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)

 

Section 3100.20  Copies of This Part (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

Section 3100.40  Time and Method of Payment (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

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)

 

Section 3100.70  Requirements of Registration (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

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)

 

Section 3100.90  Time for Application for Registration:  Expiration Date (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.100  Application Forms (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.110  Filing of Application:  Joint Filings (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.120  Acceptance for Filing:  Defective Applications (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.130  Additional Information (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.140  Amendments to and Withdrawal of Applications (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.150  Certificate of Registration:  Denial of Registration (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.160  Suspension or Revocation of Registration (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.170  Suspension of Registration Pending Final Order (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.180  Extension of Registration (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.190  Hearing Officer (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

Section 3100.210  Procedures for Hearing (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.220  Hearing – Pursuant to Paragraph 1305(b) (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.230  Default Disposition of a Contested Case (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.240  Recording of Testimony (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.250  Recording of Hearing (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.260  Rehearing (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

Section 3100.270  Final Decisions and Orders (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

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)

 

Section 3100.470  Address for Notices (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

Section 3100.490  Construction of Rules and Regulations (Repealed)

 

(Source:  Repealed at 39 Ill. Reg. 3656, effective February 27, 2015)

 

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)

 

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)

 

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)

 

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)