State of Illinois
91st General Assembly
Legislation

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91_HB2965eng

 
HB2965 Engrossed                               LRB9109621ACtm

 1        AN ACT regarding pharmaceuticals.

 2        Be  it  enacted  by  the People of the State of Illinois,
 3    represented in the General Assembly:

 4        Section 5.  The Pharmacy Practice Act of 1987 is  amended
 5    by changing Section 25 as follows:

 6        (225 ILCS 85/25) (from Ch. 111, par. 4145)
 7        Sec.  25.  No person shall compound, or sell or offer for
 8    sale, or cause to be compounded, sold or offered for sale any
 9    medicine or preparation under or by a name recognized in  the
10    United  States Pharmacopoeia National Formulary, for internal
11    or external use, which differs from the standard of strength,
12    quality or purity as determined by the test laid down in  the
13    United  States  Pharmacopoeia  National Formulary official at
14    the time of such compounding, sale or offering for sale.  Nor
15    shall any person compound, sell or offer for sale,  or  cause
16    to  be  compounded,  sold,  or  offered  for  sale, any drug,
17    medicine, poison, chemical or pharmaceutical preparation, the
18    strength or purity of which shall fall  below  the  professed
19    standard  of  strength  or purity under which it is sold.  If
20    the  physician   or   other   authorized   prescriber,   when
21    transmitting  an  oral  or  written  prescription,  does  not
22    prohibit  drug  product  selection, a different brand name or
23    nonbrand name drug product of the same generic  name  may  be
24    dispensed  by the pharmacist, provided that the such selected
25    drug has a unit price less than the drug product specified in
26    the  prescription  and  provided  that   the   selection   is
27    permitted,  is  not  subject  to  a  hearing by the Technical
28    Advisory Council, or is not specifically  prohibited  by  the
29    current  Drug  Product  Selection  Formulary  issued  by  the
30    Department  of  Public Health pursuant to Section 3.14 of the
31    "Illinois Food, Drug and Cosmetics Act",  approved  June  29,
 
HB2965 Engrossed            -2-                LRB9109621ACtm
 1    1967,   as   amended.   A   generic  drug  determined  to  be
 2    therapeutically equivalent by the United States Food and Drug
 3    Administration (FDA) shall be available for  substitution  in
 4    Illinois  in  accordance with this Act and the Illinois Food,
 5    Drug  and  Cosmetic  Act,  provided  that  each  manufacturer
 6    submits   a   notification   containing   product   technical
 7    bioequivalence  information  as  a  prerequisite  to  product
 8    substitution when they have completed all required testing to
 9    support  FDA  product  approval  and,  in  any   event,   the
10    information shall be submitted no later than 60 days prior to
11    product substitution in the State.  If the Technical Advisory
12    Council  finds  that  a  generic drug product may have issues
13    related to the  practice  of  medicine  or  the  practice  of
14    pharmacy, the Technical Advisory Council shall hold a hearing
15    at  its  next  regularly scheduled Technical Advisory Council
16    meeting.   Following   the   Technical   Advisory   Council's
17    determination that an issue exists related to the practice of
18    medicine  or  the  practice of pharmacy, the hearing shall be
19    conducted in accordance with the rules of the  Department  of
20    Public  Health  and Article 10 of the Illinois Administrative
21    Procedure Act.  The Technical Advisory Council shall make its
22    recommendation to the Department of Public Health  within  20
23    business days after the public hearing.  If the Department of
24    Public   Health,  on  the  recommendation  of  the  Technical
25    Advisory Council, determines that, based upon a preponderance
26    of  the  evidence,  the  drug  is  not   bioequivalent,   not
27    therapeutically   equivalent,   or   could  cause  clinically
28    significant  harm  to  the  health  or  safety  of   patients
29    receiving  that generic drug, the Department of Public Health
30    may prohibit the generic drug from substitution in the State.
31    A decision by the Department of Public Health to  prohibit  a
32    drug  product  from  substitution  shall  constitute  a final
33    administrative decision within the meaning of Section 22.2 of
34    the Illinois Food, Drug and Cosmetic Act and Section 3-101 of
 
HB2965 Engrossed            -3-                LRB9109621ACtm
 1    the Code of Civil Procedure, and shall be subject to judicial
 2    review pursuant to the  provisions  of  Article  III  of  the
 3    Administrative  Review Law.  A decision to prohibit a generic
 4    drug from substitution  must  be  accompanied  by  a  written
 5    detailed  explanation  of  the basis for the decision. On the
 6    prescription  forms  of  prescribers,  shall  be   placed   a
 7    signature  line  and  the words "may substitute" and "may not
 8    substitute".  The prescriber, in his or her own  handwriting,
 9    shall place a mark beside either the "may substitute" or "may
10    not  substitute"  alternatives to guide the pharmacist in the
11    dispensing of the prescription. A prescriber placing  a  mark
12    beside  the "may substitute" alternative or failing in his or
13    her own handwriting to place a mark beside either alternative
14    authorizes drug product selection  in  accordance  with  this
15    Act.  Preprinted or rubber stamped marks, or other deviations
16    from  the  above  prescription format shall not be permitted.
17    The prescriber  shall  sign  the  form  in  his  or  her  own
18    handwriting  to  authorize  the issuance of the prescription.
19    When a person presents a prescription to  be  dispensed,  the
20    pharmacist  to  whom it is presented may inform the person if
21    the pharmacy has available a different brand name or nonbrand
22    name of the same generic drug prescribed and the price of the
23    such different brand name or nonbrand name of the  such  drug
24    product.   If  the  person presenting the prescription is the
25    one to whom the drug is to be  administered,  the  pharmacist
26    may  dispense the prescription with the brand prescribed or a
27    different brand name or nonbrand name  product  of  the  same
28    generic  name  that  has  been permitted by the Department of
29    Public Health, if the such drug is of lesser  unit  cost  and
30    the  patient  is informed and agrees to the selection and the
31    pharmacist shall enter such  information  into  the  pharmacy
32    record.  If the person presenting the prescription is someone
33    other than the one to whom the drug is to be administered the
34    pharmacist  shall  not dispense the prescription with a brand
 
HB2965 Engrossed            -4-                LRB9109621ACtm
 1    other than the one specified in the prescription  unless  the
 2    pharmacist  has  the  written or oral authorization to select
 3    brands from the person to whom the drug is to be administered
 4    or a parent, legal guardian or spouse of that person.
 5        In every case in which a selection is made  as  permitted
 6    by  the  Illinois Food, Drug and Cosmetic Act, the pharmacist
 7    shall  indicate  on  the  pharmacy  record  of   the   filled
 8    prescription   the   name  or  other  identification  of  the
 9    manufacturer of the drug which has been dispensed.
10        The selection of any drug product by a  pharmacist  shall
11    not   constitute  evidence  of  negligence  if  the  selected
12    nonlegend drug product was of the same dosage form  and  each
13    of its active ingredients did not vary by more than 1 percent
14    from  the  active  ingredients of the prescribed, brand name,
15    nonlegend drug product or if the selected legend drug product
16    was included in the Illinois Drug Product Selection Formulary
17    current at the time the prescription was dispensed.   Failure
18    of  a  prescribing  physician  to  specify  that drug product
19    selection is  prohibited  does  not  constitute  evidence  of
20    negligence  unless  that practitioner has reasonable cause to
21    believe that the health condition of the patient for whom the
22    physician is prescribing warrants the use of the  brand  name
23    drug product and not another.
24        The  Department  is  authorized  to  employ an analyst or
25    chemist of recognized or  approved  standing  whose  duty  it
26    shall  be  to  examine into any claimed adulteration, illegal
27    substitution,  improper  selection,  alteration,   or   other
28    violation hereof, and report the result of his investigation,
29    and  if  such report justify such action the Department shall
30    cause the offender to be prosecuted.
31    (Source: P.A. 85-796.)

32        Section 10.  The Illinois Food, Drug and Cosmetic Act  is
33    amended by changing Section 3.14 as follows:
 
HB2965 Engrossed            -5-                LRB9109621ACtm
 1        (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
 2        Sec.  3.14.  Dispensing  or  causing  to  be  dispensed a
 3    different drug  in place of the drug or brand of drug ordered
 4    or prescribed without the express permission  of  the  person
 5    ordering  or  prescribing.  However,  this  Section  does not
 6    prohibit the interchange of  different  brands  of  the  same
 7    generically  equivalent  drug  product,  when  the  such drug
 8    products are  not  required  to  bear  the  legend  "Caution:
 9    Federal   law  prohibits  dispensing  without  prescription",
10    provided that the same dosage form is dispensed and there  is
11    no  greater  than  1%  variance  in the stated amount of each
12    active ingredient of the such drug products. Nothing in  this
13    Section  shall  prohibit the selection of different brands of
14    the same generic drug, based upon a positive  drug  formulary
15    listing  which  is  developed,  maintained, and issued by the
16    Department  of  Public  Health  under  which   drug   product
17    selection  within  a  generic class, or selection of specific
18    products for those prescribed, is permitted, is  not  subject
19    to  the  hearing  review  process  by  the Technical Advisory
20    Council, or is not specifically prohibited.  A  generic  drug
21    determined  to  be  therapeutically  equivalent by the United
22    States Food and Drug Administration (FDA) shall be  available
23    for  substitution in Illinois in accordance with this Act and
24    the  Pharmacy  Practice  Act  of  1987,  provided  that  each
25    manufacturer  submits  a  notification   containing   product
26    technical  bioequivalence  information  as  a prerequisite to
27    product substitution when they have  completed  all  required
28    testing  to  support  FDA product approval and, in any event,
29    the information shall be submitted  no  later  than  60  days
30    prior to product substitution in the State.  If the Technical
31    Advisory  Council  finds that a generic drug product may have
32    issues related to the practice of medicine or the practice of
33    pharmacy, the Technical Advisory Council shall hold a hearing
34    at its next regularly scheduled  Technical  Advisory  Council
 
HB2965 Engrossed            -6-                LRB9109621ACtm
 1    meeting.    Following   the   Technical   Advisory  Council's
 2    determination that an issue exists related to the practice of
 3    medicine or the practice of pharmacy, the  hearing  shall  be
 4    conducted  in  accordance  with  the  Department's  Rules  of
 5    Practice  and  Procedure  in Administrative Hearings (77 Ill.
 6    Admin.  Code  100)   and   Article   10   of   the   Illinois
 7    Administrative Procedure Act.  The Technical Advisory Council
 8    shall  make  its  recommendation  to the Department of Public
 9    Health within 20 business days after the public hearing.   If
10    the Department of Public Health, on the recommendation of the
11    Technical  Advisory  Council,  determines  that, based upon a
12    preponderance of the evidence, the drug is not bioequivalent,
13    not therapeutically equivalent,  or  could  cause  clinically
14    significant   harm  to  the  health  or  safety  of  patients
15    receiving that generic drug, the Department of Public  Health
16    may prohibit the generic drug from substitution in the State.
17    A  decision by the Department to prohibit a drug product from
18    substitution shall constitute a final administrative decision
19    within the meaning of Section 22.2 of the Illinois Food, Drug
20    and Cosmetic Act and Section  3-101  of  the  Code  of  Civil
21    Procedure,  and  shall be subject to judicial review pursuant
22    to the provisions of Article III of the Administrative Review
23    Law.  A decision to prohibit a generic drug from substitution
24    must be accompanied by a written detailed explanation of  the
25    basis for the decision.   Determination of products which may
26    be  selected  shall  be  recommended  by a Technical Advisory
27    Council of the Department, selected by the Director of Public
28    Health, which council shall consist of 7 persons including  2
29    physicians,  2  pharmacists,  2 pharmacologists and one other
30    prescriber who have special knowledge of  generic  drugs  and
31    formulary.   Technical  Advisory  Council members shall serve
32    without pay, and shall be appointed for a  3  year  term  and
33    until  their  successors  are  appointed  and qualified.  The
34    procedures  for  operation  of  the  Drug  Product  Selection
 
HB2965 Engrossed            -7-                LRB9109621ACtm
 1    Program shall be promulgated by  the  Director,  however  the
 2    actual  list  of  products  prohibited  or  approved for drug
 3    product selection need  not  be  promulgated.  The  Technical
 4    Advisory  Council  shall  take cognizance of federal studies,
 5    the  U.S.  Pharmacopoeia  -  National  Formulary,  or   other
 6    recognized   authoritative  sources,  and  shall  advise  the
 7    Director  of  any  necessary  modifications.  Drug   products
 8    previously  approved  by  the  Technical Advisory Council for
 9    generic interchange  may  be  substituted  in  the  State  of
10    Illinois  without further review subject to the conditions of
11    approval in the State of Illinois prior to the effective date
12    of this amendatory Act of the 91st General Assembly.
13        Timely notice of revisions  to  the  formulary  shall  be
14    furnished  at  no charge to all pharmacies by the Department.
15    Single copies of the drug formulary shall be  made  available
16    at  no  charge  upon request to licensed prescribers, student
17    pharmacists, and  pharmacists  practicing  pharmacy  in  this
18    State  under a reciprocal license. The Department shall offer
19    subscriptions to the drug  formulary  and  its  revisions  to
20    other  interested  parties  at  a  reasonable  charge  to  be
21    established  by  rule.  Before the Department makes effective
22    any  additions  to  or  deletions  from  the  procedures  for
23    operation of the Drug Product Selection  Program  under  this
24    Section,  the  Department  shall file proposed rules to amend
25    the procedures for operation of  the  program  under  Section
26    5-40  of  the  Illinois  Administrative  Procedure  Act.  The
27    Department shall issue necessary rules  and  regulations  for
28    the implementation of this Section.
29    (Source: P.A. 87-860; 87-1237; 88-45.)

30        Section  99.  Effective date.  This Act takes effect upon
31    becoming  law  solely  for  the  purpose  of   allowing   the
32    Department of Public Health to begin rulemaking to effect the
33    changes  made  by  this Act.  In all other respects, this Act
 
HB2965 Engrossed            -8-                LRB9109621ACtm
 1    takes effect on September 1, 2000.

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