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.
STATE OF NEW YORK
________________________________________________________________________
1615
2015-2016 Regular Sessions
IN ASSEMBLY
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 § 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2 remove outdated products;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 later-
5 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 § 2. This act shall take effect on the one hundred eightieth day after
11 it shall have become a law.
