Bill Text: NY A01372 | 2013-2014 | General Assembly | Introduced
Bill Title: Provides for the proper packaging and labeling of pharmaceutical drugs; creates penalties for intentional fraudulent replacement, packaging, and labeling of such drugs; provides for better consumer protection.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2014-01-08 - referred to consumer affairs and protection [A01372 Detail]
Download: New_York-2013-A01372-Introduced.html
S T A T E O F N E W Y O R K
________________________________________________________________________
1372
2013-2014 Regular Sessions
I N A S S E M B L Y
(PREFILED)
January 9, 2013
___________
Introduced by M. of A. CAHILL -- read once and referred to the Committee
on Consumer Affairs and Protection
AN ACT to amend the general business law, in relation to preserving the
integrity and safety of pharmaceutical drugs
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
1 Section 1. The general business law is amended by adding a new section
2 392-j to read as follows:
3 S 392-J. FALSE LABELS AND MISREPRESENTATIONS OF PHARMACEUTICAL DRUGS.
4 1. A PERSON, WHO WITH INTENT TO DEFRAUD:
5 A. PUTS UPON A PHARMACEUTICAL DRUG, OR UPON A CASK, BOTTLE, STOPPER,
6 VESSEL, CASE, COVER, WRAPPER, PACKAGE, BAND, TICKET, LABEL OR OTHER
7 THING, CONTAINING OR COVERING SUCH PHARMACEUTICAL DRUG, OR WITH WHICH
8 SUCH A PHARMACEUTICAL DRUG IS INTENDED TO BE SOLD, OR IS SOLD, ANY FALSE
9 DESCRIPTION OR OTHER INDICATION OF OR RESPECTING THE TYPE OF PHARMACEU-
10 TICAL SUBSTANCE OR COMPOUND, KIND, NUMBER, QUANTITY, WEIGHT OR MEASURE
11 OF SUCH SUBSTANCE, OR ANY PART THEREOF, OR THE PLACE OR COUNTRY WHERE IT
12 WAS MANUFACTURED OR PRODUCED OR THE QUALITY OR GRADE OF ANY SUCH
13 SUBSTANCE, IF THE QUALITY OR GRADE THEREOF IS REQUIRED BY LAW TO BE
14 MARKED, BRANDED OR OTHERWISE INDICATED ON OR WITH SUCH PHARMACEUTICAL
15 DRUG; OR
16 B. SELLS OR OFFERS FOR SALE A PHARMACEUTICAL DRUG, WHICH TO HIS OR HER
17 KNOWLEDGE IS FALSELY DESCRIBED OR INDICATED UPON ANY SUCH PACKAGE, OR
18 VESSEL CONTAINING THE SAME, OR LABEL THEREUPON, IN ANY OF THE PARTIC-
19 ULARS SPECIFIED; OR
20 C. DISTRIBUTES, SELLS OR EXPOSES FOR SALE ANY GOODS IN BULK TO WHICH
21 NO NAME OR TRADEMARK SHALL BE ATTACHED, AND ORALLY OR OTHERWISE REPRES-
22 ENTS THAT SUCH PHARMACEUTICAL DRUGS ARE THE MANUFACTURE OR PRODUCTION OF
23 SOME OTHER THAN THE ACTUAL MANUFACTURER OR PRODUCER; OR
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD03753-01-3
A. 1372 2
1 D. REMOVES OR CONCEALS OR WHO SHALL CAUSE TO BE, WHOLLY OR IN PART,
2 REMOVED OR CONCEALED FROM OR UPON A PHARMACEUTICAL DRUG THE MARK OF
3 ORIGIN; OR WHO SELLS OR CAUSES TO BE SOLD AN ARTICLE OF MERCHANDISE FROM
4 OR UPON WHICH TO HIS OR ITS KNOWLEDGE, OR TO THE KNOWLEDGE OF HIS OR ITS
5 AGENTS, SERVANTS OR EMPLOYEES THERE HAS BEEN IN WHOLE OR IN PART,
6 REMOVED OR CONCEALED THE MARK OF ORIGIN, OR WHO SELLS OR CAUSES TO BE
7 SOLD A PHARMACEUTICAL DRUG FROM THE INSPECTION OF WHICH SUCH KNOWLEDGE
8 COULD HAVE BEEN OBTAINED, SHALL BE GUILTY OF A MISDEMEANOR, PROVIDED
9 THAT IT SHALL NOT BE DEEMED A VIOLATION OF THIS SECTION IF AT THE TIME
10 OF SALE SAID ARTICLE OF MERCHANDISE AND THE IMMEDIATE AND OUTER CONTAIN-
11 ER OR CONTAINERS THEREOF SHALL BE MARKED, STAMPED, TAGGED, BRANDED OR
12 LABELED IN LEGIBLE AND CONSPICUOUS ENGLISH WORDS WITH SAID MARK OF
13 ORIGIN OR THE CONCEALMENT THEREOF SHALL HAVE COMPLETELY CEASED, IN A
14 CASE WHERE THE PUNISHMENT FOR SUCH OFFENSE IS NOT SPECIALLY PROVIDED FOR
15 OTHERWISE BY STATUTE, IS GUILTY OF A MISDEMEANOR.
16 2. FOR THE PURPOSES OF THIS SECTION, THE FOLLOWING WORDS SHALL HAVE
17 THE FOLLOWING DEFINITIONS:
18 A. "PERSON" SHALL BE DEEMED TO INCLUDE A FIRM, PARTNERSHIP, ASSOCI-
19 ATION OR CORPORATION.
20 B. "SELL" SHALL BE DEEMED TO INCLUDE OFFER TO SELL, EXPOSE FOR SALE,
21 AND POSSESS WITH INTENT TO DISPOSE OF OR TO SELL.
22 C. "PHARMACEUTICAL DRUG" SHALL BE DEEMED TO INCLUDE A CASK, BOTTLE,
23 STOPPER, VESSEL, CASE, COVER, WRAPPER, PACKAGE, BAND, TICKET, LABEL OR
24 OTHER THING CONTAINING OR COVERING A PHARMACEUTICAL, OR WITH WHICH PHAR-
25 MACEUTICAL DRUG IS INTENDED TO BE SOLD, OR IS SOLD.
26 D. "REMOVE" SHALL BE DEEMED TO INCLUDE DEFACE, ALTER AND OBLITERATE.
27 E. "CONCEAL" SHALL BE DEEMED TO INCLUDE THE ORIGINAL PLACING OF A MARK
28 OF ORIGIN UPON AN ARTICLE OF MERCHANDISE IN ANY MANNER WHATSOEVER, OR
29 THE ARRANGING OR COMBINING OF TWO OR MORE ARTICLES OF MERCHANDISE INTO A
30 SINGLE UNIT WHEREBY THE MARK OF ORIGIN IS REMOVED FROM OPEN VIEW, OR IS
31 RENDERED ILLEGIBLE OR INCONSPICUOUS.
32 F. THE TERMS "REMOVE" AND "CONCEAL" ARE NOT TO BE DEEMED MUTUALLY
33 EXCLUSIVE.
34 3. WHENEVER THERE SHALL BE A VIOLATION OF THIS SECTION, AN APPLICATION
35 MAY BE MADE BY THE ATTORNEY GENERAL IN THE NAME OF THE PEOPLE OF THE
36 STATE OF NEW YORK TO A COURT OR JUSTICE HAVING JURISDICTION BY A SPECIAL
37 PROCEEDING TO ISSUE AN INJUNCTION TO ENJOIN AND RESTRAIN THE CONTINUANCE
38 OF SUCH VIOLATIONS; AND IF IT SHALL APPEAR TO THE SATISFACTION OF THE
39 COURT OR JUSTICE THAT THE DEFENDANT HAS, IN FACT, VIOLATED THIS ARTICLE,
40 AN INJUNCTION MAY BE ISSUED BY SUCH COURT OR JUSTICE ENJOINING AND
41 RESTRAINING ANY FURTHER VIOLATION, WITHOUT REQUIRING PROOF THAT ANY
42 PERSON HAS, IN FACT, BEEN INJURED OR DAMAGED THEREBY. IN ANY SUCH
43 PROCEEDING, THE COURT MAY MAKE ALLOWANCES TO THE ATTORNEY GENERAL AS
44 PROVIDED IN PARAGRAPH SIX OF SUBDIVISION (A) OF SECTION EIGHTY-THREE
45 HUNDRED THREE OF THE CIVIL PRACTICE LAW AND RULES, AND DIRECT RESTITU-
46 TION. WHENEVER THE COURT SHALL DETERMINE THAT A VIOLATION OF THIS
47 SECTION HAS OCCURRED THE COURT MAY IMPOSE A CIVIL PENALTY OF NOT MORE
48 THAN FIVE HUNDRED DOLLARS FOR EACH VIOLATION. FOR THE PURPOSES OF THIS
49 SECTION EACH GROUP OF IDENTICAL ITEMS SHALL CONSTITUTE A SINGLE
50 VIOLATION. IN CONNECTION WITH ANY SUCH PROPOSED APPLICATION, THE ATTOR-
51 NEY GENERAL IS AUTHORIZED TO TAKE PROOF AND MAKE A DETERMINATION OF THE
52 RELEVANT FACTS AND TO ISSUE SUBPOENAS IN ACCORDANCE WITH THE CIVIL PRAC-
53 TICE LAW AND RULES.
54 4. BEFORE ANY VIOLATION OF THIS SECTION IS SOUGHT TO BE ENJOINED, THE
55 ATTORNEY GENERAL SHALL BE REQUIRED TO GIVE THE PERSON AGAINST WHOM SUCH
56 PROCEEDING IS CONTEMPLATED NOTICE BY CERTIFIED MAIL AND AN OPPORTUNITY
A. 1372 3
1 TO SHOW IN WRITING WITHIN FIVE BUSINESS DAYS AFTER RECEIPT OF NOTICE WHY
2 PROCEEDINGS SHOULD NOT BE INSTITUTED AGAINST HIM, UNLESS THE ATTORNEY
3 GENERAL SHALL FIND, IN ANY CASE IN WHICH HE SEEKS PRELIMINARY RELIEF,
4 THAT TO GIVE SUCH NOTICE AND OPPORTUNITY IS NOT IN THE PUBLIC INTEREST.
5 5. IN ANY SUCH ACTION IT SHALL BE A COMPLETE DEFENSE THAT THE ACTOR
6 PRACTICE IS, OR IF IN INTERSTATE COMMERCE WOULD BE, SUBJECT TO AND
7 COMPLIES WITH THE RULES AND REGULATIONS OF, AND THE STATUTES ADMINIS-
8 TERED BY, THE FEDERAL FOOD AND DRUG ADMINISTRATION OR ANY OFFICIAL
9 DEPARTMENT, DIVISION, COMMISSION OR AGENCY OF THE UNITED STATES AS SUCH
10 RULES, REGULATIONS OR STATUTES ARE INTERPRETED BY THE FEDERAL FOOD AND
11 DRUG ADMINISTRATION OR SUCH DEPARTMENT, DIVISION, COMMISSION OR AGENCY
12 OR THE FEDERAL COURTS.
13 S 2. This act shall take effect immediately.
