MPJE – Illinois (Controlled Substances)

Drug Enforcement Administration (DEA)

Depart of Human Services, Office of Alcoholism and Substance Abuse, and the Department of Financial and Professional Regulation

21 years old

Controlled Substances Act of 1970

Interpretation, Implementation, Enforcement, Development of regulations

Controlled Substances Regulation

5 schedules

All who come in contact with controlled substances must be registered (except a patient with a valid rx)

When a controlled substance is dispensed to the patient, it leaves the closed distribution network. It cannot re-enter that closed network.

(1) There has been dispensing error, and the improperly dispensed CS is brought back to the pharmacy;
(2) There has been a recall of the drug; or
(3) The pharmacy to register as an authorized collector of controlled substances by amending its existing registration to add this additional category.

(1) manufacturer; (2) distributor; (3) dispenser (C-II thru C-V); (4) narcotic treatment program; and (5) detox compounder.
(Any law enforcement agency w/o DEA registration is permitted as well)

1) maintaining collection receptacles
2) administering mail-back programs
(no particular method of destruction just rendered "non-retrievable")

when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue

(patients are not required to bring CS back for destruction; they may destroy substances themselves)

• II narcotic
• II non-narcotic
• III narcotic
• III non-narcotic
• IV
• V
(a dispenser may voluntarily select only certain schedules when completing the DEA registration application)

1) Opium, opiates, derivates of opium and opiates
2) Poppy straw and concentrate of poppy straw
3) Coca leaves, except leaves where cocaine and ecgonine have been removed
4) Cocaine
5) Ecognine
6) Any compound, mixture, or preparation which contains any quantity of any substances from 1-5

1) sole proprietor, or "owner" must sign/apply (Joe's pharmacy)
2)Any partner is the owner and can sign/apply (Joe and Flo's pharmacy)
3) Corporation - any officer or director

Person that completes the form = registrant

a registrant may authorize one or more individuals (can be assigned to anyone), whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf

(may be revoked at anytime by executing a notice of revocation)

register as a dispenser of controlled substances. One registration covers dispensing of all C-II thru C-V substances.

DEA Form 224

DEA 224a (every 3 years)

Neither federal nor Illinois law require the applicant or the person with POA to be pharmacist.
However, under state law, the ordering, securing and dispensing of controlled substances is responsibility of PIC, regardless of whether the PIC is the registrant, and regardless of whether the PIC has POA

"institutional practitioners"
-issued to entire hospital allowing CS to be stored anywhere
-nurses, pharmacists, employee practitioners have the authority to possess, prescribe, dispense, and administer CS
-separate registration for pharmacy is not required

1) Location: each site with different street address
2) Activity: For each activity (e.g. dispenser, detox compounder, distributor, manufacturer)

1) register if pharmacy participates in joint buying activities and is the location from which drugs are stored and shipped to other pharmacies
2) or annual distribution of controlled substances to other pharmacies or practitioners exceeds 5% of the total number of dosage units dispensed

1) register if pharmacy purchases controlled substances for purposes of repackaging for sale within the pharmacy without rx

1) register if pharmacy compounds a CS product for sale or distribution to a registered narcotic tx program for purposes of addiction tx

DEA Form 225, renew with 225a (every 3 years)

Illinois requires a separate state controlled substance registration, in addition to the DEA registration

1) pharmacy license
2) federal DEA registration
3) state controlled substance license or registration

Proof of federal registration and payment fee
(Registration expires on date certificate holders pharmacy license expires)

1) Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy
2) Mid-level Practitioner (NP, PA, OD, etc)
3) Reverse Distributions
4) Manufacturer/Distributer/Researcher/NTP
5) Tx of addictions on an outpatient basis

1) First letter = position
2) 2nd letter = maiden name
3) Add digits 1, 3, 5
4) Add digits 2, 4, 6 and multiply sum by 2
5) Add step 3 and 4 together. (Sum = last number of DEA number)

High potential for abuse no currently acceptable medical use
1) Heroin
2) LSD
3) Mescaline
4) Marijuana
5) Peyote
6) Controlled substance analogs (ex. GHB)

accepted medical use and high abuse potential with severe psychological or physical dependence
1) Narcotic analgesics
2) amphetamines and derivatives
3) barbituates

acceptable medical use/less abuse potential than C-I and C-II (still dangerous)
1) anabolic steroids
2) analgesics
3) GHB

Abuse may lead to only a limited physical or psychological dependence.
1) Anxiolytics/sedatives

Limited physical and psychological dependence compared to C-IV substances ("Exempt" Narcotics). Limited quantities may be purchased without a prescription
1) Cough and Cold
2) Anti-diarrheals

Fentanyl - Schedule II

Hydromorphone - Schedule II

Mepridine - Schedule II

Methylphenidate - Schedule II

Methadone - Schedule II

Morphine - Schedule II

Methamphetamine - Schedule II

Pentobarbital - Schedule II

Oxycodone/APAP - Schedule II

Oxymorphone - Schedule II

Secobarbital - Schedule II

Sufentanil - Schedule II

Oxycodone HCl - Schedule II

Tapentadol - Schedule II

Lisdexamfetramine - Schedule II

Pentazocine - Schedule II

Hydrocodone Products - Schedule II

APAP with codeine - schedule III

Anabolic steroids - schedule III

Aprobarbital -schedule III

Butalbital - schedule III

Ketamine - schedule III

Paregoric

Pentobarbital rectal suppository - schedule III

Thiopental - schedule III

Buprenorphine - schedule III

Benzphetamine - schedule III

Butobarbital - Schedule III

Butabarbital - Schedule III

Phendimetrazine - Schedule III

Dihydrocodeine - Schedule III

GHB - Schedule III

Alprazolam - Schedule IV

Butorphanol - Schedule IV

Chloral Hydrate - Schedule IV

Chlordizepoxide - Schedule IV

Diazepam - Schedule IV

Flurazepam - Schedule IV

Meprobamate - Schedule IV

Oxazepam - Schedule IV

Phenobarbital

Propoxyphene - Schedule IV

Triazolam - Schedule IV

Zaleplon - Schedule IV

Zolpidem - Schedule IV

Clonazepam - Schedule IV

Tenazepam - Schedule IV

Lorazepam - Schedule IV

Carisoprodol - Schedule IV

Dichloralphenazone - Schedule IV

Fospropofol - Schedule IV

Zopiclone - Schedule IV

Tramadol - Schedule IV

Pemoline - Schedule IV

Diphenoxylate with Atropine - Schedule V

Lacosamide - Schedule V

Pregablin - Schedule V

Ezogabine - Schedule V

Ephedrine and Pseudophedrine
(OTC available still)

Exempt Narcotics - permitted in Illinois and Federal law

-verified by pharmacist (complete log book, verify age = anyone can than ring up the sale)
-Not more than 120 mL or 120g of products containing codeine, dihydrocodeine in any 96 hours period (time of sale/signature of pharmacist)
-maintain records for 2 years
-must be 21 to purchase

-no more than 7.5g within 30 days to a single person
-no more than one pharmacy package (3g) or convenience package (360 mg) sold at non-pharmacy locations within 24 hour period
-PSE products sold by pharmacist or pharmacy technician must be behind the counter under the Pharmacy Practice Act
-Document the purchaser's name and address, date and time of transaction, product name, quantity purchased (keep for 4 years)
-must be 18 with a valid driver's license or government issued ID

1) not more than 1.8 g per 100 mL or 90 mg per dosage unit
2) not more than 1.8 g per 100 mL or 90 mg per dosage unit
3) not more than 300 mg per 100 mL or 15 mg per dosage unit
4) Not more than 500 mg per (100 mL or 100 g) or 25 mg per dosage unit
5) Not more than 50 mg per (100 mL or 100 g)

1) not more than 200 mg per (100 mL or 100 g)
2) not more than 10 mg per (100 mL or 100 g)
3) Not more than 100 mg per (100 mL or 100 g)
4) Not more than 2.5 mg and not less than 25 micrograms of atropine
5) Not more than 100 mg per (100 mL or 100 g)
6) Not more than 0.5 mg and not less than 25 micrograms of atropine

No, they always will require a rx

DEA 222 Order form - signed by DEA registrant or POA

1) Name of Drug
2) NDC
3) Strength, package size, and number of packages
4) # of lines completed (out of 10)
5) signature of purchaser
6) DEA of pharmacy
7) Date form issued

2 years

60 day grace period; if not received after 60 days item is voided

1) Brown = supplier
2) Green = supplier and forwarder to DEA
3) Blue = recipient (pharmacy)

Controlled Substance Ordering System (CSOS)
-replaces paper 222 forms
-Uses Public Key Infrastructure (PKI) = individual purchasers must enroll with DEA

1) Ordering Freedom: can order Schedule I - V with no line item limit for a single order (222 only for Schedule I - II)
2) Faster Transactions
3) Accurate Orders
4) Decreased Cost: due to order accuracy and decreased paper work

1) new form should be submitted; old form is voided
2) written statement should accompany all three copies of new form and state a) drugs were not received and b) order form is presumed lost
3) immediately report to DEA serial numbers of forms (if unable to report numbers date of receipt and names of and addresses of purchasers should be provided)

any supplier who cannot fill all or a part of the order may be endorsed to another supplier for filling
1) must state the DEA number of second supplier
2) must be signed and dated by a person authorized to obtain and execute DEA forms
3) must be reported by the second supplier in the same manner as all other distributions

-must return original form to purchaser with reason (illegible or altered)
-must be retained in files

No form required; maintan all records in readily retrievable form

1) signed and dated on date of issuance
2) full name and address of patient
3) name, address and DEA number of prescriber
3) drug name, strengths, dosage form, quantity
4) directions for use
5) must be in ink
*can be taken orally

manually signed

NO

may prepare a CS RX for practitioner signature (neither a pharmacist nor a technician may act as an agent)

1) physicians
2) dentists
3) podiatrists
4) veterinarians
5) PAs, NPs
6) Optometrist
7) Clinical Psychologists

False, under the registration of the hospital interns, residents, and foreign-trained physicians may prescribe CIIs if state law permits (a specific internal code number for each such prescriber is kept by the hospital for verification)

Advance Practice Nurses and PAs may use the institution's DEA registration to prescribe controlled substances

an order issued to an individual not in the regular course of tx or part of an authorized methadone program, which is intended to maintain that person's addiction is not a rx (the person issuing it shall be subject to penalties)

Federal and Illinois law imposes responsibility on prescribers and a corresponding responsibility on pharmacist who fills the rx

Pharmacist shall rely on standards including:
1) lack of consistency of doctor-patient relationship
2) frequency of rx for same drug by one prescriber for a large number of patients
3) abnormal quantities and dosages
4) unusual geographic distances between patient and prescriber and pharmacist
5) consistent prescribing of habit forming drugs
*Cash paying customers

1) prohibited (although not prohibited federally)
2) allowed only if a bona fide practitioner-patient relationship exists with appropriate records maintained (not prohibited federally)

False, federal and state law require written rx (can be submitted electronically) for schedule II (no verbal or fax)

-A CII is valid for 90 days after date of issuance and are not refillable
-30 day supply (no federal limit)
-partial filled allowed

situations that might result in "loss of life" or "intense suffering" allow oral CS rx to be given. The quantity dispensed must be limited to the amount needed during the emergency period

1) all info required for written rx must be taken and written at time of emergency order
2) Within 7 days after issuing an emergency rx, the prescriber shall cause a written rx to be delivered to the dispensing pharmacist
a)the rx should say "authorization for
emergency dispening" and include the
date
b) may delieverd in person or by mail
(postmarked within 7 days)
c) pharmacist must attach this rx to the
emergency oral rx taken earlier
3) If rx not timely received, the pharmacist must notify the DEA and the Illinois Department of HR, Office of Alcoholism and Substance Abuse

1) original must be present before CS is dispensed
2) Home infusion pharmacies, hospice, and LTCF - fax serves as original (if home infusion pharmacy is dispensing an IV form to be injected as opposed to infused, an original RX is still required)
3) CIII-CV fax rx permitted

IL permits electronic prescribing as long as the system complies with all federal requirements:
1) application imports, displays, and stores required contents of CS rx accurately
2) application must be able to digitally sign and archive the CS
3) application must electronically accept and store all info the DEA requires on a CS rx
4) application must allow the pharmacy to limit access for annotation, alteration or deletion of CS rx
5) application must have an internal audit trail that documents the rx process and identifies any potential security problems daily
6) application provider must hire a third party to audit application or have the application reviewed by a certified body (cannot proccess rx until this step is complete)

a pharmacist may not change the following on a CII rx:
1) date written, or add the date
2) Name of patient
3) Name of prescriber, add signature
4) name of drug
(any other components may be changed after consultation with the prescriber)

True, state and federal regulations have always required that all rx for CS be "dated as of," however prescribers may issue multiple 30-day supply rx for the same CII to be filled sequentially over the course of 90 days

CIIs are not refillable; however a pharmacist may dispense a partial quantity if:
1) unable to supply - the remainder of the rx should be filled within 72 hours. If not the rest of the rx is void and the pharmacist must contact the provider. If remaining quantity is filled within 72 hours, patient can still pick up the medication after 72 hours has passed

2) LTCF patients and terminally ill patients: partial quantities may be dispensed at any time (pharmacist must write "LTCF pt" or "terminally ill." The date, quantity dispensed, quantity remaining, identity of pharmacist is recorded on back of RX. Rx is valid for 60 days

1) limited to one time transfer between pharmacies that do not share a common electronic file
2) any number of times of refills authorized by prescriber if pharmacies linked electronically (must be done by a pharmacist)

Transferor must write "VOID" on face of transferred rx and receiving pharmacist must write "Transfer" on face of rx. (Both original and transferred RX must be maintained for 2 years - 5 years in Illinois)

1) name and address of pharmacy
2) patient name
3) rx number
4) date of dispensing
5) name of prescriber
6) directions for use
7) cautionary statement ("CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED.")
*IL also requires drug name, dosage, quantity

Two approaches:
1) Three separate files - CIIs, CIII-V, legend drugs

2) Two files - CIIs and one for all others (CIII-Vs must be stamped in red ink in the lower right corner with the letter "C"

*Records should be maintained for 5 years (Federal is 2 years)

Written notification must be submited by registered or certified mail to the DEA and include:
1) the nature of the records to be kept centrally
2) the exact location where they will be kept
3) name, address, DEA registration # and type of registrant whose records will be maintained centrally
4) Whether central records will be maintained in a manual or computerized

14 days to hear nothing back from DEA

1) executed federal order forms
2) RX
3) inventories

-annual inventory - IL (biennially - fed)
-state whether it was at opening or close of business
-signed by person taking inventory
-maintained for 5 years in IL (2 years Fed)
-CIIs actual count required
-CIII-V: quantities of 1,000 tablets or less may be estimated, while 1,000 units of larger must be physically counted

1) name of drug
2) dosage form and unit strength
3) number of units or volume in container
4) number of containers

1) Drugs "in inventory"
2) "Wasted" drugs awaiting disposal

(drugs scheduled to pick up or "will call" are no longer in inventory)

1) Return to supplier - CII must use 222; CIII-V maintain a written record of return
2) Send to Reverse Distributor - takes controlled substances from pharmacy for disposal (same records as above required)
3) Disposal or destruction by pharmacy - not favored by DEA, but allowed. Registrant requests DEA authorization and completes DEA Form 41

DEA form 41

1) Written request to DEA for destruction of CS, proposing a date and method, and listing two people who will witness
2) witnesses should be a licensed physician, pharmacist, MLP, nurse, law enforcement
3) send to nearest DEA Diversion Field Office two weeks prior

1) Prior DEA authorization is not necessary when an authorized member of state law enforcement is a witness
2) Copies of a DEA Form 41 must be forwarded to the local DEA Diversion Office after destruction
3) list of companies authorized to destroy to destroy CS is available through DHS

1) notify DEA within one business day directly
2) complete a DEA form 106 - contact nearest DEA Diversion Field Office to receive
3) possibly contact local police department

1) name and adddress of firm
2) DEA registration number
3) Date of theft
4) Name and telephone number of local police
5) type of theft
6) symbols or cost code used by pharmacy in marking containers
7) List of medication missing

-PIC must file a copy of DEA 106 loss or theft report to Department of Professional Regulation (DPR)
-only need to report theft or significant loss of drugs that are scheduled under federal law (ex: PSE is CV under state law, but not federal. If stolen it does not need to be reported with a DEA 106 form)

it is illegal under federal law to deliver, distribute, or dispense CS by means of the internet unless the online pharmacy holds a modification of DEA registration
(Does not apply to retail and mail order pharmacy websites)

1) LTCF
2) Department of Public Health Standards
3) DEA registered hospital, pharmacy, or practitioner
4) Director of Nursing, RN, licensed practical nurse, consultant pharmacist, practitioner
5) No more than 10 CS per kit, and no more than 3 single, injectable doses of each CS
6) RN, LPN, practitioner
7) "proof of use" sheet; file for 2 years
8) contact pharmacist within 24 hours, shift count shall be done each shift until the kit is closed or locked by pharmacist
9) pharmacist checks CS in kit at least monthly

dispensing for a period in excess of 21 days of a narcotic drug in the tx of an individual for dependence upon heroin or other morphine like drugs

the dispensing for a period of less than 21 days of a narcotic drug in decreasing doses to alleviate physiological effects

waived the requirement for a separate DEA registration as a opioid treatment program for practitioners who dispense or prescribe CIII-V for detoxification or maintenance tx. Those that have gone through the waiver will have a DEA registration number that starts with the letter "X"

-can be prescribed for analgesia
-may not be prescribed for a patient's narcotic addiction (must receive at NTP)
-practitioner may administer narcotic substances to alleviate addicted individuals for no more than 3 days (1 day at a time) to set up the patient with an NPT
-hospitals with no NTPs may administer narcotics for detoxification or maintenance purposes

CII-V

1) patient name, address, DOB, gender
2) NDC of drug
3) date of dispensing
4) quantity and day supply dispensed
5) DEA of pharmacy and prescriber
6) payment type used to purchase
7) patient location code

1) inpatient drug orders
2) hospital emergency room or discharge medications with quantities less than 3 day supply
3) CS at NTP
4) CS via infusion at home, hospital, LTC facility, or hospice

person intentionally seeks CS while being supplied any CS by another prescriber or pharmacy without disclosing this fact (illegal!)

fraud to obtain a CS from a pharmacy while being supplied with any CS by another pharmacy without disclosing this fact

legal to mail as long as
1) CS are not dangerous
2) inner container of a parcel must be marked and sealed in a plain outer container or securely wrapped in plain paper
3) if Rx medicines, inner container must be labeled to show name and address of pharmacy or practitioner dispensing
4) Outside wrapper must be free of marking indicating the nature of the contents