State of Illinois
91st General Assembly
Legislation

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[ Engrossed ][ Enrolled ][ House Amendment 001 ]

91_HB2256

 
                                               LRB9105244ACtm

 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 either  (i)  the  selected
27    drug   has  been  rated  therapeutically  equivalent  to  the
28    prescribed drug in Approved Drug  Products  with  Therapeutic
29    Equivalence   Evaluations  (Orange  Book)  published  by  the
30    federal Food and Drug Administration or (ii) the selection is
31    permitted by the current  Drug  Product  Selection  Formulary
 
                            -2-                LRB9105244ACtm
 1    issued by the Department of Public Health pursuant to Section
 2    3.14  of  the  "Illinois  Food,  Drug  and  Cosmetics  Act" ,
 3    approved June 29, 1967,  as  amended.   On  the  prescription
 4    forms  of  prescribers,  shall be placed a signature line and
 5    the words "may substitute" and  "may  not  substitute".   The
 6    prescriber, in his or her own handwriting, shall place a mark
 7    beside  either  the  "may substitute" or "may not substitute"
 8    alternatives to guide the pharmacist in the dispensing of the
 9    prescription. A prescriber placing a  mark  beside  the  "may
10    substitute"   alternative  or  failing  in  his  or  her  own
11    handwriting  to  place  a  mark  beside  either   alternative
12    authorizes  drug  product  selection  in accordance with this
13    Act.  Preprinted or rubber stamped marks, or other deviations
14    from the above prescription format shall  not  be  permitted.
15    The  prescriber  shall  sign  the  form  in  his  or  her own
16    handwriting to authorize the issuance  of  the  prescription.
17    When  a  person  presents a prescription to be dispensed, the
18    pharmacist to whom it is presented may inform the  person  if
19    the pharmacy has available a different brand name or nonbrand
20    name  of  the  same  generic drug prescribed and the price of
21    such different brand name  or  nonbrand  name  of  such  drug
22    product.   If  the  person presenting the prescription is the
23    one to whom the drug is to be  administered,  the  pharmacist
24    may  dispense the prescription with the brand prescribed or a
25    different brand name or nonbrand name  product  of  the  same
26    generic  name  that  has  been permitted by the Department of
27    Public Health, if such drug is of lesser unit  cost  and  the
28    patient  is  informed  and  agrees  to  the selection and the
29    pharmacist shall enter such  information  into  the  pharmacy
30    record.  If the person presenting the prescription is someone
31    other than the one to whom the drug is to be administered the
32    pharmacist  shall  not dispense the prescription with a brand
33    other than the one specified in the prescription  unless  the
34    pharmacist  has  the  written or oral authorization to select
 
                            -3-                LRB9105244ACtm
 1    brands from the person to whom the drug is to be administered
 2    or a parent, legal guardian or spouse of that person.
 3        In every case in which a selection is made  as  permitted
 4    by  the  Illinois Food, Drug and Cosmetic Act, the pharmacist
 5    shall  indicate  on  the  pharmacy  record  of   the   filled
 6    prescription   the   name  or  other  identification  of  the
 7    manufacturer of the drug which has been dispensed.
 8        The selection of any drug product by a  pharmacist  shall
 9    not   constitute  evidence  of  negligence  if  the  selected
10    nonlegend drug product was of the same dosage form  and  each
11    of its active ingredients did not vary by more than 1 percent
12    from  the  active  ingredients of the prescribed, brand name,
13    nonlegend drug product or if the selected legend drug product
14    was rated therapeutically equivalent in the  Orange  Book  or
15    was included in the Illinois Drug Product Selection Formulary
16    current  at the time the prescription was dispensed.  Failure
17    of a prescribing  physician  to  specify  that  drug  product
18    selection  is  prohibited  does  not  constitute  evidence of
19    negligence unless that practitioner has reasonable  cause  to
20    believe that the health condition of the patient for whom the
21    physician  is  prescribing warrants the use of the brand name
22    drug product and not another.
23        The Department is authorized  to  employ  an  analyst  or
24    chemist  of  recognized  or  approved  standing whose duty it
25    shall be to examine into any  claimed  adulteration,  illegal
26    substitution,   improper   selection,  alteration,  or  other
27    violation hereof, and report the result of his investigation,
28    and if such report justify such action the  Department  shall
29    cause the offender to be prosecuted.
30    (Source: P.A. 85-796.)

31        Section  10.  The Illinois Food, Drug and Cosmetic Act is
32    amended by changing Section 3.14 as follows:
 
                            -4-                LRB9105244ACtm
 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 such drug  products
 8    are  not  required  to  bear the legend "Caution: Federal law
 9    prohibits dispensing without prescription", provided that the
10    same dosage form is dispensed and there is no greater than 1%
11    variance in the stated amount of each  active  ingredient  of
12    such  drug  products.  Nothing in this Section shall prohibit
13    the selection of different brands of the same  generic  drug,
14    provided  that  either  (i)  the selected drug has been rated
15    therapeutically equivalent to the prescribed drug in Approved
16    Drug  Products  with  Therapeutic   Equivalence   Evaluations
17    (Orange   Book)  published  by  the  federal  Food  and  Drug
18    Administration or (ii) the selected drug is listed in   based
19    upon   a  positive  drug  formulary  listing  that  which  is
20    developed, maintained, and issued by the Department of Public
21    Health under which drug product selection  within  a  generic
22    class,   or   selection   of   specific  products  for  those
23    prescribed, is permitted.   Determination  of  products  that
24    have  not been rated therapeutically equivalent in the Orange
25    book, but that which may be selected shall be recommended  by
26    a  Technical  Advisory Council of the Department, selected by
27    the Director of Public Health, which council shall consist of
28    7  persons  including  2   physicians,   2   pharmacists,   2
29    pharmacologists  and  one  other  prescriber who have special
30    knowledge of generic drugs and formulary.  Technical Advisory
31    Council  members  shall  serve  without  pay,  and  shall  be
32    appointed for a 3 year term and until  their  successors  are
33    appointed and qualified.  The procedures for operation of the
34    Drug  Product  Selection  Program shall be promulgated by the
 
                            -5-                LRB9105244ACtm
 1    Director, however the actual list of  products  approved  for
 2    drug product selection need not be promulgated. The Technical
 3    Advisory  Council  shall  take cognizance of federal studies,
 4    the  U.S.  Pharmacopoeia  -  National  Formulary,  or   other
 5    recognized   authoritative  sources,  and  shall  advise  the
 6    Director of any necessary modifications.
 7        Timely notice of revisions  to  the  formulary  shall  be
 8    furnished  at  no charge to all pharmacies by the Department.
 9    Single copies of the drug formulary shall be  made  available
10    at  no  charge  upon request to licensed prescribers, student
11    pharmacists, and  pharmacists  practicing  pharmacy  in  this
12    State  under a reciprocal license. The Department shall offer
13    subscriptions to the drug  formulary  and  its  revisions  to
14    other  interested  parties  at  a  reasonable  charge  to  be
15    established  by  rule.  Before the Department makes effective
16    any  additions  to  or  deletions  from  the  procedures  for
17    operation of the Drug Product Selection  Program  under  this
18    Section,  the  Department  shall file proposed rules to amend
19    the procedures for operation of  the  program  under  Section
20    5-40  of  the  Illinois  Administrative  Procedure  Act.  The
21    Department shall issue necessary rules  and  regulations  for
22    the implementation of this Section.
23    (Source: P.A. 87-860; 87-1237; 88-45.)

24        Section  99.  Effective date.  This Act takes effect upon
25    becoming law.

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