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1		AN ACT concerning regulation.
2		Be it enacted by the People of the State of Illinois,
3		represented in the General Assembly:
4		Section 3. The Pharmacy Practice Act is amended by changing
5		Section 4 as follows:
6		(225 ILCS 85/4) (from Ch. 111, par. 4124)
7		(Section scheduled to be repealed on January 1, 2020)
8		Sec. 4. Exemptions. Nothing contained in any Section of
9		this Act shall apply to, or in any manner interfere with:
10		(a) the lawful practice of any physician licensed to
11		practice medicine in all of its branches, dentist,
12		podiatric physician, veterinarian, or therapeutically or
13		diagnostically certified optometrist within the limits of
14		his or her license, or prevent him or her from supplying to
15		his or her bona fide patients such drugs, medicines, or
16		poisons as may seem to him appropriate;
17		(b) the sale of compressed gases;
18		(c) the sale of patent or proprietary medicines and
19		household remedies when sold in original and unbroken
20		packages only, if such patent or proprietary medicines and
21		household remedies be properly and adequately labeled as to
22		content and usage and generally considered and accepted as
23		harmless and nonpoisonous when used according to the

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1		directions on the label, and also do not contain opium or
2		coca leaves, or any compound, salt or derivative thereof,
3		or any drug which, according to the latest editions of the
4		following authoritative pharmaceutical treatises and
5		standards, namely, The United States
6		Pharmacopoeia/National Formulary (USP/NF), the United
7		States Dispensatory, and the Accepted Dental Remedies of
8		the Council of Dental Therapeutics of the American Dental
9		Association or any or either of them, in use on the
10		effective date of this Act, or according to the existing
11		provisions of the Federal Food, Drug, and Cosmetic Act and
12		Regulations of the Department of Health and Human Services,
13		Food and Drug Administration, promulgated thereunder now
14		in effect, is designated, described or considered as a
15		narcotic, hypnotic, habit forming, dangerous, or poisonous
16		drug;
17		(d) the sale of poultry and livestock remedies in
18		original and unbroken packages only, labeled for poultry
19		and livestock medication;
20		(e) the sale of poisonous substances or mixture of
21		poisonous substances, in unbroken packages, for
22		nonmedicinal use in the arts or industries or for
23		insecticide purposes; provided, they are properly and
24		adequately labeled as to content and such nonmedicinal
25		usage, in conformity with the provisions of all applicable
26		federal, state and local laws and regulations promulgated

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1		thereunder now in effect relating thereto and governing the
2		same, and those which are required under such applicable
3		laws and regulations to be labeled with the word "Poison",
4		are also labeled with the word "Poison" printed thereon in
5		prominent type and the name of a readily obtainable
6		antidote with directions for its administration;
7		(f) the delegation of limited prescriptive authority
8		by a physician licensed to practice medicine in all its
9		branches to a physician assistant under Section 7.5 of the
10		Physician Assistant Practice Act of 1987. This delegated
11		authority under Section 7.5 of the Physician Assistant
12		Practice Act of 1987 may, but is not required to, include
13		prescription of controlled substances, as defined in
14		Article II of the Illinois Controlled Substances Act, in
15		accordance with a written supervision agreement;
16		(g) the delegation of prescriptive authority by a
17		physician licensed to practice medicine in all its branches
18		or a licensed podiatric physician to an advanced practice
19		registered nurse in accordance with a written
20		collaborative agreement under Sections 65-35 and 65-40 of
21		the Nurse Practice Act; and
22		(h) the sale or distribution of dialysate or devices
23		necessary to perform home peritoneal renal dialysis for
24		patients with end-stage renal disease, provided that all of
25		the following conditions are met:
26		(1) the dialysate, comprised of dextrose or

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1		icodextrin, or devices are approved or cleared by the
2		federal Food and Drug Administration, as required by
3		federal law;
4		(2) the dialysate or devices are lawfully held by a
5		manufacturer or the manufacturer's agent, which is
6		properly registered with the Board as a manufacturer,
7		third-party logistics provider, or wholesaler;
8		(3) the dialysate or devices are held and delivered
9		to the manufacturer or the manufacturer's agent in the
10		original, sealed packaging from the manufacturing
11		facility;
12		(4) the dialysate or devices are delivered only
13		upon receipt of a physician's prescription by a
14		licensed pharmacy in which the prescription is
15		processed in accordance with provisions set forth in
16		this Act, and the transmittal of an order from the
17		licensed pharmacy to the manufacturer or the
18		manufacturer's agent; and
19		(5) the manufacturer or the manufacturer's agent
20		delivers the dialysate or devices directly to: (i) a
21		patient with end-stage renal disease, or his or her
22		designee, for the patient's self-administration of the
23		dialysis therapy or (ii) a health care provider or
24		institution for administration or delivery of the
25		dialysis therapy to a patient with end-stage renal
26		disease.

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1		This paragraph (h) does not include any other drugs for
2		peritoneal dialysis, except dialysate, as described in
3		item (1) of this paragraph (h). All records of sales and
4		distribution of dialysate to patients made pursuant to this
5		paragraph (h) must be retained in accordance with Section
6		18 of this Act.
7		(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
8		100-863, eff. 8-14-18.)
9		Section 10. The Wholesale Drug Distribution Licensing Act
10		is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80,
11		and 155 and by adding Section 25.5 as follows:
12		(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
13		(Section scheduled to be repealed on January 1, 2023)
14		Sec. 15. Definitions. As used in this Act:
15		"Authentication" means the affirmative verification,
16		before any wholesale distribution of a prescription drug
17		occurs, that each transaction listed on the pedigree has
18		occurred.
19		"Authorized distributor of record" means a wholesale
20		distributor with whom a manufacturer has established an ongoing
21		relationship to distribute the manufacturer's prescription
22		drug. An ongoing relationship is deemed to exist between a
23		wholesale distributor and a manufacturer when the wholesale
24		distributor, including any affiliated group of the wholesale

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1		distributor, as defined in Section 1504 of the Internal Revenue
2		Code, complies with the following:
3		(1) The wholesale distributor has a written agreement
4		currently in effect with the manufacturer evidencing the
5		ongoing relationship; and
6		(2) The wholesale distributor is listed on the
7		manufacturer's current list of authorized distributors of
8		record, which is updated by the manufacturer on no less
9		than a monthly basis.
10		"Blood" means whole blood collected from a single donor and
11		processed either for transfusion or further manufacturing.
12		"Blood component" means that part of blood separated by
13		physical or mechanical means.
14		"Board" means the State Board of Pharmacy of the Department
15		of Professional Regulation.
16		"Chain pharmacy warehouse" means a physical location for
17		prescription drugs that acts as a central warehouse and
18		performs intracompany sales or transfers of the drugs to a
19		group of chain or mail order pharmacies that have the same
20		common ownership and control. Notwithstanding any other
21		provision of this Act, a chain pharmacy warehouse shall be
22		considered part of the normal distribution channel.
23		"Co-licensed partner or product" means an instance where
24		one or more parties have the right to engage in the
25		manufacturing or marketing of a prescription drug, consistent
26		with the FDA's implementation of the Prescription Drug

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1		Marketing Act.
2		"Department" means the Department of Financial and
3		Professional Regulation.
4		"Drop shipment" means the sale of a prescription drug to a
5		wholesale distributor by the manufacturer of the prescription
6		drug or that manufacturer's co-licensed product partner, that
7		manufacturer's third party logistics provider, or that
8		manufacturer's exclusive distributor or by an authorized
9		distributor of record that purchased the product directly from
10		the manufacturer or one of these entities whereby the wholesale
11		distributor or chain pharmacy warehouse takes title but not
12		physical possession of such prescription drug and the wholesale
13		distributor invoices the pharmacy, chain pharmacy warehouse,
14		or other person authorized by law to dispense or administer
15		such drug to a patient and the pharmacy, chain pharmacy
16		warehouse, or other authorized person receives delivery of the
17		prescription drug directly from the manufacturer, that
18		manufacturer's third party logistics provider, or that
19		manufacturer's exclusive distributor or from an authorized
20		distributor of record that purchased the product directly from
21		the manufacturer or one of these entities.
22		"Drug sample" means a unit of a prescription drug that is
23		not intended to be sold and is intended to promote the sale of
24		the drug.
25		"Facility" means a facility of a wholesale distributor
26		where prescription drugs are stored, handled, repackaged, or

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1		offered for sale, or a facility of a third-party logistics
2		provider where prescription drugs are stored or handled.
3		"FDA" means the United States Food and Drug Administration.
4		"Manufacturer" means a person licensed or approved by the
5		FDA to engage in the manufacture of drugs or devices,
6		consistent with the definition of "manufacturer" set forth in
7		the FDA's regulations and guidances implementing the
8		Prescription Drug Marketing Act.
9		"Manufacturer's exclusive distributor" means anyone who
10		contracts with a manufacturer to provide or coordinate
11		warehousing, distribution, or other services on behalf of a
12		manufacturer and who takes title to that manufacturer's
13		prescription drug, but who does not have general responsibility
14		to direct the sale or disposition of the manufacturer's
15		prescription drug. A manufacturer's exclusive distributor must
16		be licensed as a wholesale distributor under this Act and, in
17		order to be considered part of the normal distribution channel,
18		must also be an authorized distributor of record.
19		"Normal distribution channel" means a chain of custody for
20		a prescription drug that goes, directly or by drop shipment,
21		from (i) a manufacturer of the prescription drug, (ii) that
22		manufacturer to that manufacturer's co-licensed partner, (iii)
23		that manufacturer to that manufacturer's third party logistics
24		provider, or (iv) that manufacturer to that manufacturer's
25		exclusive distributor to:
26		(1) a pharmacy or to other designated persons

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1		authorized by law to dispense or administer the drug to a
2		patient;
3		(2) a wholesale distributor to a pharmacy or other
4		designated persons authorized by law to dispense or
5		administer the drug to a patient;
6		(3) a wholesale distributor to a chain pharmacy
7		warehouse to that chain pharmacy warehouse's intracompany
8		pharmacy to a patient or other designated persons
9		authorized by law to dispense or administer the drug to a
10		patient;
11		(4) a chain pharmacy warehouse to the chain pharmacy
12		warehouse's intracompany pharmacy or other designated
13		persons authorized by law to dispense or administer the
14		drug to the patient;
15		(5) an authorized distributor of record to one other
16		authorized distributor of record to an office-based health
17		care practitioner authorized by law to dispense or
18		administer the drug to the patient; or
19		(6) an authorized distributor to a pharmacy or other
20		persons licensed to dispense or administer the drug.
21		"Pedigree" means a document or electronic file containing
22		information that records each wholesale distribution of any
23		given prescription drug from the point of origin to the final
24		wholesale distribution point of any given prescription drug.
25		"Person" means and includes a natural person, partnership,
26		association, corporation, or any other legal business entity.

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1		"Pharmacy distributor" means any pharmacy licensed in this
2		State or hospital pharmacy that is engaged in the delivery or
3		distribution of prescription drugs either to any other pharmacy
4		licensed in this State or to any other person or entity
5		including, but not limited to, a wholesale drug distributor
6		engaged in the delivery or distribution of prescription drugs
7		who is involved in the actual, constructive, or attempted
8		transfer of a drug in this State to other than the ultimate
9		consumer except as otherwise provided for by law.
10		"Prescription drug" means any human drug, including any
11		biological product (except for blood and blood components
12		intended for transfusion or biological products that are also
13		medical devices), required by federal law or regulation to be
14		dispensed only by a prescription, including finished dosage
15		forms and bulk drug substances subject to Section 503 of the
16		Federal Food, Drug and Cosmetic Act.
17		"Repackage" means repackaging or otherwise changing the
18		container, wrapper, or labeling to further the distribution of
19		a prescription drug, excluding that completed by the pharmacist
20		responsible for dispensing the product to a patient.
21		"Secretary" means the Secretary of Financial and
22		Professional Regulation.
23		"Third-party Third party logistics provider" means anyone
24		who contracts with a prescription drug manufacturer to provide
25		or coordinate warehousing, distribution, or other services on
26		behalf of a manufacturer, but does not take title to the

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1		prescription drug or have general responsibility to direct the
2		prescription drug's sale or disposition. A third party
3		logistics provider must be licensed as a wholesale distributor
4		under this Act and, in order to be considered part of the
5		normal distribution channel, must also be an authorized
6		distributor of record.
7		"Wholesale distribution" means the distribution of
8		prescription drugs to persons other than a consumer or patient,
9		but does not include any of the following:
10		(1) Intracompany sales of prescription drugs, meaning
11		(i) any transaction or transfer between any division,
12		subsidiary, parent, or affiliated or related company under
13		the common ownership and control of a corporate entity or
14		(ii) any transaction or transfer between co-licensees of a
15		co-licensed product.
16		(2) The sale, purchase, distribution, trade, or
17		transfer of a prescription drug or offer to sell, purchase,
18		distribute, trade, or transfer a prescription drug for
19		emergency medical reasons.
20		(3) The distribution of prescription drug samples by
21		manufacturers' representatives.
22		(4) Drug returns, when conducted by a hospital, health
23		care entity, or charitable institution in accordance with
24		federal regulation.
25		(5) The sale of minimal quantities of prescription
26		drugs by licensed pharmacies to licensed practitioners for

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1		office use or other licensed pharmacies.
2		(6) The sale, purchase, or trade of a drug, an offer to
3		sell, purchase, or trade a drug, or the dispensing of a
4		drug pursuant to a prescription.
5		(7) The sale, transfer, merger, or consolidation of all
6		or part of the business of a pharmacy or pharmacies from or
7		with another pharmacy or pharmacies, whether accomplished
8		as a purchase and sale of stock or business assets.
9		(8) The sale, purchase, distribution, trade, or
10		transfer of a prescription drug from one authorized
11		distributor of record to one additional authorized
12		distributor of record when the manufacturer has stated in
13		writing to the receiving authorized distributor of record
14		that the manufacturer is unable to supply the prescription
15		drug and the supplying authorized distributor of record
16		states in writing that the prescription drug being supplied
17		had until that time been exclusively in the normal
18		distribution channel.
19		(9) The delivery of or the offer to deliver a
20		prescription drug by a common carrier solely in the common
21		carrier's usual course of business of transporting
22		prescription drugs when the common carrier does not store,
23		warehouse, or take legal ownership of the prescription
24		drug.
25		(10) The sale or transfer from a retail pharmacy, mail
26		order pharmacy, or chain pharmacy warehouse of expired,

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1		damaged, returned, or recalled prescription drugs to the
2		original manufacturer, the originating wholesale
3		distributor, or a third party returns processor.
4		"Wholesale drug distributor" means anyone engaged in the
5		wholesale distribution of prescription drugs into, out of, or
6		within the State, including without limitation manufacturers;
7		repackers; own label distributors; jobbers; private label
8		distributors; brokers; warehouses, including manufacturers'
9		and distributors' warehouses; manufacturer's exclusive
10		distributors; and authorized distributors of record; drug
11		wholesalers or distributors; independent wholesale drug
12		traders; specialty wholesale distributors; third party
13		logistics providers; and retail pharmacies that conduct
14		wholesale distribution; and chain pharmacy warehouses that
15		conduct wholesale distribution. In order to be considered part
16		of the normal distribution channel, a wholesale distributor
17		must also be an authorized distributor of record.
18		(Source: P.A. 97-804, eff. 1-1-13.)
19		(225 ILCS 120/20) (from Ch. 111, par. 8301-20)
20		(Section scheduled to be repealed on January 1, 2023)
21		Sec. 20. Prohibited drug purchases or receipt. It shall be
22		unlawful for any person or entity located in this State to
23		knowingly receive any prescription drug from any source other
24		than a person or entity required by the laws of this State to
25		be licensed to ship into, out of, or within this State. A

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1		person or entity licensed under the laws of this State shall
2		include, but is not limited to, a wholesale distributor,
3		manufacturer, third-party logistics provider, pharmacy
4		distributor, or pharmacy. Any person violating this Section
5		shall, upon conviction, be adjudged guilty of a Class C
6		misdemeanor. A second violation shall constitute a Class 4
7		felony.
8		(Source: P.A. 97-804, eff. 1-1-13.)
9		(225 ILCS 120/25.5 new)
10		Sec. 25.5. Third-party logistics providers.
11		(a) Each resident third-party logistics provider must be
12		licensed by the Department, and every non-resident third-party
13		logistics provider must be licensed in this State, in
14		accordance with this Act, prior to shipping a prescription drug
15		into this State.
16		(b) The Department shall require, without limitation, all
17		of the following information from each applicant for licensure
18		under this Act:
19		(1) The name, full business address, and telephone
20		number of the licensee.
21		(2) All trade or business names used by the licensee.
22		(3) Addresses, telephone numbers, and the names of
23		contact persons for all facilities used by the licensee for
24		the storage, handling, and distribution of prescription
25		drugs.

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1		(4) The type of ownership or operation, such as a
2		partnership, corporation, or sole proprietorship.
3		(5) The name of the owner or operator of the
4		third-party logistics provider, including:
5		(A) if a natural person, the name of the natural
6		person;
7		(B) if a partnership, the name of each partner and
8		the name of the partnership;
9		(C) if a corporation, the name and title of each
10		corporate officer and director, the corporate names,
11		and the name of the state of incorporation; and
12		(D) if a sole proprietorship, the full name of the
13		sole proprietor and the name of the business entity.
14		(6) A list of all licenses and permits issued to the
15		applicant by any other state that authorizes the applicant
16		to purchase or possess prescription drugs.
17		(7) The name of the designated representative for the
18		third-party logistics provider, together with the personal
19		information statement and fingerprints, as required under
20		subsection (c) of this Section.
21		(8) Minimum liability insurance and other insurance as
22		defined by rule.
23		(9) Any additional information required by the
24		Department.
25		(c) Each third-party logistics provider must designate an
26		individual representative who shall serve as the contact person

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1		for the Department. This representative must provide the
2		Department with all of the following information:
3		(1) Information concerning whether the person has been
4		enjoined, either temporarily or permanently, by a court of
5		competent jurisdiction from violating any federal or State
6		law regulating the possession, control, or distribution of
7		prescription drugs or criminal violations, together with
8		details concerning any such event.
9		(2) A description of any involvement by the person with
10		any business, including any investments, other than the
11		ownership of stock in a publicly traded company or mutual
12		fund, that manufactured, administered, prescribed,
13		distributed, or stored pharmaceutical products and any
14		lawsuits in which such businesses were named as a party.
15		(3) A description of any misdemeanor or felony criminal
16		offense of which the person, as an adult, was found guilty,
17		regardless of whether adjudication of guilt was withheld or
18		whether the person pled guilty or nolo contendere. If the
19		person indicates that a criminal conviction is under appeal
20		and submits a copy of the notice of appeal of that criminal
21		offense, the applicant must, within 15 days after the
22		disposition of the appeal, submit to the Department a copy
23		of the final written order of disposition.
24		(4) The designated representative of an applicant for
25		licensure as a third-party logistics provider shall have
26		his or her fingerprints submitted to the Department of

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1		State Police in an electronic format that complies with the
2		form and manner for requesting and furnishing criminal
3		history record information as prescribed by the Department
4		of State Police. These fingerprints shall be checked
5		against the Department of State Police and Federal Bureau
6		of Investigation criminal history record databases now and
7		hereafter filed. The Department of State Police shall
8		charge applicants a fee for conducting the criminal history
9		records check, which shall be deposited into the State
10		Police Services Fund and shall not exceed the actual cost
11		of the records check. The Department of State Police shall
12		furnish, pursuant to positive identification, records of
13		Illinois convictions to the Department. The Department may
14		require applicants to pay a separate fingerprinting fee,
15		either to the Department or to a vendor. The Department, in
16		its discretion, may allow an applicant who does not have
17		reasonable access to a designated vendor to provide his or
18		her fingerprints in an alternative manner. The Department
19		may adopt any rules necessary to implement this paragraph
20		(4).
21		(d) A third-party logistics provider shall not operate from
22		a place of residence.
23		(e) A third-party logistics provider facility shall be
24		located apart and separate from any retail pharmacy licensed by
25		the Department.
26		(f) The Department may not issue a third-party logistics

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1		provider license to an applicant, unless the Department first:
2		(1) ensures that a physical inspection of the facility
3		satisfactory to the Department has occurred at the address
4		provided by the applicant, as required under item (1) of
5		subsection (b) of this Section; such inspection is not
6		required if the resident state of the third-party logistics
7		provider facility does not license third-party logistics
8		providers or if the resident state does not inspect
9		third-party logistics providers. If the resident state
10		does not inspect third-party logistics providers, a
11		Verified Accredited Wholesale Distributors Accreditation
12		or other inspection approved by the Department meets this
13		requirement; and
14		(2) determines that the designated representative
15		meets each of the following qualifications:
16		(A) He or she is at least 21 years of age.
17		(B) He or she is employed by the applicant full
18		time in a managerial level position.
19		(C) He or she is actively involved in and aware of
20		the actual daily operation of third-party logistics
21		provider.
22		(g) A third-party logistics provider shall publicly
23		display all licenses and have the most recent state and federal
24		inspection reports readily available.
25		(225 ILCS 120/26)

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1		(Section scheduled to be repealed on January 1, 2023)
2		Sec. 26. Unlicensed practice; violation; civil penalty.
3		(a) Any person who practices, offers to practice, attempts
4		to practice, or holds oneself out to practice as a wholesale
5		drug distributor, or pharmacy distributor, or third-party
6		logistics provider without being licensed to ship into, out of,
7		or within the State under this Act shall, in addition to any
8		other penalty provided by law, pay a civil penalty to the
9		Department in an amount not to exceed $10,000 for each offense
10		as determined by the Department. The civil penalty shall be
11		assessed by the Department after a hearing is held in
12		accordance with the provisions set forth in this Act regarding
13		the provision of a hearing for the discipline of a licensee.
14		(b) The Department has the authority and power to
15		investigate any and all unlicensed activity.
16		(c) The civil penalty shall be paid within 60 days after
17		the effective date of the order imposing the civil penalty. The
18		order shall constitute a judgment and may be filed and
19		execution had thereon in the same manner as any judgment from
20		any court of record.
21		(Source: P.A. 97-804, eff. 1-1-13.)
22		(225 ILCS 120/30) (from Ch. 111, par. 8301-30)
23		(Section scheduled to be repealed on January 1, 2023)
24		Sec. 30. License renewal application procedures.
25		Application blanks for renewal of any license required by this

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1		Act shall be mailed or emailed to each licensee at least 60
2		days before the license expires. If the application for renewal
3		with the required fee is not received by the Department before
4		the expiration date, the existing license shall lapse and
5		become null and void. Failure to renew before the expiration
6		date is cause for a late payment penalty, discipline, or both.
7		(Source: P.A. 87-594.)
8		(225 ILCS 120/35) (from Ch. 111, par. 8301-35)
9		(Section scheduled to be repealed on January 1, 2023)
10		Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
11		(a) The Department shall provide by rule for a schedule of
12		fees for the administration and enforcement of this Act,
13		including but not limited to original licensure, renewal, and
14		restoration. The fees shall be nonrefundable.
15		(b) All fees collected under this Act shall be deposited
16		into the Illinois State Pharmacy Disciplinary Fund and shall be
17		appropriated to the Department for the ordinary and contingent
18		expenses of the Department in the administration of this Act.
19		Moneys in the Fund may be transferred to the Professions
20		Indirect Cost Fund as authorized by Section 2105-300 of the
21		Department of Professional Regulation Law (20 ILCS
22		2105/2105-300).
23		The moneys deposited into the Illinois State Pharmacy
24		Disciplinary Fund shall be invested to earn interest which
25		shall accrue to the Fund.

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1		The Department shall present to the Board for its review
2		and comment all appropriation requests from the Illinois State
3		Pharmacy Disciplinary Fund. The Department shall give due
4		consideration to any comments of the Board in making
5		appropriation requests.
6		(c) Any person who delivers a check or other payment to the
7		Department that is returned to the Department unpaid by the
8		financial institution upon which it is drawn shall pay to the
9		Department, in addition to the amount already owed to the
10		Department, a fine of $50. The fines imposed by this Section
11		are in addition to any other discipline provided under this Act
12		for unlicensed practice or practice on a nonrenewed license.
13		The Department shall notify the person that payment of fees and
14		fines shall be paid to the Department by certified check or
15		money order within 30 calendar days of the notification. If,
16		after the expiration of 30 days from the date of the
17		notification, the person has failed to submit the necessary
18		remittance, the Department shall automatically terminate the
19		license or certificate or deny the application, without
20		hearing. If, after termination or denial, the person seeks a
21		license or certificate, he or she shall apply to the Department
22		for restoration or issuance of the license or certificate and
23		pay all fees and fines due to the Department. The Department
24		may establish a fee for the processing of an application for
25		restoration of a license or certificate to pay all expenses of
26		processing this application. The Director may waive the fines

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1		due under this Section in individual cases where the Director
2		finds that the fines would be unreasonable or unnecessarily
3		burdensome.
4		(d) The Department shall maintain a roster of the names and
5		addresses of all registrants and of all persons whose licenses
6		have been suspended or revoked. This roster shall be available
7		upon written request and payment of the required fee.
8		(e) A manufacturer of controlled substances, or wholesale
9		distributor of controlled substances, or third-party logistics
10		provider that is licensed under this Act and owned and operated
11		by the State is exempt from licensure, registration, renewal,
12		and other fees required under this Act. Nothing in this
13		subsection (e) shall be construed to prohibit the Department
14		from imposing any fine or other penalty allowed under this Act.
15		(Source: P.A. 95-689, eff. 10-29-07.)
16		(225 ILCS 120/40) (from Ch. 111, par. 8301-40)
17		(Section scheduled to be repealed on January 1, 2023)
18		Sec. 40. Rules and regulations. The Department shall make
19		any rules and regulations, not inconsistent with law, as may be
20		necessary to carry out the purposes and enforce the provisions
21		of this Act. Rules and regulations that incorporate and set
22		detailed standards for meeting each of the license
23		prerequisites set forth in Section 25 of this Act shall be
24		adopted no later than September 14, 1992. All rules and
25		regulations promulgated under this Section shall conform to

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1		wholesale drug distributor licensing guidelines formally
2		adopted by the FDA at 21 C.F.R. Part 205. In case of conflict
3		between any rule or regulation adopted by the Department and
4		any FDA wholesale drug distributor or third-party logistics
5		provider guideline, the FDA guideline shall control.
6		(Source: P.A. 87-594.)
7		(225 ILCS 120/57)
8		(Section scheduled to be repealed on January 1, 2023)
9		Sec. 57. Pedigree.
10		(a) Each person who is engaged in the wholesale
11		distribution of prescription drugs, including repackagers, but
12		excluding the original manufacturer of the finished form of the
13		prescription drug, that leave or have ever left the normal
14		distribution channel shall, before each wholesale distribution
15		of the drug, provide a pedigree to the person who receives the
16		drug. A retail pharmacy, mail order pharmacy, or chain pharmacy
17		warehouse must comply with the requirements of this Section
18		only if the pharmacy or chain pharmacy warehouse engages in the
19		wholesale distribution of prescription drugs. On or before July
20		1, 2009, the Department shall determine a targeted
21		implementation date for electronic track and trace pedigree
22		technology. This targeted implementation date shall not be
23		sooner than July 1, 2010. Beginning on the date established by
24		the Department, pedigrees may be implemented through an
25		approved and readily available system that electronically

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1		tracks and traces the wholesale distribution of each
2		prescription drug starting with the sale by the manufacturer
3		through acquisition and sale by any wholesale distributor and
4		until final sale to a pharmacy or other authorized person
5		administering or dispensing the prescription drug. This
6		electronic tracking system shall be deemed to be readily
7		available only upon there being available a standardized system
8		originating with the manufacturers and capable of being used on
9		a wide scale across the entire pharmaceutical chain, including
10		manufacturers, wholesale distributors, third-party logistics
11		providers, and pharmacies. Consideration must also be given to
12		the large-scale implementation of this technology across the
13		supply chain and the technology must be proven to have no
14		negative impact on the safety and efficacy of the
15		pharmaceutical product.
16		(b) Each person who is engaged in the wholesale
17		distribution of a prescription drug who is provided a pedigree
18		for a prescription drug and attempts to further distribute that
19		prescription drug, including repackagers, but excluding the
20		original manufacturer of the finished form of the prescription
21		drug, must affirmatively verify before any distribution of a
22		prescription drug occurs that each transaction listed on the
23		pedigree has occurred.
24		(c) The pedigree must include all necessary identifying
25		information concerning each sale in the chain of distribution
26		of the product from the manufacturer or the manufacturer's

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1		third party logistics provider, co-licensed product partner,
2		or exclusive distributor through acquisition and sale by any
3		wholesale distributor or repackager, until final sale to a
4		pharmacy or other person dispensing or administering the drug.
5		This necessary chain of distribution information shall
6		include, without limitation all of the following:
7		(1) The name, address, telephone number and, if
8		available, the e-mail address of each owner of the
9		prescription drug and each wholesale distributor of the
10		prescription drug.
11		(2) The name and address of each location from which
12		the product was shipped, if different from the owner's.
13		(3) Transaction dates.
14		(4) Certification that each recipient has
15		authenticated the pedigree.
16		(d) The pedigree must also include without limitation all
17		of the following information concerning the prescription drug:
18		(1) The name and national drug code number of the
19		prescription drug.
20		(2) The dosage form and strength of the prescription
21		drug.
22		(3) The size of the container.
23		(4) The number of containers.
24		(5) The lot number of the prescription drug.
25		(6) The name of the manufacturer of the finished dosage
26		form.

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1		(e) Each pedigree or electronic file shall be maintained by
2		the purchaser and the wholesale distributor for at least 3
3		years from the date of sale or transfer and made available for
4		inspection or use within 5 business days upon a request of the
5		Department.
6		(Source: P.A. 95-689, eff. 10-29-07.)
7		(225 ILCS 120/80) (from Ch. 111, par. 8301-80)
8		(Section scheduled to be repealed on January 1, 2023)
9		Sec. 80. Violations of Act.
10		(a) If any person violates the provisions of this Act, the
11		Director may, in the name of the People of the State of
12		Illinois through the Attorney General of the State of Illinois
13		or the State's Attorney of any county in which the action is
14		brought, petition for an order enjoining the violation or for
15		an order enforcing compliance with this Act. Upon the filing of
16		a verified petition in the court, the court may issue a
17		temporary restraining order, without notice or bond, and may
18		preliminarily and permanently enjoin the violation. If it is
19		established that the person has violated or is violating the
20		injunction, the Court may punish the offender for contempt of
21		court. Proceedings under this Section shall be in addition to,
22		and not in lieu of, all other remedies and penalties provided
23		by this Act.
24		(b) Whoever knowingly conducts business as a wholesale drug
25		distributor or third-party logistics provider in this State

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1		without being appropriately licensed under this Act shall be
2		guilty of a Class A misdemeanor for a first violation and for
3		each subsequent conviction shall be guilty of a Class 4 felony.
4		(c) Whenever in the opinion of the Department any person
5		not licensed in good standing under this Act violates any
6		provision of this Act, the Department may issue a rule to show
7		cause why an order to cease and desist should not be entered
8		against him. The rule shall clearly set forth the grounds
9		relied upon by the Department and shall provide a period of 7
10		days from the date of the rule to file an answer to the
11		satisfaction of the Department. Failure to answer to the
12		satisfaction of the Department shall cause an order to cease
13		and desist to be issued immediately.
14		(Source: P.A. 87-594.)
15		(225 ILCS 120/155) (from Ch. 111, par. 8301-155)
16		(Section scheduled to be repealed on January 1, 2023)
17		Sec. 155. Temporary suspension of license; hearing. The
18		Director may temporarily suspend licensure as a wholesale drug
19		distributor or third-party logistics provider, without a
20		hearing, simultaneously with the institution of proceedings
21		for a hearing provided for in Section 85 of this Act, if the
22		Director finds that evidence in his or her possession indicates
23		that a continuation in business would constitute an imminent
24		danger to the public. In the event that the Director
25		temporarily suspends a license or certificate without a

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1		hearing, a hearing by the Department must be held within 10
2		days after the suspension has occurred and be concluded without
3		appreciable delay.
4		(Source: P.A. 87-594.)
5		Section 99. Effective date. This Act takes effect upon
6		becoming law.