2015 Indiana Code TITLE 16. HEALTH ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS CHAPTER 24. DRUGS: USE OF CHYMOPAPAIN
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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
Indiana Code 2015
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
Indiana Code 2015
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.
Indiana Code 2015
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