Section 2085.35 Research
Order Blanks for Dispensing Delta-9-THC Capsules
a) The hospital pharmacy may dispense delta-9-THC upon
presentation of a "Research Order for Delta-9-Tetrahydrocannabinol
Medication" signed by a physician who:
1) Has a current DEA registration and Illinois Controlled
Substances number;
2) Has registered with the pharmacy by filing a Form FDA-1573 and
has been approved by the participating pharmacy, the Department, the Illinois
Department of Law Enforcement, and NCI;
3) Affirms that the patient consent form has been signed by the
patient;
4) Limits the use of the drug to the indications outlined in the
Guidelines;
5) Will report adverse drug reactions on Form FD 1639-a to the
Investigational Drug Branch of the NCI and the Department; and
6) Has met all other requirements imposed by the NCI as set forth
in the Mechanism.
b) Procedure for Filling a Research Order for Medication:
1) delta-9-THC medication may be dispensed only pursuant to a
"Research Order for Delta-9-THC Medication" issued by the
Department. All Research Order Forms for delta-9-THC medication shall be
written in duplicate. The following items of information are on a valid
research order:
A) The name, address and zip code of the hospital pharmacy.
B) The pharmacy DEA registration number.
C) The patient's full name, address and zip code.
D) The date of issuance.
E) The period of time covered by the research order:
AGENCY NOTE: The Research Order expiration date represents
the period of time for which the THC has been dispensed to the participating
patient. The Research Order expiration and the lot expiration date need not
always be the same. The lot expiration date represents the period of time for
which NCI states the THC to be effective.
F) The name, strength, quantity and lot number of the drug.
G) The directions for use.
H) The name of the person (other than the patient) to whom the
drug may have given on behalf of the patient, if anyone.
I) Confirmation of informed patient consent.
J) The signature of the prescribing physician.
K) The DEA registration number and the Illinois Controlled
Substances registration number of the prescribing physician.
L) Confirmation that the physician is registered with the hospital
to prescribe delta-9-THC.
AGENCY NOTE: A samples research order form is attached as
Exhibit C.
2) For outpatient treatment, if any of the above items are
missing, the Research Order is to be considered invalid and is not to be
filled. For inpatient treatment, the pharmacist shall, upon receipt of a completed
physician order (the written order of a physician as required for controlled
substances by law and current hospital procedures pursuant to Section 313 of
the Illinois Controlled Substances Act (Ill. Rev. Stat. 1981, ch. 56½, par.
1313)) complete the Research Order and fill it. When filled by the pharmacy for
inpatient treatment, the physician and patient signatures are not required on
the Research Order Form. The informed consent form must be completed by both
inpatients and outpatients.
3) The hospital pharmacy, at the time of presentment of a
Research Order and prior to filling shall include on the Research Order, the
date of filling, confirmation of the prescribing physician's affiliation with
the hospital, the signature of person to whom the medication is delivered, the
method used to verify the identification of the recipient and the signature of
the dispensing pharmacist.
4) Partial filling of a quantity ordered pursuant to the Research
Order shall constitute a completed order for recordkeeping purposes.
 |
TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.40 LABELING REQUIREMENTS
Section 2085.40 Labeling
Requirements
a) Medication for Outpatient Use
The hospital pharmacy shall affix to the package or container
of delta-9-THC Medication a label showing date of filling, the hospital
pharmacy name, address and telephone number, the pharmacy DEA number, the
serial number of the research order, the name of the patient, the name of the
prescribing physician, the directions for use, the period covered by the
research order, the name, strength and quantity of medication, the pharmacist's
initials, and the following cautionary statements: The medication is non-refillable,
the patient is to return unused portions of the medication, and Federal and
State law prohibits the transfer or use of the medication by any person other
than the person for whom it is prescribed. A sample label is attached as
Exhibit D.
b) Medication for Inpatient Use
Delta-9-THC Medication prescribed and dispensed for a patient
who is institutionalized may be exempt from the provisions of subparagraph 1
above in accordance with 21 CFR 1306.14(b).
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.45 PACKAGING REQUIREMENTS
Section 2085.45 Packaging
Requirements
All delta-9-THC medication
dispensed pursuant to the authorization granted under this Part shall be in
containers having child-proof caps in conformance with the requirements of 16
CFR 1700, Annex A of this Part.
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.50 CONFIDENTIALITY OF CANCER CHEMOTHERAPY PATIENTS RECEIVING DELTA-9-THC MEDICATION
Section 2085.50
Confidentiality of Cancer Chemotherapy Patients Receiving delta-9-THC
Medication
The provisions of 77 Ill. Adm.
Code 2055.480(g), Confidentiality of Research Subjects, are applicable to
cancer chemotherapy patients receiving delta-9-THC medication as part of a
program approved by the Department under this Part.
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.55 REPORTS AND RECORDKEEPING
Section 2085.55 Reports and
Recordkeeping
a) Copies of all reports and forms required under the Mechanism
and the Guidelines to be submitted to the NCI and DEA shall be submitted to the
Department.
b) Research orders filled by the hospital pharmacy shall be kept
on pharmacy premises separate and apart from other pharmacy documents and shall
be filed by date of filling. Such Research Orders shall be available to
Department personnel for inspection and audit.
c) The original and one copy of the Research Order for
delta-9-THC Medication shall be delivered to the hospital pharmacy. The
original Research Order Form for delta-9-THC Medication shall be retained by
the hospital pharmacy and by the 15th of the month following the
month in which the Research Order Form was filled, the duplicate shall be returned
to the Department. The duplicate copy shall not contain any patient or
recipient identifying information. The pharmacy shall retain their copies of
the orders for the same period as required for controlled substances pursuant
to the Illinois Pharmacy Act (Ill. Rev. Stat. 1981, ch. 111, par. 4030).
d) Any unused medication shall be returned to the distributing
pharmacy upon completion of the Research Order expiration date. Any unused
amount of THC shall be recorded on the form which issued the THC to the
patient. It may be redispensed to the same patient pursuant to a new Research
Order. Such redistribution period shall not extend beyond the lot expiration
date.
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.60 AUDITS AND INSPECTIONS
Section 2085.60 Audits and
Inspections
Department staff shall be
permitted access during normal working hours to all records and areas for the
purpose of conducting audits and inspections to determine compliance with
applicable laws, regulations and requirements of the NCI governing the use of delta-9-THC
in the treatment of cancer chemotherapy patients.
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.65 SECURITY
Section 2085.65 Security
a) All delta-9-THC shall be stored within the pharmacy storage
area in compliance with the provisions of Title 21 of the Code of Federal
Regulations, Part 1301.75(a). The minimum security required thereunder is a
securely locked, substantially constructed cabinet.
b) Research Order forms shall be accounted for, maintained and
secured to prevent unauthorized access and use.
c) All medications governed by this Part require the same
physical security as demanded by the rules and regulations governing Schedule
II controlled substances.
d) Contaminated medication shall be returned for disposal as
authorized by the Department.
Section 2085.EXHIBIT A DASA Form 229-1
| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.EXHIBIT A DASA FORM 229-1
Section 2085.EXHIBIT A DASA
Form 229-1
(Hospital
Letter Head)
Chief of Licensing
Department of Alcoholism and
Substance Abuse
300 N. State Street–Suite 1500
Chicago, Illinois 60610
Sir:
We hereby apply for
authorization from the Department to conduct research with
Delta-9-Tetrahydrocannabinol. Enclosed is a copy of Form DEA–225 "New
Application for Registration under Controlled Substances Act of 1970", and
a copy of our application to the National Cancer Institute (NCI) to participate
in their research study. The research will be conducted under the NCI approved
Protocol I 80-12 "Group C Guidelines for the Use of
Delta-9-Tetrahydrocanncbinol NSC 134454 for Nausea and Vomiting Induced by
Antineoplastic Chemotherapy". Applications for the individual physicians
who have been approved by this hospital to issue the research order for
medication are also enclosed.
We agree to comply with all
pertinent Federal and State regulations and protocols concerning the use of
THC. We will notify the Department in writing of any new physician enrolled,
or any who no longer wish to participate in the research study.
Sincerely,
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Director of Pharmacy
Services
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Hospital Administrator
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| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.EXHIBIT B DASA FORM 229-2
Section 2085.EXHIBIT B
DASA Form 229-2
(Physician
Letter Head)
Chief of Licensing
Illinois Department of
Alcoholism and Substance Abuse
300 N. State Street–Suite 1500
Chicago, Illinois 60610
Sir:
I hereby apply for authorization
from the Department to conduct research with Delta-9-Tetrahydrocannabinol under
the National Cancer Institute (NCI) approved Protocol I 80-12 "Group C
Guidelines for the Use of Delta-9-Tetrahydrocannabinol NSC 134454 for Nausea
and Vomiting Induced by Antineoplastic Chemotherapy". Enclosed is a copy
of FDA Form 1573 "Statement of Investigator" which has been submitted
to NCI.
I agree to limit drug usage to
the indications outlined in Group C Guidelines, to ensure that each patient has
completed an informed consent form, to report adverse drug reactions
immediately to the Department, as well as NCI, and to comply with Federal and
State regulations concerning the use of THC. I will notify the Department if I
no longer choose to participate in the research study.
Sincerely,
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M.D.
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Physician's Name
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DEA #
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Illinois Controlled Substance
#
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Hospital Name and Address:
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The above named physician has
met the professional qualifications and possesses the requisite professional
experience in Cancer Chemotherapy to participate in NCI Protocol I 80-12. This
physician is approved to practice this therapy, under the NCI Protocol I 80-12,
at ____________ Hospital.
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Director of Pharmacy
Services
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Hospital Administrator
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| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.EXHIBIT C SPECIAL INSTRUCTIONS COVERING RESEARCH MEDICATION ORDER FORMS FOR DELTA-9-TETRAHYDROCANNABINOL
Section 2085.EXHIBIT C
Special Instructions Covering Research Medication Order Forms for
Delta-9-Tetrahydrocannabinol
The Department will provide
blanks of serially numbered Official Medication Order Forms to authorized
registrant hospital pharmacies. The forms shall be in the following format:
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A.
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HEADING SECTION
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Each order form heading shall
contain the following information.
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1.
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In the upper left hand corner
shall be printed "State of Illinois Department of Alcoholism and
Substance Abuse" with the agency telephone number.
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2.
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In the upper middle portion,
the name, address and zip code of the hospital pharmacy shall be imprinted
between the prepunched holes. Below this, the DEA registration number for
the hospital pharmacy should appear. The individual registrant hospital pharmacy
is responsible to accomplish that printing, which may be typewritten or
stamped.
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3.
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In the upper right hand
corner, the words "Order Serial Number" shall be imprinted. This
order serial number will serve as a control number and be placed on the hospital
pharmacy's dispensing label.
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B.
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TITLE SECTION
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Order forms shall contain the
following information in the Title Section.
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a)
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"RESEARCH ORDER FOR
DELTA-9-TETRAHYDROCANNABINOL MEDICATION."
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b)
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"Valid for ONE bottle of
NOT MORE THAN 25 capsules at the above pharmacy ONLY." This will
explain to the patient that this prescription can be filled only at the
designated pharmacy indicated at the top of the order form.
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c)
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"This order is NOT
REFILLABLE." This will explain to the patient that this medication
cannot be refilled and that the patient's physician must issue a new written
order each time a patient requires Delta-9-Tetrahydrocannabinol medication.
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C.
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PHYSICIAN SECTION
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The physician's section shall
contain the following information:
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1.
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The patient's name. This will
identify the person for which this medication is being prescribed.
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2.
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Date. This date will signify
the date on which the order was issued by the physician.
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3.
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Patient's address. This will
identify the patient's place of residence and Zip Code.
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4.
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Period covered by this order.
This information will provide the time frame in which the
Delta-9-Tetrahydrocannabinol medication is to be used by this patient. Any
use of the contents of this medication outside of the specified time periods
constitutes unauthorized use.
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5.
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Agent. If the patient is
unable to pick up the medication in person, the prescribing physician will
designate an alternate, by name, to receive the desired medication for
delivery to the patient.
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6.
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Delta-9-THC in (Strength)
mg. in (Written Quantity) caps.
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.
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The strength of Delta-9-THC,
whether 2.5 or 5.0 mg., should be designated numerically in the first space.
The quantity of Delta-9-THC capsules should be written out in long hand to
ensure that the correct quantity will be dispensed and also to guard against
alteration of the designated quantity.
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7.
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Sig. This portion of the
medication order form is provided for the physician to instruct the patient
as to frequency and quantity of the Delta-9-THC medication to be administered
during treatment.
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8.
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"PATIENT IS TO RETURN
UNUSED MEDICATION." This is to explain to the patient that unused
medication must be returned to the hospital pharmacy for disposal.
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9.
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I AFFIRM THAT INFORMED PATIENT
CONSENT HAS BEEN OBTAINED. This statement is included on the form to show
patient consent prior to the administration of any medication. This
statement implies that the prescribing physician has informed the patient of
all risks and side effects associated with use of this medication, and this
statement is attested to by cosignatures of both patient and physician.
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10.
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M.D. ILLINOIS CONTROLLED
SUBSTANCES NUMBER. Obtained from the Department of Registration and
Education to permit ordering controlled substances.
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11.
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M.D. DEA NUMBER. Obtained
from DEA to permit ordering controlled substances.
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D.
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PHARMACY SECTION
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When an order for Delta-9-Tetrahydrocannabinol
has been prepared by a hospital pharmacist for a patient, the dispensing
pharmacist must provide the following information on the lower portion of the
order form.
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1.
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Date filled. The pharmacist
must enter in the appropriate space on the order form the actual date on
which the prescription was filled.
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2.
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M.D. HOSPITAL AFFILIATION.
The pharmacist must check the list of enrolled physicians and determine that
the prescribing physician is eligible to order Delta-9-THC through the
hospital. If so, enter the word "Confirmed" in the space provided.
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3.
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RECIPIENT'S SIGNATURE. The
pharmacist must have the person who receives the medication sign for it,
whether it is the patient or another designated agent.
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4.
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VERIFICATION OF RECIPIENT. If
the person receiving the ordered medication is a person other than the
patient, the pharmacist must take steps to ascertain that the individual is
the designated agent before releasing the medication. Identifying information,
e.g., address, phone number, drivers license number, may be indicated in this
space.
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5.
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R.P.H. SIGNATURE. The
dispensing pharmacist must sign the order form.
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| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.EXHIBIT D SPECIAL INSTRUCTIONS COVERING RESEARCH MEDICATION LABELS FOR DELTA-9-TETRAHYDROCANNABINOL CONTAINERS
Section 2085.EXHIBIT D
Special Instructions Covering Research Medication Labels for
Delta-9-Tetrahydrocannabinol Containers
SPECIAL INSTRUCTIONS
COVERING RESEARCH MEDICATION
LABELS FOR
DELTA-9-TETRAHYDROCANNABINOL CONTAINERS
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HOSPITAL PHARMACY
1234 MAIN STREET
ANYWHERE, ILLINOIS
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DEA NO. XX 0000000
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PHONE NO. ( ) 000-0000
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RO NO:
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123-456
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PHYSICIAN:
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JOHN DOE
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DATE: 10-10-80
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ONE CAPSULE EVERY SIX HOURS AS NEEDED.
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DELTA-9-THC
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5MG (#25)
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VALID FROM 10-10-80 to 10-20-80
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(RPH INITIALS)
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CAUTION: FEDERAL LAW PROHIBITS
THE
TRANSFER OF THIS DRUG TO ANY
PERSON
OTHER THAN THE PATIENT FOR WHOM
IT
WAS PRESCRIBED.
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THIS PRESCRIPTION CANNOT BE
REFILLED
RETURN UNUSED PORTION TO
DISPENSING
PHARMACY FOR PROPER DISPOSAL.
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KEEP OUT OF REACH OF CHILDREN.
IN CASE
OF ACCIDENTAL OVERDOSE, CONTACT
A
PHYSICIAN IMMEDIATELY.
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| TITLE 77: PUBLIC HEALTH
CHAPTER X: DEPARTMENT OF HUMAN SERVICES
SUBCHAPTER f: CANNABIS ACTIVITIES
PART 2085
RESEARCH
SECTION 2085.EXHIBIT E RESEARCH ORDER FOR DELTA-9-TETRAHYDROCANNABINOL
Section 2085.EXHIBIT E Research
Order for Delta-9-Tetrahydrocannabinol
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STATE OF ILLINOIS
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ORDER SERIAL
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NUMBER
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(Name of Hospital)
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No.
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DANGEROUS
DRUGS
COMMISSION
(312) 822-9860
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(Address & ZIP Code)
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(Pharmacy DEA Number)
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RESEARCH ORDER FOR DELTA -9- TETRAHYDROCANNABINOL
Valid for ONE bottle of NOT MORE THAN 25 capsules at
above pharmacy ONLY. ORDER NOT REFILLABLE.
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PATIENT'S NAME:
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DATE:
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PATIENT'S ADDRESS:
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ZIP:
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PERIOD COVERED BY THIS
ORDER:
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198
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TO
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198
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AGENT (if applicable):
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ORDER:
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DELTA-9-THC AT
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MGS
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AT
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CAPSULES,
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(Strength)
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(Quantity written in
longhand)
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SIG:
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PATIENT IS TO RETURN UNUSED
MEDICATION,
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I AFFIRM THAT INFORMED
PATIENT CONSENT HAS BEEN OBTAINED.
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M.D.
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(Patient's
Signature)
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M.D. ILL CONTROLLED SUBS
NO:
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M.D. FEDERAL DEA NO:
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DATE FILLED:
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M.D. HOSPITAL
AFFILIATION:
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RECIPIENT'S
SIGNATURE:
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VERIFICATION
OF RECIPIENT:
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REG PHARMACIST'S
SIGNATURE & NUMBER:
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DDC FORM 299 (Series
October 1980) Retain original in pharmacy; forward duplicate to DDC
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