NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A4781B
SPONSOR: Rosenthal D
TITLE OF BILL: An act to amend the education law, in relation to
requiring pharmacies to make reasonable attempts to notify patients of
certain drug recalls
To require patient notification of recalled prescription medication
SUMMARY OF PROVISIONS:
Section 1 adds a new section to education law; defines 'class I recall'
and requires pharmacists to notify patients who have been issued class I
recalled medication. Section 2 sets the effective date.
SUMMARY OF AMENDMENTS:
-Provides that the pharmacy shall make reasonable attempts to contact
the patient by phone or mail
-Provides that the 3 day window of notification begins once the pharmacy
is notified of the recall from the manufacturer, wholesaler, FDA or
other means of notice
- Provides that chain pharmacies may satisfy the requirements of this
section by outreach from a central office
The FDA classifies drug recalls into 3 numerical categories. Class 1
recalls indicate the most serious adverse health implications. Drugs
that are issued a Class 1 recall have a high probability of exposing
patients to products that may cause serious adverse health consequences
or death. Currently, there is no requirement for pharmacies to notify
patients who have been dispensed recalled drugs of their status. Given
the severity of the risk associated with such products, especially to
elderly patients and those taking long-term maintenance medications,
patient notification becomes paramount. As pharmacies often act as the
most direct point of contact for many patients, this legislation helps
to protect at risk consumers from potentially harmful medication.
This is a new bill
None to the state
This act shall take effect immediately
STATE OF NEW YORK
2019-2020 Regular Sessions
February 5, 2019
Introduced by M. of A. D. ROSENTHAL -- read once and referred to the
Committee on Higher Education -- committee discharged, bill amended,
ordered reprinted as amended and recommitted to said committee --
again reported from said committee with amendments, ordered reprinted
as amended and recommitted to said committee
AN ACT to amend the education law, in relation to requiring pharmacies
to make reasonable attempts to notify patients of certain drug recalls
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The education law is amended by adding a new section 6811-c
2 to read as follows:
3 § 6811-c. Patient notification of recalled drugs. 1. For purposes of
4 this section the term "class I recall" shall mean a situation in which
5 the United States food and drug administration deems there is reasonable
6 probability that the use of or exposure to a violative product will
7 cause serious adverse health consequences or death.
8 2. Where there has been a class I recall of a prescription drug, phar-
9 macies shall make a reasonable attempt to notify all patients that have
10 been prescribed and who are currently taking such recalled drug
11 dispensed from such pharmacy by phone or by mail within three days of
12 the pharmacy being notified by the United States food and drug adminis-
13 tration, a manufacturer, a wholesaler or by other notice of such recall.
14 3. The notification required by this section may be provided by an
15 individual pharmacy or by a central office in the case of a pharmacy
16 that is part of a chain.
17 § 2. This act shall take effect immediately.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
 is old law to be omitted.