CHAPTER 24. DRUGS: USE OF CHYMOPAPAIN
IC 16-42-24
Chapter 24. Drugs: Use of Chymopapain
IC 16-42-24-1
Record of use
Sec. 1. The state department shall establish a record keepingsystem concerning the use of chymopapain and its effectiveness. Thestate department may require neurosurgeons and orthopedic surgeonsto supply information concerning the use of chymopapain.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-2
Administration restricted
Sec. 2. Only a neurosurgeon or an orthopedic surgeon mayadminister chymopapain. Chymopapain may only be administered ina hospital licensed under IC 16-21-2.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-3
Hospital's restricting or forbidding use prohibited; conditions
Sec. 3. Except as provided in section 10 of this chapter, a hospitalmay not interfere with the physician-patient relationship byrestricting or forbidding the use of chymopapain for treatment ofcertain back ailments if the following conditions are met:
(1) Chymopapain is administered by a neurosurgeon or anorthopedic surgeon holding an unlimited license to practicemedicine in Indiana.
(2) The patient has signed the request form described in section7 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-4
Disciplinary action against attending physician prohibited if userequested by patient
Revisor's Note: The version of IC 16-42-24-4 appearing in the1993 Edition of the Indiana Code was printed incorrectly. Use thefollowing version of IC 16-42-24-4.
Sec. 4. A neurosurgeon or an orthopedic surgeon may not besubjected to disciplinary action by the medical licensing board ofIndiana for administering chymopapain to a patient under theneurosurgeons's or orthopedic surgeon's care to treat certain backailments if the patient has signed the request form described insection 7 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-5
Use permitted in place of other therapies if requested by patient
Sec. 5. A neurosurgeon or an orthopedic surgeon may administerchymopapain instead of other modes of therapy for treatment ofcertain back ailments of a patient who has signed the request form
described in section 7 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-6
Construction of chapter
Sec. 6. This chapter is not an endorsement of chymopapain for thetreatment of back ailments.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-7
Use request form
Sec. 7. (a) The state department shall prepare a form for a patientto use to request administration of chymopapain. The form must besubstantially in the following form:
REQUEST FOR ADMINISTRATION OF
CHYMOPAPAIN FOR MEDICAL
TREATMENT
Patient's name _______________________________
Address _____________________________________
Age ___________ Sex ____________
Name and address of administering physician
_____________________________________________
Physical condition diagnosed for medical treatment bychymopapain
_____________________________________________
_____________________________________________
My physician has explained the following to me:
(1) That the manufacture and distribution of chymopapain hasbeen banned by the federal Food and Drug Administration.
(2) That there are alternative recognized treatments for the backailment from which I suffer that my physician has offered toprovide for me, including the following: (Here describe)
____________________________________________
____________________________________________
Notwithstanding this explanation, I request the administration ofchymopapain in the medical treatment of the back ailment fromwhich I suffer.
_______________________________________
Patient or person signing for patient
ATTEST:
______________________________________
Prescribing physician
(b) A copy of the request form shall be sent immediately afterexecution to the state department.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-8
Regulation of manufacture, distribution, sale, or use
Sec. 8. (a) Chymopapain is not a drug or a controlled substanceunder Indiana statutes governing the use, manufacture, or distribution
of drugs and controlled substances within Indiana.
(b) The state department and the Indiana board of pharmacy mayregulate the manufacture, distribution, and sale of chymopapain foruse within Indiana only to ensure that the substance is not adulteratedor misbranded within the meaning of IC 16-42-3.
(c) The state department may not adopt a rule that prohibits theuse of chymopapain in a hospital or health care facility licensed bythe state department.
(d) The Indiana board of pharmacy may not adopt a rule thatprohibits the manufacture, distribution, or sale of chymopapain by aperson or in a place licensed by the Indiana board of pharmacy.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-9
Manufacture, sale, distribution, or prescription not required
Sec. 9. (a) This chapter does not require a:
(1) physician;
(2) pharmacist;
(3) pharmacy;
(4) manufacturer; or
(5) distributor;
to manufacture, sell, or distribute chymopapain.
(b) This chapter does not require a physician to prescribechymopapain for a patient.
As added by P.L.2-1993, SEC.25.
IC 16-42-24-10
Use prohibition by health care facility facing loss of federal funding
Sec. 10. If:
(1) the federal government indicates that the federal governmentwill withdraw all federal funds from a health care facility forallowing chymopapain to be used within the facility; and
(2) providing or allowing use of chymopapain within thefacility would jeopardize the receipt of:
(A) federal funds for reimbursement for Medicare orMedicaid for all persons within the facility; or
(B) construction funds provided by the federal governmentunder the Hill-Burton Hospital Construction Program (42U.S.C. 291 et seq.) or under Title XVI of the Public HealthServices Act (42 U.S.C. 300q-300t);
the hospital or other health care facility may prohibit the use ofchymopapain within the hospital or facility.
As added by P.L.2-1993, SEC.25.