Sen. Dan Kotowski
Filed: 4/28/2010
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1 | AMENDMENT TO HOUSE BILL 5890
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2 | AMENDMENT NO. ______. Amend House Bill 5890 on page 1, by | ||||||
3 | replacing line 5 with "Sections 3 and 25 as follows:"; and
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4 | on page 3, by replacing line 10 with "age or and older or, in | ||||||
5 | the case of influenza vaccination, 9 years of age or older | ||||||
6 | pursuant to a valid prescription or standing"; and | ||||||
7 | on page 14, by replacing line 25 with "age or and older or, in | ||||||
8 | the case of influenza vaccination, 9 years of age or older | ||||||
9 | pursuant to a valid prescription or standing"; and | ||||||
10 | on page 24, immediately below line 13, by inserting the | ||||||
11 | following:
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12 | "(225 ILCS 85/25) (from Ch. 111, par. 4145)
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13 | (Section scheduled to be repealed on January 1, 2018)
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14 | Sec. 25. No person shall compound, or sell or offer for |
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1 | sale, or
cause to be compounded, sold or offered for sale any | ||||||
2 | medicine or preparation
under or by a name recognized in the | ||||||
3 | United States Pharmacopoeia
National Formulary, for internal | ||||||
4 | or external use, which differs from
the standard of strength, | ||||||
5 | quality or purity as determined by the test
laid down in the | ||||||
6 | United States Pharmacopoeia National Formulary official at
the | ||||||
7 | time
of
such compounding, sale or offering for sale. Nor shall | ||||||
8 | any person
compound, sell or offer for sale, or cause to be | ||||||
9 | compounded, sold,
or offered for sale, any drug, medicine, | ||||||
10 | poison, chemical or pharmaceutical
preparation, the strength | ||||||
11 | or purity of which shall fall below the professed
standard of | ||||||
12 | strength or purity under which it is sold. Except as set forth | ||||||
13 | in Section 26 of this Act, if the physician
or other authorized | ||||||
14 | prescriber, when transmitting an oral or written
prescription, | ||||||
15 | does not prohibit drug product selection, a different
brand | ||||||
16 | name or nonbrand name drug product of the same generic name may
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17 | be dispensed by the pharmacist, provided that the selected drug
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18 | has
a unit price less than the drug product specified in the | ||||||
19 | prescription.
A generic drug determined to be therapeutically | ||||||
20 | equivalent by the
United States Food and Drug Administration | ||||||
21 | (FDA) shall be
available for substitution in Illinois in | ||||||
22 | accordance with this
Act and the Illinois Food, Drug and | ||||||
23 | Cosmetic Act, provided that
each manufacturer submits to the | ||||||
24 | Director of the Department of Public Health a notification | ||||||
25 | containing product
technical bioequivalence information as a | ||||||
26 | prerequisite to product
substitution when they have completed |
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1 | all required testing to
support FDA product approval and, in | ||||||
2 | any event, the information
shall be submitted no later than 60 | ||||||
3 | days prior to product
substitution in the State.
On the | ||||||
4 | prescription forms of prescribers,
shall be placed a signature | ||||||
5 | line and the words
"may not substitute". The prescriber, in his | ||||||
6 | or her own handwriting,
shall place a mark beside "may not | ||||||
7 | substitute"
to direct
the pharmacist in the dispensing of the | ||||||
8 | prescription.
Preprinted or rubber stamped marks, or other | ||||||
9 | deviations from
the above prescription format shall not be | ||||||
10 | permitted. The prescriber
shall sign the form in his or her own | ||||||
11 | handwriting to authorize the
issuance of the prescription. If a | ||||||
12 | prescription has been substituted from a brand name drug to a | ||||||
13 | generic, then it shall be the policy of the pharmacy to provide | ||||||
14 | written notice of this substitution to the patient. If the | ||||||
15 | Department finds a pattern and practice of not following its | ||||||
16 | policy, then it shall be considered a violation of this Act.
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17 | In every case in which a selection is made as permitted by | ||||||
18 | the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall | ||||||
19 | indicate on the pharmacy
record of the filled prescription the | ||||||
20 | name or other identification
of the manufacturer of the drug | ||||||
21 | which has been dispensed.
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22 | The selection of any drug product by a pharmacist shall not | ||||||
23 | constitute
evidence of negligence if the selected nonlegend | ||||||
24 | drug product was of
the same dosage form and each of its active | ||||||
25 | ingredients did not vary
by more than 1 percent from the active | ||||||
26 | ingredients of the prescribed,
brand name, nonlegend drug |
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1 | product. Failure of a prescribing
physician to specify that | ||||||
2 | drug product selection is prohibited does not
constitute | ||||||
3 | evidence of negligence
unless that practitioner has reasonable | ||||||
4 | cause to believe that the health
condition of the patient for | ||||||
5 | whom the physician is prescribing warrants
the use of the brand | ||||||
6 | name drug product and not another.
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7 | The Department is authorized to employ an analyst or | ||||||
8 | chemist of recognized
or approved standing whose duty it shall | ||||||
9 | be to examine into any claimed
adulteration, illegal | ||||||
10 | substitution, improper selection, alteration,
or other | ||||||
11 | violation hereof, and report the result of his investigation,
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12 | and if such report justify such action the Department shall | ||||||
13 | cause the
offender to be prosecuted.
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14 | (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)".
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