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


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.

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

Download: Illinois-2011-HB5581-Introduced.html


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

HB5581LRB097 20467 CEL 65993 b
1 AN ACT concerning regulation.
2 Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4 Section 5. The Pharmacy Practice Act is amended by changing
5Section 30 and by adding Section 25.3 as follows:
6 (225 ILCS 85/25.3 new)
7 Sec. 25.3. Biosimilar products.
8 (a) For the purposes of this Section:
9 "Biological product", "biosimilar", "interchangeable",
10 "interchangeable biological product", "license", and
11 "reference product" have the meanings that apply to those
12 terms under Section 351 of the Public Health Service Act
13 (42 U.S.C. 262).
14 "Prescription", with respect to a biological product,
15 means a product that is subject to Section 503(b) of the
16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
17 (b) A biosimilar product determined to be interchangeable
18by the United States Food and Drug Administration (FDA) shall
19be available for substitution in this State in accordance with
20this Act and the Illinois Food, Drug and Cosmetic Act, provided
21that each manufacturer submits to the Director of the
22Department of Public Health a notification containing product
23interchangeability information as a prerequisite to product

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1substitution when they have FDA product approval, as
2interchangeable, and, in any event, the information shall be
3submitted no later than 60 days prior to product substitution
4in this State. On the prescription forms of prescribers shall
5be placed a signature line and the words "may not substitute".
6The prescriber, in his or her own handwriting, shall place a
7mark beside the words "may not substitute" to direct the
8pharmacist in the dispensing of the prescription. Preprinted or
9rubber stamped marks, or other deviations from the prescription
10format established pursuant to this Section, shall not be
11permitted. The prescriber shall sign the form in his or her own
12handwriting to authorize the issuance of the prescription.
13 (c) A pharmacy may substitute a prescription biosimilar
14product for a prescribed product only if:
15 (1) the biosimilar product has been determined by the
16 FDA to be interchangeable with the prescribed product for
17 the specified indicated use;
18 (2) the prescribing physician does not designate in
19 writing on the prescription that substitution is
20 prohibited;
21 (3) the patient (or patient's authorized
22 representative) provides written consent for the
23 substitution;
24 (4) the pharmacist notifies the prescriber in writing
25 within 24 hours after the substitution; and
26 (5) the pharmacy and the prescribing physician retain a

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1 written record of the biosimilar substitution for a period
2 of no less than 5 years.
3 (d) The Department of Public Health shall maintain on its
4public website a current list of biosimilar biological products
5determined to be interchangeable pursuant to subsections (b)
6and (c) of this Section.
7 (e) The Illinois Board of Pharmacy shall adopt rules for
8compliance with this Section, under which a pharmacy that
9violates subsections (b) and (c) of this Section shall be
10subject to a specified civil monetary penalty as provided in
11Section 30 of this Act.
12 (225 ILCS 85/30) (from Ch. 111, par. 4150)
13 (Section scheduled to be repealed on January 1, 2018)
14 Sec. 30. Refusal, revocation, or suspension.
15 (a) The Department may refuse to issue or renew, or may
16revoke a license or registration, or may suspend, place on
17probation, fine, or take any disciplinary or non-disciplinary
18action as the Department may deem proper, including fines not
19to exceed $10,000 for each violation, with regard to any
20licensee or registrant for any one or combination of the
21following causes:
22 1. Material misstatement in furnishing information to
23 the Department.
24 2. Violations of this Act, or the rules promulgated
25 hereunder.

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

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

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

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

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1license or registration of any person who fails to file a
2return, or to pay the tax, penalty or interest shown in a filed
3return, or to pay any final assessment of tax, penalty or
4interest, as required by any tax Act administered by the
5Illinois Department of Revenue, until such time as the
6requirements of any such tax Act are satisfied.
7 (c) The Department shall revoke the license or certificate
8of registration issued under the provisions of this Act or any
9prior Act of this State of any person who has been convicted a
10second time of committing any felony under the Illinois
11Controlled Substances Act, or who has been convicted a second
12time of committing a Class 1 felony under Sections 8A-3 and
138A-6 of the Illinois Public Aid Code. A person whose license or
14certificate of registration issued under the provisions of this
15Act or any prior Act of this State is revoked under this
16subsection (c) shall be prohibited from engaging in the
17practice of pharmacy in this State.
18 (d) Fines may be imposed in conjunction with other forms of
19disciplinary action, but shall not be the exclusive disposition
20of any disciplinary action arising out of conduct resulting in
21death or injury to a patient. Fines shall be paid within 60
22days or as otherwise agreed to by the Department. Any funds
23collected from such fines shall be deposited in the Illinois
24State Pharmacy Disciplinary Fund.
25 (e) The entry of an order or judgment by any circuit court
26establishing that any person holding a license or certificate

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1under this Act is a person in need of mental treatment operates
2as a suspension of that license. A licensee may resume his or
3her practice only upon the entry of an order of the Department
4based upon a finding by the Board that he or she has been
5determined to be recovered from mental illness by the court and
6upon the Board's recommendation that the licensee be permitted
7to resume his or her practice.
8 (f) The Department shall issue quarterly to the Board a
9status of all complaints related to the profession received by
10the Department.
11 (g) In enforcing this Section, the Board or the Department,
12upon a showing of a possible violation, may compel any licensee
13or applicant for licensure under this Act to submit to a mental
14or physical examination or both, as required by and at the
15expense of the Department. The examining physician, or
16multidisciplinary team involved in providing physical and
17mental examinations led by a physician consisting of one or a
18combination of licensed physicians, licensed clinical
19psychologists, licensed clinical social workers, licensed
20clinical professional counselors, and other professional and
21administrative staff, shall be those specifically designated
22by the Department. The Board or the Department may order the
23examining physician or any member of the multidisciplinary team
24to present testimony concerning this mental or physical
25examination of the licensee or applicant. No information,
26report, or other documents in any way related to the

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1examination shall be excluded by reason of any common law or
2statutory privilege relating to communication between the
3licensee or applicant and the examining physician or any member
4of the multidisciplinary team. The individual to be examined
5may have, at his or her own expense, another physician of his
6or her choice present during all aspects of the examination.
7Failure of any individual to submit to a mental or physical
8examination when directed shall be grounds for suspension of
9his or her license until such time as the individual submits to
10the examination if the Board finds, after notice and hearing,
11that the refusal to submit to the examination was without
12reasonable cause. If the Board finds a pharmacist, certified
13pharmacy technician, or pharmacy technician unable to practice
14because of the reasons set forth in this Section, the Board
15shall require such pharmacist, certified pharmacy technician,
16or pharmacy technician to submit to care, counseling, or
17treatment by physicians or other appropriate health care
18providers approved or designated by the Board as a condition
19for continued, reinstated, or renewed licensure to practice.
20Any pharmacist, certified pharmacy technician, or pharmacy
21technician whose license was granted, continued, reinstated,
22renewed, disciplined, or supervised, subject to such terms,
23conditions, or restrictions, and who fails to comply with such
24terms, conditions, or restrictions or to complete a required
25program of care, counseling, or treatment, as determined by the
26chief pharmacy coordinator or a deputy pharmacy coordinator,

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1shall be referred to the Secretary for a determination as to
2whether the licensee shall have his or her license suspended
3immediately, pending a hearing by the Board. In instances in
4which the Secretary immediately suspends a license under this
5subsection (g), a hearing upon such person's license must be
6convened by the Board within 15 days after such suspension and
7completed without appreciable delay. The Board shall have the
8authority to review the subject pharmacist's, certified
9pharmacy technician's, or pharmacy technician's record of
10treatment and counseling regarding the impairment.
11(Source: P.A. 95-331, eff. 8-21-07; 95-689, eff. 10-29-07;
1296-673, eff. 1-1-10; 96-1482, eff. 11-29-10.)
13 Section 99. Effective date. This Act takes effect January
141, 2013.
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