Illinois state laws and regulations that affect your medical practice
I. DISPENSING MEDICATION
1. What are the specific restrictions on the dispensing of medication from a medical office?
According to the Medical Practice Act, anyone licensed to practice medicine is authorized to purchase legend drugs and may dispense legend drugs in the course of practicing medicine. Those licensed to practice medicine in Illinois must maintain a file of prescriptions and preserve these files for at least five (5) years. However, a practitioner is not required to maintain a file of prescriptions when he/she dispenses professional samples that do not exceed a 72 hour supply.
225 ILCS 60/33
2. May a physician charge for medication distributed in a medical office?
Illinois law appears to allow a physician to charge a patient for medication distributed in a medical office, unless the physician is distributing professional samples.
The Medical Practice Act is silent on whether a physician may charge for medication distributed in a medical office, and it therefore appears that charging for medication is not prohibited. A physician must offer a written prescription to the patient, who may choose to have the prescription filled by either the physician or any licensed pharmacy.
225 ILCS 60/33
3. Other than a physician, who can dispense medication in a medical office setting?
A physician licensed under the Medical Practice act must personally dispense medication in an office setting unless such delegated dispensing is done under the direct supervision of the physician and the dispensing person is authorized to dispense drugs under a physician’s supervision.
225 ILCS 60/33
4. What information must physicians provide on a prescription?
Illinois requires that the following information be included on all prescriptions:
A. The date on which the drug/medicine is dispensed;
B. The name of the patient;
C. At least the last name of the person dispensing the drug/medicine;
D. Directions for use of the drug/medicine;
E. The name of the drug/medicine, the dosage, and quantity.
(The above requirements do not apply to drugs/medicines in a package that displays the label of the manufacturer, which contains information required by the Federal Food, Drug, and Cosmetic Act.”)
225 ILCS 60/33
5. Are there any restrictions regarding the dispensing of medication received as "free samples"?
The Act states that the dispensing of professional samples cannot exceed a 72 hour supply.
225 ILCS 60/33
II. PRESCRIBING OF AMPHETAMINES
1. When can a physician prescribe narcotic drugs and amphetamines?
A practitioner may dispense a Schedule II (S-II) controlled substance (a narcotic drug, which includes amphetamines) to any person upon a written prescription of any prescriber. The prescription must be dated and signed by the prescriber and contain the name and address of the patient for whom the prescription is written. The practitioner must also include his/her signature of the face of the written prescription. Additionally, either the practitioner who filled the prescription or the pharmacy in which the prescription was filled must keep the written prescription on file for at least two (2) years.
Prescriptions for S-II controlled substances must not be filled more than 7 days after the substance was prescribed. Physicians must also keep a record of all controlled substances he/she receives, as well as write a prescription for every Schedule II controlled substance he/she does not directly administer. Also, a prescriber must not pre-print any prescription for a controlled substance.
720 ILCS 570/312(a)-(i)
2. What are examples of Schedule II drugs which fall under this regulation?
(a) The following substances fall under the category of Schedule II drugs:
(b) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis:
(1) Opium and opiates, and any salt, compound, derivative or preparation of opium or opiate, excluding apomorphine, dextrorphan, levopropoxyphene, nalbuphine, nalmefene, naloxone, and naltrexone, and their respective salts, but including the following:
(i) Raw Opium;
(ii) Opium extracts;
(iii) Opium fluid extracts;
(iv) Powdered opium;
(v) Granulated opium;
(vi) Tincture of opium;
(ix) Etorphine Hydrochloride;
(xvii) Thebaine-derived butorphanol.
(xviii) Dextromethorphan, except drug products that may be dispensed pursuant to a prescription order of a practitioner and are sold in compliance with the safety and labeling standards as set forth by the United States Food and Drug Administration, or drug products containing dextromethorphan that are sold in solid, tablet, liquid, capsule, powder, thin film, or gel form and which are formulated, packaged, and sold in dosages and concentrations for use as an over-the-counter drug product. For the purposes of this Section, "over-the-counter drug product" means a drug that is available to consumers without a prescription and sold in compliance with the safety and labeling standards as set forth by the United States Food and Drug Administration.
(2) Any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subparagraph (1), but not including the isoquinoline alkaloids of opium;
(3) Opium poppy and poppy straw;
(4) Coca leaves and any salt, compound, isomer, salt of an isomer, derivative, or preparation of coca leaves including cocaine or ecgonine, and any salt, compound,isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine (for the purpose of this paragraph, the term "isomer" includes optical, positional and geometric isomers);
(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrine alkaloids of the opium poppy).
(c) Unless specifically excepted or unless listed in another schedule any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, whenever the existence of these isomers, esters, ethers and salts is possible within the specific chemical designation, dextrorphan excepted:
(5) Bulk Dextropropoxyphene (non-dosage forms);
(12) Levorphanol (Levorphan);
(15) Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl-1-butane;
(16) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid;
(17) Pethidine (meperidine);
(18) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine;
(19) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate;
(20) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid;
(25) Levo-alphacetylmethadol (some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM).
(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:
(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers;
(2) Methamphetamine, its salts, isomers, and salts of its isomers;
(3) Phenmetrazine and its salts;
(e) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(f) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:
(1) Immediate precursor to amphetamine and methamphetamine:
Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone.
(2) Immediate precursors to phencyclidine:
(ii) 1-piperidinocyclohexanecarbonitrile (PCC).
720 ILCS 570/206
3. What are the potential penalties for violating this rule?
Violation of the IL Controlled Substances Act or any provision of the Methamphetamine Precursor Control Act may warrant suspension or revocation of a registrationto dispense a controlled substance.
720 ILCS 570/304
III. CONTROLLED DANGEROUS SUBSTANCES – PRESCRIPTION REQUIREMENTS
1. What is the purpose of a prescription?
A prescription for a controlled substance must be issued for a legitimate medical purpose by a physician acting in the usual course of his/her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances falls upon the prescribing physician, and the responsibility for the proper filling of a prescription for controlled substances falls upon the pharmacist who fills the prescription.
720 ILCS 570/312(h)
2. In what form must prescriptions for controlled substances be written?
All prescriptions for controlled substances must be written, signed, and dated on the day the controlled substance is prescribed. Additionally, the physician must write the date of filling and include his/her signature on the face of the prescription.
Alternatively, for Schedule II, IV, or V substances, the prescriber may fax a prescription to a pharmacist, provided that it is written, signed, and transmitted by the prescriber or his/her agent. The prescriber may orally request a prescription, however, the pharmacist must promptly write down the user’s full name and address, the prescriber’s full name, address, and registry number if the prescriber is required to be registered. The pharmacist must also sign and date the written prescription when a prescriber orally requests it.
720 ILCS 570/312(a)-(b)
3. How long is the prescription valid?
All prescriptions for Schedule II controlled substances must be presented to a pharmacist for filling within 7 days after the date the prescription was issued. A written prescription for Schedule III, IV, or V controlled substances cannot be filled/re-illed more than six (6) months after issuance or refilled more than 5 times (unless renewed, in writing, by the prescriber).
720 ILCS 570/312(a)-(b)
4. What other requirements of prescriptions for controlled dangerous substances exist?
The requirements depend upon the schedule under which the controlled substance is categorized. The following will address the requirements based on schedule classifications.
A. Schedule II (S-III), IV (S-IV), and V (S-V) substances:
A practitioner may dispense a S-III, IV, or V controlled substance upon written prescription of any prescriber. The prescription must be dated and signed by the individual prescribing the S-III WHAT ABOUT VI AND V? controlled substance (on the day the drug is issued) and must display the name and address of the patient for whom the drug is dispensed. The practitioner’s written prescription must remain on file (either by the practitioner or the pharmacy that filled it) for two (2) years.
Alternatively, instead of a written prescription, a pharmacist may dispense a S-III, S-IV, or S-V substance upon receiving a fax of a written, signed prescription transmitted by the prescriber or prescriber’s agent. Additionally, the pharmacist can accept a lawful oral prescription from a prescriber, provided that the pharmacist promptly write a memorandum that includes the date the oral prescription was received, the full name and address of the ultimate user, the full name, address, and registry number of the prescriber (if he/she is required to be registered). The pharmacist must also include his/her own signature on the face of the written memorandum.
The faxed copy of the prescription or oral prescription (with the written memorandum) must be retained for a period of at least two (2) years, and both cannot be filled/refilled more than six (6) months after the date issued or be refilled more than five (5) times, unless renewed (in writing) by the prescriber.
720 ILCS 570/312(a)-(b)
B. Schedule V (S-V) substances (specifically)
Schedule V controlled substances shall not be distributed or dispensed other than for a medical purpose, and then:
only personally by a person registered to dispense a S-V controlled substance and then only to his/her patients, or
only personally by a pharmacist, and then only to a person over 21 who provides two (2) positive documents of identification to the pharmacist.
The dispenser shall record the name and address of the purchaser, the name and quantity of the product, the date and time of the sale, and the dispenser’s signature.
An individual cannot purchase or be dispensed greater than 120 milliliters/grams of any S-V substance containing codeine, dihydrocodeine, or any salts thereof, or ethylmorphine, or any salts thereof, in any 96 hour period. Additionally, a purchaser must sign a form attesting that he/she has not purchased any S-V substances within the last 96 hours.
A copy of the records of sale must be sent to the Department of Financial and Professional Regulation by the 15th day of the next month.
All records of purchases/sales must be maintained for at least two (2) years.
Any individual who obtains/attempts to obtain more than 120 milliliters/grams of S-V substances in (3) within a 96 hour period will be in unlawful possession of a controlled substance.
A person qualified to dispense controlled substances and registered cannot keep in stock S-V substances listed in Section 212(b)(1), (2), or (3) in excess of 4.5 liters for each substance. A pharmacy may not keep in stock S-V substances in excess of 4.5 liters for each substance, plus the additional quantity of controlled substances necessary to fill the largest number of prescription orders filled by that pharmacy for such controlled substances in any one week in the previous year.
No individual shall distribute or dispense butyl nitrite for inhalation or other introduction into the human body for euphoric or physical effect.
720 ILCS 570/312(c)(1)-(9)
Copyright © Kern Augustine Conroy and Schoppmann, P.C. Used with permission.