TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.10 DEFINITIONS
Section 3100.10 Definitions
a) Definitions: The following terms shall be defined as follows:
"Act"
means the Illinois Controlled Substances Act [720 ILCS 570].
"Administration" means
the Drug Enforcement Administration, United States Department of Justice, or
its successor agency.
"Address of Record"
means the designated address recorded by the Department in the applicant's
application file or the licensee's license file, as maintained by the
Department's licensure maintenance unit.
"DEA
Registration Number" means the number assigned to controlled substances
and controlled drug preparations by the Drug Enforcement Administration of the
Department of Justice as defined by 21 CFR 1308.03 (April 1, 2014).
"Department"
means the Department of Financial and Professional Regulation.
"Director"
means the Director of the Division of Professional Regulation with the
authority delegated by the Secretary.
"Division" means the
Department of Financial and Professional Regulation-Division of Professional
Regulation.
"Individual
Practitioner" means a physician, dentist, veterinarian, podiatrist or
optometrist licensed in the State of Illinois to practice his/her profession, a
licensed physician assistant with prescriptive authority in accordance with
Section 303.05 of the Act and a written supervision agreement required under
Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95], or a
licensed advanced practice nurse with prescriptive authority, in accordance
with Section 303.05 of the Act and a written collaborative agreement as
provided in Section 65-40 of the Nurse Practice Act [225 ILCS 65] except as
provided in Section 3100.80(c).
"License"
or "Licensure" encompasses licensure, registration, certification or
other approval of an individual in accordance with State or federal statute.
"Mid-level Practitioner"
means:
a physician assistant who has been
delegated authority to prescribe through a written delegation of authority by a
physician licensed to practice medicine in all of its branches, in accordance
with Section 7.5 of the Physician Assistant Practice Act of 1987;
an advanced practice nurse who has
been delegated authority to prescribe through a written delegation of authority
by a physician licensed to practice medicine in all of its branches or by a
podiatrist, in accordance with Section 65-40 of the Nurse Practice Act; or
an animal euthanasia agency.
"Mid-Level
Practitioner Controlled Substances License" is a license issued to a
mid-level practitioner.
"Pre-printed
Prescription" means a written prescription upon which the designated drug
has been indicated prior to the time of issuance, including any pre-inked stamp
that would be applied to a prescription blank. The term does not mean a
written prescription that is individually generated by machine or computer in
the prescriber's place of business.
"Secretary" means the
Secretary of the Department of Financial and Professional Regulation.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
 | TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.20 COPIES OF THIS PART (REPEALED)
Section 3100.20 Copies of
This Part (Repealed)
(Source: Repealed
at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.30 RENEWAL PERIODS AND FEES
Section 3100.30 Renewal
Periods and Fees
a) Renewal Periods
1) Registration/licensure to dispense. Every certificate of
registration or license to dispense controlled substances listed in Schedules
II through V of the Illinois Controlled Substances Act shall expire on the date
the certificate holder's superior professional license expires, as set by the
rules for the administration of the applicable professional licensing Act.
2) Other controlled substances registrations. Every certificate
of registration to conduct instructional activities, to conduct chemical analyses,
and as a manufacturer or wholesale distributor, shall expire on December 31 of
each even numbered year.
3) The holder of a certificate of registration may renew such
certificate during the month preceding the expiration date thereof by paying
the required fee.
4) It is the responsibility of each registrant to notify the
Department of any change of address. Failure to receive a renewal form from
the Department shall not constitute an excuse for failure to pay the renewal
fee.
b) Fees
1) The fee for a certificate of registration to dispense
controlled substances listed in Schedules II through V of the Act is $5. The
fee for the renewal of such registration shall be calculated at the rate of $5
per year.
2) The fee for a mid-level practitioner controlled substances
license is $5. The fee for renewal of a license shall be calculated at the
rate of $5 per year.
3) The fee for a certificate of registration to conduct
instructional activities is $5. The fee for the renewal of such registration shall
be calculated at the rate of $5 per year.
4) The fee for a certificate of registration to conduct chemical
analyses is $50. The fee for the renewal of such registration shall be
calculated at the rate of $50 per year.
5) The fee for a certificate of registration as a manufacturer or
wholesale distributor is $50, except the fee for registration as a manufacturer
or wholesale distributor of controlled substances that may be dispensed without
a prescription shall be $15. The fee for the renewal of such registration
shall be calculated at the rate of $50 per year and $15 per year, respectively.
6) The fee shall be waived for governmental institutions that
manufacture, distribute or dispense controlled substances or engage in chemical
analyses or instructional activities.
(Source: Amended at 24 Ill. Reg. 16672, effective October 27, 2000)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.40 TIME AND METHOD OF PAYMENT (REPEALED)
Section 3100.40 Time and
Method of Payment (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.50 SEPARATE LICENSURE FOR INDEPENDENT ACTIVITIES
Section 3100.50 Separate
Licensure for Independent Activities
a) The following groups of activities are deemed to be
independent of each other:
1) Manufacturing controlled substances;
2) Distributing controlled substances;
3) Dispensing controlled substances listed in Schedules II
through V;
4) Conducting instructional activities with controlled substances
listed in Schedules II through V;
5) Conducting instructional activities with controlled substances
listed in Schedule I;
6) Conducting chemical analysis with controlled substances listed
in any Schedule.
b) Every person who engages in more than one group of independent
activities shall obtain a separate license for each group of activities, except
as provided in this subsection. Any person, when licensed to engage in the
group of activities described in subsections (b)(1) through (6), shall be
authorized to engage in the coincident activities described in the specific
subsection without obtaining a registration to engage in those coincident
activities, provided that, unless specifically exempted, he or she complies
with all requirements and duties prescribed by law for persons licensed to
engage in those coincident activities:
1) A person licensed to manufacture any controlled substance
shall be authorized to distribute that substance, but no other substances that
he or she is not licensed to manufacture;
2) A person licensed to manufacture any controlled substance
listed in Schedules II through V shall be authorized to conduct chemical
analysis and pre-clinical research (including quality control analysis) with
narcotic and non-narcotic controlled substances listed in those Schedules in
which he or she is authorized to manufacture;
3) A person authorized by the appropriate agencies of the State
of Illinois and the federal government to conduct research with a controlled
substance shall be authorized to manufacture that substance if and to the
extent that the manufacture is set forth in the research protocol filed with
the application and to distribute that substance to other persons authorized to
conduct research with that substance or to conduct chemical analysis;
4) A person licensed to conduct chemical analysis with controlled
substances shall be authorized:
A) to manufacture and import those substances for analytical
purposes, and distribute those substances to persons licensed or authorized to
conduct chemical analysis, instructional activities or research with those
substances or persons who are exempted from licensure pursuant to law; and
B) to export those substances to persons in other countries
performing chemical analysis or enforcing laws relating to controlled
substances or drugs in those countries;
5) A person authorized by the appropriate agencies of the State
of Illinois or the federal government to conduct research with controlled
substances listed in Schedules II through V shall be authorized to conduct
chemical analysis with controlled substances listed in those Schedules in which
he or she is authorized to conduct research, to manufacture those substances if
and to the extent that the manufacture is authorized by the appropriate agency,
and to distribute those substances to other persons licensed or authorized to conduct
chemical analysis or research with those substances and to persons exempted
from licensure pursuant to law;
6) A person licensed to dispense controlled substances in
Schedules II through V shall be authorized to conduct instructional activities
with those substances.
c) A single license to engage in any group of independent
activities may include one or more controlled substances listed in the
Schedules authorized in that group of independent activities.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.60 EXEMPTED LOCATIONS
Section 3100.60 Exempted
Locations
An office used by agents of a
licensee where sales of controlled substances are solicited, made or supervised
but that neither contains controlled substances (other than substances for
display purposes or lawful distribution as samples only) nor serves as a
distribution point for filling sales orders is exempt from licensure.
(Source: Amended at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.70 REQUIREMENTS OF REGISTRATION (REPEALED)
Section 3100.70 Requirements
of Registration (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.80 EXEMPTION OF AGENTS AND EMPLOYEES: AFFILIATED PRACTITIONERS
Section 3100.80 Exemption of
Agents and Employees: Affiliated Practitioners
a) The requirement of licensure is waived for any agent or
employee of a person who is licensed to engage in any group of independent
activities (see Section 3100.50), if the agent or employee is acting in the
usual course of his or her business or employment.
b) An individual practitioner who is an agent or employee of
another practitioner licensed to dispense controlled substances may, when
acting in the usual course of his or her employment, administer and dispense
(other than by issuance of a prescription) controlled substances if and to the
extent that the individual practitioner is authorized or permitted to do so by
the employer or principal practitioner, under the license of the employer or
principal practitioner, in lieu of being licensed himself or herself.
c) In a
licensed hospital, hospital affiliate, or licensed ambulatory surgical
treatment center ("institution") a licensed advanced practice nurse,
acting pursuant to Section 65-45 of the Nurse Practice Act, or a physician
assistant, acting pursuant to Section 7.7 of the Physician Assistant Practice
Act of 1987, may be granted clinical privileges, including the authority to
select, order and administer, and issue discharge prescriptions for, controlled
substances under the DEA registration number of the hospital, hospital
affiliate or licensed ambulatory surgical treatment center by whom he or she is
employed.
d) In a licensed hospital or affiliated training facility
("institution"), a holder of a Temporary License, pursuant to Section
17 of the Medical Practice Act [225 ILCS 60/17], may select, order and
administer, and issue discharge prescriptions for, controlled substances under
the DEA registration number of the hospital or affiliated training facility by
whom he or she is employed.
e) The
exemptions provided for advanced practice nurses, physician assistants and
temporary license holders in subsections (c) and (d) are subject to the
following conditions:
1) The selection, ordering and administration of, and issuance of
discharge prescriptions for, controlled substances is done in the usual course
of his or her professional practice or training program;
2) The
institution by whom he or she is employed has verified that the individual
practitioner is authorized by the institution's medical staff, or medical staff
committee, to select, order and administer, and issue discharge prescriptions
for, controlled substances;
3) The
advanced practice nurse, physician assistant or temporary license holder is
acting only within the scope of his or her employment;
4) The institution authorizes the temporary license holder,
advanced practice nurse or physician assistant to select, order and administer,
and issue discharge prescriptions for, controlled substances under the
institution's registration and designates a specific internal code number for
each temporary license holder, advanced practice nurse or physician assitant so
authorized. The code number shall consist of numbers, letters or a combination
of numbers and letters and shall be a suffix to the institution's DEA
registration number, preceded by a hyphen (e.g., APO 123456-10 or APO
123456-A12);
5) A current list of internal codes and the corresponding
temporary license holder, advanced practice nurse or physician assistant is
kept by the institution and is made available at all times to other licensees
and law enforcement agencies upon request for the purpose of verifying the
authority of the temporary license holder, advanced practice nurse or physician
assistant; and
6) A
temporary license holder, advanced practice nurse or physician assistant shall
include on all prescriptions issued by him or her the registration number of
the institution, his or her specific internal code number, and his or her name.
f) An
official exempted from registration under the Act and this Part shall include
on all prescriptions issued by him or her, his or her branch of service or
agency (e.g., "U.S. Army" or "Public Health Service") and
his or her DOD identification number, in lieu of the license number of the
practitioner required by this Part. The DOD identification number for a Public
Health Service practitioner is his or her social security identification
number. Each prescription shall have the name of the officer stamped or
printed on it, as well as the signature of the officer.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.85 APPLICATION FOR MID-LEVEL PRACTITIONER CONTROLLED SUBSTANCES LICENSE
Section 3100.85 Application
for Mid-Level Practitioner Controlled Substances License
a) An individual applicant for a mid-level practitioner
controlled substances license shall file an application on forms provided by
the Department. The application shall include:
1) The physician assistant or advanced practice nurse license
number. The license shall be active and in good standing;
2) The license number and controlled substances license number of
the delegating or collaborating physician or collaborating podiatrist;
3) A delegation of controlled substances in Schedules III through
V or any specific controlled substance in Schedule II shall be electronically
input under rules set forth for DHS' Prescription Monitoring Program (77 Ill.
Adm. Code 2080). A printout of the inputted delegation may serve as written
notice of delegation of prescriptive authority if it is signed by the physician
or podiatrist and the schedule of controlled substances or the specific
Schedule II controlled substances that the mid-level practitioner may dispense
or prescribe is listed. A separate notice of prescriptive authority shall be
submitted by each supervising or collaborating physician or collaborating
podiatrist; and
4) The required fee.
b) For
physician assistant or advanced practice nurse controlled substance licenses
issued on or after August 11, 2011 authorizing the prescribing and dispensing
of Schedule II controlled substances, applicants must meet education
requirements in accordance with Section 303.05 of the Act.
c) Any
advanced practice nurse or physician assistant who writes a prescription for a
controlled substance without having valid prescriptive authority may be fined
by the Department not more than $50 per prescription, and the Department may
take any other disciplinary action provided for in the Act.
d) Nothing
in this Section shall be construed to prohibit generic substitutions as
provided in Section 25 of the Pharmacy Practice Act [225 ILCS 85/25].
e) Pursuant
to the Humane Euthanasia in Animal Shelters Act rules (68 Ill. Adm. Code 1248),
a euthanasia agency applicant for a mid-level practitioner controlled
substances license shall file an application on forms provided by the
Department. The application shall include:
1) The
euthanasia agency license number. The license shall be active and in good
standing;
2) The required
fee as stated in Section 3100.30.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.90 TIME FOR APPLICATION FOR REGISTRATION: EXPIRATION DATE (REPEALED)
Section 3100.90 Time for
Application for Registration: Expiration Date (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.100 APPLICATION FORMS (REPEALED)
Section 3100.100 Application
Forms (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.110 FILING OF APPLICATION: JOINT FILINGS (REPEALED)
Section 3100.110 Filing of
Application: Joint Filings (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.120 ACCEPTANCE FOR FILING: DEFECTIVE APPLICATIONS (REPEALED)
Section 3100.120 Acceptance
for Filing: Defective Applications (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.130 ADDITIONAL INFORMATION (REPEALED)
Section 3100.130 Additional
Information (Repealed)
(Source:
Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.140 AMENDMENTS TO AND WITHDRAWAL OF APPLICATIONS (REPEALED)
Section 3100.140 Amendments
to and Withdrawal of Applications (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.150 CERTIFICATE OF REGISTRATION: DENIAL OF REGISTRATION (REPEALED)
Section 3100.150 Certificate
of Registration: Denial of Registration (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.160 SUSPENSION OR REVOCATION OF REGISTRATION (REPEALED)
Section 3100.160 Suspension
or Revocation of Registration (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.170 SUSPENSION OF REGISTRATION PENDING FINAL ORDER (REPEALED)
Section 3100.170 Suspension
of Registration Pending Final Order (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.180 EXTENSION OF REGISTRATION (REPEALED)
Section 3100.180 Extension
of Registration (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.190 HEARING OFFICER (REPEALED)
Section 3100.190 Hearing
Officer (Repealed)
(Source:
Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.200 HEARINGS AND NOTICES
Section 3100.200 Hearings
and Notices
Hearings shall be conducted in accordance with Section 305
of the Act and with 68 Ill. Adm. Code 1110.
(Source: Amended at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.210 PROCEDURES FOR HEARING (REPEALED)
Section 3100.210 Procedures
for Hearing (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.220 HEARING PURSUANT TO PARAGRAPH 1305(B) (REPEALED)
Section 3100.220 Hearing –
Pursuant to Paragraph 1305(b) (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.230 DEFAULT DISPOSITION OF A CONTESTED CASE (REPEALED)
Section 3100.230 Default
Disposition of a Contested Case (Repealed)
(Source:
Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.240 RECORDING OF TESTIMONY (REPEALED)
Section 3100.240 Recording
of Testimony (Repealed)
(Source:
Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.250 RECORDING OF HEARING (REPEALED)
Section 3100.250 Recording
of Hearing (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.260 REHEARING (REPEALED)
Section 3100.260 Rehearing
(Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.270 FINAL DECISIONS AND ORDERS (REPEALED)
Section 3100.270 Final
Decisions and Orders (Repealed)
(Source: Repealed at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.280 MODIFICATION IN LICENSURE
Section 3100.280
Modification in Licensure
Any licensee may apply to modify
his or her license to authorize the handling of additional controlled
substances in the same manner as an original application for licensure on forms
provided by the Division.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.290 TERMINATION OF LICENSE
Section 3100.290 Termination
of License
a) The license of any person shall terminate if and when that
person dies, ceases legal existence, discontinues business or professional
practice, has his or her primary professional license in any status other than
active, or changes his or her name or address as shown on the license.
b) Any licensee who ceases legal existence, discontinues business
or professional practice, or changes his or her name or address as shown on the
license shall notify the Division of that fact within 10 days.
c) The license of an advanced practice nurse or physician
assistant that has been delegated controlled substance prescriptive authority
shall terminate when the delegated authority terminates.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.300 TRANSFER OF LICENSE
Section 3100.300 Transfer of
License
No license or any authority
conferred thereby shall be assigned or otherwise transferred.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.310 SECURITY REQUIREMENTS GENERALLY
Section 3100.310 Security
Requirements Generally
a) All applicants and licensees shall provide effective controls
and procedures to guard against theft and diversion of controlled substances.
In order to determine whether a person has provided effective controls against
diversion, the Division shall use the security requirements set forth in this
Section as standards for the physical security controls and operating
procedures necessary to prevent diversion. Substantial compliance with these
standards may be deemed sufficient by the Division after evaluation of the
overall security system and needs of the applicant or licensee.
b) Physical security controls shall be commensurate with the
Schedules, and quantity, type and form of controlled substances (e.g., bulk
liquids or dosage units, usable powders or non-usable powders) in the
possession of the licensee in normal business operations. When physical
controls become inadequate as a result of a controlled substance being
transferred to a different Schedule, or as a result of a non-controlled
substance being listed on any Schedule, or as a result of a significant
increase in the quantity of controlled substances in the possession of the
licensee during normal business operations, the physical security controls
shall be expanded and extended accordingly. A licensee may adjust physical
security controls within the requirements set forth in this Section when the
need for those controls decreases as a result of a controlled substance being
transferred to a different Schedule, or as a result of a controlled substance
being removed from control, or as a result of a significant decrease in the
quantity of a controlled substance in the possession of the licensee during
normal business operations.
c) Any additional security evidence, including but not limited
to: video surveillance, computer access logs or records, or falsified
prescription/medical documentation that demonstrates or captures diversion or
other illicit activity involving controlled substances shall be made available
to the Division upon request, along with a copy of any DEA Form 106 filed
pursuant to Section 3100.360(e).
d) Personal bags of any kind, including but not limited to
purses, handbags and backpacks, are prohibited in any area where controlled
substances are handled and/or stored.
e) A
basic alarm system that detects unauthorized entry into the pharmacy area.
This does not apply to 24-hour pharmacies that never close.
f) All
pharmacies are required to maintain a key to the licensed pharmacy area held by
an employee of the pharmacy who is a licensed pharmacist or a registered
pharmacy technician or certified pharmacy technician.
(Source: Amended at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.320 FACTORS IN EVALUATING PHYSICAL SECURITY SYSTEMS
Section 3100.320 Factors in
Evaluating Physical Security Systems
In evaluating the overall
security system of a licensee or applicant necessary to maintain effective
controls against theft or diversion of controlled substances, the Division may
consider any of the following factors as it may deem relevant to the need for
strict compliance with this Part:
a) The type of activity conducted;
b) The type and form of controlled substances handled;
c) The quantity of controlled substances handled;
d) The location of the premises and the relationship those
locations bear on security needs;
e) The type of building construction comprising the facility and
the general characteristics of the building or buildings;
f) The type of vault, safe and secure enclosures available;
g) The type of closures on vaults, safes and secure enclosures;
h) The adequacy of key control systems and/or combination lock
control systems;
i) The adequacy of electric detection and alarm systems;
j) The extent of unsupervised public access to the facility,
including the presence and characteristics of perimeter fencing, if any;
k) The
adequacy of supervision over employees having access to manufacturing and
storage areas;
l) The procedures for handling business guests, visitors,
maintenance personnel, and non-employee service personnel;
m) The availability of local police protection or of the
licensee's or applicant's security personnel;
n) The adequacy of the licensee's or applicant's system for
monitoring the receipt, manufacture, distribution and disposition of controlled
substances in its operations; and
o) The
applicability of the security requirements contained in all federal, State and
local laws and regulations governing the management of waste.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.330 PHYSICAL SECURITY CONTROLS FOR NON-PRACTITIONERS
Section 3100.330 Physical
Security Controls for Non-Practitioners
Raw materials, bulk materials
awaiting processing, and finished products that are controlled substances
listed in any Schedule shall be stored in compliance with the physical security
controls set forth in 21 CFR 1301.72 (April 1, 2014).
(Source: Amended at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.340 PHYSICAL SECURITY CONTROLS FOR PRACTITIONERS
Section 3100.340 Physical
Security Controls for Practitioners
a) Controlled substances listed in Schedules I and II shall be
stored in a securely locked, substantially constructed cabinet.
b) Controlled substances listed in Schedules III, IV and V shall
be stored in a securely locked, substantially constructed cabinet. However,
pharmacies may disperse those substances throughout the stock of non-controlled
substances in a manner so as to obstruct the theft or diversion of the
controlled substances.
c) This Section shall also apply to non-practitioners authorized
to conduct instructional activities or chemical analysis under another
registration.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.350 OTHER SECURITY CONTROLS FOR PRACTITIONERS
Section 3100.350 Other
Security Controls for Practitioners
a) The licensee shall not employ as an agent or employee who has
access to controlled substances any person who has had an application for DEA
registration or state controlled substances license denied, has had his or her
DEA registration or state controlled substances license suspended or revoked,
has surrendered his or her DEA registration or state controlled substances
license in lieu of discipline, or has been convicted of a violation of state or
federal law relative to the manufacture, distribution, dispensing or possession
of controlled substances.
b) The Director, for good cause shown, may, in his or her
discretion, waive the requirement of subsection (a).
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.360 RECORD AND INVENTORYING REQUIREMENTS GENERALLY
Section 3100.360 Record and
Inventorying Requirements Generally
a) Every licensee shall keep records and maintain inventories in
conformance with the record keeping and inventorying requirements of federal
law, including the requirements prescribed in 21 CFR 1304 (April 1, 2014), and,
for pharmacies, the rules promulgated pursuant to the Pharmacy Practice Act (68
Ill. Adm. Code 1330).
b) All
prescription information for electronic controlled substance prescriptions
shall be readily retrievable and immediately available to any Division
inspector upon request.
c) Every
licensee shall conduct an annual inventory that includes an inventory with an
actual count of the inventory on hand for all Schedule II Controlled Substances
and an approximate inventory for all Schedule III, IV and V Controlled
Substances. The inventory shall be maintained for a period of not less than 5
years.
d) After
a loss or theft of controlled substances, a licensee shall conduct an
approximate count inventory with a start date of the last inventory for the
controlled substance that was either lost or stolen.
e) In
every instance that a licensee is required by 21 CFR 1301.76 (April 1, 2014) to
file with the DEA a Report of Theft or Loss of Controlled Substances (Form 106),
a copy shall be sent to the Division within one business day after submission
to the DEA, along with the printed name of the person who signed the form.
Failure to do so may result in discipline of the licensee. This information
should be sent to the Drug Compliance Unit of the Division.
f) The
following shall apply to all licensed pharmacies:
1) Every
licensee shall keep a suitable book, file or electronic record keeping system
in which shall be preserved for a period of not less than 5 years the original,
or an exact, unalterable image, of every written prescription and the original
transcript or copy of every verbal prescription filled, compounded or
dispensed. The book or file of prescriptions shall at all reasonable times be
open to inspection by the duly authorized agents or employees of the Division.
2) Every
prescription filled or refilled shall contain in the prescription record the
unique identifiers of the persons authorized to practice pharmacy under the
Pharmacy Practice Act who fills or refills the prescription.
3) Records
kept pursuant to this Section may be maintained in an alternative data
retention system, such as a direct digital imaging system, provided that:
i) The
records maintained in the alternative data retention system contain all of the
information required in a manual record;
ii) The
data processing system is capable of producing a hard copy of the electronic
record on the request of the Division, its representative, or other authorized
local, State, or federal law enforcement or regulatory agency;
iii) The
digital images are recorded and stored only by means of a technology that does
not allow subsequent revision or replacement of the images; and
iv) The
prescriptions may be retained in written form or recorded in a data recording
processing system, provided that the order can be produced in printed form upon
lawful request.
4) As
used in subsection (f)(3), "digital imaging system" means a system,
including people, machines, methods of organization and procedures, that
provides input, storage, processing, communications, output and control
functions for digitized representations of original prescription records.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.370 PERSONS ENTITLED TO ISSUE PRESCRIPTIONS
Section 3100.370 Persons
Entitled to Issue Prescriptions
a) A prescription for a controlled substance may be issued only
by an individual practitioner who:
1) Holds an active professional license in Illinois as an
individual practitioner; and
2) Holds an active controlled substances license under the Act or
is exempted from licensure pursuant to Section 3100.80.
b) A prescription issued by an individual practitioner may be
communicated to a pharmacist by an employee or agent of the individual
practitioner pursuant to the directions and order of that practitioner in
conformance with Section 312 of the Act.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.380 PURPOSE OF ISSUANCE OF A PRESCRIPTION
Section 3100.380 Purpose of
Issuance of a Prescription
a) A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner acting
in the usual course of his or her professional practice. The responsibility
for the proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription. An order purporting to be a
prescription within the meaning and intent of Section 312 of the Act, but that
is not, and the person knowingly filling such a purported prescription, as well
as the person issuing it, shall be subject to the penalties provided for
violations of the provisions of law relating to controlled substances.
b) A prescription may not be issued in order for an individual
practitioner to obtain controlled substances for supplying the individual
practitioner for the purpose of general dispensing to patients.
c) A prescription may not be issued for the dispensing of
narcotic drugs listed in any Schedule to a narcotic drug dependent person for
the purpose of continuing his or her dependence upon such drugs, except in the
case of the course of conducting an authorized clinical investigation in the
development of a narcotic addict rehabilitation program.
d) A
practitioner shall not self-prescribe or self-dispense controlled substances. A
practitioner may not prescribe controlled substances to an immediate family
member unless there is a bona fide practitioner-patient relationship and appropriate
records are maintained for all treatment of the family member.
e) The
provisions of the federal Ryan Haight Online Pharmacy Consumer Protection Act
of 2008 (Ryan Haight Act) (21 USC 801 et seq.) also apply and all federal
regulations (74 Fed. Reg. 15596 (April 6, 2009)) adopted under that Act are
hereby incorporated by reference.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.390 MANNER OF ISSUANCE OF PRESCRIPTION
Section 3100.390 Manner of
Issuance of Prescription
a) All prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name and address
of the patient, the drug name, strength, dosage form, quantity prescribed,
directions for use, and the name, address and DEA registration number of the
practitioner.
b) A
practitioner may sign a paper prescription in the same manner as he or she
would sign a check or legal document (e.g., J.H. Smith or John H. Smith). When
an oral order is not permitted, paper prescriptions shall be written with ink
or printed and shall be manually signed by the practitioner. A
computer-generated prescription that is printed out or faxed by the
practitioner must be manually signed.
c) A
prescription may be prepared by the secretary or agent for the signature of a
practitioner, but the prescribing practitioner is responsible in case the
prescription does not conform in all essential respects to the Act and this
Part. A corresponding liability rests upon the pharmacist, including a pharmacist
employed by a central fill pharmacy, who fills a prescription not prepared in
the form required by this Part. Neither a pharmacist nor a pharmacy technician
may act as an agent for a practitioner.
d) Prescriptions
sent via a facsimile transmission do not constitute electronic prescriptions in
accordance with Section 311.5 of the Act.
e) Electronic prescribing
is permitted as described in Section 311.5 of the Act.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.400 REQUIREMENT OF PRESCRIPTION FOR SCHEDULE II CONTROLLED SUBSTANCES
Section 3100.400 Requirement
of Prescription for Schedule II Controlled Substances
a) A pharmacist may fill a Schedule II controlled substance
prescription upon a written or electronic prescription that conforms with the
requirements of Section 311.5 or 312 of the Act, respectively, and the
requirements of this Part.
b) An individual practitioner may administer or dispense directly
a controlled substance listed in Schedule II in the course of his or her
professional practice subject to the Act and this Part.
c) Changes
in a Prescription
1) A
pharmacist may not change the following components of a prescription for a
Schedule II controlled substance:
A) Date written, or add the
date;
B) Name of the patient;
C) Name of the prescriber,
or add a signature; and
D) Name of the drug.
2) Any
other components of a prescription for a Schedule II controlled substance may
be changed after consultation with the prescriber.
d) In an emergency situation, as defined by subsection (e), a
pharmacist, in accordance with requirements in 21 CFR 1306.11(d) (April 1,
2014) and Section 309 of the Act, may fill an oral prescription for a Schedule
II controlled substance.
e) For the purposes of authorizing an oral prescription of a
controlled substance listed in Schedule II of the Act, the term "emergency
situation" means those situations in which the prescribing practitioner
determines that:
1) Immediate administration of the controlled substance is
necessary for proper treatment of the intended ultimate user;
2) No appropriate alternative treatment is available, including
administration of a drug that is not a controlled substance under Schedule II
of the Act; and
3) It is not reasonably possible for the prescribing practitioner
to provide a written prescription to be presented to the person dispensing the
substance, prior to the dispensing.
f) Notwithstanding
any other provision in this Section, prescriptions for Schedule II controlled
substances may be sent to a pharmacy via facsimile in accordance with Section
313 of the Act.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.410 REFILLING OF PRESCRIPTION
Section 3100.410 Refilling
of Prescription
a) Each refilling of a prescription of a controlled substance
listed in Schedules III, IV or V:
1) shall be entered on the back of the prescription or in the
electronic prescription record;
2) shall indicate the date, quantity and name or initials of the
dispensing pharmacist for each prescription;
3) shall be dated by the pharmacist as of the date of dispensing;
and
4) shall state the amount dispensed.
b) If the pharmacist merely signs or initials and dates the back
of the prescription, he or she shall be deemed to have dispensed a refill for
the full face amount of the prescription.
c) A pharmacist may contact the prescriber to refill a Schedule
III, IV or V controlled substance only at the request of a patient or patient's
representative. The patient's agreement to utilize a pharmacy auto-fill
program, medication adherence plan or long term care or similar related care
contract constitutes a request from the patient.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.420 PARTIAL FILLING OF PRESCRIPTIONS
Section 3100.420 Partial
Filling of Prescriptions
a) The partial filling of a prescription for a controlled
substance listed in Schedules III, IV or V is permissible within 6 months after
the date on which the prescription was issued provided that:
1) The total quantity dispensed in all partial fillings does not
exceed the total quantity prescribed;
2) Each partial filling is recorded in the same manner as a
refilling, but shall not be considered a refill.
b) When Partial Filling of a Schedule II Controlled Substance is
Permissible
1) Except as provided in subsection (b)(2), the partial filling
of a prescription for a controlled substance listed in Schedule II is
permissible, if the pharmacist is unable to supply the full quantity called for
in a written or emergency oral prescription and he or she makes a notation of
the quantity supplied on the face of the written prescription, written record
of the emergency oral prescription, or in the electronic prescription record.
The remaining portion of the prescription may be filled within 72 hours after
the first partial filling; however, if the remaining portion is not or cannot
be filled within the 72-hour period, the pharmacist shall so notify the
prescribing individual practitioner. No further quantity may be supplied
beyond 72 hours without a new prescription.
2) A prescription for Schedule II controlled substances written
for a patient in a long term care facility (LTCF) or for a patient with a
medical diagnosis documenting a terminal illness may be filled in partial
quantities, to include individual dosage units. If there is any question
whether the patient may be classified as having a terminal illness, contact the
practitioner prior to partially filling the prescription. Both the pharmacist
and the prescribing practitioner have a corresponding responsibility to assure
that the controlled substance is for a terminally ill patient. The pharmacist
must record on the prescription whether the patient is terminally ill or an
LTCF patient. A prescription that is partially filled and does not contain the
notation "terminally ill" or "LTCF patient" shall be deemed
to have been filled in violation of the Act. For each partial filling, the
dispensing pharmacist shall record on the back of the prescription (or on
another appropriate record, uniformly maintained, and readily retrievable) the
date of the partial filling, quantity dispensed, remaining quantity authorized
to be dispensed and the identification of the dispensing pharmacist. The total
quantity of Schedule II controlled substances dispensed in all partial fillings
must not exceed the total quantity prescribed. Schedule II prescriptions, for
patients in an LTCF or for patients with a medical diagnosis documenting a
terminal illness shall be valid for a period not to exceed 60 days from the
issue date unless sooner terminated by the discontinuance of medication.
3) Information pertaining to current Schedule II prescriptions
for patients in an LTCF or for patients with a medical diagnosis documenting a
terminal illness may be maintained in a computerized system if this system has
the capability to permit:
A) Output (display or printout) of the original prescription
number, date of issue, identification of prescribing individual practitioner,
identification of patient, address of the LTCF or address of the hospital or
residence of the terminally ill patient, identification of medication
authorized (to include dosage form, strength and quantity), listing of partial
fillings that have been dispensed under each prescription and the information
required in subsection (b)(2).
B) Immediate (real time) updating of the prescription record each
time a partial filling of the Schedule II prescription is conducted.
C) Retrieval of partially filled Schedule II prescription
information is the same as required by 21 CFR 1306.22(b)(4) and (5) (April 1,
2014) for Schedule III and IV prescription refill information.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.430 PRESCRIPTIONS FROM OUT-OF-STATE PRACTITIONERS AND EXEMPT FEDERAL PRACTITIONERS
Section 3100.430
Prescriptions from Out-of-State Practitioners and Exempt Federal Practitioners
a) Notwithstanding any other provision of this Part, Illinois
pharmacists may fill prescriptions for controlled substances issued by a practitioner
actively licensed in another United States jurisdiction and who holds an active
DEA registration in conformance with the Act and this Part.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.440 AUTHORITY TO MAKE INSPECTIONS
Section 3100.440 Authority
to Make Inspections
a) In carrying out its functions under the Act, the Division,
through its inspectors, is authorized in accordance with Section 302 of the Act
to enter controlled premises and conduct administrative inspections of those
premises, with subpoena or notice, during regular business hours and without
disrupting patient care, for the purpose of:
1) Inspecting, copying and verifying the correctness of records,
reports or other documents required to be kept or made under the Act and this
Part. Upon the Division's request, the licensee's agent or employee shall
produce those records.
2) Inspecting within reasonable limits and in a reasonable manner
all pertinent equipment, finished and unfinished controlled substances and
other substances or materials, containers and labeling found at the controlled
premises relating to the Act;
3) Making a physical inventory of all controlled substances on
hand at the premises;
4) Collecting samples of controlled substances or precursors or
any other relevant evidence (in the event any samples are collected during an
inspection, the inspector shall issue a receipt for the samples to the owner,
operator or agent in charge of the premises).
b) Refusal by the licensee, owner, operator, agent or other
person in charge of the controlled premises to allow inspection and fully
comply with the inspection shall constitute a basis for suspension or
revocation of registration.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.450 INSPECTIONS
Section 3100.450 Inspections
a) An inspection shall be carried out by an inspector or designee
from the Division authorized by the Act or other Illinois statute to carry out
the inspection.
b) The inspector or designee upon entry shall:
1) State the purpose of his or her inspection to the owner,
operator, agent or other person in charge of the premises to be inspected.
2) Present appropriate credentials to the owner, operator, agent
or other person in charge.
c) Appropriate credentials for the making of an inspection shall
include but are not limited to a duly issued identification card, badge, etc.,
of the Division for the inspector or designee.
d) A designee is an employee of the Division with the training
and expertise equivalent to an inspector of the Division.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.460 FAILURE TO COMPLY WITH RULES
Section 3100.460 Failure to
Comply with Rules
a) Failure of a licensee to comply with this Part constitutes a
basis for revocation, suspension or other discipline of the licensee's license.
b) Failure of an applicant to comply with this Part as applicable
to that applicant constitutes a basis for denial of licensure.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.470 ADDRESS FOR NOTICES (REPEALED)
Section 3100.470 Address for
Notices (Repealed)
(Source: Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.480 GRANTING VARIANCES
Section 3100.480 Granting
Variances
The Director may grant variances from this Part in
individual cases when he or she finds that:
a) the provision from which
the variance is granted is not statutorily
mandated;
b) no party will be injured
by the granting of the variance; and
c) the
rule from which the variance is granted would, in the particular case, be
unreasonable or unnecessarily burdensome.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.490 CONSTRUCTION OF RULES AND REGULATIONS (REPEALED)
Section 3100.490
Construction of Rules and Regulations (Repealed)
(Source:
Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.500 ORDERING SCHEDULE II CONTROLLED SUBSTANCES
Section 3100.500 Ordering
Schedule II Controlled Substances
a) Schedule II controlled substances shall be distributed to a
licensee and received by a licensee only upon completion of an Administration
Form 222.
b) The original of the Administration Form 222 shall be
maintained by the selling or transferring licensee for a period of two years
with such other controlled substances records as shall be maintained by the
licensee. A copy of the Administration Form 222 shall be maintained by the
ordering licensee for a period of two years.
(Source: Amended at 39 Ill. Reg.
3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.510 RECORD KEEPING
Section 3100.510 Record
Keeping
Records for dispensing and
administering required by Section 312(d) of the Act shall be kept in accordance
with 21 CFR 1304 (April 1, 2014).
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.520 EMERGENCY MEDICATION KITS
Section 3100.520 Emergency
Medication Kits
Long term care facilities may
store controlled substances in an emergency medication kit if permitted by the
licensing regulations of the Illinois Department of Public Health for the
facility's particular level of care ("DPH Standards"). The following
requirements must be met when controlled substances are stored in emergency
medication kits:
a) Controlled substances for emergency medication kits must be
obtained from a DEA registered hospital, pharmacy or practitioner.
b) Emergency medication kits shall be safeguarded as provided in
DPH Standards.
c) Only the director of nursing services, registered nurse on
duty, licensed practical nurse on duty, or consultant pharmacist or
practitioner shall have access to controlled substances stored in emergency medication
kits.
d) No more than 10 different controlled substances shall be
placed in an emergency medication kit, and there shall be no more than three
single, injectible doses of each controlled substance.
e) Controlled substances in emergency medication kits may be
administered only under the emergency conditions set forth in DPH Standards and
only by registered nurses, licensed practical nurses or practitioners, in
compliance with 21 CFR 1306.11 and 1306.21 (April 1, 2014).
f) A proof-of-use sheet shall be contained in the emergency
medication kit for each separate controlled substance included. Entries shall
be made on the proof-of-use sheet by the nursing staff or practitioner when any
controlled substances from the kit are used. The consultant pharmacist shall
receive and file for two years a copy of all completed proof-of-use sheets.
g) Whenever the emergency medication kit is opened, the
consultant pharmacist shall be notified within 24 hours. During any period
that the emergency kit is opened, a shift count shall be done on all controlled
substances until the kit is closed or locked by the consultant pharmacist.
Shift counts are not mandatory when the kit is sealed. Proper forms for shift
counts shall be contained in the emergency medication kit.
h) The consultant pharmacist shall check the controlled
substances in the emergency medication kit at least monthly and so document
inside the kit.
i) Failure to comply with any provision of this Section, or of
any applicable provision of State or federal statutes or regulations pertaining
to controlled substances will result in loss of the privilege of having or
placing controlled substances in emergency medication kits.
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
| TITLE 77: PUBLIC HEALTH
CHAPTER XV: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION
PART 3100
ILLINOIS CONTROLLED SUBSTANCES ACT
SECTION 3100.530 TRANSFER BETWEEN PHARMACIES OF PRESCRIPTION INFORMATION FOR REFILL PURPOSES
Section 3100.530 Transfer
Between Pharmacies of Prescription Information for Refill Purposes
Transfer between pharmacies of prescription information
shall be done in accordance with 68 Ill. Adm. Code 1330.720 (rules of the
Pharmacy Practice Act).
(Source: Amended at 39 Ill.
Reg. 3656, effective February 27, 2015)
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