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40 terms

Controlled Substances ACT

STUDY
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Addict
any person who habitually uses a drug, chemical, or dangerous drug other than alcohol and endangers public morals, health, safety or welfare, or who has lost self control of his/her addiction
Administer
direct application of a controlled substance whether by injection, inhalation, ingestion or to the body
Agent
authorized person who acts on behalf of the manufacturer, distributor, or dispenser, doesn't include a common or contract carrier, or employee of the carrier or warehouseman
Anabolic Steroids
Any drug or hormone that is chemically and pharmacologically related to testosterone that promotes MUSCLE growth and includes: boldenone, chlorotestosterone, chostebol, dehydrochloromethyltestosterone, drostanolone, ethyesternol, fluoxymesterone, testosterone
Deliver or Delivery
actual, constructive, or attempted transfer of possession of a control whether not there is a relationship
Depressant or Stimulant substance
1. drug that has any amount of barbituric acid or salts or
2. drug that has any amount of amphetamine, methamphetamine or their salts, or their optical isomers
3. lysergic acid diethylamide
4 any amount of drug that the Dept deems habit forming
Dispense
deliver a controlled substance to a user or research subject or pursuant to the order of the prescriber, includes prescribing, administering, packing, labeling, or compounding to prepare the substance for delivery
Dispenser
practitioner that dispenses
Distribute
deliver other than by administering or dispensing a control
Distributor
person who distributes
Mail order pharmacy
a pharmacy that is outside of IL that delivers
Good Faith
prescribing or dispensing of a control by a practitioner to professionally treat a person for a pathology or condition other than the person's individual physical or psychological dependence or addition except: application of the term to an RPh dispensing a control according to the prescriber's order in which professional judgment of the RPh is lawful
Good Faith
1Ma. RPh will make the judgment:
a. lack of a consistent patient-doctor relationship
b. frequency of scripts for the same drug by one prescriber for a lot of patients
c. quantities beyond those normally
prescribed
d. unusual dosages
e. unusual geographic distance between patient, pharmacist, and prescriber
f. consistent prescribing of habit -forming drugs
Manufacture
produce, preparation, compounding, or processing of a control other than methamphetamine by extracting from substances of natural origin or thru chemical means, or a comb of extraction and chemical synthesis; includes any packaging, labeling, or repacking of the substance
Manufacturing DOES NOT include:
-does not include by the ultimate user, the preparation or compounding of a controlled substances for his own use
-a practitioner, or his authorized agent under his supervision, the prep, compounding, packing, or labeling of a control
-as an incident to his administering or dispensing of a control or
- as an incident of lawful research, teaching, or chemical analysis and not for sale
Narcotic Drug
made directly or indirectly by extraction of substances natural or or chemically or a combo of:
- opium and opiate, and any salts, derivatives
- opium poppy and poppy straw
- coca leaves and any of its salts, isomers, derivatives
Opiate
Any substance that can become habit forming or addictive similar to morphine or capable of being converted into a drug that is addictive or habit forming
Opium poppy
plant of the species Papaver somniferum L, except its seeds
Practitioner
a physician licensed to practice medicine in all its branches or other entities that are licensed, registered, or lawfully allows to distribute, dispense or conduct research, admin or use in teaching or chemical analysis, a control substance in the profession research or practice
Pre printed prescription
a written script that the designated drugs have been indicated before issuance
Duties of the Department relating to schedules
the Dept will carry out these provisions:
1. actual or relative potential for abuse
2. scientific knowledge regarding the control
3. history and current pattern of abuse
5. scope, durations, and significance of abuse
6. risk to the public health
7. potential of the substance to make psychological or physiological dependence
8. if the substance is an immediate precursor of control
9. immediate harmful effects in terms of potentially fatal dosage
Findings for Inclusion in Schedule I
Dept will issue a rule in Schedule I if:
1. the substance has a high potential for abuse and
2. NO current accepted medical use in the U.S. or lacks accepted safety medical supervision
3. Examples: acetylemethadol, benzethidine, betamethadol, clonitazene, dextromoramide, diampromide, heroin; any amount, salt, derivative or isomers
Findings required for Inclusion in Schedule II
1. substance has high potential abuse
2. HAS current accepted medical use in the U.S. or with restrictions
3. abuse will lead to severe psychological or physiological dependence
4. Examples: opium, codeine, methadone, moprhine, fentanyl
Findings required for Inclusion in Schedule III
1. Has potential for abuse less than Schedule I & II
2. HAS current accepted medical use
3. Abuse leads to low or moderate psychological or physiological dependence
4. Examples: testosterone, ketamine, anything with barbituric acid, lysergic acid
Findings required for Inclusion in Schedule VI
1. Low potential for abuse relative to Schedule III
2. Current accepted medical use in the U.S.
3. Can result in limited psychological or physiological dependence
4. Examples: Alprazolam, barbital, phenobarbital, sibutramine
Findings required for Inclusion in Schedule V
1. Low potential abuse relative to Schedule IV
2. Has current accepted medical use in the U.S.
3. Abuse leads to limited psychological or physiological dependence
4. <200mg codeine, or any or its salts, per 100ml or per 100 grams
- <100 mg dihydrocodeine; any of its salts 100ml or 100 grams
-<2.5 mg diphenoxylate
Ephedrine
marketing, advertising, dispensing,verbal advertisement, or labeling of any product with ephedrine, its salt or isomer for stimulation, mental alertness, weight loss, or appetite control is prohibited
DOES NOT apply to dietary supplement, herbs, or OTC which aren't prohibited by law and may contain naturally occurring ephedrine or pseudoephedrine
Dextromethorphan
1. Possession of a drug product with dextromethorphan in violation of this act is a CLASS 4 FELONY.
2. The sale, delivery, distribution or possession with intent to, sell or distribute a product with dextromethorphan in violation is a CLASS 2 FELONY
Registration Required for Manufacture, Distribution, & Dispensing
1. Every person who will manufacture, distribute, and dispense controls needs to get registration issued by Dept of Professional Regulations
2. Registered=possess, manufacture, distribute, dispense, buy, or administer controls or euthanasia drugs
3. Separate registration is required for EACH place of business where the applicant manufactures, distributes, or dispenses, stores, or admin euthanasia drugs
4. Person are required to get a separate registration for each place of business or professional practice
5. A separate registration is NOT required for every location a control is prescribed
6. Dept of Professional Regulations or the Dept of State Police can inspect the place
Persons who don't need to register and can lawfully have controls
1. an agent or employee of any registered entity
2. common or contract carrier
3. user with a lawful script
4. officer and employees of IL acting lawfully
5. registered RPh acting lawfully
Applicant to be registered unless consistent with public interest
1. Dept of Professional Regulation will license an applicant to manufacture, distribute, buy, store, or administer euthanasia drugs or dispense controlled substance; unless the public doesn't allow it
2. cannot make, distribute, or dispense schedule I or II other than those specified
3. authorized practitioner can dispense the controls and instructional activities
4. Fee is $50.00 per year for a manufacturer or wholesale distributor, except that the fee for registration for controls dispensed w/o a script is $15/year
Consider the following for applicant registration unless inconsistent with public interest
1. Effective maintenance of controls from diversion
2. Compliance with applicable Fed, State, and Local law
3. Any convictions of the applicant under any law of the U.S. or IL
4. Past experience of effective controls
5. Evidence of fraud
6. Suspension of registration
7. Equipment to carry out operations
8. Good moral character
9. Public Health safety
10. Evidence the applicant has not or does not prescribe controlled substances
No license will be granted to or renewed for any person who has been convicted within 5 years been convicted of a violation
Mid-Level Practitioner Registration (PA)
Dept of Financial and Professional Regulation will register PA and licensed advanced nurses to prescribe and dispense controlled substances if:
PA are authorized to prescribe any C-III-V by a physician license to practice
or
PA has been told to prescribe the controls II. No more than 5 C-II oral, scripts must be less than 30 days
Mid-Level Practitioner Registration Advanced Nurse Practitioner
Has been told to prescribe CIII-V by licensed or collaborating physician:
no more than 5 C-II oral, must collaborate with MD monthly, <30 days supply
Mid-Level Practitioner Registration
Animal euthanasia needs a license from Dept of Professional Regulation
Mid-level practitioner will be licensed to prescribe to those schedules of controls except an animal euthanasia does not have prescriptive authority, PA and APN are prohibited from prescribing controls
Records; Inventories, Quarterly Reports
Anyone who manufactures, dispenses, or buys euthanasia drugs will keep records and inventories according to rules issued by the Dept of Professional Regulation
Prescriptions required; Emergency Prescription
"authorization for emergency dispensing" if loss of life or intense pain may occur, have to have a hard copy from MD within 7 days, RPh must notify the Dept of Human Services if they don't
all scripts for C-II have to include both written and number quantity on the script
no refills!
Requirements for Dispensing Controlled Substances
1. RPh can dispense a C-II to a patient with a written script dated and signed with the patient's full name, address, and prescriber registry #, animal scripts must state species, write fill date on face of script in good faith
2. Written script will be on file for TWO YEARS
3. C-II Cannot be filled more than 90 days after the issue date
4. 1. RPh can dispense a C-II to a patient with a written script dated and signed with the patient's full name, address, and prescriber registry #, animal scripts must state species, write fill date on face of script in good faith, and time received
Requirements for Dispensing Controlled Substances
Dispenser needs to be registered, can only dispense to persons >21 y/o with 2 ID, must record name, address, product name and quantity, and date and time of purchase
no more than >120ml or >120 grams of any C-V which has codeine etc in 96 hours
copy of records fw d to DPR by 15th day
keep records no less than 2 years
dispenser cannot keep more than 4.5 L of substances
Requirements for Dispensing Controlled Substances
1. practitioner must keep a record of controls received, administered, dispensed or used other than scripts
2. Controls (besides a non script Methamphetamine) he/she will put on the label: date of first fill, practitioner and prescriber name, address, patient name and any warnings, dosage, quantity, and drug name
3. Prescriber and RPh are responsible for proper filling and dispensing and anyone outside of that will be subject to penalty