Bill Text: IL HB3219 | 2015-2016 | 99th General Assembly | Chaptered

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Bill Title: Amends the Pharmacy Practice Act. Provides that beginning January 1, 2016, the Department of Financial and Professional Regulation shall implement a pilot project requiring that every new or refilled prescription for a Schedule II controlled substance containing hydrocodone shall only be dispensed in a non-reusable medicine locking closure package. Defines "medicine locking closure package" and "Schedule II controlled substance". Provides that the medicine locking closure package must be dispensed by the pharmacy with instructions for patient use. Provides that the manufacturer of the medicine locking closure package must make available assistance online or through a toll-free number for patient use. Provides that prescriptions reimbursed via Medicare Part D and Medicaid and prescriptions for individuals residing in facilities licensed under the Nursing Home Care Act are exempt from the requirements of the pilot project. Repeals the provisions creating the pilot project on January 1, 2017. Effective immediately.

Sponsorship: Moderate Partisan Bill (Democrat 23-7)

Status: (Passed) 2015-08-27 - Public Act . . . . . . . . . 99-0473 [HB3219 Detail]

Download: Illinois-2015-HB3219-Chaptered.html

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Public Act 099-0473
HB3219 Enrolled LRB099 05820 HAF 25864 b
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
Sections 9, 9.5, and 11 and by adding Section 16c as follows:
(225 ILCS 85/9) (from Ch. 111, par. 4129)
(Section scheduled to be repealed on January 1, 2018)
Sec. 9. Registration as pharmacy technician. Any person
shall be entitled to registration as a registered pharmacy
technician who is of the age of 16 or over, has not engaged in
conduct or behavior determined to be grounds for discipline
under this Act, is attending or has graduated from an
accredited high school or comparable school or educational
institution or received a high school equivalency certificate,
and has filed a written application for registration on a form
to be prescribed and furnished by the Department for that
purpose. The Department shall issue a certificate of
registration as a registered pharmacy technician to any
applicant who has qualified as aforesaid, and such registration
shall be the sole authority required to assist licensed
pharmacists in the practice of pharmacy, under the supervision
of a licensed pharmacist. A registered pharmacy technician may,
under the supervision of a pharmacist, assist in the practice

of pharmacy and perform such functions as assisting in the
dispensing process, offering counseling, receiving new verbal
prescription orders, and having prescriber contact concerning
prescription drug order clarification. A registered pharmacy
technician may not engage in patient counseling, drug regimen
review, or clinical conflict resolution.
Beginning on January 1, 2017 January 1, 2010, within 2
years after initial registration as a registered pharmacy
technician, the registrant must meet the requirements
described in Section 9.5 of this Act and register as a
registered certified pharmacy technician. If the registrant
has not yet attained the age of 18, then upon the next renewal
as a registered pharmacy technician, the registrant must meet
the requirements described in Section 9.5 of this Act and
register as a registered certified pharmacy technician a
pharmacy technician must become certified by successfully
passing the Pharmacy Technician Certification Board (PTCB)
examination or another Board-approved pharmacy technician
examination and register as a certified pharmacy technician
with the Department in order to continue to perform pharmacy
technician's duties. This requirement does not apply to
pharmacy technicians registered prior to January 1, 2008.
Any person registered as a pharmacy technician who is also
enrolled in a first professional degree program in pharmacy in
a school or college of pharmacy or a department of pharmacy of
a university approved by the Department or has graduated from

such a program within the last 18 months, shall be considered a
"student pharmacist" and entitled to use the title "student
pharmacist". A student pharmacist must meet all of the
requirements for registration as a pharmacy technician set
forth in this Section excluding the requirement of
certification prior to the second registration renewal and pay
the required pharmacy technician registration fees. A student
pharmacist may, under the supervision of a pharmacist, assist
in the practice of pharmacy and perform any and all functions
delegated to him or her by the pharmacist.
Any person seeking licensure as a pharmacist who has
graduated from a pharmacy program outside the United States
must register as a pharmacy technician and shall be considered
a "student pharmacist" and be entitled to use the title
"student pharmacist" while completing the 1,200 clinical hours
of training approved by the Board of Pharmacy described and for
no more than 18 months after completion of these hours. These
individuals are not required to become registered certified
pharmacy technicians while completing their Board approved
clinical training, but must become licensed as a pharmacist or
become a registered certified pharmacy technician before the
second pharmacy technician registration renewal following
completion of the Board approved clinical training.
The Department shall not renew the pharmacy technician
license of any person who has been registered as a "student
pharmacist" and has dropped out of or been expelled from an

ACPE accredited college of pharmacy, who has failed to complete
his or her 1,200 hours of Board approved clinical training
within 24 months or who has failed the pharmacist licensure
examination 3 times and shall require these individuals to meet
the requirements of and become registered as a registered
certified pharmacy technician.
The Department may take any action set forth in Section 30
of this Act with regard to registrations pursuant to this
Section.
Any person who is enrolled in a non-traditional Pharm.D.
program at an ACPE accredited college of pharmacy and is a
licensed pharmacist under the laws of another United States
jurisdiction shall be permitted to engage in the program of
practice experience required in the academic program by virtue
of such license. Such person shall be exempt from the
requirement of registration as a registered pharmacy
technician while engaged in the program of practice experience
required in the academic program.
An applicant for registration as a pharmacy technician may
assist a pharmacist in the practice of pharmacy for a period of
up to 60 days prior to the issuance of a certificate of
registration if the applicant has submitted the required fee
and an application for registration to the Department. The
applicant shall keep a copy of the submitted application on the
premises where the applicant is assisting in the practice of
pharmacy. The Department shall forward confirmation of receipt

of the application with start and expiration dates of practice
pending registration.
(Source: P.A. 98-718, eff. 1-1-15.)
(225 ILCS 85/9.5)
(Section scheduled to be repealed on January 1, 2018)
Sec. 9.5. Registered certified Certified pharmacy
technician.
(a) An individual registered as a registered pharmacy
technician under this Act may be registered as a registered
certified pharmacy technician, if he or she meets all of the
following requirements:
(1) He or she has submitted a written application in
the form and manner prescribed by the Department.
(2) He or she has attained the age of 18.
(3) He or she is of good moral character, as determined
by the Department.
(4) He or she has (i) graduated from pharmacy
technician training meeting the requirements set forth in
subsection (a) of Section 17.1 of this Act or (ii) obtained
documentation from the pharmacist-in-charge of the
pharmacy where the applicant is employed verifying that he
or she has successfully completed a training program and
has successfully completed an objective assessment
mechanism prepared in accordance with rules established by
the Department.

(5) He or she has successfully passed an examination
accredited by the National Commission for Certifying
Agencies National Organization of Certifying Agencies, as
approved and required by the Board.
(6) He or she has paid the required certification fees.
(b) No pharmacist whose license has been denied, revoked,
suspended, or restricted for disciplinary purposes may be
eligible to be registered as a certified pharmacy technician.
(c) The Department may, by rule, establish any additional
requirements for certification under this Section.
(d) A person who is not a registered pharmacy technician
and meets the requirements of this Section may register as a
registered certified pharmacy technician without first
registering as a pharmacy technician.
(e) As a condition for the renewal of a certificate of
registration as a registered certified pharmacy technician,
the registrant shall provide evidence to the Department of
completion of a total of 20 hours of continuing pharmacy
education during the 24 months preceding the expiration date of
the certificate. One hour of continuing pharmacy education must
be in the subject of pharmacy law. One hour of continuing
pharmacy education must be in the subject of patient safety.
The continuing education shall be approved by the Accreditation
Council on Pharmacy Education.
The Department shall establish by rule a means for the
verification of completion of the continuing education

required by this subsection (e). This verification may be
accomplished through audits of records maintained by
registrants, by requiring the filing of continuing education
certificates with the Department or a qualified organization
selected by the Department to maintain such records, or by
other means established by the Department.
Rules developed under this subsection (e) may provide for a
reasonable annual fee, not to exceed $20, to fund the cost of
such recordkeeping. The Department shall, by rule, further
provide an orderly process for the reinstatement of a
registration that has not been renewed due to the failure to
meet the continuing pharmacy education requirements of this
subsection (e). The Department may waive the requirements of
continuing pharmacy education, in whole or in part, in cases of
extreme hardship as defined by rule of the Department. The
waivers shall be granted for not more than one of any 3
consecutive renewal periods.
(Source: P.A. 95-689, eff. 10-29-07; 96-673, eff. 1-1-10.)
(225 ILCS 85/11) (from Ch. 111, par. 4131)
(Section scheduled to be repealed on January 1, 2018)
Sec. 11. Duties of the Department. The Department shall
exercise the powers and duties prescribed by the Civil
Administrative Code of Illinois for the administration of
Licensing Acts and shall exercise such other powers and duties
necessary for effectuating the purpose of this Act. However,

the following powers and duties shall be exercised only upon
review of the Board of Pharmacy to take such action:
(a) Formulate such rules, not inconsistent with law and
subject to the Illinois Administrative Procedure Act, as may be
necessary to carry out the purposes and enforce the provisions
of this Act. The Director may grant variances from any such
rules as provided for in this Section;
(b) The suspension, revocation, placing on probationary
status, reprimand, and refusing to issue or restore any license
or certificate of registration issued under the provisions of
this Act for the reasons set forth in Section 30 of this Act.
(c) The issuance, renewal, restoration or reissuance of any
license or certificate which has been previously refused to be
issued or renewed, or has been revoked, suspended or placed on
probationary status.
The granting of variances from rules promulgated pursuant
to this Section in individual cases where there is a finding
that:
(1) the provision from which the variance is granted is
not statutorily mandated;
(2) no party will be injured by the granting of the
variance; and
(3) the rule from which the variance is granted would,
in the particular case, be unreasonable or unnecessarily
burdensome.
The Director shall notify the State Board of Pharmacy of

the granting of such variance and the reasons therefor, at the
next meeting of the Board.
(d) The Secretary shall appoint a chief pharmacy
coordinator and at least 2 deputy pharmacy coordinators, all of
whom shall be registered pharmacists in good standing in this
State, shall be graduates of an accredited college of pharmacy
or hold, at a minimum, a bachelor of science degree in
pharmacy, and shall have at least 5 years of experience in the
practice of pharmacy immediately prior to his or her
appointment. The chief pharmacy coordinator shall be the
executive administrator and the chief enforcement officer of
this Act. The deputy pharmacy coordinators shall report to the
chief pharmacy coordinator. The Secretary shall assign at least
one deputy pharmacy coordinator to a region composed of Cook
County and such other counties as the Secretary may deem
appropriate, and such deputy pharmacy coordinator shall have
his or her primary office in Chicago. The Secretary shall
assign at least one deputy pharmacy coordinator to a region
composed of the balance of counties in the State, and such
deputy pharmacy coordinator shall have his or her primary
office in Springfield.
(e) The Secretary shall, in conformity with the Personnel
Code, employ not less than 4 pharmacy investigators who shall
report to the pharmacy coordinator or a deputy pharmacy
coordinator. Each pharmacy investigator shall be a graduate of
a 4-year college or university and shall (i) have at least 2

years of investigative experience; (ii) have 2 years of
responsible pharmacy experience; or (iii) be a licensed
pharmacist unless employed as a pharmacy investigator on or
before the effective date of this amendatory Act of the 99th
General Assembly. The Department shall also employ at least one
attorney to prosecute violations of this Act and its rules. The
Department may, in conformity with the Personnel Code, employ
such clerical and other employees as are necessary to carry out
the duties of the Board and Department.
The duly authorized pharmacy investigators of the
Department shall have the right to enter and inspect, during
business hours, any pharmacy or any other place in this State
holding itself out to be a pharmacy where medicines, drugs or
drug products, or proprietary medicines are sold, offered for
sale, exposed for sale, or kept for sale.
(Source: P.A. 95-689, eff. 10-29-07.)
(225 ILCS 85/16c new)
Sec. 16c. Medicine locking closure package.
(a) As used in this Section:
"Medicine locking closure package" means any alphanumeric
combination locking closure mechanism that can only be unlocked
with a user-generated, resettable alphanumeric code in
combination with an amber prescription container that forms a
package that allows only the person with a prescription access
to the medicine.

"Schedule II controlled substance" means a Schedule II
controlled substance under the United States Controlled
Substances Act and 21 CFR 1308.
(b) Subject to appropriation, effective January 1, 2016,
the Department shall by rule implement a pilot project
requiring that every new or refilled prescription for a
Schedule II controlled substance containing hydrocodone
dispensed by a pharmacy that voluntarily decides to participate
in the pilot program shall only be dispensed in a non-reusable
medicine locking closure package. The Department shall not
expend more than $150,000 on this pilot program. The Department
may contract with third parties to implement the pilot program
in whole or in part.
(c) The medicine locking closure package must be dispensed
by the pharmacy with instructions for patient use unless the
prescriber indicates orally, in writing, or electronically
that a medicine locking closure package shall not be used.
(d) The manufacturer of the medicine locking closure
package must make available assistance online or through a
toll-free number for patient use.
(e) Prescriptions reimbursed via the Medicare Part D and
Medicaid programs, including Medicaid managed care plans, are
exempt from the provisions of this Section.
(f) Prescriptions for individuals residing in facilities
licensed under the Nursing Home Care Act are exempt from the
provisions of this Section.

(g) This Section is repealed on January 1, 2017.
Section 99. Effective date. This Act takes effect upon
becoming law, except that the changes to Sections 9 and 9.5 of
the Pharmacy Practice Act take effect January 1, 2017.