Full Text of SB2578 94th General Assembly
SB2578enr 94TH GENERAL ASSEMBLY
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SB2578 Enrolled |
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LRB094 17772 RAS 53071 b |
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| AN ACT concerning regulation.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| Section 5. The Pharmacy Practice Act of 1987 is amended by | 5 |
| changing Section 25 and by adding Section 26 as follows:
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| (225 ILCS 85/25) (from Ch. 111, par. 4145)
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| (Section scheduled to be repealed on January 1, 2008)
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| Sec. 25. No person shall compound, or sell or offer for | 9 |
| sale, or
cause to be compounded, sold or offered for sale any | 10 |
| medicine or preparation
under or by a name recognized in the | 11 |
| United States Pharmacopoeia
National Formulary, for internal | 12 |
| or external use, which differs from
the standard of strength, | 13 |
| quality or purity as determined by the test
laid down in the | 14 |
| United States Pharmacopoeia National Formulary official at
the | 15 |
| time
of
such compounding, sale or offering for sale. Nor shall | 16 |
| any person
compound, sell or offer for sale, or cause to be | 17 |
| compounded, sold,
or offered for sale, any drug, medicine, | 18 |
| poison, chemical or pharmaceutical
preparation, the strength | 19 |
| or purity of which shall fall below the professed
standard of | 20 |
| strength or purity under which it is sold. Except as set forth | 21 |
| in Section 26 of this Act, if
If the physician
or other | 22 |
| authorized prescriber, when transmitting an oral or written
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| prescription, does not prohibit drug product selection, a | 24 |
| different
brand name or nonbrand name drug product of the same | 25 |
| generic name may
be dispensed by the pharmacist, provided that | 26 |
| the selected drug
has
a unit price less than the drug product | 27 |
| specified in the prescription
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A generic drug determined to be | 28 |
| therapeutically equivalent by the
United States Food and Drug | 29 |
| Administration (FDA) shall be
available for substitution in | 30 |
| Illinois in accordance with this
Act and the Illinois Food, | 31 |
| Drug and Cosmetic Act, provided that
each manufacturer submits | 32 |
| to the Director of the Department of Public Health a |
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| notification containing product
technical bioequivalence | 2 |
| information as a prerequisite to product
substitution when they | 3 |
| have completed all required testing to
support FDA product | 4 |
| approval and, in any event, the information
shall be submitted | 5 |
| no later than 60 days prior to product
substitution in the | 6 |
| State.
On the prescription forms of prescribers,
shall be | 7 |
| placed a signature line and the words "may substitute" and
"may | 8 |
| not substitute". The prescriber, in his or her own handwriting,
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| 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
Act. | 15 |
| Preprinted or rubber stamped marks, or other deviations from
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| the above prescription format shall not be permitted. The | 17 |
| prescriber
shall sign the form in his or her own handwriting to | 18 |
| authorize the
issuance of the prescription. When a person | 19 |
| presents a prescription
to be dispensed, the pharmacist to whom | 20 |
| it is presented may inform
the person if the pharmacy has | 21 |
| available a different brand name or
nonbrand name of the same | 22 |
| generic drug prescribed and the price of
the different brand | 23 |
| name or nonbrand name of the drug
product. If
the person | 24 |
| presenting the prescription is the one to whom the drug
is to | 25 |
| be administered, the pharmacist may dispense the prescription
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| with the brand prescribed or a different brand name or nonbrand | 27 |
| name
product of the same generic name, if the drug is of lesser | 28 |
| unit cost and the
patient
is informed and agrees to the | 29 |
| selection and the pharmacist shall enter
such information into | 30 |
| the pharmacy record. If the person
presenting
the prescription | 31 |
| is someone other than the one to whom the drug is
to be | 32 |
| administered the pharmacist shall not dispense the | 33 |
| prescription
with a brand other than the one specified in the | 34 |
| prescription unless
the pharmacist has the written or oral | 35 |
| authorization to select brands
from the person to whom the drug | 36 |
| is to be administered or a parent,
legal guardian or spouse of |
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| that person.
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| In every case in which a selection is made as permitted by | 3 |
| the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall | 4 |
| indicate on the pharmacy
record of the filled prescription the | 5 |
| name or other identification
of the manufacturer of the drug | 6 |
| which has been dispensed.
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| The selection of any drug product by a pharmacist shall not | 8 |
| constitute
evidence of negligence if the selected nonlegend | 9 |
| drug product was of
the same dosage form and each of its active | 10 |
| ingredients did not vary
by more than 1 percent from the active | 11 |
| ingredients of the prescribed,
brand name, nonlegend drug | 12 |
| product. Failure of a prescribing
physician to specify that | 13 |
| drug product selection is prohibited does not
constitute | 14 |
| evidence of negligence
unless that practitioner has reasonable | 15 |
| cause to believe that the health
condition of the patient for | 16 |
| whom the physician is prescribing warrants
the use of the brand | 17 |
| name drug product and not another.
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| The Department is authorized to employ an analyst or | 19 |
| chemist of recognized
or approved standing whose duty it shall | 20 |
| be to examine into any claimed
adulteration, illegal | 21 |
| substitution, improper selection, alteration,
or other | 22 |
| violation hereof, and report the result of his investigation,
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| and if such report justify such action the Department shall | 24 |
| cause the
offender to be prosecuted.
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| (Source: P.A. 92-112, eff. 7-20-01; 93-841, eff. 7-30-04.)
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| (225 ILCS 85/26 new)
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| (Section scheduled to be repealed on January 1, 2008) | 28 |
| Sec. 26. Anti-epileptic drug product selection prohibited.
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| (a) The General Assembly finds that this Section is | 30 |
| necessary for the immediate preservation of the public peace, | 31 |
| health, and safety. | 32 |
| (b) In this Section: | 33 |
| "Anti-epileptic drug means (i) any drug prescribed for the | 34 |
| treatment of epilepsy or (ii) a drug used to treat or prevent | 35 |
| seizures. |
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| "Epilepsy" means a neurological condition characterized by | 2 |
| recurrent seizures. | 3 |
| "Seizure" means a brief disturbance in the electrical | 4 |
| activity of the brain. | 5 |
| (c) When the prescribing physician has indicated on the | 6 |
| original prescription "dispense as written" or "may not | 7 |
| substitute", a pharmacist may not interchange an | 8 |
| anti-epileptic drug or formulation of an anti-epileptic drug | 9 |
| for the treatment of epilepsy without notification and the | 10 |
| documented consent of the prescribing physician and the patient | 11 |
| or the patient's parent, legal guardian, or spouse.
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| Section 10. The Illinois Food, Drug and Cosmetic Act is | 13 |
| amended by changing Section 3.14 as follows:
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| (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
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| Sec. 3.14. Dispensing or causing to be dispensed a | 16 |
| different drug in
place of the drug or brand of drug ordered or | 17 |
| prescribed without the
express permission of the person | 18 |
| ordering or prescribing.
Except as set forth in Section 26 of | 19 |
| the Pharmacy Practice Act
However , this Section does not | 20 |
| prohibit the interchange of different brands
of the same | 21 |
| generically equivalent drug product, when the drug
products
are | 22 |
| not required to bear the legend "Caution: Federal law prohibits | 23 |
| dispensing
without prescription", provided that the same | 24 |
| dosage form is dispensed and
there is no greater than 1% | 25 |
| variance in the stated amount of each active
ingredient of the | 26 |
| drug products.
A generic drug determined to be therapeutically | 27 |
| equivalent by the
United States Food and Drug Administration | 28 |
| (FDA) shall be available
for substitution in Illinois in | 29 |
| accordance with this Act and the
Pharmacy Practice Act of 1987, | 30 |
| provided that each manufacturer
submits to the Director of the | 31 |
| Department of Public Health a notification containing product | 32 |
| technical
bioequivalence information as a prerequisite to | 33 |
| product
substitution when they have completed all required | 34 |
| testing to
support FDA product approval and, in any event, the |
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SB2578 Enrolled |
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LRB094 17772 RAS 53071 b |
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| information
shall be submitted no later than 60 days prior to | 2 |
| product
substitution in the State.
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| (Source: P.A. 92-112, eff. 7-20-01; 93-841, eff. 7-30-04.)
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| Section 99. Effective date. This Act takes effect upon | 5 |
| becoming law.
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