Assembly Bill A9374

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

                                  9374

                          I N  A S S E M B L Y

                            February 24, 2012
                               ___________

Introduced  by M. of A. BRENNAN, JACOBS, BARRON, CASTRO, GUNTHER, ROSEN-
  THAL, COOK, JAFFEE, LINARES -- Multi-Sponsored by -- M. of A. BOYLAND,
  HIKIND, McENENY, ROBINSON, STEVENSON,  WEISENBERG  --  read  once  and
  referred to the Committee on Health

AN ACT to amend the public health law, in relation to enacting the "drug
  shortage notification act of 2012"

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Legislative findings. In order to prevent the shortages  of
drugs  in  this  state,  the legislature finds that creating a system to
notify the commissioner of health, pharmacies,  hospitals,  health  care
providers  and  the general public of the discontinuance or interruption
of the manufacture of a  drug  is  necessary  and  consistent  with  the
state's duty to protect the health and welfare of its residents.
  S  2.  This  act shall be known and may be cited as the "drug shortage
notification act of 2012".
  S 3. The public health law is amended by adding a new section  281  to
read as follows:
  S 281. DRUG SHORTAGE NOTIFICATION. 1. DEFINITIONS. FOR THE PURPOSES OF
THIS SECTION:
  A.  "AVERAGE  HISTORIC DEMAND" MEANS THE PHARMACEUTICAL MANUFACTURER'S
AVERAGE MONTHLY VOLUME OF SALES OF THE DRUG DURING  THE  PRIOR  CALENDAR
YEAR.
  B. "DISCONTINUANCE" MEANS THE PERMANENT TERMINATION OF THE MANUFACTURE
OF A PRESCRIPTION DRUG BY A PHARMACEUTICAL MANUFACTURER.
  C.  "DRUG"  OR  "PRESCRIPTION DRUG" SHALL HAVE THE SAME MEANING AS SET
FORTH IN SECTION TWO HUNDRED SEVENTY OF THIS ARTICLE.
  D. "INTERRUPTION" MEANS A CHANGE THAT MAY RESULT IN THE  TOTAL  SUPPLY
OF  A  DRUG  MANUFACTURED  BY  A PHARMACEUTICAL MANUFACTURER NOT MEETING
AVERAGE HISTORIC DEMAND.
  E. "PHARMACEUTICAL MANUFACTURER" OR "MANUFACTURER" MEANS  ANY  PERSON,
COMPANY  OR  CORPORATION  THAT  COMPOUNDS,  MIXES, PREPARES, PRODUCES OR
OTHERWISE MANUFACTURES PRESCRIPTION DRUGS.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD14329-02-2
              

A. 9374                             2

  F. "PHARMACY" SHALL HAVE THE SAME MEANING AS SET FORTH IN  SUBDIVISION
ONE OF SECTION SIXTY-EIGHT HUNDRED TWO OF THE EDUCATION LAW.
  2.  A. A PHARMACEUTICAL MANUFACTURER SHALL PROVIDE NOTICE OF A DISCON-
TINUANCE OR INTERRUPTION IN THE MANUFACTURE  OF  A  DRUG  AT  LEAST  SIX
MONTHS PRIOR TO THE DATE OF SUCH DISCONTINUANCE OR INTERRUPTION.
  B.  SUCH NOTICE SHALL BE SENT TO THE COMMISSIONER AND TO ANY PHARMACY,
HOSPITAL, HEALTH CARE PROVIDER OR OTHER ENTITY  AUTHORIZED  TO  DISPENSE
THE  DRUG UNDER STATE LAW TO WHICH THE MANUFACTURER SELLS OR DISTRIBUTES
SUCH DRUG.
  C. IN THE CASE OF AN INTERRUPTION, IF THE MANUFACTURER CANNOT  PROVIDE
A  SIX MONTH ADVANCE NOTICE, THE NOTICE SHALL BE SENT AS SOON AS PRACTI-
CABLE AFTER THE MANUFACTURER: (I) BECOMES AWARE OF SUCH INTERRUPTION  OR
ADJUSTMENT;  OR  (II) BECOMES AWARE THAT SUCH INTERRUPTION OR ADJUSTMENT
MAY RESULT IN THE TOTAL SUPPLY OF THE DRUG NOT MEETING AVERAGE  HISTORIC
DEMAND.
  3.  A. UPON RECEIPT OF THE NOTICE REQUIRED PURSUANT TO SUBDIVISION TWO
OF THIS SECTION, THE COMMISSIONER SHALL,  WITHIN  THREE  BUSINESS  DAYS,
NOTIFY OR CAUSE TO BE NOTIFIED, LOCAL BOARDS OF HEALTH, STATE HOSPITALS,
HOMES  THAT  ARE  SUBJECT  TO  THE  JURISDICTION  OF THE DEPARTMENT, AND
PATIENT ORGANIZATIONS, OF THE  DISCONTINUANCE  OR  INTERRUPTION  OF  THE
DRUG.
  B.  THE COMMISSIONER SHALL ALSO POST IMMEDIATELY ON THE WEBSITE OF THE
DEPARTMENT COMPLETE INFORMATION ON THE DISCONTINUANCE OR INTERRUPTION OF
THE DRUG, AND THE AVAILABILITY, IF ANY, OF AN ALTERNATIVE SOURCE OF  THE
DRUG OR OF A DRUG WITH THE SAME ACTIVE INGREDIENTS.
  4.  A.  ANY  MANUFACTURER  THAT  KNOWINGLY  FAILS TO PROVIDE NOTICE IN
VIOLATION OF SUBDIVISION TWO OF THIS SECTION SHALL BE SUBJECT TO A CIVIL
PENALTY NOT TO EXCEED  TEN  THOUSAND  DOLLARS  FOR  EACH  DAY  THAT  THE
VIOLATION  CONTINUES,  NOT  TO EXCEED ONE MILLION EIGHT HUNDRED THOUSAND
DOLLARS.
  B. THE COMMISSIONER SHALL PROMULGATE RULES AND REGULATIONS  TO  IMPLE-
MENT  THE  PROVISIONS OF THIS SECTION, INCLUDING ESTABLISHING A SCHEDULE
OF CIVIL MONETARY PENALTIES FOR FAILURE TO COMPLY WITH THE  NOTIFICATION
REQUIREMENTS PURSUANT TO SUBDIVISION TWO OF THIS SECTION.
  5.  NOTWITHSTANDING  ANY  OTHER PROVISIONS OF LAW TO THE CONTRARY, THE
COMMISSIONER SHALL ENSURE THE CONFIDENTIALITY OF ANY PROPRIETARY  INFOR-
MATION SUBMITTED IN A NOTICE UNDER SUBDIVISION TWO OF THIS SECTION.
  S 4. Severability. If any clause, sentence, paragraph, section or part
of  this act shall be adjudged by any court of competent jurisdiction to
be invalid, the judgment shall not affect,  impair,  or  invalidate  the
remainder thereof, but shall be confined in its operation to the clause,
sentence,  paragraph,  section  or part thereof directly involved in the
controversy in which the judgement shall have been rendered.
  S 5. This act shall take effect immediately, provided that section 281
of the public health law, as added by section three of this  act,  shall
survive  the  repeal of article 2-A of the public health law as provided
in subdivision 1 of section 79 of part C of chapter 58 of  the  laws  of
2005, as amended.