Bill Amendment: IL SB1839 | 2019-2020 | 101st General Assembly
NOTE: For additional amemendments please see the Bill Drafting List
Bill Title: DRUG DISTRIB-LOGISTIC PROVIDER
Status: 2019-08-16 - Public Act . . . . . . . . . 101-0420 [SB1839 Detail]
Download: Illinois-2019-SB1839-Senate_Amendment_002.html
Bill Title: DRUG DISTRIB-LOGISTIC PROVIDER
Status: 2019-08-16 - Public Act . . . . . . . . . 101-0420 [SB1839 Detail]
Download: Illinois-2019-SB1839-Senate_Amendment_002.html
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1 | AMENDMENT TO SENATE BILL 1839
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2 | AMENDMENT NO. ______. Amend Senate Bill 1839, AS AMENDED, | ||||||
3 | by replacing everything after the enacting clause with the | ||||||
4 | following:
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5 | "Section 3. The Pharmacy Practice Act is amended by | ||||||
6 | changing Section 4 as follows:
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7 | (225 ILCS 85/4) (from Ch. 111, par. 4124)
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8 | (Section scheduled to be repealed on January 1, 2020)
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9 | Sec. 4. Exemptions. Nothing contained in any Section of | ||||||
10 | this Act shall
apply
to, or in any manner interfere with:
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11 | (a) the lawful practice of any physician licensed to | ||||||
12 | practice medicine in
all of its branches, dentist, | ||||||
13 | podiatric physician,
veterinarian, or therapeutically or | ||||||
14 | diagnostically certified optometrist within
the limits of
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15 | his or her license, or prevent him or her from
supplying to | ||||||
16 | his
or her
bona fide patients
such drugs, medicines, or |
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1 | poisons as may seem to him appropriate;
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2 | (b) the sale of compressed gases;
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3 | (c) the sale of patent or proprietary medicines and | ||||||
4 | household remedies
when sold in original and unbroken | ||||||
5 | packages only, if such patent or
proprietary medicines and | ||||||
6 | household remedies be properly and adequately
labeled as to | ||||||
7 | content and usage and generally considered and accepted
as | ||||||
8 | harmless and nonpoisonous when used according to the | ||||||
9 | directions
on the label, and also do not contain opium or | ||||||
10 | coca leaves, or any
compound, salt or derivative thereof, | ||||||
11 | or any drug which, according
to the latest editions of the | ||||||
12 | following authoritative pharmaceutical
treatises and | ||||||
13 | standards, namely, The United States | ||||||
14 | Pharmacopoeia/National
Formulary (USP/NF), the United | ||||||
15 | States Dispensatory, and the Accepted
Dental Remedies of | ||||||
16 | the Council of Dental Therapeutics of the American
Dental | ||||||
17 | Association or any or either of them, in use on the | ||||||
18 | effective
date of this Act, or according to the existing | ||||||
19 | provisions of the Federal
Food, Drug, and Cosmetic Act and | ||||||
20 | Regulations of the Department of Health
and Human Services, | ||||||
21 | Food and Drug Administration, promulgated thereunder
now | ||||||
22 | in effect, is designated, described or considered as a | ||||||
23 | narcotic,
hypnotic, habit forming, dangerous, or poisonous | ||||||
24 | drug;
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25 | (d) the sale of poultry and livestock remedies in | ||||||
26 | original and unbroken
packages only, labeled for poultry |
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1 | and livestock medication;
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2 | (e) the sale of poisonous substances or mixture of | ||||||
3 | poisonous substances,
in unbroken packages, for | ||||||
4 | nonmedicinal use in the arts or industries
or for | ||||||
5 | insecticide purposes; provided, they are properly and | ||||||
6 | adequately
labeled as to content and such nonmedicinal | ||||||
7 | usage, in conformity
with the provisions of all applicable | ||||||
8 | federal, state and local laws
and regulations promulgated | ||||||
9 | thereunder now in effect relating thereto
and governing the | ||||||
10 | same, and those which are required under such applicable
| ||||||
11 | laws and regulations to be labeled with the word "Poison", | ||||||
12 | are also labeled
with the word "Poison" printed
thereon in | ||||||
13 | prominent type and the name of a readily obtainable | ||||||
14 | antidote
with directions for its administration;
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15 | (f) the delegation of limited prescriptive authority | ||||||
16 | by a physician
licensed to
practice medicine in all its | ||||||
17 | branches to a physician assistant
under Section 7.5 of the | ||||||
18 | Physician Assistant Practice Act of 1987. This
delegated | ||||||
19 | authority under Section 7.5 of the Physician Assistant | ||||||
20 | Practice Act of 1987 may, but is not required to, include | ||||||
21 | prescription of
controlled substances, as defined in | ||||||
22 | Article II of the
Illinois Controlled Substances Act, in | ||||||
23 | accordance with a written supervision agreement;
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24 | (g) the delegation of prescriptive authority by a | ||||||
25 | physician
licensed to practice medicine in all its branches | ||||||
26 | or a licensed podiatric physician to an advanced practice
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1 | registered nurse in accordance with a written | ||||||
2 | collaborative
agreement under Sections 65-35 and 65-40 of | ||||||
3 | the Nurse Practice Act; and
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4 | (h) the sale or distribution of dialysate or devices | ||||||
5 | necessary to perform home peritoneal renal dialysis for | ||||||
6 | patients with end-stage renal disease, provided that all of | ||||||
7 | the following conditions are met: | ||||||
8 | (1) the dialysate, comprised of dextrose or | ||||||
9 | icodextrin, or devices are approved or cleared by the | ||||||
10 | federal Food and Drug Administration, as required by | ||||||
11 | federal law; | ||||||
12 | (2) the dialysate or devices are lawfully held by a | ||||||
13 | manufacturer or the manufacturer's agent, which is | ||||||
14 | properly registered with the Board as a manufacturer , | ||||||
15 | third-party logistics provider, or wholesaler; | ||||||
16 | (3) the dialysate or devices are held and delivered | ||||||
17 | to the manufacturer or the manufacturer's agent in the | ||||||
18 | original, sealed packaging from the manufacturing | ||||||
19 | facility; | ||||||
20 | (4) the dialysate or devices are delivered only | ||||||
21 | upon receipt of a physician's prescription by a | ||||||
22 | licensed pharmacy in which the prescription is | ||||||
23 | processed in accordance with provisions set forth in | ||||||
24 | this Act, and the transmittal of an order from the | ||||||
25 | licensed pharmacy to the manufacturer or the | ||||||
26 | manufacturer's agent; and |
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1 | (5) the manufacturer or the manufacturer's agent | ||||||
2 | delivers the dialysate or devices directly to: (i) a | ||||||
3 | patient with end-stage renal disease, or his or her | ||||||
4 | designee, for the patient's self-administration of the | ||||||
5 | dialysis therapy or (ii) a health care provider or | ||||||
6 | institution for administration or delivery of the | ||||||
7 | dialysis therapy to a patient with end-stage renal | ||||||
8 | disease. | ||||||
9 | This paragraph (h) does not include any other drugs for | ||||||
10 | peritoneal dialysis, except dialysate, as described in | ||||||
11 | item (1) of this paragraph (h). All records of sales and | ||||||
12 | distribution of dialysate to patients made pursuant to this | ||||||
13 | paragraph (h) must be retained in accordance with Section | ||||||
14 | 18 of this Act. | ||||||
15 | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | ||||||
16 | 100-863, eff. 8-14-18.)
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17 | Section 10. The Wholesale Drug Distribution Licensing Act | ||||||
18 | is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80, | ||||||
19 | and 155 and by adding Section 25.5 as follows:
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20 | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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21 | (Section scheduled to be repealed on January 1, 2023)
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22 | Sec. 15. Definitions. As used in this Act:
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23 | "Authentication" means the affirmative verification, | ||||||
24 | before any wholesale distribution of a prescription drug |
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1 | occurs, that each transaction listed on the pedigree has | ||||||
2 | occurred. | ||||||
3 | "Authorized distributor of record" means a wholesale | ||||||
4 | distributor with whom a manufacturer has established an ongoing | ||||||
5 | relationship to distribute the manufacturer's prescription | ||||||
6 | drug. An ongoing relationship is deemed to exist between a | ||||||
7 | wholesale distributor and a manufacturer when the wholesale | ||||||
8 | distributor, including any affiliated group of the wholesale | ||||||
9 | distributor, as defined in Section 1504 of the Internal Revenue | ||||||
10 | Code, complies with the following: | ||||||
11 | (1) The wholesale distributor has a written agreement | ||||||
12 | currently in effect with the manufacturer evidencing the | ||||||
13 | ongoing relationship; and | ||||||
14 | (2) The wholesale distributor is listed on the | ||||||
15 | manufacturer's current list of authorized distributors of | ||||||
16 | record, which is updated by the manufacturer on no less | ||||||
17 | than a monthly basis.
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18 | "Blood" means whole blood collected from a single donor and | ||||||
19 | processed
either for transfusion or further manufacturing.
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20 | "Blood component" means that part of blood separated by | ||||||
21 | physical or
mechanical means.
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22 | "Board" means the State Board of Pharmacy of the Department | ||||||
23 | of
Professional Regulation.
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24 | "Chain pharmacy warehouse" means a physical location for | ||||||
25 | prescription drugs that acts as a central warehouse and | ||||||
26 | performs intracompany sales or transfers of the drugs to a |
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1 | group of chain or mail order pharmacies that have the same | ||||||
2 | common ownership and control. Notwithstanding any other | ||||||
3 | provision of this Act, a chain pharmacy warehouse shall be | ||||||
4 | considered part of the normal distribution channel. | ||||||
5 | "Co-licensed partner or product" means an instance where | ||||||
6 | one or more parties have the right to engage in the | ||||||
7 | manufacturing or marketing of a prescription drug, consistent | ||||||
8 | with the FDA's implementation of the Prescription Drug | ||||||
9 | Marketing Act.
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10 | "Department" means the Department of Financial and
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11 | Professional Regulation.
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12 | "Drop shipment" means the sale of a prescription drug to a | ||||||
13 | wholesale distributor by the manufacturer of the prescription | ||||||
14 | drug or that manufacturer's co-licensed product partner, that | ||||||
15 | manufacturer's third party logistics provider, or that | ||||||
16 | manufacturer's exclusive distributor or by an authorized | ||||||
17 | distributor of record that purchased the product directly from | ||||||
18 | the manufacturer or one of these entities whereby the wholesale | ||||||
19 | distributor or chain pharmacy warehouse takes title but not | ||||||
20 | physical possession of such prescription drug and the wholesale | ||||||
21 | distributor invoices the pharmacy, chain pharmacy warehouse, | ||||||
22 | or other person authorized by law to dispense or administer | ||||||
23 | such drug to a patient and the pharmacy, chain pharmacy | ||||||
24 | warehouse, or other authorized person receives delivery of the | ||||||
25 | prescription drug directly from the manufacturer, that | ||||||
26 | manufacturer's third party logistics provider, or that |
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1 | manufacturer's exclusive distributor or from an authorized | ||||||
2 | distributor of record that purchased the product directly from | ||||||
3 | the manufacturer or one of these entities.
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4 | "Drug sample" means a unit of a prescription drug that is | ||||||
5 | not intended to
be sold and is intended to promote the sale of | ||||||
6 | the drug.
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7 | "Facility" means a facility of a wholesale distributor | ||||||
8 | where prescription drugs are stored, handled, repackaged, or | ||||||
9 | offered for sale , or a facility of a third-party logistics | ||||||
10 | provider where prescription drugs are stored or handled . | ||||||
11 | "FDA" means the United States Food and Drug Administration.
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12 | "Manufacturer" means a person licensed or approved by the | ||||||
13 | FDA to engage in the manufacture of drugs or devices, | ||||||
14 | consistent with the definition of "manufacturer" set forth in | ||||||
15 | the FDA's regulations and guidances implementing the | ||||||
16 | Prescription Drug Marketing Act. | ||||||
17 | "Manufacturer's exclusive distributor" means anyone who | ||||||
18 | contracts with a manufacturer to provide or coordinate | ||||||
19 | warehousing, distribution, or other services on behalf of a | ||||||
20 | manufacturer and who takes title to that manufacturer's | ||||||
21 | prescription drug, but who does not have general responsibility | ||||||
22 | to direct the sale or disposition of the manufacturer's | ||||||
23 | prescription drug. A manufacturer's exclusive distributor must | ||||||
24 | be licensed as a wholesale distributor under this Act and, in | ||||||
25 | order to be considered part of the normal distribution channel, | ||||||
26 | must also be an authorized distributor of record.
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1 | "Normal distribution channel" means a chain of custody for | ||||||
2 | a prescription drug that goes, directly or by drop shipment, | ||||||
3 | from (i) a manufacturer of the prescription drug, (ii) that | ||||||
4 | manufacturer to that manufacturer's co-licensed partner, (iii) | ||||||
5 | that manufacturer to that manufacturer's third party logistics | ||||||
6 | provider, or (iv) that manufacturer to that manufacturer's | ||||||
7 | exclusive distributor to: | ||||||
8 | (1) a pharmacy or to other designated persons | ||||||
9 | authorized by law to dispense or administer the drug to a | ||||||
10 | patient; | ||||||
11 | (2) a wholesale distributor to a pharmacy or other | ||||||
12 | designated persons authorized by law to dispense or | ||||||
13 | administer the drug to a patient; | ||||||
14 | (3) a wholesale distributor to a chain pharmacy | ||||||
15 | warehouse to that chain pharmacy warehouse's intracompany | ||||||
16 | pharmacy to a patient or other designated persons | ||||||
17 | authorized by law to dispense or administer the drug to a | ||||||
18 | patient; | ||||||
19 | (4) a chain pharmacy warehouse to the chain pharmacy | ||||||
20 | warehouse's intracompany pharmacy or other designated | ||||||
21 | persons authorized by law to dispense or administer the | ||||||
22 | drug to the patient; | ||||||
23 | (5) an authorized distributor of record to one other | ||||||
24 | authorized distributor of record to an office-based health | ||||||
25 | care practitioner authorized by law to dispense or | ||||||
26 | administer the drug to the patient; or |
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1 | (6) an authorized distributor to a pharmacy or other | ||||||
2 | persons licensed to dispense or administer the drug. | ||||||
3 | "Pedigree" means a document or electronic file containing | ||||||
4 | information that records each wholesale distribution of any | ||||||
5 | given prescription drug from the point of origin to the final | ||||||
6 | wholesale distribution point of any given prescription drug.
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7 | "Person" means and includes a natural person, partnership, | ||||||
8 | association,
corporation, or any other legal business entity.
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9 | "Pharmacy distributor" means any pharmacy licensed in this | ||||||
10 | State or
hospital pharmacy that is engaged in the delivery or | ||||||
11 | distribution of
prescription drugs either to any other pharmacy | ||||||
12 | licensed in this State or
to any other person or entity | ||||||
13 | including, but not limited to, a wholesale
drug distributor | ||||||
14 | engaged in the delivery or distribution of prescription
drugs | ||||||
15 | who is involved in the actual, constructive, or attempted | ||||||
16 | transfer of
a drug in this State to other than the ultimate | ||||||
17 | consumer except as
otherwise provided for by law.
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18 | "Prescription drug" means any human drug, including any | ||||||
19 | biological product (except for blood and blood components | ||||||
20 | intended for transfusion or biological products that are also | ||||||
21 | medical devices), required by federal law or
regulation to be | ||||||
22 | dispensed only by a prescription, including finished
dosage | ||||||
23 | forms and bulk drug substances
subject to Section
503 of the | ||||||
24 | Federal Food, Drug and Cosmetic Act.
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25 | "Repackage" means repackaging or otherwise changing the | ||||||
26 | container, wrapper, or labeling to further the distribution of |
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1 | a prescription drug, excluding that completed by the pharmacist | ||||||
2 | responsible for dispensing the product to a patient. | ||||||
3 | "Secretary" means the Secretary of Financial and | ||||||
4 | Professional Regulation. | ||||||
5 | " Third-party Third party logistics provider" means anyone | ||||||
6 | who contracts with a prescription drug manufacturer to provide | ||||||
7 | or coordinate warehousing, distribution, or other services on | ||||||
8 | behalf of a manufacturer, but does not take title to the | ||||||
9 | prescription drug or have general responsibility to direct the | ||||||
10 | prescription drug's sale or disposition. A third party | ||||||
11 | logistics provider must be licensed as a wholesale distributor | ||||||
12 | under this Act and, in order to be considered part of the | ||||||
13 | normal distribution channel, must also be an authorized | ||||||
14 | distributor of record. | ||||||
15 | "Wholesale distribution"
means the distribution
of | ||||||
16 | prescription drugs to persons other than a consumer or patient, | ||||||
17 | but does
not include any of the following:
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18 | (1)
Intracompany sales of prescription drugs, meaning | ||||||
19 | (i) any transaction or transfer
between any division, | ||||||
20 | subsidiary, parent, or affiliated or related company
under | ||||||
21 | the common ownership and control of a corporate entity or | ||||||
22 | (ii) any transaction or transfer between co-licensees of a | ||||||
23 | co-licensed product.
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24 | (2) The sale, purchase, distribution, trade, or | ||||||
25 | transfer of a prescription drug or offer to sell, purchase, | ||||||
26 | distribute, trade, or transfer a prescription drug for |
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1 | emergency medical reasons.
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2 | (3) The distribution of prescription drug samples by | ||||||
3 | manufacturers' representatives. | ||||||
4 | (4) Drug returns, when conducted by a hospital, health | ||||||
5 | care entity, or charitable institution in accordance with | ||||||
6 | federal regulation. | ||||||
7 | (5) The sale of minimal quantities of prescription | ||||||
8 | drugs by licensed pharmacies to licensed practitioners for | ||||||
9 | office use or other licensed pharmacies. | ||||||
10 | (6) The sale, purchase, or trade of a drug, an offer to | ||||||
11 | sell, purchase, or trade a drug, or the dispensing of a | ||||||
12 | drug pursuant to a prescription. | ||||||
13 | (7) The sale, transfer, merger, or consolidation of all | ||||||
14 | or part of the business of a pharmacy or pharmacies from or | ||||||
15 | with another pharmacy or pharmacies, whether accomplished | ||||||
16 | as a purchase and sale of stock or business assets. | ||||||
17 | (8) The sale, purchase, distribution, trade, or | ||||||
18 | transfer of a prescription drug from one authorized | ||||||
19 | distributor of record to one additional authorized | ||||||
20 | distributor of record when the manufacturer has stated in | ||||||
21 | writing to the receiving authorized distributor of record | ||||||
22 | that the manufacturer is unable to supply the prescription | ||||||
23 | drug and the supplying authorized distributor of record | ||||||
24 | states in writing that the prescription drug being supplied | ||||||
25 | had until that time been exclusively in the normal | ||||||
26 | distribution channel. |
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1 | (9) The delivery of or the offer to deliver a | ||||||
2 | prescription drug by a common carrier solely in the common | ||||||
3 | carrier's usual course of business of transporting | ||||||
4 | prescription drugs when the common carrier does not store, | ||||||
5 | warehouse, or take legal ownership of the prescription | ||||||
6 | drug. | ||||||
7 | (10) The sale or transfer from a retail pharmacy, mail | ||||||
8 | order pharmacy, or chain pharmacy warehouse of expired, | ||||||
9 | damaged, returned, or recalled prescription drugs to the | ||||||
10 | original manufacturer, the originating wholesale | ||||||
11 | distributor, or a third party returns processor.
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12 | "Wholesale drug distributor" means anyone
engaged in the
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13 | wholesale distribution of prescription drugs into, out of, or | ||||||
14 | within the State, including without limitation
manufacturers; | ||||||
15 | repackers; own label distributors; jobbers; private
label | ||||||
16 | distributors; brokers; warehouses, including manufacturers' | ||||||
17 | and
distributors' warehouses; manufacturer's exclusive | ||||||
18 | distributors; and authorized distributors of record; drug | ||||||
19 | wholesalers or distributors; independent wholesale drug | ||||||
20 | traders; specialty wholesale distributors; third party | ||||||
21 | logistics providers; and retail pharmacies that conduct | ||||||
22 | wholesale distribution; and chain pharmacy warehouses that | ||||||
23 | conduct wholesale distribution. In order to be considered part | ||||||
24 | of the normal distribution channel, a wholesale distributor | ||||||
25 | must also be an authorized distributor of record.
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26 | (Source: P.A. 97-804, eff. 1-1-13.)
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1 | (225 ILCS 120/20) (from Ch. 111, par. 8301-20)
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2 | (Section scheduled to be repealed on January 1, 2023)
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3 | Sec. 20. Prohibited drug purchases or receipt. It shall be | ||||||
4 | unlawful
for any person or entity located in this State to | ||||||
5 | knowingly receive any prescription
drug from any source other | ||||||
6 | than a person or entity required by the laws of this State to | ||||||
7 | be licensed to ship into, out of, or within this State. A | ||||||
8 | person or entity licensed under the laws of this State shall
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9 | include, but is not limited to, a wholesale distributor, | ||||||
10 | manufacturer, third-party logistics provider,
pharmacy | ||||||
11 | distributor, or pharmacy. Any person violating
this Section | ||||||
12 | shall, upon conviction, be adjudged guilty of a Class C
| ||||||
13 | misdemeanor. A second violation shall constitute a Class 4 | ||||||
14 | felony.
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15 | (Source: P.A. 97-804, eff. 1-1-13.)
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16 | (225 ILCS 120/25.5 new) | ||||||
17 | Sec. 25.5. Third-party logistics providers. | ||||||
18 | (a) Each resident third-party logistics provider must be | ||||||
19 | licensed by the Department, and every non-resident third-party | ||||||
20 | logistics provider must be licensed in this State, in | ||||||
21 | accordance with this Act, prior to shipping a prescription drug | ||||||
22 | into this State. | ||||||
23 | (b) The Department shall require, without limitation, all | ||||||
24 | of the following information from each applicant for licensure |
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1 | under this Act: | ||||||
2 | (1) The name, full business address, and telephone | ||||||
3 | number of the licensee. | ||||||
4 | (2) All trade or business names used by the licensee. | ||||||
5 | (3) Addresses, telephone numbers, and the names of | ||||||
6 | contact persons for all facilities used by the licensee for | ||||||
7 | the storage, handling, and distribution of prescription | ||||||
8 | drugs. | ||||||
9 | (4) The type of ownership or operation, such as a | ||||||
10 | partnership, corporation, or sole proprietorship. | ||||||
11 | (5) The name of the owner or operator of the | ||||||
12 | third-party logistics provider, including: | ||||||
13 | (A) if a natural person, the name of the natural | ||||||
14 | person; | ||||||
15 | (B) if a partnership, the name of each partner and | ||||||
16 | the name of the partnership; | ||||||
17 | (C) if a corporation, the name and title of each | ||||||
18 | corporate officer and director, the corporate names, | ||||||
19 | and the name of the state of incorporation; and | ||||||
20 | (D) if a sole proprietorship, the full name of the | ||||||
21 | sole proprietor and the name of the business entity. | ||||||
22 | (6) A list of all licenses and permits issued to the | ||||||
23 | applicant by any other state that authorizes the applicant | ||||||
24 | to purchase or possess prescription drugs. | ||||||
25 | (7) The name of the designated representative for the | ||||||
26 | third-party logistics provider, together with the personal |
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1 | information statement and fingerprints, as required under | ||||||
2 | subsection (c) of this Section. | ||||||
3 | (8) Minimum liability insurance and other insurance as | ||||||
4 | defined by rule. | ||||||
5 | (9) Any additional information required by the | ||||||
6 | Department. | ||||||
7 | (c) Each third-party logistics provider must designate an | ||||||
8 | individual representative who shall serve as the contact person | ||||||
9 | for the Department. This representative must provide the | ||||||
10 | Department with all of the following information: | ||||||
11 | (1) Information concerning whether the person has been | ||||||
12 | enjoined, either temporarily or permanently, by a court of | ||||||
13 | competent jurisdiction from violating any federal or State | ||||||
14 | law regulating the possession, control, or distribution of | ||||||
15 | prescription drugs or criminal violations, together with | ||||||
16 | details concerning any such event. | ||||||
17 | (2) A description of any involvement by the person with | ||||||
18 | any business, including any investments, other than the | ||||||
19 | ownership of stock in a publicly traded company or mutual | ||||||
20 | fund, that manufactured, administered, prescribed, | ||||||
21 | distributed, or stored pharmaceutical products and any | ||||||
22 | lawsuits in which such businesses were named as a party. | ||||||
23 | (3) A description of any misdemeanor or felony criminal | ||||||
24 | offense of which the person, as an adult, was found guilty, | ||||||
25 | regardless of whether adjudication of guilt was withheld or | ||||||
26 | whether the person pled guilty or nolo contendere. If the |
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| |||||||
1 | person indicates that a criminal conviction is under appeal | ||||||
2 | and submits a copy of the notice of appeal of that criminal | ||||||
3 | offense, the applicant must, within 15 days after the | ||||||
4 | disposition of the appeal, submit to the Department a copy | ||||||
5 | of the final written order of disposition. | ||||||
6 | (4) The designated representative of an applicant for | ||||||
7 | licensure as a third-party logistics provider shall have | ||||||
8 | his or her fingerprints submitted to the Department of | ||||||
9 | State Police in an electronic format that complies with the | ||||||
10 | form and manner for requesting and furnishing criminal | ||||||
11 | history record information as prescribed by the Department | ||||||
12 | of State Police. These fingerprints shall be checked | ||||||
13 | against the Department of State Police and Federal Bureau | ||||||
14 | of Investigation criminal history record databases now and | ||||||
15 | hereafter filed. The Department of State Police shall | ||||||
16 | charge applicants a fee for conducting the criminal history | ||||||
17 | records check, which shall be deposited into the State | ||||||
18 | Police Services Fund and shall not exceed the actual cost | ||||||
19 | of the records check. The Department of State Police shall | ||||||
20 | furnish, pursuant to positive identification, records of | ||||||
21 | Illinois convictions to the Department. The Department may | ||||||
22 | require applicants to pay a separate fingerprinting fee, | ||||||
23 | either to the Department or to a vendor. The Department, in | ||||||
24 | its discretion, may allow an applicant who does not have | ||||||
25 | reasonable access to a designated vendor to provide his or | ||||||
26 | her fingerprints in an alternative manner. The Department |
| |||||||
| |||||||
1 | may adopt any rules necessary to implement this paragraph | ||||||
2 | (4). | ||||||
3 | (d) A third-party logistics provider shall not operate from | ||||||
4 | a place of residence. | ||||||
5 | (e) A third-party logistics provider facility shall be | ||||||
6 | located apart and separate from any retail pharmacy licensed by | ||||||
7 | the Department. | ||||||
8 | (f) The Department may not issue a third-party logistics | ||||||
9 | provider license to an applicant, unless the Department first: | ||||||
10 | (1) ensures that a physical inspection of the facility | ||||||
11 | satisfactory to the Department has occurred at the address | ||||||
12 | provided by the applicant, as required under item (1) of | ||||||
13 | subsection (b) of this Section; such inspection is not | ||||||
14 | required if the resident state of the third-party logistics | ||||||
15 | provider facility does not license third-party logistics | ||||||
16 | providers or if the resident state does not inspect | ||||||
17 | third-party logistics providers. If the resident state | ||||||
18 | does not inspect third-party logistics providers, a | ||||||
19 | Verified Accredited Wholesale Distributors Accreditation | ||||||
20 | or other inspection approved by the Department meets this | ||||||
21 | requirement; and | ||||||
22 | (2) determines that the designated representative | ||||||
23 | meets each of the following qualifications: | ||||||
24 | (A) He or she is at least 21 years of age. | ||||||
25 | (B) He or she is employed by the applicant full | ||||||
26 | time in a managerial level position. |
| |||||||
| |||||||
1 | (C) He or she is actively involved in and aware of | ||||||
2 | the actual daily operation of third-party logistics | ||||||
3 | provider. | ||||||
4 | (g) A third-party logistics provider shall publicly | ||||||
5 | display all licenses and have the most recent state and federal | ||||||
6 | inspection reports readily available.
| ||||||
7 | (225 ILCS 120/26)
| ||||||
8 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
9 | Sec. 26. Unlicensed practice; violation; civil penalty.
| ||||||
10 | (a) Any person who practices, offers to practice, attempts | ||||||
11 | to practice, or
holds oneself out to practice as a wholesale | ||||||
12 | drug distributor , or pharmacy
distributor , or third-party | ||||||
13 | logistics provider without being licensed to ship into, out of, | ||||||
14 | or within the State under this Act shall, in
addition to any | ||||||
15 | other penalty provided by law, pay a civil penalty to the
| ||||||
16 | Department in an amount not to exceed $10,000 for each offense | ||||||
17 | as determined by
the Department. The civil penalty shall be | ||||||
18 | assessed by the Department after a
hearing is held in | ||||||
19 | accordance with the provisions set forth in this Act
regarding | ||||||
20 | the provision of a hearing for the discipline of a licensee.
| ||||||
21 | (b) The Department has the authority and power to | ||||||
22 | investigate any and all
unlicensed activity.
| ||||||
23 | (c) The civil penalty shall be paid within 60 days after | ||||||
24 | the effective date
of the order imposing the civil penalty. The | ||||||
25 | order shall constitute a judgment
and may be filed and |
| |||||||
| |||||||
1 | execution had thereon in the same manner as any judgment
from | ||||||
2 | any court of record.
| ||||||
3 | (Source: P.A. 97-804, eff. 1-1-13.)
| ||||||
4 | (225 ILCS 120/30) (from Ch. 111, par. 8301-30)
| ||||||
5 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
6 | Sec. 30. License renewal application procedures. | ||||||
7 | Application blanks
for renewal of any license required by this | ||||||
8 | Act shall be mailed or emailed to each
licensee at least 60 | ||||||
9 | days before the license expires. If the application
for renewal | ||||||
10 | with the required fee is not received by the Department before
| ||||||
11 | the expiration date, the existing license shall lapse and | ||||||
12 | become null and
void. Failure to renew before the expiration | ||||||
13 | date is cause for a late
payment penalty, discipline, or both.
| ||||||
14 | (Source: P.A. 87-594 .)
| ||||||
15 | (225 ILCS 120/35) (from Ch. 111, par. 8301-35)
| ||||||
16 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
17 | Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
| ||||||
18 | (a) The Department shall provide by rule for a schedule of | ||||||
19 | fees for the
administration and
enforcement of this Act, | ||||||
20 | including but not limited to original licensure,
renewal, and
| ||||||
21 | restoration. The fees shall be nonrefundable.
| ||||||
22 | (b) All fees collected under this Act shall be deposited | ||||||
23 | into the Illinois
State
Pharmacy
Disciplinary Fund and shall be | ||||||
24 | appropriated to the Department for the ordinary
and
contingent |
| |||||||
| |||||||
1 | expenses of the Department in the administration of this Act. | ||||||
2 | Moneys in the Fund may be transferred to the Professions
| ||||||
3 | Indirect Cost Fund as authorized by Section 2105-300 of the
| ||||||
4 | Department of Professional Regulation Law (20 ILCS | ||||||
5 | 2105/2105-300).
| ||||||
6 | The moneys deposited into the Illinois State Pharmacy | ||||||
7 | Disciplinary Fund shall
be invested to earn interest which | ||||||
8 | shall accrue to the Fund.
| ||||||
9 | The Department shall present to the Board for its review | ||||||
10 | and comment all
appropriation requests from the Illinois State | ||||||
11 | Pharmacy Disciplinary Fund. The
Department shall give due | ||||||
12 | consideration to any comments of the Board in making
| ||||||
13 | appropriation requests.
| ||||||
14 | (c) Any person who delivers a check or other payment to the | ||||||
15 | Department that
is returned to the Department unpaid by the | ||||||
16 | financial institution upon
which it is drawn shall pay to the | ||||||
17 | Department, in addition to the amount
already owed to the | ||||||
18 | Department, a fine of $50. The fines imposed by this Section | ||||||
19 | are in addition
to any other discipline provided under this Act | ||||||
20 | for unlicensed
practice or practice on a nonrenewed license. | ||||||
21 | The Department shall notify
the person that payment of fees and | ||||||
22 | fines shall be paid to the Department
by certified check or | ||||||
23 | money order within 30 calendar days of the
notification. If, | ||||||
24 | after the expiration of 30 days from the date of the
| ||||||
25 | notification, the person has failed to submit the necessary | ||||||
26 | remittance, the
Department shall automatically terminate the |
| |||||||
| |||||||
1 | license or certificate or deny
the application, without | ||||||
2 | hearing. If, after termination or denial, the
person seeks a | ||||||
3 | license or certificate, he or she shall apply to the
Department | ||||||
4 | for restoration or issuance of the license or certificate and
| ||||||
5 | pay all fees and fines due to the Department. The Department | ||||||
6 | may establish
a fee for the processing of an application for | ||||||
7 | restoration of a license or
certificate to pay all expenses of | ||||||
8 | processing this application. The Director
may waive the fines | ||||||
9 | due under this Section in individual cases where the
Director | ||||||
10 | finds that the fines would be unreasonable or unnecessarily
| ||||||
11 | burdensome.
| ||||||
12 | (d) The Department shall maintain a roster of the names and | ||||||
13 | addresses of
all registrants and of all persons whose licenses | ||||||
14 | have been suspended or
revoked. This roster shall be available | ||||||
15 | upon written request and payment of
the required fee.
| ||||||
16 | (e) A manufacturer of controlled substances , or wholesale | ||||||
17 | distributor of controlled substances , or third-party logistics | ||||||
18 | provider that is licensed under this Act and owned and operated | ||||||
19 | by the State is exempt from licensure, registration, renewal, | ||||||
20 | and other fees required under this Act. Nothing in this | ||||||
21 | subsection (e) shall be construed to prohibit the Department
| ||||||
22 | from imposing any fine or other penalty allowed under this Act.
| ||||||
23 | (Source: P.A. 95-689, eff. 10-29-07 .)
| ||||||
24 | (225 ILCS 120/40) (from Ch. 111, par. 8301-40)
| ||||||
25 | (Section scheduled to be repealed on January 1, 2023)
|
| |||||||
| |||||||
1 | Sec. 40. Rules and regulations. The Department shall
make | ||||||
2 | any rules and regulations, not inconsistent with law, as may be
| ||||||
3 | necessary to carry out the purposes and enforce the provisions | ||||||
4 | of this Act.
Rules and regulations that incorporate and set | ||||||
5 | detailed standards for
meeting each of the license | ||||||
6 | prerequisites set forth in Section 25 of this
Act shall be | ||||||
7 | adopted no later than September 14, 1992.
All rules and | ||||||
8 | regulations promulgated under this Section shall
conform to | ||||||
9 | wholesale drug distributor licensing guidelines formally | ||||||
10 | adopted
by the FDA at 21 C.F.R. Part 205. In case of conflict | ||||||
11 | between any rule
or regulation adopted by the Department and | ||||||
12 | any FDA wholesale drug
distributor or third-party logistics | ||||||
13 | provider guideline, the FDA guideline shall control.
| ||||||
14 | (Source: P.A. 87-594 .)
| ||||||
15 | (225 ILCS 120/57)
| ||||||
16 | (Section scheduled to be repealed on January 1, 2023) | ||||||
17 | Sec. 57. Pedigree. | ||||||
18 | (a) Each person who is engaged in the wholesale | ||||||
19 | distribution of prescription drugs, including repackagers, but | ||||||
20 | excluding the original manufacturer of the finished form of the | ||||||
21 | prescription drug, that leave or have ever left the normal | ||||||
22 | distribution channel shall, before each wholesale distribution | ||||||
23 | of the drug, provide a pedigree to the person who receives the
| ||||||
24 | drug. A retail pharmacy, mail order pharmacy, or chain pharmacy | ||||||
25 | warehouse must comply with the requirements of this Section |
| |||||||
| |||||||
1 | only if the pharmacy or chain pharmacy warehouse engages in the | ||||||
2 | wholesale distribution of prescription drugs. On or before July | ||||||
3 | 1, 2009, the Department shall determine a targeted | ||||||
4 | implementation date for electronic track and trace pedigree | ||||||
5 | technology. This targeted implementation date shall not be | ||||||
6 | sooner than July 1, 2010. Beginning on the date established by | ||||||
7 | the Department, pedigrees may be implemented through an | ||||||
8 | approved and readily available system that electronically | ||||||
9 | tracks and traces the wholesale distribution of each | ||||||
10 | prescription drug starting with the sale by the manufacturer | ||||||
11 | through acquisition and sale by any wholesale distributor and | ||||||
12 | until final sale to a pharmacy or other authorized person | ||||||
13 | administering or dispensing the prescription drug. This | ||||||
14 | electronic tracking system shall be deemed to be readily | ||||||
15 | available only upon there being available a standardized system | ||||||
16 | originating with the manufacturers and capable of being used on | ||||||
17 | a wide scale across the entire pharmaceutical chain, including | ||||||
18 | manufacturers, wholesale distributors, third-party logistics | ||||||
19 | providers, and pharmacies. Consideration must also be given to | ||||||
20 | the large-scale implementation of this technology across the | ||||||
21 | supply chain and the technology must be proven to have no | ||||||
22 | negative impact on the safety and efficacy of the | ||||||
23 | pharmaceutical product. | ||||||
24 | (b) Each person who is engaged in the wholesale | ||||||
25 | distribution of a prescription drug who is provided a pedigree | ||||||
26 | for a prescription drug and attempts to further distribute that |
| |||||||
| |||||||
1 | prescription drug, including repackagers, but excluding the | ||||||
2 | original manufacturer of the finished form of the prescription | ||||||
3 | drug, must affirmatively verify before any distribution of a | ||||||
4 | prescription drug occurs that each transaction listed on the | ||||||
5 | pedigree has occurred. | ||||||
6 | (c) The pedigree must include all necessary identifying | ||||||
7 | information concerning each sale in the chain of distribution | ||||||
8 | of the product from the manufacturer or the manufacturer's | ||||||
9 | third party logistics provider, co-licensed product partner, | ||||||
10 | or exclusive distributor through acquisition and sale by any | ||||||
11 | wholesale distributor or repackager, until final sale to a | ||||||
12 | pharmacy or other person dispensing or administering the drug. | ||||||
13 | This necessary chain of distribution information shall | ||||||
14 | include, without limitation all of the following: | ||||||
15 | (1) The name, address, telephone number and, if | ||||||
16 | available, the e-mail address of each owner of the | ||||||
17 | prescription drug and each wholesale distributor of the | ||||||
18 | prescription drug. | ||||||
19 | (2) The name and address of each location from which | ||||||
20 | the product was shipped, if different from the owner's. | ||||||
21 | (3) Transaction dates. | ||||||
22 | (4) Certification that each recipient has | ||||||
23 | authenticated the pedigree. | ||||||
24 | (d) The pedigree must also include without limitation all | ||||||
25 | of the following information concerning the prescription drug: | ||||||
26 | (1) The name and national drug code number of the |
| |||||||
| |||||||
1 | prescription drug. | ||||||
2 | (2) The dosage form and strength of the prescription | ||||||
3 | drug. | ||||||
4 | (3) The size of the container. | ||||||
5 | (4) The number of containers. | ||||||
6 | (5) The lot number of the prescription drug. | ||||||
7 | (6) The name of the manufacturer of the finished dosage | ||||||
8 | form. | ||||||
9 | (e) Each pedigree or electronic file shall be maintained by | ||||||
10 | the purchaser and the wholesale distributor for at least 3 | ||||||
11 | years from the date of sale or transfer and made available for | ||||||
12 | inspection or use within 5 business days upon a request of the | ||||||
13 | Department.
| ||||||
14 | (Source: P.A. 95-689, eff. 10-29-07 .)
| ||||||
15 | (225 ILCS 120/80) (from Ch. 111, par. 8301-80)
| ||||||
16 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
17 | Sec. 80. Violations of Act.
| ||||||
18 | (a) If any person violates the provisions of this Act, the
| ||||||
19 | Director may, in the name of the People of the State of | ||||||
20 | Illinois through
the Attorney General of the State of Illinois | ||||||
21 | or the State's Attorney of
any county in which the action is | ||||||
22 | brought, petition for an order enjoining
the violation or for | ||||||
23 | an order enforcing compliance with this Act. Upon
the filing of | ||||||
24 | a verified petition in the court, the court may issue a
| ||||||
25 | temporary restraining order, without notice or bond, and may |
| |||||||
| |||||||
1 | preliminarily
and permanently enjoin the violation. If it is | ||||||
2 | established that the
person has violated or is violating the | ||||||
3 | injunction, the Court may punish
the offender for contempt of | ||||||
4 | court. Proceedings under this Section shall
be in addition to, | ||||||
5 | and not in lieu of, all other remedies and penalties
provided | ||||||
6 | by this Act.
| ||||||
7 | (b) Whoever knowingly conducts business as a wholesale drug | ||||||
8 | distributor or third-party logistics provider
in this State | ||||||
9 | without being appropriately licensed under this Act shall be
| ||||||
10 | guilty of a Class A misdemeanor for a first violation and for | ||||||
11 | each
subsequent conviction shall be guilty of a Class 4 felony.
| ||||||
12 | (c) Whenever in the opinion of the Department any person | ||||||
13 | not licensed in
good standing under this Act violates any | ||||||
14 | provision of this Act, the
Department may issue a rule to show | ||||||
15 | cause why an order to cease and desist
should not be entered | ||||||
16 | against him. The rule shall clearly set forth the
grounds | ||||||
17 | relied upon by the Department and shall provide a period of 7 | ||||||
18 | days
from the date of the rule to file an answer to the | ||||||
19 | satisfaction of the
Department. Failure to answer to the | ||||||
20 | satisfaction of the Department shall
cause an order to cease | ||||||
21 | and desist to be issued immediately.
| ||||||
22 | (Source: P.A. 87-594 .)
| ||||||
23 | (225 ILCS 120/155) (from Ch. 111, par. 8301-155)
| ||||||
24 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
25 | Sec. 155. Temporary suspension of license; hearing. The |
| |||||||
| |||||||
1 | Director
may temporarily suspend licensure as a wholesale drug | ||||||
2 | distributor or third-party logistics provider ,
without a | ||||||
3 | hearing, simultaneously with the institution of proceedings | ||||||
4 | for a
hearing provided for in Section 85 of this Act, if the | ||||||
5 | Director finds that
evidence in his or her possession indicates | ||||||
6 | that a continuation in business
would constitute an imminent | ||||||
7 | danger to the public. In the event that the
Director | ||||||
8 | temporarily suspends a license or certificate without a
| ||||||
9 | hearing, a hearing by the Department must be held within 10 | ||||||
10 | days after
the suspension has occurred and be concluded without | ||||||
11 | appreciable delay.
| ||||||
12 | (Source: P.A. 87-594 .)
| ||||||
13 | Section 99. Effective date. This Act takes effect upon | ||||||
14 | becoming law.".
|