What's happening
This bill requires pharmacies to quickly notify patients when a prescription drug they dispensed is subject to a Class I FDA recall.
Why it matters
Enhances patient safety by ensuring those at risk are quickly informed. By mandating pharmacies to notify patients within three days of learning about a Class I recall, this bill aims to reduce the chances of patients unknowingly taking dangerous or potentially fatal medications.
Shifts more responsibility onto pharmacies for post-dispensing drug safety. Pharmacies would need to develop or strengthen systems to track which patients received specific drugs and maintain up-to-date contact information, increasing operational accountability.
Recognizes the urgency and severity of Class I recalls. The focus on Class I recalls—cases where continued drug use could cause serious health consequences or death—prioritizes the most critical threats to public health and emphasizes rapid response.
Offers flexibility in notification processes for pharmacy chains. The bill allows for either individual pharmacies or central offices (in the case of chains) to handle notifications, potentially streamlining compliance for larger organizations while still ensuring patient outreach.
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Who cares
Headline styles
Notify Patients of Drug Recalls
Plain English, a few words. Used as the page title.
Sponsors
Senator · Senate District 14
1 Co-sponsor
History
- Substituted by A4781B
- Ordered to third reading cal.1252
- Committee discharged and committed to rules
- Print number 5091b
- Amend and recommit to higher education
- Print number 5091a
- Amend (t) and recommit to higher education
- Referred to higher education
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Pharmacies Must Alert on Recalls
Signed by Governor · Sponsor Daniel Rosenthal
Full text
1 pageUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
5091--B
2019-2020 Regular Sessions
IN SENATE
April 9, 2019
Introduced by Sen. COMRIE -- read twice and ordered printed, and when printed to be committed to the Committee on Higher Education -committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee -- committee discharged, bill amended, 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 Assembly, do enact as follows:
Section 1. The education law is amended by adding a new section 6811-c to read as follows:
§ 6811-c. Patient notification of recalled drugs. 1. For purposes of this section the term "class I recall" shall mean a situation in which the United States food and drug administration deems there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
2. Where there has been a class I recall of a prescription drug, pharmacies shall make a reasonable attempt to notify all patients that have been prescribed and who are currently taking such recalled drug dispensed from such pharmacy by phone or by mail within three days of the pharmacy being notified by the United States food and drug administration, a manufacturer, a wholesaler or by other notice of such recall.
3. The notification required by this section may be provided by an individual pharmacy or by a central office in the case of a pharmacy that is part of a chain.
§ 2. This act shall take effect immediately.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD06542-07-9
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
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
Purpose
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 pharma- cy 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
Justification
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 I 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.
Legislative history
This is a new bill
Fiscal implications
None to the state
Effective date
This act shall take effect immediately
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.