NY State Senate Bill 2013-S4144

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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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2014	referred to higher education
Mar 12, 2013	referred to higher education

2013-S4144 (ACTIVE) - Details

See Assembly Version of this Bill:: A5925
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6808, Ed L
Versions Introduced in Other Legislative Sessions:: 2011-2012: A2460
2015-2016: S3487, A60
2017-2018: A2848

2013-S4144 (ACTIVE) - Summary

Relates to applicant registration for wholesalers or manufacturers of prescription drugs; criminal history search.

2013-S4144 (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S4144

TITLE OF BILL:  An act to amend the education law, in relation to
wholesalers and manufacturers of prescription drugs

PURPOSE: To strengthen the requirements for registration as a
wholesaler or manufacturer.

SUMMARY OF PROVISIONS:  Section one amends subparagraph 2 of paragraph
a of subdivision 4 of section 6808 of the education law, as amended by
chapter 62 of the laws of 1989, by increasing the application fee that
shall accompany the registration for a wholesaler or manufacturer to
one thousand two hundred dollars from the current eight hundred
twenty-five dollars.

Section two amends paragraphs b and d of subdivision 4 of section 6808
of the education law, paragraph b as amended by chapter 538 of the
laws of 2001 and paragraph d as amended by chapter 62 of the laws of
1989. Paragraph b is amended by providing that the triennial
registration fee that is paid by wholesalers and manufacturers shall
be increased to eight hundred dollars, from five hundred twenty
dollars, or a pro rated portion as determined by the department of
education. Paragraph d provides that in the event that the location of
a business changes, the fee for inspection and endorsement shall be
increased to three hundred dollars from the current one hundred
seventy dollars.

Section three amends subdivision 4 of section 6808 of the education
law by adding six new paragraphs e, f, g, h, i and j. Paragraph e
provides that any applicant for registration as a wholesaler or
manufacturer shall be of good moral character, as determined by the
department of education. The department shall require a criminal
history records search for officers, directors and owners of such
wholesaler or manufacturer. Paragraph f provides that upon receipt of
an application for registration, the commissioner shall initiate a
criminal history records search of the persons identified in paragraph
e. Prior to conducting the criminal history records search and
fingerprinting process, the commissioner shall obtain the applicant's
consent to the criminal history records search. Paragraph f further
sets forth the process and procedures to be followed by the
commissioner and the division of criminal justice services in
conducting the criminal history records search. "Criminal history
record" is defined. All such criminal history records shall be
confidential pursuant to applicable federal and state laws, rules and
regulations, and shall not be published or disclosed to persons other
than the commissioner unless otherwise authorized by law. Any person
who willfully permits the release of any confidential criminal history
information to persons not permitted to receive such information shall
be guilty of a misdemeanor.

Paragraph g provides additional duties of the commissioner and the
department, including promulgating rules and regulations to require
the performance of a criminal history records check of the individuals
identified in paragraph e, and a form to be provided to all applicants
for registration. Specifics of such form are outlined.  Paragraph-h
provides that every wholesaler shall submit a performance or surety


bond of not less than one hundred thousand dollars to the department
to ensure compliance with the provisions of this article.  The
department may waive such bond for certain not-for-profit entities or
certain other wholesalers. Paragraph i provides that the department
may promulgate rules and regulations to exempt from the requirements
of paragraphs e, E, g and h a wholesaler that has received
accreditation from a nationally recognized accreditation body approved
by the commissioner and that meets the licensing standards under this
subdivision. Paragraph j provides that the commissioner shall exempt
certain manufacturers from the requirements of paragraphs e, f, g and
h in the event that such requirements are not required by federal law
or regulation, unless the commissioner determines that such
requirements are necessary to prevent a risk to prescription drug
distribution in the state.

Section four provides the effective date.

JUSTIFICATION: The marketing of counterfeit drugs has become prevalent
throughout the United States as well as around the world. The World
Health Organization (WHO) estimates that counterfeit drugs make up 10%
of all drugs sold worldwide, With the percentage much higher in
developing countries. January 2009 Report by the American Council on
Science and Health, "Counterfeit Drugs: Coming to a Pharmacy Near You
with an Update for 2009Ö (ACSH 2009 Report). According to the National
Association of Boards of Pharmacy (NAP), counterfeit drug sales
accounted for $75 billion in global sales in 2010, with an estimated 1
to 2 percent of drugs in North America being counterfeit.  Moreover,
counterfeit drugs have contributed to the increasing drug resistance
of the most deadly infectious diseases such as HIV/AIDS, tuberculosis
and malaria.

Despite the view that the U.S. drug supply is among the most secure in
the world, the growing size and sophistication of counterfeit, drug
rings have allowed them to penetrate the legitimate drug supplies of
the United States. In the last five years, counterfeit drug
investigations by the Office of Criminal Investigations of the Food
and Drug Administration (FDA) increased almost ten-fold, from 6 in
2000 to 59 in 2004.

If we accept the NABP's estimate that 1-2% of drugs sold in North
America are counterfeit (compared to a WHO estimate of 5% to 7% in the
United States), the odds are, conservatively, 1 in 100 that the drug a
consumer receives at a pharmacy in the U.S. is counterfeit and that
out of the approximately 3.7 billion prescriptions filled in the U.S.
this year, as many as 37 million may have been filled with counterfeit
versions.  There is, however, no way to know the true degree to which
counterfeit drugs have contaminated our drug supply. Most of the
incidents go undetected since the evidence is usually destroyed when
the drug is consumed and the results of taking the counterfeit drug
are blamed on other causes, such as incorrect diagnosis, or in the
case of HIV/AIDS further complications and death are expected.
Recently, two highly publicized examples of counterfeit drugs come to
mind: Lipitor tablets used to lower cholesterol, where in 2005 in New
York State alone, New Yorkers received an estimated 100,000 dosage
units of counterfeit Lipitor; and Procrit, an injectable drug used to
stimulate red blood cell growth to treat severe anemia and anemia
related to treatment for HIV/AIDS. There have been cases of


counterfeits of other well-known brands as well as drugs used to.
treat critically-ill patients in the U.S. in the last few years to
hundreds of thousands of unwitting patients, including:

*Combivir, used to prolong the life of HIV/AIDS patients by preventing
the virus from reproducing--replaced with another HIV medication that
can cause fatal allergic reactions

*Serostim, a human growth hormone used to prevent HIV/AIDS patients
from wasting-replaced with dangerous levels of a fertility drug

*Celebrex, used to treat arthritis--replaced with vitamins

*Viagra, used to treat impotence--over 700,000 counterfeit pills were
manufactured

*Zyprexa, used to help prevent hallucinations and delusions in
schizophrenic and bipolar patients-replaced with aspirin

*Neupogen, an injectable used to boost the immune system of cancer
patients-replaced with saline

ACSH 2009 Report. In addition; there have been multiple incidents
involving counterfeit versions of Tamiflu, used to treat seasonal or
avian flu. Aside from the obvious direct result of receiving the
counterfeit medicine, treatment from counterfeit versions may also
increase the risk of causing the virus to develop a resistance to the
Tamiflu drug.

The nature of the drug supply system in the U.S. makes our drugs ripe
for diversion and counterfeiting. The path of a drug from manufacturer
to distributor to pharmacy more often than not is not a single or
linear one; in fact, a substantial portion of our drugs flow through a
complex network of distributors, intermediaries and secondary
wholesalers.

Recognizing the need to assure the safe and effective distribution of
prescription drugs, Congress enacted more than 20 years ago the
Prescription Drug Manufacturing Act (PDMA) which, among other things,
imposed a requirement on wholesale distributors to maintain either a
paper or electronic pedigree of prescription drugs. Pending
development of appropriate technology to facilitate the establishment
of an electronic pedigree for prescription drugs, and thereby allow us
to track and trade prescription drugs through the supply chain, the
FDA has stated that all levels of government, in addition to the
private sector, should take responsibility for ensuring the safety and
security of the U.S. drug distribution system. Counterfeit Drug Task
Eeport February 2004 Update, 2009. At the State level, the Update
noted that it would be beneficial for states to strengthen their
provisions governing wholesale distribution. The Update further
reported that the FDA planned to pursue increased criminal penalties
for counterfeiting in the United States Sentencing Commissions
sentencing guidelines. To date, thirty six states have strengthened
licensure requirements of wholesalers through legislation and/or
regulations.


To better secure the drug supply system pending implementation of
federal law, we must adopt at the state level a multi-layered strategy
that includes strengthening the licensing requirements of wholesalers
so that our regulatory agencies have the authority to carry out the
law.  Ensuring that all persons and entities involved in the wholesale
distribution of drug products meet stringent licensing criteria and
maintain high ethical and business standards is critical.

This bill toughens the licensing requirements of manufacturers and
wholesalers by, among other things, carrying out criminal background
checks of responsible individuals and requiring significant surety
bonds, decreasing the likelihood that corrupt, "fly-by-night"
operations will be able to infiltrate the supply chain and adulterate
or taint the prescription drugs.

Without enacting legislation at the state level to address the
weaknesses inherent in our drug supply system, we will continue to
leave the Public vulnerable to individuals who are willing to harm,
and even kill, people for profit.

LEGISLATIVE HISTORY: Similar to A.2460-A, 2011 referred to higher
education and 2012 referred to Codes. Same as S.5286-A, 2011 and 2012,
referred to higher education. Similar to A.6546-A, 2009 and 2010
referred to higher education. Similar to A.7810-C, 2007 and 2008
referred to higher education. Same as S.5290-C, 2007 and 2008 referred
to health. Similar to A.2957-B, 2005 and 2006 referred to higher
education. Same as S.3278-A, 2005 passed senate and 2006 referred to
higher education.

FISCAL IMPLICATIONS: None to the state.

EFFECTIVE DATE: This act shall take effect on the one hundred and
eightieth day after it shall have become law.

2013-S4144 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  4144

                       2013-2014 Regular Sessions

                            I N  S E N A T E

                             March 12, 2013
                               ___________

Introduced  by  Sen.  LANZA  -- 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  wholesalers  and
  manufacturers of prescription drugs

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1.  Subparagraph 2 of paragraph a of subdivision 4 of  section
6808 of the education law, as amended by chapter 62 of the laws of 1989,
is amended to read as follows:
  (2)  The  application  shall be accompanied by a fee of [eight hundred
twenty-five] TWELVE HUNDRED dollars.
  S 2. Paragraphs b and d of subdivision 4 of section 6808 of the educa-
tion law, paragraph b as amended by chapter 538 of the laws of 2001  and
paragraph d as amended by chapter 62 of the laws of 1989, are amended to
read as follows:
  b. Renewal of registration. All wholesalers' and manufacturers' regis-
trations  shall be renewed on dates set by the department. The triennial
registration fee shall be [five hundred twenty] EIGHT HUNDRED dollars or
a pro rated portion thereof as determined by the department.
  d. Change of location. In the event that the location of such place of
business shall be changed, the owner shall apply to the  department  for
inspection  of  the new location and endorsement of the registration for
the new location. The fee for inspection and endorsement shall  be  [one
hundred  seventy] THREE HUNDRED dollars, unless it appears to the satis-
faction of the department that the change in location is of a  temporary
nature due to fire, flood or other disaster.
  S  3. Subdivision 4 of section 6808 of the education law is amended by
adding six new paragraphs e, f, g, h, i and j to read as follows:
  E. APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A  WHOLE-
SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY
THE  DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F AND G OF THIS

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD05506-03-3

S. 4144                             2

SUBDIVISION, THE DEPARTMENT SHALL REQUIRE  A  CRIMINAL  HISTORY  RECORDS
SEARCH FOR OFFICERS, DIRECTORS AND OWNERS OF SUCH WHOLESALER OR MANUFAC-
TURER.  FOR  THE PURPOSES OF THIS PARAGRAPH, "OWNER" SHALL MEAN A PERSON
WHO  HAS  A TEN PERCENT OR GREATER OWNERSHIP INTEREST IN SUCH WHOLESALER
OR MANUFACTURER.
  F. CRIMINAL HISTORY RECORDS SEARCH. (1) UPON RECEIPT OF AN APPLICATION
FOR REGISTRATION PURSUANT TO THIS SUBDIVISION, THE  COMMISSIONER  SHALL,
SUBJECT TO THE RULES AND REGULATIONS OF THE DIVISION OF CRIMINAL JUSTICE
SERVICES,  INITIATE  A  CRIMINAL  HISTORY  RECORDS SEARCH OF THE PERSONS
IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION.  PRIOR TO INITIATING  THE
BACKGROUND  CHECKS  AND  FINGERPRINTING  PROCESS, THE COMMISSIONER SHALL
FURNISH THE APPLICANT WITH THE FORM DESCRIBED IN  PARAGRAPH  G  OF  THIS
SUBDIVISION  AND  SHALL  OBTAIN  THE APPLICANT'S CONSENT TO THE CRIMINAL
HISTORY RECORDS SEARCH. THE COMMISSIONER SHALL OBTAIN FROM  EACH  APPLI-
CANT  TWO  SETS  OF  FINGERPRINTS  AND  THE DIVISION OF CRIMINAL JUSTICE
SERVICES PROCESSING FEE  IMPOSED  PURSUANT  TO  SUBDIVISION  EIGHT-A  OF
SECTION  EIGHT  HUNDRED  THIRTY-SEVEN  OF  THE EXECUTIVE LAW AND ANY FEE
IMPOSED BY THE FEDERAL BUREAU OF INVESTIGATION FOR A  NATIONAL  CRIMINAL
HISTORY  RECORD  CHECK.  THE  COMMISSIONER  SHALL PROMPTLY TRANSMIT SUCH
FINGERPRINTS AND FEES TO THE DIVISION OF CRIMINAL JUSTICE  SERVICES  FOR
ITS  FULL SEARCH AND RETAIN PROCESSING. THE DIVISION OF CRIMINAL JUSTICE
SERVICES IS AUTHORIZED TO SUBMIT THE FINGERPRINTS  AND  THE  APPROPRIATE
FEE  TO  THE  FEDERAL  BUREAU  OF  INVESTIGATION FOR A NATIONAL CRIMINAL
HISTORY RECORD CHECK. THE DIVISION OF CRIMINAL JUSTICE SERVICES AND  THE
FEDERAL  BUREAU  OF  INVESTIGATION  SHALL  FORWARD SUCH CRIMINAL HISTORY
RECORD, IF ANY, TO THE COMMISSIONER IN A TIMELY MANNER.  CRIMINAL HISTO-
RY INFORMATION PROVIDED BY THE DIVISION  OF  CRIMINAL  JUSTICE  SERVICES
PURSUANT  TO  THIS  SUBDIVISION SHALL BE FURNISHED ONLY BY MAIL OR OTHER
METHOD OF SECURE AND CONFIDENTIAL DELIVERY, ADDRESSED TO THE COMMISSION-
ER. SUCH INFORMATION AND THE ENVELOPE IN WHICH IT IS ENCLOSED,  IF  ANY,
SHALL  BE  PROMINENTLY  MARKED "CONFIDENTIAL," AND SHALL AT ALL TIMES BE
MAINTAINED BY THE OFFICE IN A SECURE  PLACE.    THE  COMMISSIONER  SHALL
CONSIDER  SUCH  CRIMINAL  HISTORY RECORD IN ACCORDANCE WITH THE REQUIRE-
MENTS OF ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW  AND  SUBDIVISIONS
FIFTEEN  AND  SIXTEEN OF SECTION TWO-HUNDRED NINETY-SIX OF THE EXECUTIVE
LAW.
  (2) FOR THE PURPOSES  OF  THIS  SECTION  THE  TERM  "CRIMINAL  HISTORY
RECORD"  SHALL  MEAN A RECORD OF ALL CONVICTIONS OF CRIMES THAT HAVE NOT
BEEN VACATED, REVERSED OR SEALED, AND ANY PENDING CRIMINAL CHARGES MAIN-
TAINED BY THE DIVISION OF CRIMINAL  JUSTICE  SERVICES  AND  THE  FEDERAL
BUREAU OF INVESTIGATION.
  FURTHERMORE,  UPON  NOTIFICATION  THAT  SUCH APPLICANT HAS BEEN REGIS-
TERED, THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL HAVE THE AUTHORI-
TY TO PROVIDE SUBSEQUENT CRIMINAL HISTORY NOTIFICATIONS DIRECTLY TO  THE
COMMISSIONER.  ALL  SUCH  CRIMINAL  HISTORY  RECORDS  PROCESSED AND SENT
PURSUANT TO THIS SUBDIVISION  SHALL  BE  CONFIDENTIAL  PURSUANT  TO  THE
APPLICABLE  FEDERAL AND STATE LAWS, RULES AND REGULATIONS, AND SHALL NOT
BE PUBLISHED OR IN ANY WAY DISCLOSED TO PERSONS OTHER THAN  THE  COMMIS-
SIONER,  UNLESS  OTHERWISE  AUTHORIZED  BY LAW. ANY PERSON WHO WILLFULLY
PERMITS THE RELEASE OF ANY  CONFIDENTIAL  CRIMINAL  HISTORY  INFORMATION
CONTAINED  IN  THE  REPORT  TO  PERSONS NOT PERMITTED BY THIS SECTION TO
RECEIVE SUCH INFORMATION SHALL BE GUILTY OF A MISDEMEANOR.
  G. ADDITIONAL DUTIES OF  THE  COMMISSIONER  AND  DEPARTMENT.  (1)  THE
COMMISSIONER,  IN  COOPERATION  WITH  THE  DIVISION  OF CRIMINAL JUSTICE
SERVICES AND IN ACCORDANCE WITH ALL APPLICABLE PROVISIONS OF LAW,  SHALL
PROMULGATE  RULES AND REGULATIONS TO REQUIRE THE PERFORMANCE OF A CRIMI-

S. 4144                             3

NAL HISTORY RECORDS CHECK OF THE INDIVIDUALS IDENTIFIED IN  PARAGRAPH  E
OF THIS SUBDIVISION.
  (2)  THE  COMMISSIONER,  IN  COOPERATION WITH THE DIVISION OF CRIMINAL
JUSTICE SERVICES, SHALL PROMULGATE A FORM TO BE PROVIDED TO  ALL  APPLI-
CANTS FOR REGISTRATION PURSUANT TO THIS SUBDIVISION THAT SHALL:
  (I) INFORM THE PROSPECTIVE APPLICANT THAT THE COMMISSIONER IS REQUIRED
TO  REQUEST HIS OR HER CRIMINAL HISTORY INFORMATION FROM THE DIVISION OF
CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU  OF  INVESTIGATION  AND
REVIEW  SUCH  INFORMATION  PURSUANT  TO  THIS  SECTION,  AND  PROVIDE  A
DESCRIPTION OF THE MANNER IN WHICH HIS OR HER FINGERPRINT CARDS WILL  BE
USED UPON SUBMISSION TO THE DIVISION OF CRIMINAL JUSTICE SERVICES; AND
  (II)  INFORM THE PROSPECTIVE APPLICANT THAT HE OR SHE HAS THE RIGHT TO
OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFOR-
MATION PURSUANT TO REGULATIONS AND PROCEDURES ESTABLISHED BY  THE  DIVI-
SION OF CRIMINAL JUSTICE SERVICES.
  (3)  THE  DEPARTMENT SHALL OBTAIN THE SIGNED, INFORMED CONSENT OF EACH
INDIVIDUAL IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, ON  SUCH  FORM
SUPPLIED BY THE COMMISSIONER, WHICH INDICATES THAT SUCH PERSON HAS:
  (I)  BEEN  INFORMED  OF THE RIGHTS AND PROCEDURES NECESSARY TO OBTAIN,
REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFORMATION;
  (II) BEEN INFORMED OF THE REASON FOR THE REQUEST FOR HIS OR HER CRIMI-
NAL HISTORY INFORMATION;
  (III) CONSENTED TO SUCH REQUEST FOR A REPORT;
  (IV) SUPPLIED ON THE FORM A CURRENT MAILING OR HOME ADDRESS  FOR  SUCH
INDIVIDUAL;
  (V)  BEEN  INFORMED  THAT  HE  OR SHE MAY WITHDRAW HIS OR HER CONSENT,
REGARDLESS OF WHETHER THE  DEPARTMENT  HAS  REVIEWED  SUCH  INDIVIDUAL'S
CRIMINAL HISTORY INFORMATION;
  (VI)  BEEN  INFORMED THAT IN THE EVENT THE WHOLESALER'S OR MANUFACTUR-
ER'S REGISTRATION PURSUANT TO THIS SUBDIVISION HAS EXPIRED OR  OTHERWISE
TERMINATED,  THE  COMMISSIONER  SHALL  NOTIFY  THE  DIVISION OF CRIMINAL
JUSTICE SERVICES OF SUCH EXPIRATION OR TERMINATION, AND THE DIVISION  OF
CRIMINAL JUSTICE SERVICES SHALL DESTROY THE FINGERPRINTS OF THE INDIVID-
UAL  OR  INDIVIDUALS ASSOCIATED WITH SUCH WHOLESALER'S OR MANUFACTURER'S
REGISTRATION; AND
  (VII) BEEN INFORMED OF THE MANNER IN WHICH HE OR SHE MAY SUBMIT TO THE
COMMISSIONER ANY INFORMATION THAT MAY BE RELEVANT TO  THE  CONSIDERATION
OF THE APPLICANT'S REGISTRATION INCLUDING, WHERE APPLICABLE, INFORMATION
IN SUPPORT OF HIS OR HER GOOD MORAL CHARACTER OR REHABILITATION THEREOF.
  (4)  UPON  RECEIPT  OF  CRIMINAL  HISTORY INFORMATION PURSUANT TO THIS
SECTION AND BEFORE MAKING ANY DETERMINATION  THEREON,  THE  COMMISSIONER
SHALL PROVIDE THE INDIVIDUAL WITH A COPY OF SUCH CRIMINAL HISTORY INFOR-
MATION  AND  A  COPY OF ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW AND
INFORM SUCH INDIVIDUAL OF HIS OR HER RIGHT TO  SEEK  CORRECTION  OF  ANY
INCORRECT  INFORMATION  CONTAINED  IN  SUCH CRIMINAL HISTORY INFORMATION
PURSUANT TO THE REGULATIONS AND PROCEDURES ESTABLISHED BY  THE  DIVISION
OF CRIMINAL JUSTICE SERVICES.
  H.  PERFORMANCE  OR  SURETY  BOND.  EVERY  WHOLESALER  SHALL  SUBMIT A
PERFORMANCE OR SURETY BOND OF NOT LESS THAN ONE HUNDRED THOUSAND DOLLARS
TO THE DEPARTMENT TO ENSURE COMPLIANCE WITH THE PROVISIONS OF THIS ARTI-
CLE, EXCEPT  THAT  THE  DEPARTMENT  MAY  WAIVE  SUCH  BOND  FOR  CERTAIN
NOT-FOR-PROFIT  ENTITIES  SUCH  AS HOSPITALS AND CORRECTIONAL FACILITIES
THAT LIMIT DISTRIBUTION TO THEIR OWN FACILITIES AND DO NOT  RETURN  SUCH
MEDICATIONS  TO  OTHER ENTITIES. THE DEPARTMENT MAY ALSO EXEMPT A WHOLE-
SALER FROM THE SURETY BOND REQUIREMENT WHEN SUCH WHOLESALER IS OWNED AND
OPERATED  BY  A  FACILITY,  SUBJECT  TO  THE   PROVISIONS   OF   ARTICLE

S. 4144                             4

TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A
STATE  AGENCY  THAT  LIMITS  ITS  DISTRIBUTION  OF PRESCRIPTION DRUGS TO
FACILITIES AND PRACTITIONERS WITHIN THE INSTITUTION'S NETWORK AND  OPER-
ATIONS  AND DOES NOT SELL OR RETURN SUCH MEDICATIONS TO MANUFACTURERS OR
TO OTHER WHOLESALERS.
  I. WHOLESALER REGISTRATION. THE DEPARTMENT MAY  PROMULGATE  RULES  AND
REGULATIONS  TO EXEMPT FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND H
OF THIS SUBDIVISION A WHOLESALER THAT HAS RECEIVED ACCREDITATION FROM  A
NATIONALLY  RECOGNIZED  ACCREDITATION  BODY APPROVED BY THE COMMISSIONER
AND THAT MEETS THE LICENSING STANDARDS UNDER THIS SUBDIVISION. THE STAN-
DARDS SHALL BE DEFINED BY THE COMMISSIONER PURSUANT TO REGULATIONS.
  J. MANUFACTURER REGISTRATION.  NOTWITHSTANDING  THE  REQUIREMENTS  FOR
REGISTRATION  UNDER  THIS  SUBDIVISION,  THE COMMISSIONER SHALL EXEMPT A
MANUFACTURER LICENSED OR APPROVED BY THE FEDERAL FOOD AND DRUG  ADMINIS-
TRATION  (FDA)  OR  ITS SUCCESSOR AGENCY TO MANUFACTURE DRUGS OR DEVICES
WITH REGARD TO SUCH DRUGS OR DEVICES FROM THE REQUIREMENTS OF PARAGRAPHS
E, F, G AND H OF THIS SUBDIVISION IN THE EVENT  THAT  SUCH  REQUIREMENTS
ARE  NOT  REQUIRED  BY FEDERAL LAW OR REGULATION UNLESS THE COMMISSIONER
DETERMINES THAT SUCH REQUIREMENTS ARE NECESSARY TO  PREVENT  A  RISK  TO
PRESCRIPTION DRUG DISTRIBUTION IN THE STATE.
  S 4. This act shall take effect on the one hundred eightieth day after
it shall have become a law.

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Senate Bill S4144

Sponsored By

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

2013-S4144 (ACTIVE) - Details

2013-S4144 (ACTIVE) - Summary

2013-S4144 (ACTIVE) - Sponsor Memo

2013-S4144 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S4144

Share this bill

Sponsored By

Andrew J. Lanza

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

2013-S4144 (ACTIVE) - Details

2013-S4144 (ACTIVE) - Summary

2013-S4144 (ACTIVE) - Sponsor Memo

2013-S4144 (ACTIVE) - Bill Text download pdf

Comments