NY State Senate Bill 2019-S6108A

Senate Bill S6108A

2019-2020 Legislative Session

Relates to labeling requirements of prescription drug containers where such drugs contain gluten, lactose or food dye

download bill text pdf

Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2020	referred to higher education
Dec 18, 2019	print number 6108a
Dec 18, 2019	amend and recommit to higher education
May 16, 2019	referred to higher education

Bill Amendments

Original

A (Active)

2019-S6108 - Details

See Assembly Version of this Bill:: A7379
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6810, Ed L

2019-S6108 - Summary

Requires the labeling of prescription drug containers where such drugs contain gluten, lactose or food dye.

2019-S6108 - Sponsor Memo

                                
 
BILL NUMBER: S6108

SPONSOR: LIU
 
TITLE OF BILL:  An act to amend the education law, in relation to
labeling of prescription drugs containing gluten, lactose or food dye

 
PURPOSE OR GENERAL IDEA OF BILL:;

Relates to labeling requirements of prescription drug containers were
such drugs contain gluten, lactose, or food dye

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1. Subdivision 2 of Section 6811-A of the Education Law is
amended by adding subparagraph c, which provides that where a
prescription drug product contains any active or inactive ingredient
made from any gluten-containing grain, including wheat, barley, rye, or
any crossbred hybrid of such grain, or where a prescription drug product
contains any active or Inactive ingredient containing lactose, or where
a prescription drug product contains food dye, such ingredients shall
appear on the label In words clearly identifying each.

 
JUSTIFICATION:;

According to a report published in Science Translational Medicine, "the
vast majority of frequently prescribed drugs contain at least one inac-
tive ingredient that can lead to an adverse reaction." NBC News reported
that the researchers found that "approximately 45 percent of medications
contained lactose and approximately 33 percent contained a food dye."
These inactive ingredients pose a risk for those with allergies to
gluten, lactose, and food dyes, and they have the potential to worsen
symptoms for people suffering from celiac disease or irritable bowel
syndrome.

By requiring prescription drug containers to be labeled with warnings
regarding gluten, lactose, or food dyes, people with severe allergies
and chronic conditions will be able to avoid taking medicine which could
cause them to become ill.

 
PRIOR LEGISLATIVE HISTORY:;

This is a new bill.

 
FISCAL IMPLICATIONS:

None to state.

 
EFFECTIVE DATE:
This act shall take effect Immediately.

2019-S6108 - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6108
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                               May 16, 2019
                                ___________
 
 Introduced  by  Sen.  LIU  --  read  twice and ordered printed, and when
   printed to be committed to the Committee on Higher Education
 
 AN  ACT  to  amend  the  education  law,  in  relation  to  labeling  of
   prescription drugs containing gluten, lactose or food dye
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Subdivision 2 of section 6811-a of the  education  law,  as
 amended  by  section  9  of part D of chapter 60 of the laws of 2014, is
 amended to read as follows:
   2. Except as otherwise  authorized  in  the  Federal  Food,  Drug  and
 Cosmetic  Act,  no  drug  for  which any prescription is required by the
 provisions of the Federal Food, Drug and Cosmetic Act or by the  commis-
 sioner  of  health  contained  within  a  bottle,  vial, carton or other
 container, or in any way affixed or appended to  or  enclosed  within  a
 package  of  any  kind,  and  designed  or intended for delivery in such
 container or package to an ultimate consumer, shall be  manufactured  or
 distributed  within  this  state  unless  such  container or package has
 clearly and permanently marked or imprinted upon it in conformance  with
 the applicable plan required by subdivision three of this section:
   (a)  an  individual  symbol,  N.  D.  C. number, company name, number,
 letters, words or marking identifying the manufacturer or distributor of
 the drug;
   (b) an N. D. C. number, symbol,  number,  letters,  words  or  marking
 identifying such drug or combination of drugs;
   (C)  WHERE A PRESCRIPTION DRUG PRODUCT CONTAINS ANY ACTIVE OR INACTIVE
 INGREDIENT MADE  FROM  ANY  GLUTEN-CONTAINING  GRAIN,  INCLUDING  WHEAT,
 BARLEY,  RYE,  OR  ANY  CROSSBRED    HYBRID  OF  SUCH GRAINS, OR WHERE A
 PRESCRIPTION DRUG PRODUCT CONTAINS ANY  ACTIVE  OR  INACTIVE  INGREDIENT
 CONTAINING  LACTOSE,  OR WHERE A PRESCRIPTION DRUG PRODUCT CONTAINS FOOD
 DYE, SUCH INGREDIENTS SHALL APPEAR ON THE LABEL IN WORDS CLEARLY IDENTI-
 FYING EACH; and

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD10881-02-9

 S. 6108                             2
 
   [(c)] (D) whenever the distributor of the  prescription  drug  product
 does  not  also manufacture the product the names and places of business
 of both shall appear on the label in words clearly distinguishing each.
   § 2. This act shall take effect immediately.

2019-S6108A (ACTIVE) - Details

See Assembly Version of this Bill:: A7379
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6810, Ed L

2019-S6108A (ACTIVE) - Summary

Requires the labeling of prescription drug containers where such drugs contain gluten, lactose or food dye.

2019-S6108A (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S6108A

SPONSOR: LIU
 
TITLE OF BILL:

An act to amend the education law, in relation to labeling of
prescription drugs containing gluten, lactose or food dye

 
PURPOSE OR GENERAL IDEA OF BILL:

Relates to labeling requirements of prescription drug containers were
such drugs contain gluten, lactose, or food dye

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1. Subdivision 1 of Section 6810 of the Education Law is amended
by providing that except as otherwise authorized by the Federal Food and
Drug Administration, in relation to any prescription drug containing any
active or inactive ingredient made from any gluten-containing grain,
including wheat, barley, rye, or any crossbred hybrid of such grain, or
where a prescription drug product contains any active or inactive ingre-

dient containing lactose, or where a prescription drug product contains
food dye, such ingredients shall appear on the label.

 
JUSTIFICATION:

According to a report published in Science Translational Medicine, "the
vast majority of frequently prescribed drugs contain at least one inac-
tive ingredient that can lead to an adverse reaction." NBC News reported
that the researchers found that "approximately 45 percent of medications
contained lactose and approximately 33 percent contained a food dye."
These inactive ingredients pose a risk for those with allergies to
gluten, lactose, and food dyes, and they have the potential to worsen
symptoms for people suffering from celiac disease or irritable bowel
syndrome.

By requiring pharmacists to label prescription drug containers with
warnings regarding gluten, lactose, or food dyes, people with severe
allergies and chronic conditions will be able to avoid taking medicine
which could cause them to become ill.

 
PRIOR LEGISLATIVE HISTORY:

This is a new bill.

 
FISCAL IMPLICATIONS:

None to state.

 
EFFECTIVE DATE:
This act shall take effect on the ninetieth day after it shall have
become law. Effective immediately, the addition, amendment and/or repeal
of any rule or regulation necessary for the implementation of this act
on its effective date are authorized to be made and completed on or
before such effective date.

2019-S6108A (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  6108--A
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                               May 16, 2019
                                ___________
 
 Introduced  by  Sen.  LIU  --  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
 
 AN  ACT  to  amend  the  education  law,  in  relation  to  labeling  of
   prescription drugs containing gluten, lactose or food dye
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Subdivision 1 of section 6810  of  the  education  law,  as
 amended  by  section  2  of part V of chapter 57 of the laws of 2012, is
 amended to read as follows:
   1. No drug for which a prescription is required by the  provisions  of
 the Federal Food, Drug and Cosmetic Act or by the commissioner of health
 shall   be  distributed  or  dispensed  to  any  person  except  upon  a
 prescription written by  a  person  legally  authorized  to  issue  such
 prescription.  Such  drug shall be compounded or dispensed by a licensed
 pharmacist, and no such drug shall be dispensed without affixing to  the
 immediate container in which the drug is sold or dispensed a label bear-
 ing  the  name and address of the owner of the establishment in which it
 was dispensed, the date compounded, the number of the prescription under
 which it is recorded in the pharmacist's prescription files, the name of
 the prescriber, the name and address of the patient, and the  directions
 for  the  use of the drug by the patient as given upon the prescription.
 EXCEPT AS OTHERWISE AUTHORIZED IN THE FEDERAL FOOD,  DRUG  AND  COSMETIC
 ACT,  NO DRUG CONTAINING ANY ACTIVE OR INACTIVE INGREDIENT MADE FROM ANY
 GLUTEN-CONTAINING GRAIN, INCLUDING WHEAT, BARLEY, RYE, OR ANY  CROSSBRED
 HYBRID  OF  SUCH GRAINS, OR CONTAINING ANY ACTIVE OR INACTIVE INGREDIENT
 CONTAINING  LACTOSE,  OR  CONTAINING  FOOD  DYE,  AND  FOR   WHICH   ANY
 PRESCRIPTION IS REQUIRED BY THE PROVISIONS OF THE FEDERAL FOOD, DRUG AND
 COSMETIC ACT OR BY THE COMMISSIONER OF HEALTH CONTAINED WITHIN A BOTTLE,
 VIAL, CARTON OR OTHER CONTAINER, OR IN ANY WAY AFFIXED OR APPENDED TO OR
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD10881-08-9

 S. 6108--A                          2
 
 ENCLOSED  WITHIN  A  PACKAGE OF ANY KIND, AND DESIGNATED OR INTENDED FOR
 DELIVERY IN SUCH CONTAINER OR PACKAGE TO AN ULTIMATE CONSUMER, SHALL  BE
 DISPENSED  OR SOLD TO AN ULTIMATE CONSUMER WITHIN THIS STATE UNLESS SUCH
 CONTAINER  OR  PACKAGE  HAS  CLEARLY AND PERMANENTLY MARKED OR IMPRINTED
 UPON IT IN CONFORMANCE WITH THE APPLICABLE PLAN REQUIRED BY  SUBDIVISION
 THREE  OF  THIS  SECTION  WORDS  CLEARLY IDENTIFYING EACH SUCH ACTIVE OR
 INACTIVE INGREDIENT MADE FROM ANY GLUTEN-CONTAINING GRAIN  OR  CROSSBRED
 HYBRID, LACTOSE, OR FOOD DYE. All labels shall conform to such rules and
 regulations  as  promulgated  by  the  commissioner  pursuant to section
 sixty-eight hundred twenty-nine of this  article.  The  prescribing  and
 dispensing of a drug which is a controlled substance shall be subject to
 additional  requirements  provided in article thirty-three of the public
 health law. The words "drug" and "prescription required drug" within the
 meaning of this article shall not be construed to include soft  or  hard
 contact  lenses,  eyeglasses,  or  any  other  device  for  the  aid  or
 correction of vision. Nothing in this subdivision shall prevent a  phar-
 macy from furnishing a drug to another pharmacy which does not have such
 drug in stock for the purpose of filling a prescription.
   §  2.  This  act shall take effect on the ninetieth day after it shall
 have become a law. Effective immediately, the addition, amendment and/or
 repeal of any rule or regulation necessary  for  the  implementation  of
 this  act  on its effective date are authorized to be made and completed
 on or before such effective date.

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