2011 Indiana Code
TITLE 16. HEALTH
ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS
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 keeping system concerning the use of chymopapain and its effectiveness. The state department may require neurosurgeons and orthopedic surgeons to 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 may administer chymopapain. Chymopapain may only be administered in a 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 hospital may not interfere with the physician-patient relationship by restricting or forbidding the use of chymopapain for treatment of certain back ailments if the following conditions are met:
(1) Chymopapain is administered by a neurosurgeon or an orthopedic surgeon holding an unlimited license to practice medicine in Indiana.
(2) The patient has signed the request form described in section 7 of this chapter.
As added by P.L.2-1993, SEC.25.

IC 16-42-24-4
Disciplinary action against attending physician prohibited if use requested by patient
Revisor's Note: The version of IC 16-42-24-4 appearing in the 1993 Edition of the Indiana Code was printed incorrectly. Use the following version of IC 16-42-24-4.
Sec. 4. A neurosurgeon or an orthopedic surgeon may not be subjected to disciplinary action by the medical licensing board of Indiana for administering chymopapain to a patient under the neurosurgeons's or orthopedic surgeon's care to treat certain back ailments if the patient has signed the request form described in section 7 of this chapter.
As added by P.L.2-1993, SEC.25.

IC 16-42-24-5
Use permitted in place of other therapies if requested by patient
Sec. 5. A neurosurgeon or an orthopedic surgeon may administer chymopapain instead of other modes of therapy for treatment of certain 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 the treatment 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 patient to use to request administration of chymopapain. The form must be substantially 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 by chymopapain
_____________________________________________
_____________________________________________
My physician has explained the following to me:
(1) That the manufacture and distribution of chymopapain has been banned by the federal Food and Drug Administration.
(2) That there are alternative recognized treatments for the back ailment from which I suffer that my physician has offered to provide for me, including the following: (Here describe)
____________________________________________
____________________________________________
Notwithstanding this explanation, I request the administration of chymopapain in the medical treatment of the back ailment from which I suffer.

_______________________________________

Patient or person signing for patient

ATTEST:
______________________________________
Prescribing physician
(b) A copy of the request form shall be sent immediately after execution 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 substance under 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 may regulate the manufacture, distribution, and sale of chymopapain for use within Indiana only to ensure that the substance is not adulterated or misbranded within the meaning of IC 16-42-3.
(c) The state department may not adopt a rule that prohibits the use of chymopapain in a hospital or health care facility licensed by the state department.
(d) The Indiana board of pharmacy may not adopt a rule that prohibits the manufacture, distribution, or sale of chymopapain by a person 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 prescribe chymopapain 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 government will withdraw all federal funds from a health care facility for allowing chymopapain to be used within the facility; and
(2) providing or allowing use of chymopapain within the facility would jeopardize the receipt of:
(A) federal funds for reimbursement for Medicare or Medicaid for all persons within the facility; or
(B) construction funds provided by the federal government under the Hill-Burton Hospital Construction Program (42 U.S.C. 291 et seq.) or under Title XVI of the Public Health Services Act (42 U.S.C. 300q-300t);
the hospital or other health care facility may prohibit the use of chymopapain within the hospital or facility.
As added by P.L.2-1993, SEC.25.