senate Bill S6739A

2013-2014 Legislative Session

Requires the commissioner of health to establish and publish a list of generic drug products; repealer

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Archive: Last Bill Status - In Committee


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Jun 02, 2014 print number 6739a
amend and recommit to health
Mar 05, 2014 referred to health

Bill Amendments

Original
A (Active)
Original
A (Active)

S6739 - Bill Details

See Assembly Version of this Bill:
A8057A
Current Committee:
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L

S6739 - Bill Texts

view summary

Requires the commissioner of health to establish and publish a list of generic drug products.

view sponsor memo
BILL NUMBER:S6739

TITLE OF BILL: An act to amend the public health law and the
education law, in relation to generic drug products; and to repeal
paragraph (o) of subdivision 1 of section 206 of the public health law
relating thereto

PURPOSE OR GENERAL IDEA OF BILL:

To make relevant information related to generic drugs freely and
publicly available.

SUMMARY OF SPECIFIC PROVISIONS:

Section one repeals paragraph (o) of subdivision 1 of section 206 of
the public health law (PHL).

Section two adds a new section 280-a, named "generic drug products",
to the PHL. The provisions included in subdivision one are taken from
paragraph (o) of subdivision one of section 205 of the PHL, which has
been repealed. This new subdivision provides that the health
commissioner shall establish a list of drug products, which must be
certified or approved and evaluated as therapeutically and
pharmaceutically equivalent by the Federal Food and Drug
Administration. Subdivision two provides that the distributor or
manufacturer of a generic drug product shall make available to the
department of health the biopharmaceutic studies and summaries
(including bioequivalence data and incidence of adverse events) and
associated analytical methods (including dissolution data and test
methods) provided to the FDA as part of the application for such
generic drug product. The department shall make such information
freely and publicly available on its website.

Section 3 and section 4 change the references to paragraph (o) of
subdivision 1 of section 206 of the PHL in the Education Law.

Section 5 provides the effective date.

JUSTIFICATION:

New York State Law (paragraph (o) of subdivision 1 of section 206 of
the Public Health Law) provides that the health commissioner shall
establish and maintain a list of generic drug products, which must
meet specified conditions. The bill repeals this paragraph and
transfers its language to a new section (280-a) of the PHL, named
"generic drug products.Ö This way, the provisions related to generic
drugs are easily accessible.

The bill also introduces a new provision (subdivision 2 of the new
section 208-a) to make relevant information related to generic drug
products freely and publicly available.

The Center for Drug Evaluation and Research defines a generic drug as
a drug product that is comparable to a brand/reference listed drug
product in dosage form, strength, route of administration, quality and
performance characteristics, and intended use. Generic drugs are
approved by the FDA and represent an affordable option for users. To


receive approval by the FDA, generic drug manufacturers have to submit
specified documents and reports, proving that their drug is
bioequivalent to the respective brand name drug.

The information that producers and manufacturers provide to the FDA is
not publicly available. For most generic drugs, consumers can access
such information only by going through a formal FOIL request. This
process can be extremely difficult and time-consuming.

Moreover, the availability of such information is extremely valuable.
The FDA has to process thousands of drug applications and mostly
relies on studies submitted by the drug producers or manufacturers
when making bioequivalence assessments.

In 2008, the FDA declared Teva's Budeprion XL 300 (generic version of
the antidepressant Wellbutrin XL 300 mg) as safe and effective.
However, consumers started to complain about the generic version of
Wellbutrin: after switching to the generic formulation, many reported
symptoms such as headaches, irritability, nausea, and return of
depression.

In 2012, the FDA announced that the Teva's generic drug is NOT
bioequivalent to the brand name drug. The reversal was based on a FDA
bioequivalence study which found Budeprion XL 300 achieved only 75%.
of the maximum drug concentration attained with Wellbutrin XL 300 mg
(potentially explaining the return of depression in patients switched
to Budeprion XL 300). Teva's product released much of its drug earlier
than Wellbutrin. The dissolution rate greatly affects how a drug is
released in the human body. This ultimately affects the drug
effectiveness. The new results obtained by the FDA closely matched the
results of independent organizations that tested the two drugs for
bioequivalence.

The biopharmaceutic studies and summaries, dissolution data, and test
methods provided to the FDA by generic drugs producers must be
available. This way, such information can be reviewed and analyzed by
experts who can conduct independent evaluations of the drugs.

The intent of the bill is to encourage transparency, in order to
protect consumers. Certainly, consumers should have the option to have
their prescription filled with a generic product, particularly since
generics often cost less than brand name drugs. However, consumers
must be informed of the drawbacks, if any, of taking a generic drug
instead of the brand name drug. Consumers have the right to know what
the differences between brand and generic drugs are and decide, with
their physicians and pharmacists, whether the generic product is
appropriate for them.

PRIOR LEGISLATIVE HISTORY:

This is a new bill.

FISCAL IMPLICATIONS:

None to the State.

EFFECTIVE DATE:


This act shall take effect on the ninetieth day after it shall have
become a law.

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

                                  6739

                            I N  S E N A T E

                              March 5, 2014
                               ___________

Introduced  by  Sen.  LANZA  -- 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 generic drug products; and to repeal paragraph (o) of subdivision 1
  of section 206 of the public health law relating thereto

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

  Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
health law is REPEALED.
  S 2. The public health law is amended by adding a new section 280-a to
read as follows:
  S  280-A.  GENERIC  DRUG PRODUCTS. 1. THE COMMISSIONER SHALL ESTABLISH
AND PUBLISH A LIST OF DRUG PRODUCTS, REFERRED  TO  IN  THIS  SECTION  AS
"GENERIC  DRUG"  PRODUCTS, EACH OF WHICH SHALL MEET THE FOLLOWING CONDI-
TIONS:
  (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
ER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND  EFFEC-
TIVE  FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION OR
AN ABBREVIATED NEW-DRUG APPLICATION APPROVED  PURSUANT  TO  THE  FEDERAL
FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
  (B)  THE  COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION HAS
EVALUATED SUCH DRUG  PRODUCT  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY
EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
PRODUCTS  WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED, HOWEV-
ER, THAT THE LIST PREPARED BY THE COMMISSIONER  SHALL  NOT  INCLUDE  ANY
DRUG  PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMIN-
ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
PROBLEM.
  2. THE DISTRIBUTOR OR MANUFACTURER OF A  GENERIC  DRUG  PRODUCT  SHALL
MAKE  AVAILABLE TO THE DEPARTMENT THE BIOPHARMACEUTIC STUDIES AND SUMMA-
RIES, INCLUDING BIOEQUIVALENCE DATA AND INCIDENCE OF ADVERSE EVENTS, AND
ASSOCIATED ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METH-
ODS PROVIDED TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF  THE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11513-01-3

S. 6739                             2

APPLICATION  FOR  SUCH  GENERIC  DRUG PRODUCT. THE DEPARTMENT SHALL MAKE
SUCH INFORMATION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
  S  3.  Paragraphs  (a) and (d) of subdivision 6 of section 6810 of the
education law, paragraph (a) as amended by chapter 590 of  the  laws  of
2011  and paragraph (d) as added by chapter 913 of the laws of 1986, are
amended to read as follows:
  (a) Every prescription written in this state by a person authorized to
issue such prescription shall be on prescription  forms  containing  one
line  for  the  prescriber's signature. The prescriber's signature shall
validate the prescription. Every electronic prescription  shall  provide
for  the  prescriber's  electronic  signature,  which shall validate the
electronic prescription. Imprinted conspicuously on  every  prescription
written  in  this state in eight point upper case type immediately below
the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless
the  prescriber  writes  d a w in such box in the prescriber's own hand-
writing or, in the case of electronic prescriptions,  inserts  an  elec-
tronic  direction  to  dispense  the  drug  as written, the prescriber's
signature or electronic signature shall designate  approval  of  substi-
tution  by a pharmacist of a GENERIC drug product pursuant to [paragraph
(o) of subdivision one of] section [two hundred six] TWO HUNDRED  EIGHT-
Y-A  of  the  public health law.   No other letters or marks in such box
shall prohibit substitution. No prescription forms used or  intended  to
be  used  by a person authorized to issue a prescription shall have 'd a
w' preprinted in such box. Such box shall be placed directly  under  the
signature  line  and shall be three-quarters inch in length and one-half
inch in height, or in comparable form for an electronic prescription  as
may  be  specified  by regulation of the commissioner. Immediately below
such box shall be imprinted in six point type  the  words  "Dispense  As
Written".    Notwithstanding  any other provision of law, no state offi-
cial, agency, board or other entity shall promulgate any  regulation  or
guideline  modifying  those elements of the prescription form's contents
specified in this subdivision. To the extent otherwise permitted by law,
a prescriber may modify only those elements of the  prescription  form's
contents  not  specified  in this subdivision. Notwithstanding any other
provision of this section or any other law, when a generic drug  is  not
available and the brand name drug originally prescribed is available and
the  pharmacist  agrees  to  dispense the brand name product for a price
that will not exceed the price that would  have  been  charged  for  the
generic substitute had it been available, substitution of a generic drug
product  will not be required. If the generic drug product is not avail-
able and a medical emergency  situation,  which  for  purposes  of  this
section is defined as any condition requiring alleviation of severe pain
or  which  threatens  to  cause  disability or take life if not promptly
treated, exists, then the pharmacist may dispense the brand name product
at his regular price. In such instances the pharmacist must  record  the
date,  hour  and  nature  of  the  medical  emergency on the back of the
prescription and keep a copy of all such prescriptions.
  (d) No prescriber shall be subjected to civil liability arising solely
from authorizing, in accordance with this subdivision, the  substitution
by  a pharmacist of a GENERIC drug product pursuant to [paragraph (o) of
subdivision one of] section [two hundred six] TWO  HUNDRED  EIGHTY-A  of
the public health law.
  S 4. Paragraph (b) of subdivision 1 of section 6816-a of the education
law,  as added by chapter 776 of the laws of 1977, is amended to read as
follows:

S. 6739                             3

  (b) The substituted drug product is contained in the list  of  GENERIC
drug  products established pursuant to [paragraph (o) of subdivision one
of] section [two hundred six] TWO HUNDRED EIGHTY-A of the public  health
law; and
  S  5.  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 is authorized to be made and completed on
or before such effective date.

S6739A (ACTIVE) - Bill Details

See Assembly Version of this Bill:
A8057A
Current Committee:
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L

S6739A (ACTIVE) - Bill Texts

view summary

Requires the commissioner of health to establish and publish a list of generic drug products.

view sponsor memo
BILL NUMBER:S6739A

TITLE OF BILL: An act to amend the public health law and the
education law, in relation to generic drug products; and to repeal
paragraph (o) of subdivision 1 of section 206 of the public health law
relating thereto

PURPOSE OR GENERAL IDEA OF BILL: To make relevant information related
to generic drugs freely and publicly available.

SUMMARY OF SPECIFIC PROVISIONS:

Section one repeals paragraph (o) of subdivision 1 of section 206 of
the public health law (PHL).

Section two adds a new section 280-a, named "generic drug products",
to the PHL. The provisions included in subdivision one are taken from
paragraph (o) of subdivision one of section 205 of the PHL, which has
been repealed. This new subdivision provides that the health
commissioner shall establish a list of drug products, which must be
certified or approved and evaluated as therapeutically and
pharmaceutically equivalent by the Federal Food and Drug
Administration. Subdivision two provides that the manufacturer of a
generic drug product shall make available to the department of health
the biopharmaceutic studies and summaries (including bioequivalence
data and incidence of adverse events) and associated analytical
methods (including dissolution data and test methods) provided to the
FDA as part of the application for such generic drug product. The
department shall make such information freely and publicly available
on its website.

Section 3 and section 4 change the references to paragraph (o) of
subdivision 1 of section 206 of the PHL in the Education Law.

Section 5 provides the effective date.

JUSTIFICATION: New York State Law (paragraph (o) of subdivision 1 of
section 206 of the Public Health Law) provides that the health
commissioner shall establish and maintain a list of generic drug
products, which must meet specified conditions. The bill repeals this
paragraph and transfers its language to a new section (280-a) of the
PHL, named "generic drug products. This way, the provisions related to
generic drugs are easily accessible.

The bill also introduces a new provision (subdivision 2 of the new
section 208-a) to make relevant information related to generic drug
products freely and publicly available.

The Center for Drug Evaluation and Research defines a generic drug as
a drug product that is comparable to a brand/reference listed drug
product in dosage form, strength, route of administration, quality and
performance characteristics, and intended use. Generic drugs are
approved by the FDA and represent an affordable option for users. To
receive approval by the FDA, generic drug manufacturers have to submit
specified documents and reports, proving that their drug is
bioequivalent to the respective brand name drug. The information that
producers and manufacturers provide to the FDA is not publicly


available. For most generic drugs, consumers can access such
information only by going through a formal FOIL request. This process
can be extremely difficult and time-consuming.

Moreover, the availability of such information is extremely valuable.
The FDA has to process thousands of drug applications and mostly
relies on studies submitted by the drug producers or manufacturers
when making bioequivalence assessments.

In 2008, the FDA declared Teva's Budeprion XL 300 (generic version of
the antidepressant Wellbutrin XL 300 mg) as safe and effective.
However, consumers started to complain about the generic version of
Wellbutrin: after switching to the generic formulation, many reported
symptoms such as headaches, irritability, nausea, and return of
depression.

In 2012, the FDA announced that the Teva's generic drug is NOT
bioequivalent to the brand name drug. The reversal was based on a FDA
bioequivalence study which found Budeprion XL 300 achieved only 75%.
of the maximum drug concentration attained with Wellbutrin XL 300 mg
(potentially explaining the return of depression in patients switched
to Budeprion XL 300). Teva's product released much of its drug earlier
than Wellbutrin. The dissolution rate greatly affects how a drug is
released in the human body. This ultimately affects the drug
effectiveness. The new results obtained by the FDA closely matched the
results of independent organizations that tested the two drugs for
bioequivalence.

The biopharmaceutic studies and summaries, dissolution data, and test
methods provided to the FDA by generic drugs producers must be
available. This way, such information can be reviewed and analyzed by
experts who can conduct independent evaluations of the drugs.

The intent of the bill is to encourage transparency, in order to
protect consumers. Certainly, consumers should have the option to have
their prescription filled with a generic product, particularly since
generics often cost less than brand name drugs. However, consumers
must be informed of the drawbacks, if any, of taking a generic drug
instead of the brand name drug. Consumers have the right to know what
the differences between brand and generic drugs are and decide, with
their physicians and pharmacists, whether the generic product is
appropriate for them.

PRIOR LEGISLATIVE HISTORY: This is a new bill.

FISCAL IMPLICATIONS: None to the State.

EFFECTIVE DATE: This act shall take effect on the ninetieth day after
it shall have become a law.

view full text
download pdf
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 6739--A

                            I N  S E N A T E

                              March 5, 2014
                               ___________

Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
  printed to be committed  to  the  Committee  on  Health  --  committee
  discharged, bill amended, ordered reprinted as amended and recommitted
  to said committee

AN ACT to amend the public health law and the education law, in relation
  to generic drug products; and to repeal paragraph (o) of subdivision 1
  of section 206 of the public health law relating thereto

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

  Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
health law is REPEALED.
  S 2. The public health law is amended by adding a new section 280-a to
read as follows:
  S 280-A. GENERIC DRUG PRODUCTS. 1. THE  COMMISSIONER  SHALL  ESTABLISH
AND  PUBLISH  A  LIST  OF  DRUG PRODUCTS, REFERRED TO IN THIS SECTION AS
"GENERIC DRUG" PRODUCTS, EACH OF WHICH SHALL MEET THE  FOLLOWING  CONDI-
TIONS:
  (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
ER  OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND EFFEC-
TIVE FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION  OR
AN  ABBREVIATED  NEW-DRUG  APPLICATION  APPROVED PURSUANT TO THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
  (B) THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG  ADMINISTRATION  HAS
EVALUATED  SUCH  DRUG  PRODUCT  AS  PHARMACEUTICALLY AND THERAPEUTICALLY
EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
PRODUCTS WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED,  HOWEV-
ER,  THAT  THE  LIST  PREPARED BY THE COMMISSIONER SHALL NOT INCLUDE ANY
DRUG PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG  ADMIN-
ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
PROBLEM.
  2.  THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE TO
THE DEPARTMENT THE  BIOPHARMACEUTIC  STUDIES  AND  SUMMARIES,  INCLUDING
BIOEQUIVALENCE  DATA  AND  INCIDENCE  OF  ADVERSE EVENTS, AND ASSOCIATED
ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METHODS PROVIDED

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11513-03-4

S. 6739--A                          2

TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF  THE  APPLICATION
FOR  SUCH  GENERIC DRUG PRODUCT. THE DEPARTMENT SHALL MAKE SUCH INFORMA-
TION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
  S  3.  Paragraphs  (a) and (d) of subdivision 6 of section 6810 of the
education law, paragraph (a) as amended by chapter 590 of  the  laws  of
2011  and paragraph (d) as added by chapter 913 of the laws of 1986, are
amended to read as follows:
  (a) Every prescription written in this state by a person authorized to
issue such prescription shall be on prescription  forms  containing  one
line  for  the  prescriber's signature. The prescriber's signature shall
validate the prescription. Every electronic prescription  shall  provide
for  the  prescriber's  electronic  signature,  which shall validate the
electronic prescription. Imprinted conspicuously on  every  prescription
written  in  this state in eight point upper case type immediately below
the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless
the  prescriber  writes  d a w in such box in the prescriber's own hand-
writing or, in the case of electronic prescriptions,  inserts  an  elec-
tronic  direction  to  dispense  the  drug  as written, the prescriber's
signature or electronic signature shall designate  approval  of  substi-
tution  by a pharmacist of a GENERIC drug product pursuant to [paragraph
(o) of subdivision one of] section [two hundred six] TWO HUNDRED  EIGHT-
Y-A  of  the  public health law.   No other letters or marks in such box
shall prohibit substitution. No prescription forms used or  intended  to
be  used  by a person authorized to issue a prescription shall have 'd a
w' preprinted in such box. Such box shall be placed directly  under  the
signature  line  and shall be three-quarters inch in length and one-half
inch in height, or in comparable form for an electronic prescription  as
may  be  specified  by regulation of the commissioner. Immediately below
such box shall be imprinted in six point type  the  words  "Dispense  As
Written".    Notwithstanding  any other provision of law, no state offi-
cial, agency, board or other entity shall promulgate any  regulation  or
guideline  modifying  those elements of the prescription form's contents
specified in this subdivision. To the extent otherwise permitted by law,
a prescriber may modify only those elements of the  prescription  form's
contents  not  specified  in this subdivision. Notwithstanding any other
provision of this section or any other law, when a generic drug  is  not
available and the brand name drug originally prescribed is available and
the  pharmacist  agrees  to  dispense the brand name product for a price
that will not exceed the price that would  have  been  charged  for  the
generic substitute had it been available, substitution of a generic drug
product  will not be required. If the generic drug product is not avail-
able and a medical emergency  situation,  which  for  purposes  of  this
section is defined as any condition requiring alleviation of severe pain
or  which  threatens  to  cause  disability or take life if not promptly
treated, exists, then the pharmacist may dispense the brand name product
at his regular price. In such instances the pharmacist must  record  the
date,  hour  and  nature  of  the  medical  emergency on the back of the
prescription and keep a copy of all such prescriptions.
  (d) No prescriber shall be subjected to civil liability arising solely
from authorizing, in accordance with this subdivision, the  substitution
by  a pharmacist of a GENERIC drug product pursuant to [paragraph (o) of
subdivision one of] section [two hundred six] TWO  HUNDRED  EIGHTY-A  of
the public health law.

S. 6739--A                          3

  S 4. Paragraph (b) of subdivision 1 of section 6816-a of the education
law,  as added by chapter 776 of the laws of 1977, is amended to read as
follows:
  (b)  The  substituted drug product is contained in the list of GENERIC
drug products established pursuant to [paragraph (o) of subdivision  one
of]  section [two hundred six] TWO HUNDRED EIGHTY-A of the public health
law; and
  S 5. 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 is authorized to be made and completed on
or before such effective date.

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