State of Illinois
92nd General Assembly
Legislation

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92_HB3199eng

 
HB3199 Engrossed                               LRB9206284LBmg

 1        AN ACT concerning 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 selected  drug
25    has  a unit price less than the drug product specified in the
26    prescription and provided that the selection is permitted, is
27    not subject to review at  a  meeting  of  a  hearing  by  the
28    Technical  Advisory  Council,  is not subject to a hearing in
29    accordance  with  this  Section,  or  is   not   specifically
30    prohibited  by  the  current Drug Product Selection Formulary
31    issued by the Department of Public Health pursuant to Section
 
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 1    3.14 of  the  Illinois  Food,  Drug  and  Cosmetics  Act,  as
 2    amended.  A  generic  drug  determined  to be therapeutically
 3    equivalent by the United States Food and Drug  Administration
 4    (FDA)  shall  be  available  for  substitution in Illinois in
 5    accordance with this Act and  the  Illinois  Food,  Drug  and
 6    Cosmetic  Act,  provided  that  each  manufacturer  submits a
 7    notification  containing  product  technical   bioequivalence
 8    information  as  a  prerequisite to product substitution when
 9    they have completed  all  required  testing  to  support  FDA
10    product  approval and, in any event, the information shall be
11    submitted no later than 60 days prior to product substitution
12    in the State.  If the Technical Advisory Council finds that a
13    generic drug product may have issues related to the  practice
14    of  medicine  or  the  practice  of  pharmacy,  the Technical
15    Advisory Council shall review the generic drug product hold a
16    hearing at its next regularly  scheduled  Technical  Advisory
17    Council  meeting.  Following the Technical Advisory Council's
18    review and initial recommendation that a generic drug product
19    not be included in the Illinois  Formulary,  a  determination
20    that  an  issue exists related to the practice of medicine or
21    the practice of pharmacy, the hearing shall be  conducted  in
22    accordance  with the rules of the Department of Public Health
23    and Article 10 of the Illinois Administrative  Procedure  Act
24    if  requested  by  the  manufacturer.  The Technical Advisory
25    Council shall make its recommendation to  the  Department  of
26    Public  Health  within  20  business  days  after  the public
27    hearing.   If  the  Department  of  Public  Health,  on   the
28    recommendation  of the Technical Advisory Council, determines
29    that, based upon a preponderance of the evidence, the drug is
30    not bioequivalent, not therapeutically equivalent,  or  could
31    cause  clinically significant harm to the health or safety of
32    patients receiving  that  generic  drug,  the  Department  of
33    Public Health may prohibit the generic drug from substitution
34    in  the State.  A decision by the Department of Public Health
 
HB3199 Engrossed            -3-                LRB9206284LBmg
 1    to prohibit a drug product from substitution shall constitute
 2    a final administrative decision within the meaning of Section
 3    22.2 of the Illinois Food, Drug and Cosmetic Act and  Section
 4    3-101 of the Code of Civil Procedure, and shall be subject to
 5    judicial  review pursuant to the provisions of Article III of
 6    the Administrative Review Law.   A  decision  to  prohibit  a
 7    generic  drug  from  substitution  must  be  accompanied by a
 8    written detailed explanation of the basis for  the  decision.
 9    On  the  prescription forms of prescribers, shall be placed a
10    signature line and the words "may substitute"  and  "may  not
11    substitute".   The prescriber, in his or her own handwriting,
12    shall place a mark beside either the "may substitute" or "may
13    not substitute" alternatives to guide the pharmacist  in  the
14    dispensing  of  the prescription. A prescriber placing a mark
15    beside the "may substitute" alternative or failing in his  or
16    her own handwriting to place a mark beside either alternative
17    authorizes  drug  product  selection  in accordance with this
18    Act.  Preprinted or rubber stamped marks, or other deviations
19    from the above prescription format shall  not  be  permitted.
20    The  prescriber  shall  sign  the  form  in  his  or  her own
21    handwriting to authorize the issuance  of  the  prescription.
22    When  a  person  presents a prescription to be dispensed, the
23    pharmacist to whom it is presented may inform the  person  if
24    the pharmacy has available a different brand name or nonbrand
25    name of the same generic drug prescribed and the price of the
26    different  brand  name  or nonbrand name of the drug product.
27    If the person presenting the prescription is the one to  whom
28    the  drug  is to be administered, the pharmacist may dispense
29    the prescription with the brand  prescribed  or  a  different
30    brand  name or nonbrand name product of the same generic name
31    that has been permitted by the Department of  Public  Health,
32    if  the  drug  is  of  lesser  unit  cost  and the patient is
33    informed and agrees to the selection and the pharmacist shall
34    enter such information into  the  pharmacy  record.   If  the
 
HB3199 Engrossed            -4-                LRB9206284LBmg
 1    person  presenting the prescription is someone other than the
 2    one to whom the drug is to  be  administered  the  pharmacist
 3    shall  not  dispense the prescription with a brand other than
 4    the one specified in the prescription unless  the  pharmacist
 5    has  the  written or oral authorization to select brands from
 6    the person to whom the  drug  is  to  be  administered  or  a
 7    parent, legal guardian or spouse of that person.
 8        In  every  case in which a selection is made as permitted
 9    by the Illinois Food, Drug and Cosmetic Act,  the  pharmacist
10    shall   indicate   on  the  pharmacy  record  of  the  filled
11    prescription  the  name  or  other  identification   of   the
12    manufacturer of the drug which has been dispensed.
13        The  selection  of any drug product by a pharmacist shall
14    not  constitute  evidence  of  negligence  if  the   selected
15    nonlegend  drug  product was of the same dosage form and each
16    of its active ingredients did not vary by more than 1 percent
17    from the active ingredients of the  prescribed,  brand  name,
18    nonlegend drug product or if the selected legend drug product
19    was included in the Illinois Drug Product Selection Formulary
20    current  at the time the prescription was dispensed.  Failure
21    of a prescribing  physician  to  specify  that  drug  product
22    selection  is  prohibited  does  not  constitute  evidence of
23    negligence unless that practitioner has reasonable  cause  to
24    believe that the health condition of the patient for whom the
25    physician  is  prescribing warrants the use of the brand name
26    drug product and not another.
27        The Department is authorized  to  employ  an  analyst  or
28    chemist  of  recognized  or  approved  standing whose duty it
29    shall be to examine into any  claimed  adulteration,  illegal
30    substitution,   improper   selection,  alteration,  or  other
31    violation hereof, and report the result of his investigation,
32    and if such report justify such action the  Department  shall
33    cause the offender to be prosecuted.
34    (Source: P.A. 91-766, eff. 9-1-00.)
 
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 1        Section  10.  The Illinois Food, Drug and Cosmetic Act is
 2    amended by changing Section 3.14 as follows:

 3        (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
 4        Sec. 3.14.  Dispensing  or  causing  to  be  dispensed  a
 5    different drug  in place of the drug or brand of drug ordered
 6    or  prescribed  without  the express permission of the person
 7    ordering or  prescribing.  However,  this  Section  does  not
 8    prohibit  the  interchange  of  different  brands of the same
 9    generically equivalent drug product, when the  drug  products
10    are  not  required  to  bear the legend "Caution: Federal law
11    prohibits dispensing without prescription", provided that the
12    same dosage form is dispensed and there is no greater than 1%
13    variance in the stated amount of each  active  ingredient  of
14    the drug products. Nothing in this Section shall prohibit the
15    selection of different brands of the same generic drug, based
16    upon a drug formulary listing which is developed, maintained,
17    and  issued  by  the  Department of Public Health under which
18    drug product selection is permitted, is not subject to review
19    at a meeting of the hearing review process by  the  Technical
20    Advisory  Council,  is not subject to a hearing in accordance
21    with this Section,  or  is  not  specifically  prohibited.  A
22    generic  drug  determined to be therapeutically equivalent by
23    the United States Food and Drug Administration (FDA) shall be
24    available for substitution in  Illinois  in  accordance  with
25    this Act and the Pharmacy Practice Act of 1987, provided that
26    each  manufacturer  submits a notification containing product
27    technical bioequivalence information  as  a  prerequisite  to
28    product  substitution  when  they have completed all required
29    testing to support FDA product approval and,  in  any  event,
30    the  information  shall  be  submitted  no later than 60 days
31    prior to product substitution in the State.  If the Technical
32    Advisory Council finds that a generic drug product  may  have
33    issues related to the practice of medicine or the practice of
 
HB3199 Engrossed            -6-                LRB9206284LBmg
 1    pharmacy,  the  Technical  Advisory  Council shall review the
 2    generic drug product hold a hearing  at  its  next  regularly
 3    scheduled  Technical Advisory Council meeting.  Following the
 4    Technical   Advisory    Council's    review    and    initial
 5    recommendation that a generic drug product not be included in
 6    the  Illinois Formulary, a determination that an issue exists
 7    related to the  practice  of  medicine  or  the  practice  of
 8    pharmacy,  the  hearing shall be conducted in accordance with
 9    the  Department's  Rules  of  Practice   and   Procedure   in
10    Administrative Hearings (77 Ill. Admin. Code 100) and Article
11    10  of the Illinois Administrative Procedure Act if requested
12    by the manufacturer.  The Technical  Advisory  Council  shall
13    make  its  recommendation  to the Department of Public Health
14    within 20 business days after the  public  hearing.   If  the
15    Department  of  Public  Health,  on the recommendation of the
16    Technical Advisory Council, determines  that,  based  upon  a
17    preponderance of the evidence, the drug is not bioequivalent,
18    not  therapeutically  equivalent,  or  could cause clinically
19    significant  harm  to  the  health  or  safety  of   patients
20    receiving  that generic drug, the Department of Public Health
21    may prohibit the generic drug from substitution in the State.
22    A decision by the Department to prohibit a drug product  from
23    substitution shall constitute a final administrative decision
24    within the meaning of Section 22.2 of the Illinois Food, Drug
25    and  Cosmetic  Act  and  Section  3-101  of the Code of Civil
26    Procedure, and shall be subject to judicial  review  pursuant
27    to the provisions of Article III of the Administrative Review
28    Law.  A decision to prohibit a generic drug from substitution
29    must  be accompanied by a written detailed explanation of the
30    basis for the decision.   Determination of products which may
31    be selected shall be  recommended  by  a  Technical  Advisory
32    Council of the Department, selected by the Director of Public
33    Health,  which council shall consist of 7 persons including 2
34    physicians, 2 pharmacists, 2 pharmacologists  and  one  other
 
HB3199 Engrossed            -7-                LRB9206284LBmg
 1    prescriber  who  have  special knowledge of generic drugs and
 2    formulary.  Technical Advisory Council  members  shall  serve
 3    without  pay,  and  shall  be appointed for a 3 year term and
 4    until their successors  are  appointed  and  qualified.   The
 5    procedures  for  operation  of  the  Drug  Product  Selection
 6    Program  shall  be  promulgated  by the Director, however the
 7    actual list of  products  prohibited  or  approved  for  drug
 8    product  selection  need  not  be  promulgated. The Technical
 9    Advisory Council shall take cognizance  of  federal  studies,
10    the   U.S.  Pharmacopoeia  -  National  Formulary,  or  other
11    recognized  authoritative  sources,  and  shall  advise   the
12    Director   of  any  necessary  modifications.  Drug  products
13    previously approved by the  Technical  Advisory  Council  for
14    generic  interchange  may  be  substituted  in  the  State of
15    Illinois without further review subject to the conditions  of
16    approval in the State of Illinois prior to the effective date
17    of this amendatory Act of the 91st General Assembly.
18        Timely  notice  of  revisions  to  the formulary shall be
19    furnished at no charge to all pharmacies by  the  Department.
20    Single  copies  of the drug formulary shall be made available
21    at no charge upon request to  licensed  prescribers,  student
22    pharmacists,  and  pharmacists  practicing  pharmacy  in this
23    State under a reciprocal license. The Department shall  offer
24    subscriptions  to  the  drug  formulary  and its revisions to
25    other  interested  parties  at  a  reasonable  charge  to  be
26    established by rule. Before the  Department  makes  effective
27    any  additions  to  or  deletions  from  the  procedures  for
28    operation  of  the  Drug Product Selection Program under this
29    Section, the Department shall file proposed  rules  to  amend
30    the  procedures  for  operation  of the program under Section
31    5-40 of  the  Illinois  Administrative  Procedure  Act.   The
32    Department  shall  issue  necessary rules and regulations for
33    the implementation of this Section.
34    (Source: P.A. 91-766, eff. 9-1-00.)
 
HB3199 Engrossed            -8-                LRB9206284LBmg
 1        Section 99.  Effective date.  This Act takes effect  upon
 2    becoming law.

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