Bill Text: NY A01615 | 2015-2016 | General Assembly | Introduced


Bill Title: Enacts requirements relating to the safe handling of prescription drug samples by certain health care professionals; requires maintenance of certain records and information regarding samples received and distributed including expiration dates.

Spectrum: Partisan Bill (Democrat 16-0)

Status: (Introduced - Dead) 2016-01-28 - advanced to third reading cal.348 [A01615 Detail]

Download: New_York-2015-A01615-Introduced.html
                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                         1615
                              2015-2016 Regular Sessions
                                 I N  A S S E M B L Y
                                   January 12, 2015
                                      ___________
       Introduced by M. of A. GOTTFRIED, GALEF, DINOWITZ, PAULIN, CAHILL, COOK,
         BRENNAN,  ROSENTHAL,  ENGLEBRIGHT  --  Multi-Sponsored  by -- M. of A.
         COLTON, FARRELL, JAFFEE, LAVINE, PERRY -- read once  and  referred  to
         the Committee on Health
       AN  ACT  to  amend the public health law, in relation to reducing health
         risks involved with receipt, handling and distribution of  samples  of
         prescription drug products
         THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
       BLY, DO ENACT AS FOLLOWS:
    1    Section 1.  The public health law is amended by adding a  new  article
    2  33-B to read as follows:
    3                                ARTICLE 33-B
    4                   THE PRESCRIPTION DRUG SAMPLE SAFETY ACT
    5  SECTION 3398. REQUIREMENTS  FOR  THE  SAFE HANDLING OF PRESCRIPTION DRUG
    6                  SAMPLES.
    7    S 3398. REQUIREMENTS  FOR  THE  SAFE  HANDLING  OF  PRESCRIPTION  DRUG
    8  SAMPLES.  1. A PERSON AUTHORIZED TO DISPENSE DRUGS PURSUANT TO PARAGRAPH
    9  B  OF SUBDIVISION ONE OF SECTION SIXTY-EIGHT HUNDRED SEVEN OF THE EDUCA-
   10  TION LAW SHALL ESTABLISH AND ADHERE  TO  THE  FOLLOWING  PROCEDURES  AND
   11  REQUIREMENTS REGARDING THE HANDLING OF SUCH DRUGS:
   12    (A)  SAMPLES  SHALL BE PROPERLY LOGGED IN (INCLUDING IDENTIFICATION OF
   13  THE MANUFACTURER OR ENTITY SUPPLYING  OR  PROVIDING  SUCH  SAMPLES,  THE
   14  DATE,  TYPE  AND  THE  AMOUNT  OF DRUG RECEIVED AND EXPIRATION DATES, IF
   15  ANY), LABELED, STORED,  SECURED  AND  TRACKED  TO  PREVENT  UNAUTHORIZED
   16  ACCESS AND LOSS;
   17    (B)  PRESCRIBERS  SHALL  MAINTAIN DOCUMENTATION OF THE DISTRIBUTION OF
   18  SAMPLES IN PATIENTS' MEDICAL RECORDS,  INCLUDING  THE  DATE,  TYPE,  AND
   19  AMOUNT  DISPENSED, AND OBTAIN THE INFORMED CONSENT OF PATIENTS RECEIVING
   20  SAMPLE PRODUCTS;
   21    (C) SAMPLES SHALL BE LABELED WITH APPROPRIATE PRESCRIBING INFORMATION;
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD02421-01-5
       A. 1615                             2
    1    (D) PRESCRIBERS SHALL REGULARLY REVIEW  SAMPLE  EXPIRATION  DATES  AND
    2  REMOVE OUTDATED PRODUCTS;
    3    (E)  PRESCRIBERS  SHALL MAINTAIN PROPER DOCUMENTATION OF RECIPIENTS OF
    4  SAMPLE PRODUCTS FOR  PATIENT  CONTACT  IN  THE  EVENT  OF  A  RECALL  OR
    5  LATER-DISCOVERED INTERACTION WARNING; AND
    6    (F)  PRESCRIBERS SHALL MAINTAIN A RECORD OF THE DISPOSAL, DESTRUCTION,
    7  OR RETURN OF EXPIRED OR RECALLED SAMPLE PRODUCTS.
    8    2. THE COMMISSIONER SHALL PROMULGATE REGULATIONS NECESSARY  TO  IMPLE-
    9  MENT AND ENFORCE THIS SECTION.
   10    S 2. This act shall take effect on the one hundred eightieth day after
   11  it shall have become a law.
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