Assembly Bill A1615

                            
                    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:

  Section 1.  The public health law is amended by adding a  new  article
33-B to read as follows:
                              ARTICLE 33-B
                 THE PRESCRIPTION DRUG SAMPLE SAFETY ACT
SECTION 3398. REQUIREMENTS  FOR  THE  SAFE HANDLING OF PRESCRIPTION DRUG
                SAMPLES.
  S 3398. REQUIREMENTS  FOR  THE  SAFE  HANDLING  OF  PRESCRIPTION  DRUG
SAMPLES.  1. A PERSON AUTHORIZED TO DISPENSE DRUGS PURSUANT TO PARAGRAPH
B  OF SUBDIVISION ONE OF SECTION SIXTY-EIGHT HUNDRED SEVEN OF THE EDUCA-
TION LAW SHALL ESTABLISH AND ADHERE  TO  THE  FOLLOWING  PROCEDURES  AND
REQUIREMENTS REGARDING THE HANDLING OF SUCH DRUGS:
  (A)  SAMPLES  SHALL BE PROPERLY LOGGED IN (INCLUDING IDENTIFICATION OF
THE MANUFACTURER OR ENTITY SUPPLYING  OR  PROVIDING  SUCH  SAMPLES,  THE
DATE,  TYPE  AND  THE  AMOUNT  OF DRUG RECEIVED AND EXPIRATION DATES, IF
ANY), LABELED, STORED,  SECURED  AND  TRACKED  TO  PREVENT  UNAUTHORIZED
ACCESS AND LOSS;
  (B)  PRESCRIBERS  SHALL  MAINTAIN DOCUMENTATION OF THE DISTRIBUTION OF
SAMPLES IN PATIENTS' MEDICAL RECORDS,  INCLUDING  THE  DATE,  TYPE,  AND
AMOUNT  DISPENSED, AND OBTAIN THE INFORMED CONSENT OF PATIENTS RECEIVING
SAMPLE PRODUCTS;
  (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

  (D) PRESCRIBERS SHALL REGULARLY REVIEW  SAMPLE  EXPIRATION  DATES  AND
REMOVE OUTDATED PRODUCTS;
  (E)  PRESCRIBERS  SHALL MAINTAIN PROPER DOCUMENTATION OF RECIPIENTS OF
SAMPLE PRODUCTS FOR  PATIENT  CONTACT  IN  THE  EVENT  OF  A  RECALL  OR
LATER-DISCOVERED INTERACTION WARNING; AND
  (F)  PRESCRIBERS SHALL MAINTAIN A RECORD OF THE DISPOSAL, DESTRUCTION,
OR RETURN OF EXPIRED OR RECALLED SAMPLE PRODUCTS.
  2. THE COMMISSIONER SHALL PROMULGATE REGULATIONS NECESSARY  TO  IMPLE-
MENT AND ENFORCE THIS SECTION.
  S 2. This act shall take effect on the one hundred eightieth day after
it shall have become a law.