR OTHER PERSON FOR FURNISHING, ADMINISTERING,
OR  DISPENSING  THE  PRESCRIPTION  DRUG,  REGARDLESS  OF  REPACKAGING OR
ASSIGNMENT OF ANOTHER NATIONAL DRUG CODE DIRECTORY NUMBER.  PRESCRIPTION
DRUGS  THAT  ARE  REPACKAGED SHALL BE SERIALIZED BY THE REPACKAGER AND A
PEDIGREE SHALL BE PROVIDED THAT REFERENCES THE PEDIGREE OF THE  ORIGINAL
PACKAGE OR PACKAGES PROVIDED BY THE MANUFACTURER.
  4. A PEDIGREE SHALL TRACK EACH PRESCRIPTION DRUG AT THE SMALLEST PACK-
AGE OR IMMEDIATE CONTAINER DISTRIBUTED BY THE MANUFACTURER, RECEIVED AND
DISTRIBUTED BY THE WHOLESALER OR REPACKAGER, AND RECEIVED BY THE PHARMA-
CY  OR  ANOTHER  PERSON  FURNISHING,  ADMINISTERING,  OR  DISPENSING THE
PRESCRIPTION DRUG. FOR PURPOSES OF THIS SECTION,  "SMALLEST  PACKAGE  OR
IMMEDIATE   CONTAINER"   OF   A  PRESCRIPTION  DRUG  SHALL  INCLUDE  ANY
PRESCRIPTION DRUG PACKAGE OR CONTAINER MADE AVAILABLE TO  A  REPACKAGER,
WHOLESALER, PHARMACY, OR OTHER ENTITY FOR REPACKAGING OR REDISTRIBUTION,
AS  WELL  AS  THE SMALLEST UNIT MADE BY THE MANUFACTURER FOR SALE TO THE
PHARMACY OR OTHER PERSON FURNISHING, ADMINISTERING,  OR  DISPENSING  THE
DRUG.
  5.  ANY  RETURN OF A PRESCRIPTION DRUG TO A WHOLESALER OR MANUFACTURER
SHALL BE DOCUMENTED  ON  THE  SAME  PEDIGREE  AS  THE  TRANSACTION  THAT
RESULTED  IN THE RECEIPT OF THE PRESCRIPTION DRUG BY THE PARTY RETURNING
IT.

A. 6546--A                          6

  6. THE FOLLOWING TRANSACTIONS ARE EXEMPT FROM  THE  PEDIGREE  REQUIRE-
MENTS CREATED BY THIS SECTION:
  A.  AN  INTRACOMPANY  SALE  OR  TRANSFER  OF  A PRESCRIPTION DRUG. FOR
PURPOSES OF THIS SECTION, "INTRACOMPANY  SALE  OR  TRANSFER"  MEANS  ANY
TRANSACTION  FOR  ANY VALID BUSINESS PURPOSE BETWEEN A DIVISION, SUBSID-
IARY, PARENT, OR AFFILIATED OR RELATED COMPANY UNDER THE  COMMON  OWNER-
SHIP AND CONTROL OF THE SAME CORPORATE OR LEGAL ENTITY.
  B.  PRESCRIPTION  DRUGS  RECEIVED  BY  THE STATE OR A LOCAL GOVERNMENT
ENTITY FROM A DEPARTMENT OR AGENCY OF THE FEDERAL GOVERNMENT OR AN AGENT
OF  THE  FEDERAL   GOVERNMENT   SPECIFICALLY   AUTHORIZED   TO   DELIVER
PRESCRIPTION DRUGS TO THE STATE OR LOCAL GOVERNMENT ENTITY.
  C.  THE PROVISION OF SAMPLES OF PRESCRIPTION DRUGS BY A MANUFACTURER'S
EMPLOYEE TO AN AUTHORIZED PRESCRIBER, PROVIDED THE SAMPLES ARE DISPENSED
WITHOUT CHARGE ONLY TO A PATIENT OF THE PRESCRIBER.
  D. (I) A SALE, TRADE, OR TRANSFER OF A RADIOACTIVE  DRUG  BETWEEN  ANY
TWO ENTITIES LICENSED BY THE DEPARTMENT OF HEALTH OR THE FEDERAL NUCLEAR
REGULATORY COMMISSION.
  (II) THE EXEMPTION IN THIS PARAGRAPH SHALL REMAIN IN EFFECT UNLESS THE
DEPARTMENT  DETERMINES THAT THE RISK OF COUNTERFEITING OR DIVERSION OF A
RADIOACTIVE DRUG IS SUFFICIENT TO REQUIRE A PEDIGREE, IN WHICH EVENT THE
EXEMPTION IN THIS PARAGRAPH SHALL BECOME INOPERATIVE AS  PROVIDED  IN  A
REGULATION PROMULGATED BY THE DEPARTMENT.
  E. THE SALE, TRADE, OR TRANSFER OF A DANGEROUS DRUG THAT IS LABELED BY
THE MANUFACTURER AS "FOR VETERINARY USE ONLY".
  F.  THE  SALE,  TRADE,  OR  TRANSFER  OF  COMPRESSED  MEDICAL GAS. FOR
PURPOSES OF THIS SECTION, "COMPRESSED MEDICAL GAS" MEANS  ANY  SUBSTANCE
IN ITS GASEOUS OR CRYOGENIC LIQUID FORM THAT MEETS MEDICAL PURITY STAND-
ARDS  AND  HAS APPLICATION IN A MEDICAL OR HOMECARE ENVIRONMENT, INCLUD-
ING, BUT NOT LIMITED TO, OXYGEN AND NITROUS OXIDE.
  G. THE SALE, TRADE, OR TRANSFER OF SOLUTIONS.  FOR  PURPOSES  OF  THIS
SECTION, "SOLUTIONS" MEANS ANY OF THE FOLLOWING:
  (I)  THOSE  INTRAVENOUS  PRODUCTS  THAT,  BY  THEIR  FORMULATION,  ARE
INTENDED FOR THE REPLENISHMENT OF FLUIDS AND ELECTROLYTES, SUCH AS SODI-
UM, CHLORIDE, AND POTASSIUM AND CALORIES, SUCH  AS  DEXTROSE  AND  AMINO
ACIDS, OR BOTH.
  (II)  THOSE  INTRAVENOUS  PRODUCTS USED TO MAINTAIN THE EQUILIBRIUM OF
WATER AND MINERALS IN THE BODY, SUCH AS DIALYSIS SOLUTIONS.
  (III) PRODUCTS THAT ARE INTENDED FOR IRRIGATION OR RECONSTITUTION,  AS
WELL  AS  STERILE  WATER,  WHETHER  INTENDED  FOR  THOSE PURPOSES OR FOR
INJECTION.
  H. PRESCRIPTION DRUGS THAT ARE PLACED  IN  A  SEALED  PACKAGE  WITH  A
MEDICAL  DEVICE  OR MEDICAL SUPPLIES AT THE POINT OF FIRST SHIPMENT INTO
COMMERCE BY THE MANUFACTURER AND THE PACKAGE REMAINS  SEALED  UNTIL  THE
DRUG  AND  DEVICE  ARE  USED, PROVIDED THAT THE PACKAGE IS ONLY USED FOR
SURGICAL PURPOSES.
  I. A PRODUCT THAT MEETS EITHER OF THE FOLLOWING CRITERIA:
  (I) A PRODUCT COMPRISED OF TWO OR MORE REGULATED COMPONENTS, SUCH AS A
DRUG/DEVICE, BIOLOGIC/DEVICE, OR DRUG/DEVICE/BIOLOGIC,  THAT  ARE  PHYS-
ICALLY,  CHEMICALLY,  OR  OTHERWISE  COMBINED OR MIXED AND PRODUCED AS A
SINGLE ENTITY.
  (II) TWO OR MORE SEPARATE PRODUCTS PACKAGED TOGETHER IN A SINGLE PACK-
AGE OR AS A UNIT AND COMPRISED OF DRUG AND DEVICE PRODUCTS OR DEVICE AND
BIOLOGICAL PRODUCTS.
  7. IF A MANUFACTURER, WHOLESALER, OR PHARMACY HAS REASONABLE CAUSE  TO
BELIEVE  THAT  A PRESCRIPTION DRUG IN, OR HAVING BEEN IN, ITS POSSESSION
IS COUNTERFEIT OR THE SUBJECT OF A FRAUDULENT TRANSACTION, THE  MANUFAC-

A. 6546--A                          7

TURE,  WHOLESALER, OR PHARMACY SHALL NOTIFY THE DEPARTMENT WITHIN SEVEN-
TY-TWO HOURS OF OBTAINING SUCH KNOWLEDGE. THIS SUBDIVISION  SHALL  APPLY
TO ANY PRESCRIPTION DRUG THAT HAS BEEN SOLD OR DISTRIBUTED IN OR THROUGH
THIS STATE.
  8. EVERY PEDIGREE SHALL BE MAINTAINED FOR A PERIOD OF THREE YEARS OR A
REASONABLE  PERIOD  OF TIME AS DETERMINED BY THE COMMISSIONER, AND SHALL
BE MADE AVAILABLE FOR INSPECTION, UPON REASONABLE NOTICE, BY THE DEPART-
MENT.
  9. A. A PEDIGREE SHALL BE MAINTAINED IN AN ELECTRONIC PEDIGREE  TRACK-
ING  OR  ALTERNATIVE SYSTEM DETERMINED BY THE DEPARTMENT TO BE FEASIBLE.
IN DETERMINING WHETHER AN ELECTRONIC PEDIGREE  TRACKING  OR  ALTERNATIVE
SYSTEM IS FEASIBLE, THE DEPARTMENT SHALL CONSIDER WHETHER SUCH SYSTEM OR
FORMAT IS:
  (I) READILY AVAILABLE WITH RESPECT TO ALL PRESCRIPTION DRUGS,
  (II)  IN  A STANDARDIZED NON-PROPRIETARY DATA FORMAT AND ARCHITECTURE,
AND WIDELY AVAILABLE TO MANUFACTURERS,  WHOLESALERS  AND  PHARMACIES  SO
THAT  THE  SYSTEM  OR  FORMAT IS CAPABLE OF BEING USED BY MANUFACTURERS,
WHOLESALERS AND PHARMACIES FROM SALE BY THE MANUFACTURER THROUGH  ACQUI-
SITION  BY  OR  TRANSFER TO A WHOLESALER, MANUFACTURER OR PHARMACY UNTIL
FINAL SALE OR TRANSFER TO A PHARMACY OR OTHER PERSON FURNISHING,  ADMIN-
ISTERING OR DISPENSING THE PRESCRIPTION DRUG, AND
  (III) CONSISTENT AND COMPATIBLE WITH FEDERAL REQUIREMENTS FOR AN ELEC-
TRONIC PEDIGREE TRACKING OR ALTERNATIVE SYSTEM AND A STANDARDIZED NUMER-
ICAL IDENTIFIER.
  B.  THE  PROVISIONS  OF THIS SECTION SHALL BECOME OPERATIVE ON JANUARY
FIRST, TWO THOUSAND SIXTEEN, WHICH SHALL BE THE PEDIGREE EFFECTIVE DATE;
PROVIDED, HOWEVER, IF AN ELECTRONIC  PEDIGREE  TRACKING  OR  ALTERNATIVE
SYSTEM  IS  NOT  FEASIBLE BY THE PEDIGREE EFFECTIVE DATE, THE DEPARTMENT
SHALL ISSUE ONE-YEAR EXTENSIONS OF THE PEDIGREE EFFECTIVE DATE UNTIL THE
DEPARTMENT DETERMINES SUCH SYSTEM TO BE FEASIBLE.
  10. A. COMMENCING ON JULY FIRST, TWO THOUSAND SIXTEEN, A WHOLESALER OR
OTHER PERSON FURNISHING A PRESCRIPTION DRUG SHALL NOT (I)  SELL,  TRANS-
FER,  DISTRIBUTE,  OR  DELIVER  A  PRESCRIPTION DRUG WITHOUT PROVIDING A
PEDIGREE, OR (II) ACQUIRE A PRESCRIPTION DRUG WITHOUT RECEIVING A  PEDI-
GREE.  IF  AN  ELECTRONIC PEDIGREE TRACKING OR ALTERNATIVE SYSTEM IS NOT
FEASIBLE BY THE PEDIGREE EFFECTIVE DATE, THE DEPARTMENT MAY  EXTEND  THE
DATE  UPON WHICH THE PROVISIONS OF THIS PARAGRAPH SHALL BECOME OPERATIVE
AS IT SHALL DETERMINE IN ITS DISCRETION.
  B. COMMENCING ON JULY FIRST, TWO THOUSAND  SEVENTEEN,  A  PHARMACY  OR
OTHER  PERSON FURNISHING OR DISPENSING A PRESCRIPTION DRUG SHALL NOT (I)
SELL, TRANSFER, DISTRIBUTE,  OR  DELIVER  A  PRESCRIPTION  DRUG  WITHOUT
PROVIDING  A  PEDIGREE,  OR  (II)  ACQUIRE  A  PRESCRIPTION DRUG WITHOUT
RECEIVING A PEDIGREE. IF AN ELECTRONIC PEDIGREE TRACKING OR  ALTERNATIVE
SYSTEM  IS  NOT  FEASIBLE BY THE PEDIGREE EFFECTIVE DATE, THE DEPARTMENT
MAY EXTEND THE DATE UPON WHICH THE PROVISIONS OF  THIS  PARAGRAPH  SHALL
BECOME OPERATIVE AS IT SHALL DETERMINE IN ITS DISCRETION.
  11.  A. (I) UPON THE EFFECTIVE DATE OF FEDERAL LEGISLATION OR ADOPTION
OF A FEDERAL REGULATION GOVERNING THE FORM OR CONTENT OF PEDIGREE OR THE
STANDARDS AND TECHNOLOGIES FOR THE IDENTIFICATION, VALIDATION,  TRACKING
AND TRACING AND AUTHENTICATION FOR PRESCRIPTION DRUGS, THE PROVISIONS OF
THIS  SECTION  THAT  ARE  INCONSISTENT  WITH SUCH FEDERAL LEGISLATION OR
FEDERAL REGULATION SHALL BECOME INOPERATIVE.
  (II) WITHIN NINETY DAYS OF THE ENACTMENT  OF  FEDERAL  LEGISLATION  OR
ADOPTION   OF  A  FEDERAL  REGULATION  THAT  IS  INCONSISTENT  WITH  THE
PROVISIONS OF THIS SECTION AS PROVIDED IN SUBPARAGRAPH (I) OF THIS PARA-
GRAPH, THE DEPARTMENT SHALL PUBLISH A NOTICE STATING WHICH PROVISIONS OF

A. 6546--A                          8

THIS SECTION ARE INOPERATIVE. THE DEPARTMENT SHALL HAVE THE AUTHORITY TO
ADOPT EMERGENCY REGULATIONS AS IT DEEMS NECESSARY IN  ITS  DETERMINATION
TO  REFLECT THE INOPERATION OF ANY PROVISION OF THIS SECTION AS PROVIDED
IN THIS PARAGRAPH.
  B.  (I) IF THE FEDERAL FOOD AND DRUG ADMINISTRATION ENACTS ANY RULE OR
STANDARD OR TAKES  ANY  OTHER  ACTION  THAT  IS  INCONSISTENT  WITH  ANY
PROVISION  OF  THIS SECTION GOVERNING THE FORM OR CONTENT OF PEDIGREE OR
THE STANDARDS  AND  TECHNOLOGIES  FOR  THE  IDENTIFICATION,  VALIDATION,
TRACKING  AND  TRACING,  AND AUTHENTICATION FOR PRESCRIPTION DRUGS, SUCH
PROVISION OF THIS SECTION SHALL BE DEEMED INOPERATIVE.
  (II) WITHIN NINETY DAYS OF THE FEDERAL FOOD  AND  DRUG  ADMINISTRATION
ENACTING  ANY RULE OR STANDARD OR TAKING ANY OTHER ACTION THAT IS INCON-
SISTENT WITH THE PROVISIONS OF THIS SECTION AS PROVIDED IN  SUBPARAGRAPH
(I)  OF  THIS  PARAGRAPH,  THE DEPARTMENT SHALL PUBLISH A NOTICE STATING
WHICH PROVISIONS OF THIS SECTION ARE INOPERATIVE. THE  DEPARTMENT  SHALL
HAVE  THE AUTHORITY TO ADOPT EMERGENCY REGULATIONS AS IT DEEMS NECESSARY
IN ITS DETERMINATION TO REFLECT THE INOPERATION OF ANY PROVISION OF THIS
SECTION AS PROVIDED IN THIS PARAGRAPH.
  12. A. ALL UNITS OF PRESCRIPTION DRUGS IN THE POSSESSION OF  A  WHOLE-
SALER  OR  PHARMACY FOR WHICH THE MANUFACTURER DOES NOT HOLD LEGAL TITLE
ON THE PEDIGREE EFFECTIVE DATE SHALL NOT  BE  SUBJECT  TO  THE  PEDIGREE
REQUIREMENTS  SET  FORTH IN THIS SECTION; PROVIDED, HOWEVER, IF ANY SUCH
UNITS OF PRESCRIPTION DRUGS ARE SUBSEQUENTLY RETURNED TO THE MANUFACTUR-
ER, THEY SHALL BE SUBJECT TO THE PEDIGREE REQUIREMENTS IF  THE  MANUFAC-
TURER DISTRIBUTES SUCH UNITS IN THIS STATE.
  B. ALL UNITS OF PRESCRIPTION DRUGS IN THE POSSESSION OF A MANUFACTURER
FOR  WHICH  THE  MANUFACTURER  DOES NOT HOLD LEGAL TITLE ON THE PEDIGREE
EFFECTIVE DATE SHALL NOT BE SUBJECT TO  THE  PEDIGREE  REQUIREMENTS  SET
FORTH IN THIS SECTION.
  13.  ANY  PERSON  WHO  VIOLATES ANY PROVISION OF THIS SECTION SHALL BE
SUBJECT TO A FINE OF NOT MORE THAN TWO THOUSAND DOLLARS  PER  VIOLATION.
IN  ADDITION,  ANY  PRESCRIPTION DRUG DISTRIBUTED, TRANSFERRED, ADMINIS-
TERED, FURNISHED, OR DISPENSED IN VIOLATION OF  THIS  SECTION  SHALL  BE
CONTRABAND  AND  SUBJECT  TO SEIZURE EITHER BY THE DEPARTMENT, THE STATE
BOARD OF PHARMACY OR ANY LAW ENFORCEMENT OFFICER OF THE STATE.
  S 7. Section 6824 of the education law, as added by chapter 987 of the
laws of 1971, is amended to read as follows:
  S 6824. Injunction proceedings. In addition to the remedies hereinaft-
er provided, the secretary is hereby authorized to apply to the court of
the proper venue for an injunction  to  restrain  any  person  from  (a)
introducing or causing to be introduced into commerce any adulterated or
misbranded  drug, device or cosmetic; or (b) from introducing or causing
to be introduced in commerce any new drug which does not comply with the
provisions of this article; or (c) from disseminating or causing  to  be
disseminated  a  false  advertisement; OR (D) VIOLATING ANY PROVISION OF
SECTION  SIXTY-EIGHT  HUNDRED  TEN-A  OF  THIS  ARTICLE,  without  being
compelled  to  allege  or  prove that an adequate remedy at law does not
exist.
  S 8. This act shall take effect on the one hundred eightieth day after
it shall have become a law. The department of education shall promulgate
rules and regulations, issue forms and take any other  action  necessary
to implement the provisions of this act on or before the pedigree effec-
tive date, as provided in paragraph b of subdivision 9 of section 6810-b
of the education law, as added by section six of this act.