Bill Text: NY S05287 | 2011-2012 | General Assembly | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: 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.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2012-01-31 - PRINT NUMBER 5287A [S05287 Detail]

Download: New_York-2011-S05287-Amended.html

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                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                        5287--A
                              2011-2012 Regular Sessions
                                   I N  S E N A T E
                                      May 3, 2011
                                      ___________
       Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
         printed to be committed to the Committee on Higher Education -- recom-
         mitted to the Committee on Higher Education in accordance with  Senate
         Rule  6,  sec.  8  --  committee  discharged,  bill  amended,  ordered
         reprinted as amended and recommitted to said committee
       AN ACT  to  amend  the  education  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 6802 of the education law is amended  by  adding  a
    2  new subdivision 24 to read as follows:
    3    24.  "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 OR
    7  PHARMACIES, UNTIL FINAL SALE OR TRANSFER TO A PHARMACY OR  OTHER  PERSON
    8  FURNISHING,  ADMINISTERING  OR  DISPENSING  THE  PRESCRIPTION  DRUG,  AS
    9  PROVIDED IN SECTION SIXTY-EIGHT HUNDRED TEN-B OF THIS ARTICLE.
   10    S 2. The education law is amended by adding a new  section  6810-b  to
   11  read as follows:
   12    S 6810-B. 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
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD02278-03-1
       S. 5287--A                          2
    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.
       S. 5287--A                          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 TWO
   16  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 PURPOSES
   26  OF THIS SECTION, "COMPRESSED MEDICAL GAS" MEANS  ANY  SUBSTANCE  IN  ITS
   27  GASEOUS OR CRYOGENIC LIQUID FORM THAT MEETS MEDICAL PURITY STANDARDS AND
   28  HAS APPLICATION IN A MEDICAL OR HOMECARE ENVIRONMENT, INCLUDING, BUT NOT
   29  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-
       S. 5287--A                          4
    1  TURER, 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 SEVENTEEN, WHICH SHALL  BE  THE  PEDIGREE  EFFECTIVE
   27  DATE;  PROVIDED, HOWEVER, IF AN ELECTRONIC PEDIGREE TRACKING OR ALTERNA-
   28  TIVE SYSTEM IS NOT FEASIBLE BY THE PEDIGREE EFFECTIVE DATE, THE  DEPART-
   29  MENT  SHALL  ISSUE  ONE-YEAR  EXTENSIONS  OF THE PEDIGREE EFFECTIVE DATE
   30  UNTIL THE DEPARTMENT DETERMINES SUCH SYSTEM TO BE FEASIBLE.
   31    10. A. COMMENCING ON JULY FIRST, TWO THOUSAND SEVENTEEN, A  WHOLESALER
   32  OR  OTHER  PERSON  FURNISHING  A  PRESCRIPTION  DRUG SHALL NOT (I) SELL,
   33  TRANSFER, 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 EIGHTEEN, 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
       S. 5287--A                          5
    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    S 3. This act shall take effect on the one hundred eightieth day after
   37  it shall have become a law. The department of education shall promulgate
   38  rules and regulations, issue forms and take any other  action  necessary
   39  to implement the provisions of this act on or before the pedigree effec-
   40  tive date, as provided in paragraph b of subdivision 9 of section 6810-b
   41  of the education law, as added by section two of this act.