State of Illinois
2017 and 2018


Introduced , by Rep. Michelle Mussman


225 ILCS 85/3
225 ILCS 85/19.7 new

    Amends the Pharmacy Practice Act. Provides that "practice of pharmacy" includes the prescribing and dispensing of hormonal contraceptive patches and self-administered oral hormonal contraceptives. Defines "hormonal contraceptive patch" as a transdermal patch applied to the skin of a patient, by the patient or by a practitioner, that releases a drug composed of a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and "self-administered oral hormonal contraceptive" as a drug composed of a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that the patient to whom the drug is prescribed may take orally. Allows pharmacists to prescribe and dispense contraceptives to a person over 18 years of age and a person under 18 years of age only if the person has evidence of a previous prescription from a primary care or a women's health care practitioner. Requires the Department of Financial and Professional Regulation to adopt rules to establish standard procedures for pharmacists to prescribe contraceptives. Provides requirements for the rules to be adopted by the Department. Provides that all State and federal laws governing insurance coverage of contraceptive drugs and products shall apply to the provisions.

LRB100 04385 SMS 14391 b






HB0274LRB100 04385 SMS 14391 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 3 and by adding Section 19.7 as follows:
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2018)
8    Sec. 3. Definitions. For the purpose of this Act, except
9where otherwise limited therein:
10    (a) "Pharmacy" or "drugstore" means and includes every
11store, shop, pharmacy department, or other place where
12pharmacist care is provided by a pharmacist (1) where drugs,
13medicines, or poisons are dispensed, sold or offered for sale
14at retail, or displayed for sale at retail; or (2) where
15prescriptions of physicians, dentists, advanced practice
16nurses, physician assistants, veterinarians, podiatric
17physicians, or optometrists, within the limits of their
18licenses, are compounded, filled, or dispensed; or (3) which
19has upon it or displayed within it, or affixed to or used in
20connection with it, a sign bearing the word or words
21"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
22"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
23"Drugs", "Dispensary", "Medicines", or any word or words of



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1similar or like import, either in the English language or any
2other language; or (4) where the characteristic prescription
3sign (Rx) or similar design is exhibited; or (5) any store, or
4shop, or other place with respect to which any of the above
5words, objects, signs or designs are used in any advertisement.
6    (b) "Drugs" means and includes (1) articles recognized in
7the official United States Pharmacopoeia/National Formulary
8(USP/NF), or any supplement thereto and being intended for and
9having for their main use the diagnosis, cure, mitigation,
10treatment or prevention of disease in man or other animals, as
11approved by the United States Food and Drug Administration, but
12does not include devices or their components, parts, or
13accessories; and (2) all other articles intended for and having
14for their main use the diagnosis, cure, mitigation, treatment
15or prevention of disease in man or other animals, as approved
16by the United States Food and Drug Administration, but does not
17include devices or their components, parts, or accessories; and
18(3) articles (other than food) having for their main use and
19intended to affect the structure or any function of the body of
20man or other animals; and (4) articles having for their main
21use and intended for use as a component or any articles
22specified in clause (1), (2) or (3); but does not include
23devices or their components, parts or accessories.
24    (c) "Medicines" means and includes all drugs intended for
25human or veterinary use approved by the United States Food and
26Drug Administration.



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1    (d) "Practice of pharmacy" means (1) the interpretation and
2the provision of assistance in the monitoring, evaluation, and
3implementation of prescription drug orders; (2) the dispensing
4of prescription drug orders; (3) participation in drug and
5device selection; (4) drug administration limited to the
6administration of oral, topical, injectable, and inhalation as
7follows: in the context of patient education on the proper use
8or delivery of medications; vaccination of patients 14 years of
9age and older pursuant to a valid prescription or standing
10order, by a physician licensed to practice medicine in all its
11branches, upon completion of appropriate training, including
12how to address contraindications and adverse reactions set
13forth by rule, with notification to the patient's physician and
14appropriate record retention, or pursuant to hospital pharmacy
15and therapeutics committee policies and procedures; (5)
16vaccination of patients ages 10 through 13 limited to the
17Influenza (inactivated influenza vaccine and live attenuated
18influenza intranasal vaccine) and Tdap (defined as tetanus,
19diphtheria, acellular pertussis) vaccines, pursuant to a valid
20prescription or standing order, by a physician licensed to
21practice medicine in all its branches, upon completion of
22appropriate training, including how to address
23contraindications and adverse reactions set forth by rule, with
24notification to the patient's physician and appropriate record
25retention, or pursuant to hospital pharmacy and therapeutics
26committee policies and procedures; (6) drug regimen review; (7)



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1drug or drug-related research; (8) the provision of patient
2counseling; (9) the practice of telepharmacy; (10) the
3provision of those acts or services necessary to provide
4pharmacist care; (11) medication therapy management; and (12)
5the responsibility for compounding and labeling of drugs and
6devices (except labeling by a manufacturer, repackager, or
7distributor of non-prescription drugs and commercially
8packaged legend drugs and devices), proper and safe storage of
9drugs and devices, and maintenance of required records; and
10(13) the prescribing and dispensing of hormonal contraceptive
11patches and self-administered oral hormonal contraceptives. A
12pharmacist who performs any of the acts defined as the practice
13of pharmacy in this State must be actively licensed as a
14pharmacist under this Act.
15    (e) "Prescription" means and includes any written, oral,
16facsimile, or electronically transmitted order for drugs or
17medical devices, issued by a physician licensed to practice
18medicine in all its branches, dentist, veterinarian, podiatric
19physician, or optometrist, within the limits of their licenses,
20by a physician assistant in accordance with subsection (f) of
21Section 4, or by an advanced practice nurse in accordance with
22subsection (g) of Section 4, containing the following: (1) name
23of the patient; (2) date when prescription was issued; (3) name
24and strength of drug or description of the medical device
25prescribed; and (4) quantity; (5) directions for use; (6)
26prescriber's name, address, and signature; and (7) DEA number



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1where required, for controlled substances. The prescription
2may, but is not required to, list the illness, disease, or
3condition for which the drug or device is being prescribed. DEA
4numbers shall not be required on inpatient drug orders.
5    (f) "Person" means and includes a natural person,
6copartnership, association, corporation, government entity, or
7any other legal entity.
8    (g) "Department" means the Department of Financial and
9Professional Regulation.
10    (h) "Board of Pharmacy" or "Board" means the State Board of
11Pharmacy of the Department of Financial and Professional
13    (i) "Secretary" means the Secretary of Financial and
14Professional Regulation.
15    (j) "Drug product selection" means the interchange for a
16prescribed pharmaceutical product in accordance with Section
1725 of this Act and Section 3.14 of the Illinois Food, Drug and
18Cosmetic Act.
19    (k) "Inpatient drug order" means an order issued by an
20authorized prescriber for a resident or patient of a facility
21licensed under the Nursing Home Care Act, the ID/DD Community
22Care Act, the MC/DD Act, the Specialized Mental Health
23Rehabilitation Act of 2013, or the Hospital Licensing Act, or
24"An Act in relation to the founding and operation of the
25University of Illinois Hospital and the conduct of University
26of Illinois health care programs", approved July 3, 1931, as



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1amended, or a facility which is operated by the Department of
2Human Services (as successor to the Department of Mental Health
3and Developmental Disabilities) or the Department of
5    (k-5) "Pharmacist" means an individual health care
6professional and provider currently licensed by this State to
7engage in the practice of pharmacy.
8    (l) "Pharmacist in charge" means the licensed pharmacist
9whose name appears on a pharmacy license and who is responsible
10for all aspects of the operation related to the practice of
12    (m) "Dispense" or "dispensing" means the interpretation,
13evaluation, and implementation of a prescription drug order,
14including the preparation and delivery of a drug or device to a
15patient or patient's agent in a suitable container
16appropriately labeled for subsequent administration to or use
17by a patient in accordance with applicable State and federal
18laws and regulations. "Dispense" or "dispensing" does not mean
19the physical delivery to a patient or a patient's
20representative in a home or institution by a designee of a
21pharmacist or by common carrier. "Dispense" or "dispensing"
22also does not mean the physical delivery of a drug or medical
23device to a patient or patient's representative by a
24pharmacist's designee within a pharmacy or drugstore while the
25pharmacist is on duty and the pharmacy is open.
26    (n) "Nonresident pharmacy" means a pharmacy that is located



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1in a state, commonwealth, or territory of the United States,
2other than Illinois, that delivers, dispenses, or distributes,
3through the United States Postal Service, commercially
4acceptable parcel delivery service, or other common carrier, to
5Illinois residents, any substance which requires a
7    (o) "Compounding" means the preparation and mixing of
8components, excluding flavorings, (1) as the result of a
9prescriber's prescription drug order or initiative based on the
10prescriber-patient-pharmacist relationship in the course of
11professional practice or (2) for the purpose of, or incident
12to, research, teaching, or chemical analysis and not for sale
13or dispensing. "Compounding" includes the preparation of drugs
14or devices in anticipation of receiving prescription drug
15orders based on routine, regularly observed dispensing
16patterns. Commercially available products may be compounded
17for dispensing to individual patients only if all of the
18following conditions are met: (i) the commercial product is not
19reasonably available from normal distribution channels in a
20timely manner to meet the patient's needs and (ii) the
21prescribing practitioner has requested that the drug be
23    (p) (Blank).
24    (q) (Blank).
25    (r) "Patient counseling" means the communication between a
26pharmacist or a student pharmacist under the supervision of a



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1pharmacist and a patient or the patient's representative about
2the patient's medication or device for the purpose of
3optimizing proper use of prescription medications or devices.
4"Patient counseling" may include without limitation (1)
5obtaining a medication history; (2) acquiring a patient's
6allergies and health conditions; (3) facilitation of the
7patient's understanding of the intended use of the medication;
8(4) proper directions for use; (5) significant potential
9adverse events; (6) potential food-drug interactions; and (7)
10the need to be compliant with the medication therapy. A
11pharmacy technician may only participate in the following
12aspects of patient counseling under the supervision of a
13pharmacist: (1) obtaining medication history; (2) providing
14the offer for counseling by a pharmacist or student pharmacist;
15and (3) acquiring a patient's allergies and health conditions.
16    (s) "Patient profiles" or "patient drug therapy record"
17means the obtaining, recording, and maintenance of patient
18prescription information, including prescriptions for
19controlled substances, and personal information.
20    (t) (Blank).
21    (u) "Medical device" means an instrument, apparatus,
22implement, machine, contrivance, implant, in vitro reagent, or
23other similar or related article, including any component part
24or accessory, required under federal law to bear the label
25"Caution: Federal law requires dispensing by or on the order of
26a physician". A seller of goods and services who, only for the



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1purpose of retail sales, compounds, sells, rents, or leases
2medical devices shall not, by reasons thereof, be required to
3be a licensed pharmacy.
4    (v) "Unique identifier" means an electronic signature,
5handwritten signature or initials, thumb print, or other
6acceptable biometric or electronic identification process as
7approved by the Department.
8    (w) "Current usual and customary retail price" means the
9price that a pharmacy charges to a non-third-party payor.
10    (x) "Automated pharmacy system" means a mechanical system
11located within the confines of the pharmacy or remote location
12that performs operations or activities, other than compounding
13or administration, relative to storage, packaging, dispensing,
14or distribution of medication, and which collects, controls,
15and maintains all transaction information.
16    (y) "Drug regimen review" means and includes the evaluation
17of prescription drug orders and patient records for (1) known
18allergies; (2) drug or potential therapy contraindications;
19(3) reasonable dose, duration of use, and route of
20administration, taking into consideration factors such as age,
21gender, and contraindications; (4) reasonable directions for
22use; (5) potential or actual adverse drug reactions; (6)
23drug-drug interactions; (7) drug-food interactions; (8)
24drug-disease contraindications; (9) therapeutic duplication;
25(10) patient laboratory values when authorized and available;
26(11) proper utilization (including over or under utilization)



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1and optimum therapeutic outcomes; and (12) abuse and misuse.
2    (z) "Electronic transmission prescription" means any
3prescription order for which a facsimile or electronic image of
4the order is electronically transmitted from a licensed
5prescriber to a pharmacy. "Electronic transmission
6prescription" includes both data and image prescriptions.
7    (aa) "Medication therapy management services" means a
8distinct service or group of services offered by licensed
9pharmacists, physicians licensed to practice medicine in all
10its branches, advanced practice nurses authorized in a written
11agreement with a physician licensed to practice medicine in all
12its branches, or physician assistants authorized in guidelines
13by a supervising physician that optimize therapeutic outcomes
14for individual patients through improved medication use. In a
15retail or other non-hospital pharmacy, medication therapy
16management services shall consist of the evaluation of
17prescription drug orders and patient medication records to
18resolve conflicts with the following:
19        (1) known allergies;
20        (2) drug or potential therapy contraindications;
21        (3) reasonable dose, duration of use, and route of
22    administration, taking into consideration factors such as
23    age, gender, and contraindications;
24        (4) reasonable directions for use;
25        (5) potential or actual adverse drug reactions;
26        (6) drug-drug interactions;



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1        (7) drug-food interactions;
2        (8) drug-disease contraindications;
3        (9) identification of therapeutic duplication;
4        (10) patient laboratory values when authorized and
5    available;
6        (11) proper utilization (including over or under
7    utilization) and optimum therapeutic outcomes; and
8        (12) drug abuse and misuse.
9    "Medication therapy management services" includes the
11        (1) documenting the services delivered and
12    communicating the information provided to patients'
13    prescribers within an appropriate time frame, not to exceed
14    48 hours;
15        (2) providing patient counseling designed to enhance a
16    patient's understanding and the appropriate use of his or
17    her medications; and
18        (3) providing information, support services, and
19    resources designed to enhance a patient's adherence with
20    his or her prescribed therapeutic regimens.
21    "Medication therapy management services" may also include
22patient care functions authorized by a physician licensed to
23practice medicine in all its branches for his or her identified
24patient or groups of patients under specified conditions or
25limitations in a standing order from the physician.
26    "Medication therapy management services" in a licensed



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1hospital may also include the following:
2        (1) reviewing assessments of the patient's health
3    status; and
4        (2) following protocols of a hospital pharmacy and
5    therapeutics committee with respect to the fulfillment of
6    medication orders.
7    (bb) "Pharmacist care" means the provision by a pharmacist
8of medication therapy management services, with or without the
9dispensing of drugs or devices, intended to achieve outcomes
10that improve patient health, quality of life, and comfort and
11enhance patient safety.
12    (cc) "Protected health information" means individually
13identifiable health information that, except as otherwise
14provided, is:
15        (1) transmitted by electronic media;
16        (2) maintained in any medium set forth in the
17    definition of "electronic media" in the federal Health
18    Insurance Portability and Accountability Act; or
19        (3) transmitted or maintained in any other form or
20    medium.
21    "Protected health information" does not include
22individually identifiable health information found in:
23        (1) education records covered by the federal Family
24    Educational Right and Privacy Act; or
25        (2) employment records held by a licensee in its role
26    as an employer.



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1    (dd) "Standing order" means a specific order for a patient
2or group of patients issued by a physician licensed to practice
3medicine in all its branches in Illinois.
4    (ee) "Address of record" means the address recorded by the
5Department in the applicant's or licensee's application file or
6license file, as maintained by the Department's licensure
7maintenance unit.
8    (ff) "Home pharmacy" means the location of a pharmacy's
9primary operations.
10(Source: P.A. 98-104, eff. 7-22-13; 98-214, eff. 8-9-13;
1198-756, eff. 7-16-14; 99-180, eff. 7-29-15.)
12    (225 ILCS 85/19.7 new)
13    Sec. 19.7. Contraceptive drugs and products.
14    (a) As used in this Section:
15    "Hormonal contraceptive patch" means a transdermal patch
16applied to the skin of a patient, by the patient or by a
17practitioner, that releases a drug composed of a combination of
18hormones that is approved by the United States Food and Drug
19Administration to prevent pregnancy.
20    "Self-administered oral hormonal contraceptives" means a
21drug composed of a combination of hormones that is approved by
22the United States Food and Drug Administration to prevent
23pregnancy and that the patient to whom the drug is prescribed
24may take orally.
25    (b) A pharmacist may prescribe and dispense hormonal



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1contraceptive patches and self-administered oral hormonal
2contraceptives to a person who is:
3        (1) at least 18 years of age, regardless of whether the
4    person has evidence of a previous prescription from a
5    primary care practitioner or a women's health care
6    practitioner for a hormonal contraceptive patch or
7    self-administered oral hormonal contraceptive; or
8        (2) under 18 years of age only if the person has
9    evidence of a previous prescription from a primary care
10    practitioner or a women's health care practitioner for a
11    hormonal contraceptive patch or self-administered oral
12    hormonal contraceptive.
13    (c) The Department shall adopt rules to establish, in
14consideration of guidelines established by the American
15Congress of Obstetricians and Gynecologists, standard
16procedures for the prescribing of hormonal contraceptive
17patches and self-administered oral hormonal contraceptives by
19    (d) The rules adopted under this Section must require a
20pharmacist to:
21        (1) complete a training program approved by the
22    Department that is related to prescribing hormonal
23    contraceptive patches and self-administered oral hormonal
24    contraceptives;
25        (2) provide a self-screening risk assessment tool that
26    the patient must use prior to the pharmacist's prescribing



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1    the hormonal contraceptive patch or self-administered oral
2    hormonal contraceptive;
3        (3) refer the patient to the patient's primary care
4    practitioner or women's health care practitioner upon
5    prescribing and dispensing the hormonal contraceptive
6    patch or self-administered oral hormonal contraceptive;
7        (4) provide the patient with a written record of the
8    hormonal contraceptive patch or self-administered oral
9    hormonal contraceptive prescribed and dispensed and advise
10    the patient to consult with a primary care practitioner or
11    women's health care practitioner; and
12        (5) dispense the hormonal contraceptive patch or
13    self-administered oral hormonal contraceptive to the
14    patient as soon as practicable after the pharmacist issues
15    the prescription.
16    (e) The rules adopted under this Section must prohibit a
17pharmacist from:
18        (1) requiring a patient to schedule an appointment with
19    the pharmacist for the prescribing or dispensing of a
20    hormonal contraceptive patch or self-administered oral
21    hormonal contraceptive; and
22        (2) prescribing and dispensing a hormonal
23    contraceptive patch or self-administered oral hormonal
24    contraceptive to a patient who does not have evidence of a
25    clinical visit for women's health within the 3 years
26    immediately following the initial prescription and



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1    dispensation of a hormonal contraceptive patch or
2    self-administered oral hormonal contraceptive by a
3    pharmacist to the patient.
4    (f) All State and federal laws governing insurance coverage
5of contraceptive drugs, devices, products, and services shall
6apply to hormonal contraceptive patches and self-administered
7oral hormonal contraceptives prescribed by a pharmacist under
8this Section.