Part 3100: ILLINOIS CONTROLLED SUBSTANCES ACT

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…

Section 3100.100 Application Forms (Repealed) (Source: Repealed at 39 Ill.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Section 3100.110 Filing of Application: Joint Filings (Repealed) (Source: Repealed at 39 Ill.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Section 3100.120 Acceptance for Filing: Defective Applications (Repealed) (Source: Repealed at 39 Ill.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Section 3100.130 Additional Information (Repealed) (Source: Repealed at 39 Ill.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Section 3100.140 Amendments to and Withdrawal of Applications (Repealed) (Source: Repealed at 39 Ill.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Section 3100.150 Certificate of Registration: Denial of Registration (Repealed) (Source: Repealed at 39 Ill.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Section 3100.160 Suspension or Revocation of Registration (Repealed) (Source: Repealed at 39 Ill.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Section 3100.170 Suspension of Registration Pending Final Order (Repealed) (Source: Repealed at 39 Ill.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Section 3100.180 Extension of Registration (Repealed) (Source: Repealed at 39 Ill.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Section 3100.190 Hearing Officer (Repealed) (Source: Repealed at 39 Ill.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Section 3100.20 Copies of This Part (Repealed) (Source: Repealed at 39 Ill.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Section 3100.210 Procedures for Hearing (Repealed) (Source: Repealed at 39 Ill.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Section 3100.220 Hearing – Pursuant to Paragraph 1305(b) (Repealed) (Source: Repealed at 39 Ill.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Section 3100.230 Default Disposition of a Contested Case (Repealed) (Source: Repealed at 39 Ill.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Section 3100.240 Recording of Testimony (Repealed) (Source: Repealed at 39 Ill.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. …

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 o…

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 th…

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…

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 facto…

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 1…

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 lo…

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…

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),…

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 substan…

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…

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, directio…

Section 3100.40 Time and Method of Payment (Repealed) (Source: Repealed 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, respective…

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 o…

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…

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 …

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…

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 inspecti…

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 consti…

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) …

Section 3100.490 Construction of Rules and Regulations (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 I…

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…

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").…

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. …

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…