Bill Text: IL HB5581 | 2011-2012 | 97th General Assembly | Introduced

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Bill Title: Amends the Pharmacy Practice Act. Provides that a biosimilar product determined to be interchangeable by the United States Food and Drug Administration shall be available for substitution in the State in accordance with the Act and the Illinois Food, Drug and Cosmetic Act, provided that each manufacturer submits to the Director of the Department of Public Health a notification containing product interchangeability information as a prerequisite to product substitution when they have FDA product approval, as interchangeable, and, in any event, the information shall be submitted no later than 60 days prior to product substitution in the State. Sets forth provisions concerning prescription forms. Provides that a pharmacy may substitute a prescription biosimilar product for a prescribed product only under certain circumstances. Sets forth provisions concerning publication and compliance. Provides that a violation of the biosimilar products provision shall be include in the list of causes for which the Department of Financial and Professional Regulation may take disciplinary or non-disciplinary action as the Department may deem proper. Effective January 1, 2013.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Failed) 2013-01-08 - Session Sine Die [HB5581 Detail]

Download: Illinois-2011-HB5581-Introduced.html

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97TH GENERAL ASSEMBLY State of Illinois 2011 and 2012 HB5581 Introduced , by Rep. Ann Williams SYNOPSIS AS INTRODUCED:
225 ILCS 85/25.3 new
225 ILCS 85/30 from Ch. 111, par. 4150
Amends the Pharmacy Practice Act. Provides that a biosimilar product determined to be interchangeable by the United States Food and Drug Administration shall be available for substitution in the State in accordance with the Act and the Illinois Food, Drug and Cosmetic Act, provided that each manufacturer submits to the Director of the Department of Public Health a notification containing product interchangeability information as a prerequisite to product substitution when they have FDA product approval, as interchangeable, and, in any event, the information shall be submitted no later than 60 days prior to product substitution in the State. Sets forth provisions concerning prescription forms. Provides that a pharmacy may substitute a prescription biosimilar product for a prescribed product only under certain circumstances. Sets forth provisions concerning publication and compliance. Provides that a violation of the biosimilar products provision shall be include in the list of causes for which the Department of Financial and Professional Regulation may take disciplinary or non-disciplinary action as the Department may deem proper. Effective January 1, 2013.
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FISCAL NOTE ACT MAY APPLY
A BILL FOR
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AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Pharmacy Practice Act is amended by changing
Section 30 and by adding Section 25.3 as follows:
(225 ILCS 85/25.3 new)
Sec. 25.3. Biosimilar products.
(a) For the purposes of this Section:
"Biological product", "biosimilar", "interchangeable",
"interchangeable biological product", "license", and
"reference product" have the meanings that apply to those
terms under Section 351 of the Public Health Service Act
(42 U.S.C. 262).
"Prescription", with respect to a biological product,
means a product that is subject to Section 503(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
(b) A biosimilar product determined to be interchangeable
by the United States Food and Drug Administration (FDA) shall
be available for substitution in this State in accordance with
this Act and the Illinois Food, Drug and Cosmetic Act, provided
that each manufacturer submits to the Director of the
Department of Public Health a notification containing product
interchangeability information as a prerequisite to product

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substitution when they have FDA product approval, as
interchangeable, and, in any event, the information shall be
submitted no later than 60 days prior to product substitution
in this State. On the prescription forms of prescribers shall
be placed a signature line and the words "may not substitute".
The prescriber, in his or her own handwriting, shall place a
mark beside the words "may not substitute" to direct the
pharmacist in the dispensing of the prescription. Preprinted or
rubber stamped marks, or other deviations from the prescription
format established pursuant to this Section, shall not be
permitted. The prescriber shall sign the form in his or her own
handwriting to authorize the issuance of the prescription.
(c) A pharmacy may substitute a prescription biosimilar
product for a prescribed product only if:
(1) the biosimilar product has been determined by the
FDA to be interchangeable with the prescribed product for
the specified indicated use;
(2) the prescribing physician does not designate in
writing on the prescription that substitution is
prohibited;
(3) the patient (or patient's authorized
representative) provides written consent for the
substitution;
(4) the pharmacist notifies the prescriber in writing
within 24 hours after the substitution; and
(5) the pharmacy and the prescribing physician retain a

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written record of the biosimilar substitution for a period
of no less than 5 years.
(d) The Department of Public Health shall maintain on its
public website a current list of biosimilar biological products
determined to be interchangeable pursuant to subsections (b)
and (c) of this Section.
(e) The Illinois Board of Pharmacy shall adopt rules for
compliance with this Section, under which a pharmacy that
violates subsections (b) and (c) of this Section shall be
subject to a specified civil monetary penalty as provided in
Section 30 of this Act.
(225 ILCS 85/30) (from Ch. 111, par. 4150)
(Section scheduled to be repealed on January 1, 2018)
Sec. 30. Refusal, revocation, or suspension.
(a) The Department may refuse to issue or renew, or may
revoke a license or registration, or may suspend, place on
probation, fine, or take any disciplinary or non-disciplinary
action as the Department may deem proper, including fines not
to exceed $10,000 for each violation, with regard to any
licensee or registrant for any one or combination of the
following causes:
1. Material misstatement in furnishing information to
the Department.
2. Violations of this Act, or the rules promulgated
hereunder.

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3. Making any misrepresentation for the purpose of
obtaining licenses.
4. A pattern of conduct which demonstrates
incompetence or unfitness to practice.
5. Aiding or assisting another person in violating any
provision of this Act or rules.
6. Failing, within 60 days, to respond to a written
request made by the Department for information.
7. Engaging in unprofessional, dishonorable, or
unethical conduct of a character likely to deceive, defraud
or harm the public.
8. Discipline by another U.S. jurisdiction or foreign
nation, if at least one of the grounds for the discipline
is the same or substantially equivalent to those set forth
herein.
9. Directly or indirectly giving to or receiving from
any person, firm, corporation, partnership, or association
any fee, commission, rebate or other form of compensation
for any professional services not actually or personally
rendered. Nothing in this item 9 affects any bona fide
independent contractor or employment arrangements among
health care professionals, health facilities, health care
providers, or other entities, except as otherwise
prohibited by law. Any employment arrangements may include
provisions for compensation, health insurance, pension, or
other employment benefits for the provision of services

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within the scope of the licensee's practice under this Act.
Nothing in this item 9 shall be construed to require an
employment arrangement to receive professional fees for
services rendered.
10. A finding by the Department that the licensee,
after having his license placed on probationary status has
violated the terms of probation.
11. Selling or engaging in the sale of drug samples
provided at no cost by drug manufacturers.
12. Physical illness, including but not limited to,
deterioration through the aging process, or loss of motor
skill which results in the inability to practice the
profession with reasonable judgment, skill or safety.
13. A finding that licensure or registration has been
applied for or obtained by fraudulent means.
14. The applicant or licensee has been convicted in
state or federal court of or entered a plea of guilty, nolo
contendere, or the equivalent in a state or federal court
to any crime which is a felony or any misdemeanor related
to the practice of pharmacy or which an essential element
is dishonesty.
15. Habitual or excessive use or addiction to alcohol,
narcotics, stimulants or any other chemical agent or drug
which results in the inability to practice with reasonable
judgment, skill or safety.
16. Willfully making or filing false records or reports

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in the practice of pharmacy, including, but not limited to
false records to support claims against the medical
assistance program of the Department of Healthcare and
Family Services (formerly Department of Public Aid) under
the Public Aid Code.
17. Gross and willful overcharging for professional
services including filing false statements for collection
of fees for which services are not rendered, including, but
not limited to, filing false statements for collection of
monies for services not rendered from the medical
assistance program of the Department of Healthcare and
Family Services (formerly Department of Public Aid) under
the Public Aid Code.
18. Dispensing prescription drugs without receiving a
written or oral prescription in violation of law.
19. Upon a finding of a substantial discrepancy in a
Department audit of a prescription drug, including
controlled substances, as that term is defined in this Act
or in the Illinois Controlled Substances Act.
20. Physical or mental illness or any other impairment
or disability, including without limitation deterioration
through the aging process or loss of motor skills that
results in the inability to practice with reasonable
judgment, skill or safety, or mental incompetence, as
declared by a court of competent jurisdiction.
21. Violation of the Health Care Worker Self-Referral

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Act.
22. Failing to sell or dispense any drug, medicine, or
poison in good faith. "Good faith", for the purposes of
this Section, has the meaning ascribed to it in subsection
(u) of Section 102 of the Illinois Controlled Substances
Act. "Good faith", as used in this item (22), shall not be
limited to the sale or dispensing of controlled substances,
but shall apply to all prescription drugs.
23. Interfering with the professional judgment of a
pharmacist by any registrant under this Act, or his or her
agents or employees.
24. Failing to report within 60 days to the Department
any adverse final action taken against a pharmacist,
pharmacist technician, or certified pharmacist technician
by another licensing jurisdiction in any other state or any
territory of the United States or any foreign jurisdiction,
any governmental agency, any law enforcement agency, or any
court for acts or conduct similar to acts or conduct that
would constitute grounds for discipline as defined in this
Section.
25. Failing to comply with a subpoena issued in
accordance with Section 35.5 of this Act.
26. Disclosing protected health information in
violation of any State or federal law.
27. Failing to comply with Section 25.3 of this Act.
(b) The Department may refuse to issue or may suspend the

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license or registration of any person who fails to file a
return, or to pay the tax, penalty or interest shown in a filed
return, or to pay any final assessment of tax, penalty or
interest, as required by any tax Act administered by the
Illinois Department of Revenue, until such time as the
requirements of any such tax Act are satisfied.
(c) The Department shall revoke the license or certificate
of registration issued under the provisions of this Act or any
prior Act of this State of any person who has been convicted a
second time of committing any felony under the Illinois
Controlled Substances Act, or who has been convicted a second
time of committing a Class 1 felony under Sections 8A-3 and
8A-6 of the Illinois Public Aid Code. A person whose license or
certificate of registration issued under the provisions of this
Act or any prior Act of this State is revoked under this
subsection (c) shall be prohibited from engaging in the
practice of pharmacy in this State.
(d) Fines may be imposed in conjunction with other forms of
disciplinary action, but shall not be the exclusive disposition
of any disciplinary action arising out of conduct resulting in
death or injury to a patient. Fines shall be paid within 60
days or as otherwise agreed to by the Department. Any funds
collected from such fines shall be deposited in the Illinois
State Pharmacy Disciplinary Fund.
(e) The entry of an order or judgment by any circuit court
establishing that any person holding a license or certificate

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under this Act is a person in need of mental treatment operates
as a suspension of that license. A licensee may resume his or
her practice only upon the entry of an order of the Department
based upon a finding by the Board that he or she has been
determined to be recovered from mental illness by the court and
upon the Board's recommendation that the licensee be permitted
to resume his or her practice.
(f) The Department shall issue quarterly to the Board a
status of all complaints related to the profession received by
the Department.
(g) In enforcing this Section, the Board or the Department,
upon a showing of a possible violation, may compel any licensee
or applicant for licensure under this Act to submit to a mental
or physical examination or both, as required by and at the
expense of the Department. The examining physician, or
multidisciplinary team involved in providing physical and
mental examinations led by a physician consisting of one or a
combination of licensed physicians, licensed clinical
psychologists, licensed clinical social workers, licensed
clinical professional counselors, and other professional and
administrative staff, shall be those specifically designated
by the Department. The Board or the Department may order the
examining physician or any member of the multidisciplinary team
to present testimony concerning this mental or physical
examination of the licensee or applicant. No information,
report, or other documents in any way related to the

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examination shall be excluded by reason of any common law or
statutory privilege relating to communication between the
licensee or applicant and the examining physician or any member
of the multidisciplinary team. The individual to be examined
may have, at his or her own expense, another physician of his
or her choice present during all aspects of the examination.
Failure of any individual to submit to a mental or physical
examination when directed shall be grounds for suspension of
his or her license until such time as the individual submits to
the examination if the Board finds, after notice and hearing,
that the refusal to submit to the examination was without
reasonable cause. If the Board finds a pharmacist, certified
pharmacy technician, or pharmacy technician unable to practice
because of the reasons set forth in this Section, the Board
shall require such pharmacist, certified pharmacy technician,
or pharmacy technician to submit to care, counseling, or
treatment by physicians or other appropriate health care
providers approved or designated by the Board as a condition
for continued, reinstated, or renewed licensure to practice.
Any pharmacist, certified pharmacy technician, or pharmacy
technician whose license was granted, continued, reinstated,
renewed, disciplined, or supervised, subject to such terms,
conditions, or restrictions, and who fails to comply with such
terms, conditions, or restrictions or to complete a required
program of care, counseling, or treatment, as determined by the
chief pharmacy coordinator or a deputy pharmacy coordinator,

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shall be referred to the Secretary for a determination as to
whether the licensee shall have his or her license suspended
immediately, pending a hearing by the Board. In instances in
which the Secretary immediately suspends a license under this
subsection (g), a hearing upon such person's license must be
convened by the Board within 15 days after such suspension and
completed without appreciable delay. The Board shall have the
authority to review the subject pharmacist's, certified
pharmacy technician's, or pharmacy technician's record of
treatment and counseling regarding the impairment.
(Source: P.A. 95-331, eff. 8-21-07; 95-689, eff. 10-29-07;
96-673, eff. 1-1-10; 96-1482, eff. 11-29-10.)
Section 99. Effective date. This Act takes effect January
1, 2013.