HB3219eng 99TH GENERAL ASSEMBLY

HB3219 Engrossed 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(Section scheduled to be repealed on January 1, 2018)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) Effective January 1, 2016, the Department shall 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.

(c) The medicine locking closure package must be dispensed by the pharmacy with instructions for patient use.

(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, 9.5, and 11 of the Pharmacy Practice Act take effect January 1, 2017.