S T A T E O F N E W Y O R K
________________________________________________________________________
3213
2009-2010 Regular Sessions
I N S E N A T E
March 12, 2009
___________
Introduced by Sens. MAZIARZ, ALESI, BONACIC, GOLDEN, GRIFFO, LARKIN,
MORAHAN, NOZZOLIO, RANZENHOFER, SEWARD, VOLKER -- read twice and
ordered printed, and when printed to be committed to the Committee on
Health
AN ACT to amend the public health law and the education law, in relation
to required labeling on prescription drugs
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
REQUIRED LABELING ON PRESCRIPTION DRUGS
SECTION 3398. IDENTIFICATION OF THE COUNTRY OF ORIGIN OF A PRESCRIBED
DRUG.
S 3398. IDENTIFICATION OF THE COUNTRY OF ORIGIN OF A PRESCRIBED DRUG.
1. NO PRESCRIBED DRUG DISPENSED BY A PHARMACY PURSUANT TO A
PRESCRIPTION BY AN AUTHORIZED PRACTITIONER OF MEDICINE OR OTHER PERSON
LEGALLY AUTHORIZED TO ISSUE SUCH PRESCRIPTION MAY BE SOLD TO THE PUBLIC
UNLESS THE PACKAGING INCLUDES A LABEL WHICH LISTS THE COUNTRY OF ORIGIN
OF THE PRESCRIBED DRUG.
2. WHENEVER THE ATTORNEY GENERAL SHALL BELIEVE FROM EVIDENCE SATISFAC-
TORY TO HIM OR HER THAT ANY PERSON, FIRM, CORPORATION OR ASSOCIATION OR
AGENT OR EMPLOYEE THEREOF HAS VIOLATED ANY PROVISION OF THIS SECTION, HE
OR SHE MAY BRING AN ACTION IN THE SUPREME COURT OF THE STATE OF NEW YORK
FOR A JUDGMENT ENJOINING THE CONTINUANCE OF SUCH VIOLATION AND FOR A
CIVIL PENALTY OF NOT MORE THAN FIVE HUNDRED DOLLARS FOR EACH VIOLATION.
IF IT SHALL APPEAR TO THE SATISFACTION OF THE COURT OR JUSTICE THAT THE
DEFENDANT HAS VIOLATED ANY PROVISION OF THIS SECTION, NO PROOF SHALL BE
REQUIRED THAT ANY PERSON HAS BEEN INJURED THEREBY NOR THAT THE DEFENDANT
KNOWINGLY OR INTENTIONALLY VIOLATED SUCH PROVISION. IN SUCH ACTION,
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD07119-01-9
S. 3213 2
PRELIMINARY RELIEF MAY BE GRANTED UNDER ARTICLE SIXTY-THREE OF THE CIVIL
PRACTICE LAW AND RULES.
S 2. Subdivision 2 of section 6811-a of the education law, as added by
chapter 729 of the laws of 1981, is amended to read as follows:
2. No drug 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 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; [and]
(c) ITS COUNTRY OF ORIGIN; AND
(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.
S 3. This act shall take effect on the one hundred eightieth day after
it shall have become a law.